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Senate Approves Additional $150M in FDA Funding

SmartBrief -- The U.S. Senate has cleared legislation providing the FDA with an additional $150 million for the fiscal year ending Sept. 30, 2009. The supplemental-appropriations bill, which awaits President George W. Bush's approval, would allocate $28 million for the Center for Drug Evaluation and Research and related field work involving the Office of Regulatory Affairs. The funding is less than...

Shire Limited to Buy German Biotech Jerini AG for $518 Million

BERLIN, July 3, 2008 (PRIME NEWSWIRE) -- Jerini AG and Shire Limited today reached a strategic agreement according to which Shire shall be obliged to make a voluntary public takeover offer to all shareholders of Jerini AG. After a thorough evaluation of different strategic options, the Management Board of Jerini AG has concluded that Shire is the best partner with which it can further pursue and ensure...

Ohio State University Chemists Create Synthetic Molecules that Emulate Enzyme Behavior

ScienceDaily When chemists want to produce a lot of a substance -- such as a newly designed drug -- they often turn to catalysts, molecules that speed chemical reactions.<br><br>Ohio State University chemists have created a synthetic catalyst that can fold its molecular structure into a specific shape for a specific job, similar to natural catalysts.

New Technique Produces Genetically Identical Stem Cells in Whitehead Institute Study

The Hindu -- Adult cells of mice created from genetically reprogrammed cellsso-called induced pluripotent stem (IPS) stem cellscan be triggered via drug to enter an embryonic-stem-cell-like state, without the need for further genetic alteration, according to Eurekalert, the news service of the American Association for the Advancement of Science.

FDA Cites Problems with Unapproved Use of Bone-Growth Products

CNN -- The U.S. Food and Drug Administration has alerted doctors to reports of "life- threatening complications" associated with using bone growth-promoting products in the neck, where the FDA hasn't approved usage.

Vasogen Implements Additional Restructuring

<p> MISSISSAUGA, ON, July 3 /PRNewswire-FirstCall/ - Vasogen Inc. today announced that it has implemented additional restructuring plans to further reduce its cash burn rate. As previously announced, the Company has been exploring strategic alternatives that may include potential acquisitions and mergers. In conjunction with this process, the Company has also completed an extensive review of its...

Malaysian Biotechnology Corporation Malaysia Can Become Biotech Hub

NST Online -- Malaysia has the attributes and credibility to evolve as a regional biotechnology hub for production and supply of a wide range of halal products and services.

Texas A&M University Study Finds Watermelon Has Effects Similar to Viagra

WMTW -- People often eat watermelon to cool down, but it could help get you heated up, in one way. Researchers at Texas A&M University said that a substance in the rind of the fruit may relax blood vessels in a manner similar to Viagra, the popular erectile-dysfunction drug.

Gene Directs Stem Cells to Build the Heart in Washington University School of Medicine Study

ScienceDaily Researchers have shown that they can put mouse embryonic stem cells to work building the heart, potentially moving medical science a significant step closer to a new generation of heart disease treatments that use human stem cells.

Duke University Discover New Hope Against the Cold Sore Virus

HealthDay News -- Millions of Americans are afflicted by breakouts of unsightly cold sores, caused by the herpes simplex 1 virus, but new research is finally offering them the possibility of a cure.

Skyepharma PLC Phase 3 FlutiformTM Study Meets Primary Endpoints

LONDON, UK, 3 July, 2008 - SkyePharma PLC (LSE:SKP.L - News) today announcesthat its third Phase III efficacy study evaluating FlutiformTM for thetreatment of mild to moderate asthma in adolescent and adult patientshas met its primary endpoints. This is the third of several clinicalefficacy studies being carried out in preparation for regulatoryfiling and completes the original core clinical...

Amgen's Tumor-Starving Pill Helps Thyroid Cancer: M. D. Anderson Cancer Center Study

Reuters -- Amgen's once-a-day pill to starve tumors can help many patients with hard-to-treat thyroid cancer, either by shrinking tumors or slowing their growth, researchers reported on Wednesday.

Senetek PLC Announces Termination of Invicorp(R) License Agreement With Ardana Bioscience Ltd.

NAPA, California, July 3 /PRNewswire/ -- Senetek PLC (OTC Bulletin Board: SNKTY - News), a Life Sciences company engaged in the development of technologies that target the science of healthy aging, today announced termination of the Invicorp License Agreement with Ardana Bioscience Limited ("Ardana"). The Agreement was a license to manufacture, market, sell and distribute Invicorp in Europe and was...

FDA Lifts Clinical Hold on Adolor Corporation Bowel Drug

EXTON, Pa. - Adolor Corp. said Thursday the Food and Drug Administration has lifted its clinical hold on the company's Entereg drug in chronically constipated patients taking opioid pain drugs.

Protein that Can Predict Prostate Cancer Metastasis Identified in Mount Sinai School of Medicine Study

GEN News -- A specific form of the protein KLF6 (KLF6-SV1) is an indicator of poor survival in men with prostate cancer, according to researchers at Mount Sinai School of Medicine.

Baylor College of Medicine Led Research Finds Asthma Risk Increases in Children Treated for HIV

ScienceDaily Children whose immune systems rebound after treatment with potent anti-viral drugs for HIV infection face an increased risk of developing asthma, said a federally funded consortium of researchers led by those from Baylor College of Medicine in a new report.

Novexel Discontinues Development of NXL 101

Paris, France, 30 June 2008 -- Novexel, a speciality pharmaceutical company focused on the discovery and development of novel antibacterials designed to overcome the significant global problem of bacterial resistance, announces that it has decided to discontinue the development of NXL101. NXL101 is an i.v. / oral antibiotic targeting Gram positive bacteria such as MRSA in hospitals. This decision was...

National Institute on Aging Study Finds Resveratrol to Improve Health, but Not Longevity in Aging Mice on Standard Diet

NIH -- Scientists have found that the compound resveratrol slows age-related deterioration and functional decline of mice on a standard diet, but does not increase longevity when started at middle age. This study, conducted and supported in part by the National Institute on Aging (NIA), part of the National Institutes of Health, is a follow-up to 2006 findings that resveratrol improves health and longevity...

OncoGenex Technologies Inc. Increases Economic Interest in Lead Cancer Drug OGX-011

VANCOUVER, July 3 /PRNewswire/ - OncoGenex Technologies Inc. and Isis Pharmaceuticals, Inc. (NASDAQ: ISIS - News) announced today that the companies have amended their agreement and OncoGenex has elected to independently develop its lead cancer drug OGX-011. Under the amended agreement, OncoGenex is solely responsible for all future development activities, costs and partnering decisions related to...

Pfizer Inc. Spun-Off Japan Lab, RaQualia Targets IPO by 2011

TOKYO, July 3 (Reuters) - RaQualia, a pharma venture that was recently spun off by drug maker Pfizer Inc (PFE.N: Quote, Profile, Research, Stock Buzz), aims to go public by the first quarter of 2011, its president said on Thursday.

Northstar Neuroscience, Inc. Gets Unsolicited Bid

SEATTLE--(BUSINESS WIRE)--Northstar Neuroscience, Inc., (NASDAQ: NSTR - News), a medical device company developing therapies for the treatment of neurological diseases and disorders, announced today that the Company and its Board of Directors received an unsolicited proposal from Tang Capital Partners LP to enter into negotiations to acquire Northstar for $2.25 per share. The Companys Board of Directors...

ARYx Therapeutics, Inc. Announces Procter & Gamble Exercises Option to End Collaboration on ATI-7505

FREMONT, Calif.--(BUSINESS WIRE)--ARYx Therapeutics, Inc., (NASDAQ:ARYX), a biopharmaceutical company, today announced that Procter & Gamble Pharmaceuticals, Inc. (P&G) has utilized a one-time thirty day cancellation option linked to the completion of a Thorough QT (TQT) study to end the collaboration agreement between the companies covering the late-stage development and commercialization of ATI...

Bioheart, Inc. Board Appoints Chief Executive Officer

<p> SUNRISE, Fla., July 3 /PRNewswire-FirstCall/ -- Bioheart, Inc., a biotechnology company that is focused on the development of autologous (patient-derived) cell therapies and devices for the treatment of chronic and acute heart damage, today announced that its Board of Directors appointed Howard J. Leonhardt, Bioheart's co-founder, Chairman of the Board and Chief Technology Officer, to serve...

Nabriva Therapeutics Announces Appointment of New CEO

VIENNA, Austria, July 3 /PRNewswire/ -- Nabriva Therapeutics, a specialist in antibiotics development, announces that Dr. George Golumbeski has been appointed as Chief Executive Officer of the Company.</p><p>Dr. Golumbeski brings to the team nearly twenty years of industry experience serving most recently as Vice President of Business Development, Licensing & Strategy for the oncology business...

FDA Panel Urges More Testing for Diabetes Drugs

SILVER SPRING, Md., July 2 (Reuters) - U.S. regulators should require drugmakers to study the potential heart risks of all new diabetes medicines, an advisory panel said on Wednesday.

Bayer HealthCare and Maxygen, Inc. Announce $120 Million Hematology Agreement

LEVERKUSEN, Germany & REDWOOD CITY, Calif.--(BUSINESS WIRE)--Bayer HealthCare is expanding its commitment to hemophilia with the acquisition of Maxygens (NASDAQ:MAXY - News) hemophilia program assets, including a next-generation recombinant Factor VIIa protein known as MAXY-VII. The lead therapeutic candidate is expected to enter Phase 1 clinical testing in the third quarter of 2008. The total transaction...

Children's Hospital of Philadelphia Pediatric Researchers Find Possible 'Master Switch' Gene in Juvenile Arthritis

ScienceDaily Researchers have found that a gene region known to play a role in some varieties of adult rheumatoid arthritis is also present in all types of childhood arthritis. The researchers say the responsible gene may be a "master switch" that helps turn on the debilitating disease.

Cancer Cells Revert to Normal at Specific Signal Threshold, Stanford University School of Medicine Researchers Find

HealthDay News -- Scientists have discovered that they can use a kind of dimmer switch to stop a "cancer signal" from contributing to the development of tumors.

Vanderbilt University School of Medicine Study Suggests Migraines Linked to Genetic Mutations

New Kerala -- Researchers from Vanderbilt University Medical Centre have revealed that migraines might be linked to genetic mutations.

Altea Therapeutics and Hospira, Inc. Enter into Development and Commercialization Agreement for Transdermal Product; Could Receive Milestone Payments up to $109M and Royalties

ATLANTA--(BUSINESS WIRE)--July 2, 2008 - Altea Therapeutics announced today that it has entered into a partnership with Hospira, Inc., a global specialty pharmaceutical and medication delivery company, for the development and commercialization of an undisclosed product utilizing the Company's proprietary PassPort(TM) Transdermal Delivery System.</p><p>Under the terms of the agreement, Altea Therapeutics...

University of Missouri Study Finds New Targeted Treatment Promising in Breast Cancer

Reuters Health - An novel investigational chemotherapy regimen targeting both a mutated protein called p53 and tumor blood vessels "has complementary and potent antitumor activity and could define a new strategy for suppression of advanced breast cancers," Dr. Yayun Liang reported at the Department of Defense's annual Era of Hope breast cancer meeting that just wrapped in Baltimore, Maryland.

UK Biotech Ardana Bioscience Ltd. Folds as Fails to Find Buyer

LONDON, June 30 (Reuters) - Scotland's Ardana has gone into voluntary administration after failing to refinance the business or find a buyer, underlining the tough environment facing many small British biotech companies.

Small Protein May Have Big Role in Making More Bone and Less Fat, Medical College of Georgia Institute of Molecular Medicine and Genetics Study Finds

GEN News -- A small protein may have a big role in helping you make more bone and less fat, researchers say. "The pathways are parallel, and the idea is if you can somehow disrupt the fat production pathway, you will get more bone," says Dr. Xingming Shi, bone biologist at the Medical College of Georgia Institute of Molecular Medicine and Genetics.

Cells in Blood May Help Cancers Spread, University of North Carolina Researchers Say

Reuters -- Normal cells in the blood that play a role in healing wounds may also be creating the right conditions for cancer cells to spread, U.S. researchers said on Tuesday.

SuperGen, Inc. Drug Dacogen Fails Trial; Likely Delay to European Nod

<p> DUBLIN, Calif., July 1 /PRNewswire-FirstCall/ -- SuperGen Inc. , a pharmaceutical company dedicated to the discovery, rapid development and commercialization of therapies for solid tumors and hematological malignancies, today commented on the preliminary efficacy data from a trial, initiated in 2002, comparing Dacogen(R) (decitabine) for Injection to best supportive care (BSC) in elderly patients...

Titan Pharmaceuticals Announces Spheramine(R) Initial Phase IIb Results; Study Does Not Meet Primary or Key Secondary Endpoints

SOUTH SAN FRANCISCO--(BUSINESS WIRE)--Titan Pharmaceuticals, Inc. (AMEX:TTP - News) today announced initial analyses show that Spheramine did not meet the Phase IIb clinical studys primary or key secondary endpoints, with no significant differences detected between the Spheramine and sham surgery arms of the study after 12 months of follow-up. The Phase IIb trial was designed to explore the safety...

UT Southwestern Medical Center Study Warns Resuscitation Technique after Brain Injury may do More Harm than Good

ScienceDaily The current standard practice of giving infants and children 100 percent oxygen to prevent brain damage caused by oxygen deprivation may actually inflict additional harm, researchers at UT Southwestern Medical Center have found.

Alimera Sciences Files for $75 Million IPO

WASHINGTON, July 1 (Reuters) - Biopharmaceutical company Alimera Sciences Inc on Tuesday filed to raise up to $75 million in an initial public offering of common stock.

Lack of Protein in Neural Stem Cell Linked to Rett Syndrome, Burnham Institute for Medical Research Study Finds

GEN News -- A group of researchers have shown that neural stem cell development may be linked to autism. The study demonstrated that mice lacking the myocyte enhancer factor 2C (MEF2C) protein in neural stem cells had smaller brains, fewer nerve cells, and showed behaviors similar to those seen in humans with a form of autism known as Rett syndrome.

Life-Extending Protein Can Also Have Damaging Effects on Brain Cells, University of Southern California Study

ScienceDaily Proteins widely believed to protect against aging can actually cause oxidative damage in mammalian brain cells, according to a new report in the July Cell Metabolism, a publication of Cell Press. The findings suggest that the proteins can have both proaging and protective functions, depending on the circumstances, the researchers said.

'Multi-Target' Immune Therapy Improves Outcomes of Severe Lupus Nephritis in Study

EurekAlert -- A new treatment using a combination of drugs targeting different parts of the immune system improves the recovery rate for patients with severe lupus involving the kidneys, according to a report in the October Journal of the American Society of Nephrology (JASN).

MiddleBrook Pharmaceuticals, Inc. CEO Resigns; Announces $100 Million Investment

<p> GERMANTOWN, Md., July 1 /PRNewswire-FirstCall/ -- MiddleBrook Pharmaceuticals, Inc. , a pharmaceutical company focused on developing and commercializing novel anti-infective products, today announced that its Board of Directors has completed its previously announced review of strategic alternatives and has entered into an agreement with Equity Group Investments, L.L.C. (EGI) for a $100 million...

Addrenex Pharmaceuticals Licenses New Compound to Sciele Pharma, Inc. for the Treatment of Hypertension and Other Potential Indications

<p> DURHAM, N.C., July 1 /PRNewswire/ -- Two years after Addrenex Pharmaceuticals set it sights on building a new class of drugs to regulate "adrenergic excess," the small Durham company has signed its second major deal with Sciele Pharma, this time to co-develop a new compound for hypertension and other potential indications.</p><p> Adrenalin is well known as the hormone that triggers the ...

Roche to Switch to Primary Care Focus

The new chief executive of Roche has embraced a broadening of the Swiss pharmaceutical group's focus from hospital-based medicines to primary care treatments, provided they offer significantly greater benefits than existing drugs.

Pearl Therapeutics Closes $18 Million Financing Round Led By Committed Investors

<p> REDWOOD CITY, Calif., July 2 /PRNewswire/ -- Pearl Therapeutics, Inc., a biopharmaceutical company developing products for major respiratory diseases, today announced that it has completed the closing of an $18 million round of financing. This financing was executed as an extension to its first venture financing, which closed in May 2007. Participating in the internal round were Pearl's existing...

McKesson Corporation Opens Shared Service Center in Wales, UK, Creating 300 Jobs

Operation to Serve UKs National Health Service, Worlds Largest Integrated System of Its Kind</p><p>SAN FRANCISCO--(BUSINESS WIRE)--McKesson Corp., the worlds leading healthcare services provider, is opening a shared service center in Bangor, Wales, UK to support integrated payroll and human resources for the UK National Health Service (NHS), the worlds largest healthcare operation.</p><p...

Eisai Corporation of North America Provides Preliminary Efficacy Update On EORTC Phase III Trial of Dacogen(R) Versus Supportive Care in Patients With Myelodysplastic Syndromes

<p> WOODCLIFF LAKE, N.J., July 1, 2008 /PRNewswire/ -- Eisai Corporation of North America today announced the preliminary efficacy data from a trial initiated in 2002 comparing Dacogen(R) (decitabine) to Best Supportive Care (BSC) in elderly patients with myelodysplastic syndromes (MDS). The data did not demonstrate a statistically significant advantage of Dacogen treatment on median overall survival...

Abbott Laboratories Invests Additional $20M in Subsidiary Ibis Biosciences

CARLSBAD, Calif., July 1 /PRNewswire-FirstCall/ -- Isis Pharmaceuticals, Inc. (Nasdaq: ISIS) announced today that Abbott has invested an additional $20 million in Ibis Biosciences, Inc., an Isis subsidiary. The investment will allow Ibis to further develop the Ibis T5000(TM) Biosensor System, which offers a unique solution for rapid identification and characterization of infectious agents. By making...

QIAGEN Inc. Acquires Corbett Life Science for $66 Million

VENLO, The Netherlands, July 1, 2008 (PRIME NEWSWIRE) -- QIAGEN N.V. (NasdaqGS:QGEN - News) (Frankfurt:QIA.F - News) today announced that it has acquired Corbett Life Science Pty. Ltd. (Corbett), a privately-held developer, manufacturer, and distributor of life sciences instrumentation headquartered in Sydney, Australia. The transaction is valued at approximately US$66 million in cash (subject to certain...

Human-Pig Hybrid Embryos Given Go-Ahead for Study

Guardian -- British scientists plan to create the world's first human stem cells from embryos that are part human and part animal, after the government's fertility watchdog approved the research.

Caffeine Could Stave Off Multiple Sclerosis, Oklahoma Medical Research Foundation (OMRF) Researchers Say

HealthDay News -- Giving mice the equivalent of 6 to 8 cups of coffee a day prevented mice from getting the animal model equivalent of MS, said Dr. Linda Thompson, of the Oklahoma Medical Research Foundation, and a member of the team reporting the finding in this week's issue of the Proceedings of the National Academy of Sciences.

CoLucid Pharmaceuticals, Inc. Announces $25 Million Series B Financing for Advancement of First-in-Class Migraine Compound

<p> INDIANAPOLIS, July 1 /PRNewswire/ -- CoLucid Pharmaceuticals, Inc., an innovative biotechnology company focusing on therapies for central nervous system disorders, announced it closed a $25 million Series B financing. New investor Care Capital led the round, which included previous investors Pappas Ventures, Domain Associates, Pearl Street Venture Funds and Triathlon Medical Ventures. The financing...

Johns Hopkins University Study Finds Long-Term Benefit in Illegal 'Magic Mushroom' Drug

USA Today -- In 2002, at a Johns Hopkins University laboratory, a business consultant named Dede Osborn took a psychedelic drug as part of a research project. She felt like she was taking off. She saw colors. Then it felt like her heart was ripping open. But she called the experience joyful as well as painful, and says that it has helped her to this day.

Promising Finding in Severe Lung Disease in University of Illinois Study

ScienceDaily Researchers at the University of Illinois at Chicago have identified a novel function for an enzyme that plays a role in the tissue injury in acute respiratory distress syndrome, also known as ARDS.

FDA Approves Eisai Corporation of North America's ACIPHEX(R) (rabeprazole sodium) 20 mg for Short-Term Treatment of GERD in Adolescents

<p> WOODCLIFF LAKE, N.J., June 30 /PRNewswire/ -- Eisai Corporation of North America, a wholly-owned subsidiary of Tokyo-based Eisai Co., Ltd., announced today that the Food and Drug Administration (FDA) has approved ACIPHEX (rabeprazole sodium) 20 mg for the short-term (up to eight weeks) treatment of gastroesophageal reflux disease (GERD) in adolescents ages 12 and above.</p><p> Included in...

Bentley Pharmaceuticals Completes Spin-off of Drug Delivery Business

EXETER, N.H.--(BUSINESS WIRE)--Bentley Pharmaceuticals, Inc. (NYSE: BNT) completed the previously announced taxable spin-off of its drug delivery business, CPEX Pharmaceuticals, Inc. (NASDAQ: CPEX) yesterday at 11:59 p.m. Each Bentley stockholder received, on a pro rata basis, a dividend on Bentley common stock of one CPEX share for every 10 shares of Bentley common stock they owned as of the close...

Peregrine Pharmaceuticals, Inc. Awarded Contract Worth up to $44.4 Million to Develop Bavituximab for Viral Hemorrhagic Fevers

<p> TUSTIN, Calif., July 1 /PRNewswire-FirstCall/ -- Peregrine Pharmaceuticals, Inc. , a clinical stage biopharmaceutical company developing monoclonal antibodies for the treatment of cancer and hepatitis C virus (HCV) infection, today announced it has entered into a five-year contract worth up to $44.4 million to test and develop bavituximab and an equivalent fully human antibody as potential broad...

Transplant Drug May Ease Disorder Linked to Autism, University of California, Los Angeles (UCLA) Scientists Find

New Scientist -- A drug that prevents immune rejection in human transplant patients has improved the memory of mice with a hereditary learning disorder. The finding suggests the disorder is a result of reversible abnormalities in brain chemistry rather than irreversible differences in architecture, as was previously assumed.

New Safety Standards Set for Baby Formula and Nuts at Meeting

Reuters -- Diplomats in Geneva have agreed new limits for bacteria in baby formula and natural toxins in nuts, setting safety standards to apply for internationally shipped food, the World Health Organisation said on Tuesday.

Silencing of Molecular 'Conversation' May Help Curb Severe Allergies, Garvan Institute of Medical Research Study Finds

ScienceDaily Scientists in Sydney have identified a process, a synergistic encounter between two molecules, that may account for the extreme allergic reactions some people experience. By silencing at least one of these molecules, it may be possible to treat allergies.

Halozyme Therapeutics, Inc. Announces Chemophase Meets Primary Endpoint in Phase I/IIa Clinical Trial

<p> SAN DIEGO, June 30 /PRNewswire-FirstCall/ -- Halozyme Therapeutics, Inc. , a biopharmaceutical company developing and commercializing products targeting the extracellular matrix, today announced a status update for its continuing Phase I/IIa Chemophase(R) clinical trial in the treatment of superficial bladder cancer. Based on the results, the Chemophase combination treatment of mitomycin plus...

Nanotubes Could Help Study Retrovirus Transmission Between Human Cells in Sandia National Laboratories Study

ScienceDaily Recent findings by medical researchers indicate that naturally occurring nanotubes may serve as tunnels that protect retroviruses and bacteria in transit from diseased to healthy cells -- a fact that may explain why vaccines fare poorly against some invaders.

Introgen Therapeutics, Inc. Seeks FDA Approval for 'Groundbreaking' Cancer Drug

AUSTIN, Texas & DUBLIN, Ireland--(BUSINESS WIRE)--Introgen Therapeutics, Inc. (NASDAQ:INGN) submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) requesting marketing approval for ADVEXIN p53 therapy to treat recurrent, refractory head and neck cancer. Simultaneously, Gendux Molecular Limited, an Introgen subsidiary, submitted a Marketing Authorization Application...

Heavy Babies Prone to Arthritis as Adults, Study Suggests

Reuters Health -- People who were heavier than average when they were born appear to be twice as likely to develop rheumatoid arthritis as their normal birth-weight counterparts, researchers report.

MTM Laboratories AG Appoints as CEO

Heidelberg, Germany; July 1, 2008- mtm laboratories, a privately held biotech company globally developing, manufacturing and commercializing in vitro diagnostics for cervical cancer screening, today announced that it has appointed Bob Silverman as its new CEO. Mr Silverman has been the mtms Chief Commercial Officer and the President of the mtm US subsidiary since mid 2005. </p><p>Dr Gerald...

Palatin Technologies Announces Amendment Expanding AstraZeneca PLC Obesity Collaboration

CRANBURY, N.J., July 1 /PRNewswire-FirstCall/ -- Palatin Technologies, Inc. (Amex: PTN - News) today announced that AstraZeneca and Palatin have amended their exclusive global licensing and research collaboration agreement to discover, develop and commercialize compounds that target melanocortin receptors. The original agreement was effective in January 2007.</p><p>Under the amendment, Palatin...

Experts at Examine Challenges of Split Liver Transplantation

EurekAlert -- Can split liver transplantation reliably yield grafts for two adults? Experts consider this question alongside new findings about the procedure in the July issue of Liver Transplantation, a journal by John Wiley & Sons. The articles are also available online at Wiley Interscience (www.interscience.wiley.com).

ADVENTRX Pharmaceuticals Inc. Announces Preliminary Response Rate Data From Discontinued Phase 3 Trial of CoFactor(R)

<p> SAN DIEGO, July 1 /PRNewswire-FirstCall/ -- ADVENTRX Pharmaceuticals, Inc. today announced preliminary response rate results from its discontinued Phase 3 clinical trial of ANX-510, or CoFactor, the Company's folate-based biomodulator of 5-FU (5 fluorouracil), for the treatment of first-line metastatic colorectal cancer. The primary endpoint of the study was progression-free survival, which...

GlaxoSmithKline Sells 4 Drugs to Aspen Pharmacare Ltd. for 170M Pounds (USD $339M)

LONDON (Reuters) - GlaxoSmithKline Plc (GSK.L: Quote, Profile, Research, Stock Buzz) has sold four of its older drugs to a unit of South Africa's Aspen Pharmacare Holdings (APNJ.J: Quote, Profile, Research, Stock Buzz) for 170 million pounds ($339 million), the world's second biggest drugmaker said on Monday. The medicines involved are Eltroxin, a thyroid hormone for hyperthyroidism; Lanoxin, a cardiac...

Bridge Fertility Centre's "Designer Baby" Free of Cancer Gene

Press Association -- A couple are expecting Britain's first baby screened not to have hereditary breast cancer in a move hailed as "an exciting technological development".

Myriad Genetics, Inc. , Lundbeck Alzheimer's Drug Fails Key Study

SALT LAKE CITY, UT--(MARKET WIRE)--Jun 30, 2008 -- Myriad Genetics, Inc. (NasdaqGS:MYGN - News) today announced results of the Act-Earli-AD trial, an 18-month Phase 3 study of Flurizan (tarenflurbil) in patients with mild Alzheimer's disease. The study did not achieve statistical significance on either of its primary endpoints -- cognition and activities of daily living.</p><p>"We are disappointed...

Indevus Pharmaceuticals, Inc. Receives Approvable Letter from FDA for NEBIDO(R); Company Announces Revised Operating Plan to Respond to NEBIDO Delay

<p> LEXINGTON, Mass., June 30 /PRNewswire-FirstCall/ -- Indevus Pharmaceuticals, Inc. today announced that it has received an approvable letter from the U.S. Food and Drug Administration (FDA) for NEBIDO(R) related to a New Drug Application (NDA) submitted to the FDA in August 2007. The letter, received on June 27, 2008, indicated that the application may be approved if the Company is able to...

Cancer Cure which Worked on Mice in Wake Forest University Study will be Tested on Humans

Times of India -- Scientists are all set to embark on human trials to test whether a new cancer treatment found effective in mice will be as good for humans.

GlaxoSmithKline Responds to FDA on CERVARIX(R) and Plans to Submit Final Study Data for Approval; Drug Faces Further U.S. Delay

LONDON and PHILADELPHIA, June 30 /PRNewswire-FirstCall/ -- GlaxoSmithKline (NYSE: GSK - News) today provided the following update regarding its application to the U.S. Food and Drug Administration (FDA) for approval of CERVARIX, its vaccine to prevent cervical cancer.</p><p>GSK has submitted its response to questions raised by the FDA in their Complete Response Letter, received in December, ...

First Pharmaceutical Drug to Improve Survival Amongst Patients with Advanced Hepatocarcinoma, Study

ScienceDaily International research involving the University Hospital of the University of Navarra, together with other hospitals in Spain, has shown that Sorafenib, an orally administered pharmaceutical medicine, results in patients with primary hepatocarcinomas (liver tumours) to live 40% more on average compared to those not taking the drug. The study, led by the Barcelona Hospital Clinic, will...

FDA Ponders Requiring Heart Studies for Diabetes Drugs

WSJ -- The FDA is summoning a panel of experts to consider whether drug makers should be forced to study the cardiovascular effects of diabetes drugs. Its a complicated question that raises some thorny (and interesting) issues.

Fake Virus Tested at Could Make Safe New Vaccines

Reuters -- A "wimpy" artificial virus protected mice against polio, and the approach might be used to make a range of safer new vaccines against viruses, U.S. researchers reported on Friday.

Bayhill Therapeutics, Inc. Withdraws IPO Plans

WASHINGTON, June 27 (Reuters) - Bayhill Therapeutics Inc filed on Friday to withdraw its plans for an initial public offering, citing unfavorable market conditions.

Gemin X Pharmaceuticals, Inc. Closes $38 Million Series C Financing to Advance Lead Cancer Drug, Obatoclax, Into Registration Trials

MALVERN, Pa. & MONTREAL--(BUSINESS WIRE)--Gemin X Pharmaceuticals, Inc., a privately held pharmaceutical company focused on developing novel treatments for cancer, today announced the closing of a $38 million tranched Series C financing. The financing was led by the Caxton Advantage Life Sciences Fund and Caxton Global. All previous Gemin X investors also participated in the financing, including: Sanderling...

Drug Helps Heroin Addicts Stay Clean in Yale University School Of Medicine Study

HealthDay News -- Buprenorphine helps heroin addicts stay clean, and widespread use of the drug could prove to be an effective public health measure, U.S. researchers say.

FDA Aesthetics Group Release: FDA Approves EVOLENCE(R), a New Generation Collagen-Based Facial Filler

HERZLIYA, Israel & MORRIS PLAINS, N.J.--(BUSINESS WIRE)--The U.S. Food and Drug Administration (FDA) today announced the approval of EVOLENCE for the correction of moderate to deep facial wrinkles and folds, such as nasolabial folds. EVOLENCE is a new advanced collagen-based structural dermal filler, and a first of its kind product. The introduction of EVOLENCE marks the first dermal filler entry...

Accidental Fungus Leads to Promising Cancer Drug, Data Presented in Nature Biotechnology Journal

Reuters -- A drug developed using nanotechnology and a fungus that contaminated a lab experiment may be broadly effective against a range of cancers, U.S. researchers reported on Sunday.

A Single Mechanism for Hypertension, Insulin Resistance and Immune Suppression Found in University of California, San Diego (UCSD) Study

EurekAlert -- Many of the 75 million Americans with essential hypertension also develop diabetes and other complications in addition to their high blood pressure, and researchers have discovered a common molecular mechanism in a strain of rat that explains why such metabolic disorders arise together in mammals.

Complexity of Crohn's Disease Revealed in University of Oxford Study as 'Gene' Count Tops 30

ScienceDaily New research has trebled the number of genetic regions known to be implicated in Crohn's disease, a form of inflammatory bowel disease, to over thirty. The research, published in the journal Nature Genetics, has identified a number of potential new targets for drug development as well as providing surprising new links between the condition and other common diseases including asthma...

FDA Denies Labopharm's Appeal, Requests Analysis

LAVAL, QC, June 30 /PRNewswire-FirstCall/ - Labopharm Inc. (TSX: DDS - News; NASDAQ: DDSS - News) today announced that the Company has received a response from the U.S. Food and Drug Administration (FDA) regarding its most recent appeal of the decision in the Agency's Approvable Letter for its once-daily tramadol formulation through the Formal Dispute Resolution process.</p><p>Procedurally, Dr...

Genmab A/S Reaches Milestone in Ofatumumab Collaboration Summary

<p> COPENHAGEN, June 30 /PRNewswire-FirstCall/ -- Genmab A/S (OMX: GEN) announced today it has reached a development milestone for ofatumumab (HuMax-CD20(R)) under the terms of its collaboration with GlaxoSmithKline (GSK). A milestone payment of approximately DKK 29 million (approximately USD 6 million) was triggered by treatment of the first patient participating in the Phase II study of ofatumumab...

ZymoGenetics, Inc. Secures $100 Million Funding Commitment

SEATTLE--(BUSINESS WIRE)--ZymoGenetics, Inc. (NASDAQ:ZGEN - News), today announced that it has received a $100 million funding commitment from Deerfield Management, a leading healthcare investment organization and a significant ZymoGenetics' shareholder. The funds can be drawn at any time over the next 18 months at ZymoGenetics discretion. Funds drawn, together with accrued interest, will be repayable...

Antibiotics Effective for Vaginal Injury After Childbirth, Stanford University School of Medicine Study

HealthDay News -- Antibiotics can make a big difference in the healing of vaginal tissues damaged during childbirth, a new study finds.

Quintiles, Inc. Says It Will Not Bid for ClinPhone

LONDON, June 30 (Reuters) - Drug research firm Quintiles Transnational said on Monday it had decided not to proceed with an offer for Britain's Clinphone (CNP1.L: Quote, Profile, Research, Stock Buzz), leaving the way clear for Parexel International (PRXL.O: Quote, Profile, Research, Stock Buzz) to buy the business.

Biotech Training at Gets $2M Boost

Crain's Cleveland Business -- Kent State University has received a $2 million grant from the Ohio Innovation Partnership to head up an initiative to train people for biomedical and biotechnology jobs.

Ohio Third Frontier Commission Proposes Nearly $20 Million for Research Work

Business First of Columbus -- A state technology development commission has proposed sending nearly $20 million to seven Ohio research institutions and universities.

University of Pennsylvania Breast Cancer Vaccines Look Promising

HealthDay News -- Women with metastatic breast cancer who developed an immune response to an investigational vaccine lived twice as long as those who didn't have an immune response, new research shows.

Researchers at Dana-Farber Cancer Institute Identify Promising Cancer Drug Target in Prostate Tumors

EurekAlert -- Scientists at Dana-Farber Cancer Institute report they have blocked the development of prostate tumors in cancer-prone mice by knocking out a molecular unit they describe as a "powerhouse" that drives runaway cell growth.

Tongjitang Chinese Medicines Company Announces the Withdrawal of the Proposal to Acquire All Outstanding Shares of the Company

SHENZHEN, China--(BUSINESS WIRE)--Tongjitang Chinese Medicines Company (the Company ; NYSE: TCM), a leading specialty pharmaceutical company focusing on the development, manufacturing, marketing and selling of modernized traditional Chinese medicine in China, today announced that Mr. Xiaochun Wang, Chairman of the Board of Directors and Chief Executive Officer of the Company, and Mr. Yongcun Chen...

Welichem Biotech Inc. Announces Appointment of President & CEO

BURNABY, BC, June 27 /CNW/ - Welichem Biotech Inc. (the "Company") (TSX-V: WBI - News) today announces the appointment of Dr. Genhui Chen as President & CEO of the Company, effective immediately. A long time director and one of the founders of the Company, he will guide Welichem through the next crucial stage of development as it realizes the potential value of its drug candidates in clinical trials...

Roche's Avastin Prolongs Colorectal Cancer Patients Survival

ZURICH, June 30 (Reuters) - A new Phase III study of Roche Holding AG's (ROG.VX: Quote, Profile, Research, Stock Buzz) cancer drug Avastin showed significantly improved survival in patients with metastatic colorectal cancer irrespective of K-Ras gene mutations, the Basel-based drug maker said on Monday.

PDI, Inc. Announces $33 Million Contract Extension and Expansion with Top-Five Pharmaceutical Company

SADDLE RIVER, N.J.--(BUSINESS WIRE)--PDI, Inc. (NASDAQ: PDII - News), a provider of commercialization services to the biopharmaceutical industry, today announced the extension and expansion of the scope of its contract sales engagement with a top-five pharmaceutical company. The original engagement ran from May 2007 through May 2008 and had an annual value of approximately $23 million. The new contract...

Depomed, Inc. Secures $15 Million in Non-Dilutive Funding for Hot Flash Program

MENLO PARK, Calif.--(BUSINESS WIRE)--Depomed, Inc. (NASDAQ:DEPO - News) announced today that it has entered into an agreement with Oxford Finance Corporation and GE Healthcare Financial Services for a $15 million senior secured loan that will be funded in three tranches through September 30, 2008.</p><p>Carl A. Pelzel, president and chief executive officer of Depomed, noted, We set out last fall...

Aradigm Corporation Reports Successful Top-line Phase 2 Data with Inhaled Liposomal Ciprofloxacin for Cystic Fibrosis

HAYWARD, Calif.--(BUSINESS WIRE)--Aradigm Corporation (OTCBB:ARDM - News) (the Company) today announced positive results from an open-label, two week efficacy and safety study of its once daily inhaled liposomal ciprofloxacin in patients with cystic fibrosis (CF). The study conducted at leading CF centers in Australia and New Zealand enrolled a total of 22 patients.</p><p>The primary efficacy...

Caraco Pharmaceutical Laboratories, Ltd. Announces FDA Approval to Market Generic Version of Elavil(R)

<p> DETROIT, June 30 /PRNewswire-FirstCall/ -- Caraco Pharmaceutical Laboratories, Ltd., announced today that the US Food and Drug Administration (FDA) has granted final approval for the Company's Abbreviated New Drug Applications (ANDAs) for Amitriptyline Hydrochloride USP Tablets, 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, and 150 mg.</p><p> Amitriptyline Hydrochloride is an antidepressant. Its...

Bristol-Myers Squibb Company Could Be an Acquisition Target:

Reuters -- Drugmaker Bristol-Myers Squibb Co could be an acquisition target as the industry gets closer to losing exclusivity on several leading drugs, said a Sanford C. Bernstein analyst, who upgraded the stock to "outperform" from "market-perform."

Schering-Plough Corporation and Merck & Co., Inc. Announce Withdrawal of Loratadine/Montelukast NDA and Termination of Respiratory Joint Venture

KENILWORTH and WHITEHOUSE STATION, N.J., June 27 /PRNewswire-FirstCall/ -- Schering-Plough Corp. (NYSE: SGP - News) and Merck & Co., Inc. (NYSE: MRK - News) announce the withdrawal of the New Drug Application (NDA) for the loratadine/montelukast combination tablet.</p><p>The companies also terminated the Schering-Plough/Merck Pharmaceuticals respiratory joint venture, which was formed in May ...

Millipore Corporation Unveils Expanded Drug Discovery Development Facility; Expansion Includes New Labs, Offices, Employees

BILLERICA, Mass.--(BUSINESS WIRE)--Millipore Corporation, a Life Science leader providing technologies, tools and services for bioscience research and biopharmaceutical manufacturing, today unveiled a major expansion of its St. Charles, Missouri facility headquarters for its Drug Discovery Business Unit.</p><p>The $3.4 million expansion will enable Millipore to keep pace with the growth of its...

Umbilical Cord Blood Cell Transplants May Help ALS Patients, University of South Florida Study Shows

ScienceDaily A study at the University of South Florida has shown that transplants of mononuclear human umbilical cord blood (MNChUCB) cells may help patients suffering from Amyotrophic Lateral Sclerosis (ALS), also known as Lou Gehrig's disease. A disease in which the motor neurons in the spinal cord and brain degenerate, ALS leaves its victims with progressive muscle weakness, paralysis and, finally...

'One egg' IVF Strategy Launched by

BBC -- IVF clinics in the UK will be expected to reduce the number of multiple births from a national average of one in four to 10% over the next three years.

One in 10 Had "Silent Strokes": Boston University School of Medicine Study

Reuters -- Routine brain scans in a group of middle-aged people showed that 10 percent of them had suffered a stroke without knowing it, raising their risk for further strokes and memory loss, U.S. researchers said on Thursday.

Allon Therapeutics, Inc. Enters into Agreement for a $20 Million Bought Deal of Common Shares

VANCOUVER, Canada, June 23, 2008 Allon Therapeutics Inc. (TSX: NPC), today announced that it has entered into a bought deal agreement with a syndicate of underwriters led by GMP Securities L.P. and including Canaccord Capital Corporation and Cormark Securities Inc. Under the agreement, the syndicate has agreed to purchase 19,050,000 common shares (Common Shares) at a price of $1.05 per Common Share...

Multiple Regions of Chromosome 8 Found to be Associated With Different Cancers in University of Cambridge Study

ScienceDaily A recently discovered, but not yet understood, section of chromosome 8, called 8q24, may contain at least five distinct regions that are associated with different cancers, according to a study in the June 24 issue of the Journal of the National Cancer Institute.

Exelixis, Inc. and GlaxoSmithKline Agree to Successfully Conclude Six-Year Discovery and Development Collaboration

SOUTH SAN FRANCISCO, Calif., June 27 /PRNewswire-FirstCall/ -- Exelixis, Inc. (Nasdaq: EXEL - News) announced today that the company and GlaxoSmithKline, Inc. (NYSE: GSK - News) will bring their six-year collaboration to a successful conclusion on October 27, 2008, as scheduled. Under the terms of the collaboration, GSK has the right to select up to two of the compounds in the collaboration for further...

Sinclair Pharma plc Signs First Agreement for Distribution and Manufacture in India; 10 Year Agreement Covers Atopiclair, Aloclair, Papulex, Decapinol

27th June 2008, Godalming, UK: Sinclair Pharma plc (Sinclair: SPH:L), the international specialty pharmaceutical company, announces it has concluded its first marketing distribution agreement in India. This agreement is a further step towards Sinclair's goal of establishing its brands in the key BRIC (Brazil, Russia, India, China) countries. </p><p>The agreement has been signed with Wockhardt...

EU Body Warns on Amgen , Johnson & Johnson Anemia Drugs in Cancer Patients

LONDON, June 26 (Reuters) - Epoetin, or Epo, drugs should carry a new warning for their use in cancer patients stating that blood transfusion should be the preferred method of correcting anaemia, the European Medicines Agency said on Thursday.

FDA Approves Johnson and Johnson Pharmaceutical Research and Development, LLC (CA)'s CONCERTA(R) (methylphenidate HCI) Extended-release Tablets for Treatment of ADHD

<p> RARITAN, N.J., June 27 /PRNewswire/ -- ADHD is the most common emotional, cognitive and behavioral disorder treated in children(1), and according to the National Institute of Mental Health (NIMH), between 30 percent and 70 percent of children with ADHD continue to exhibit symptoms in the adult years(2). ADHD is thought to affect about eight million, or one in 20, adults in the United States...

Weizmann Institute of Science and Researchers Discover How an Injured Embryo Can Regenerate Itself

ScienceDaily -- More than 80 years have passed since the German scientist Hans Spemann conducted his famous experiment that laid the foundations for the field of embryonic development...but how exactly is a half embryo able to maintain its tissues and organs in the correct proportions despite being smaller than a normal sized embryo? <br><br>Despite many years of research, this question has remained...

EU Strengthens Heart Warnings on Merck & Co., Inc.'s Arcoxia

LONDON, June 26 (Reuters) - The European Medicines Agency said on Thursday it had concluded that Merck & Co's Arcoxia can be used to treat rheumatoid arthritis and ankylosing spondylitis but with heightened warnings on cardiovascular risks.

Athletes Use Pfizer Inc.'s Viagra for a Competitive Edge, Experts Say

Internation Herald Tribune -- Athletes looking for a performance boost are increasingly turning to a little blue pill more usually taken for its off-the-field benefits: Viagra.

New Clinical Trial at and Columbia-Presbyterian Medical Center for Patients with Asbestos-Associated Lung Cancer

EurekAlert -- The Mesothelioma Center within the Herbert Irving Comprehensive Cancer Center at NewYork-Presbyterian Hospital and Columbia University Medical Center is now recruiting patients for a clinical research study of a new targeted radiation and chemotherapy protocol for pleural mesothelioma, a cancer of the lung's lining that is almost always caused by previous exposure to asbestos.

Isconova Secures 30 Million Swedish Kronor Growth Financing

UPPSALA, Sweden--(BUSINESS WIRE)--Leading vaccine adjuvant provider set to grow in animal vaccine market and to unlock the value of its technology for human vaccines</p><p>Isconova AB, announced today that it has secured financing of 30 million Swedish kronor ( 3,3 m ) from InnovationsKapital, a leading Nordic venture capital firm, and a group of private investors. Isconova is a pioneer in vaccine...

UCB Group to Launch Epilepsy Drug in Autumn

BRUSSELS, June 27 (Reuters) - Shares in UCB SA jumped on Friday as the Belgian pharmaceutical group said it aimed to launch its new epilepsy drug Vimpat in the autumn, after winning a green light from the European Medicines Agency.

Rabies Vaccines in Short Supply, Centers for Disease Control and Prevention (CDC) Says

Reuters -- Vaccines to prevent rabies in people are in short supply in the United States and should be used only if needed, federal health officials advised on Thursday.

Bank of America Donates $250K to Institute for Regenerative Medicine

Charlotte Business Journal -- The Bank of America Charitable Foundation is donating $250,000 to the Institute for Regenerative Medicine at Wake Forest University's Baptist Medical Center.

AEterna Zentaris Sells Quebec City Building for $7.1 Million

QUEBEC CITY, June 27 /PRNewswire-FirstCall/ - AEterna Zentaris Inc. (NASDAQ: AEZS - News; TSX: AEZ - News), a global biopharmaceutical company focused on endocrine therapy and oncology, today announced it has completed the sale of its Quebec City property for a purchase price of $7.1 million, payable in cash. AEterna Zentaris also entered into a long-term lease agreement enabling the Company to continue...

Orexo AB Report Abstral (Rapinyl) Approval in Europe

UPPSALA, Sweden--(BUSINESS WIRE)- Orexo AB (OMX: ORX), the Swedish pharmaceutical company, announces that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has issued a positive opinion recommending approval of Rapinyl, for breakthrough cancer pain. ProStrakan Group plc, the international speciality pharmaceutical is Orexos exclusive partner for sales...

Centocor, Inc. Submits Application to FDA Requesting Approval of Golimumab for the Treatment of Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis

<p> HORSHAM, Pa., June 27 /PRNewswire/ -- Centocor, Inc. announced today that a Biologics License Application (BLA) has been submitted to the U.S. Food and Drug Administration (FDA) requesting the approval of golimumab (CNTO 148) as a monthly subcutaneous treatment for adults with active forms of rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis. Golimumab, Centocor's next-generation...

European Issues Positive Opinion on Eli Lilly and Company's Cymbalta for the Treatment of Generalised Anxiety Disorder

INDIANAPOLIS, June 27 /PRNewswire-FirstCall/ -- Eli Lilly and Co (NYSE: LLY - News) and Boehringer Ingelheim today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has issued a positive opinion supporting the approval of Cymbalta (duloxetine hydrochloride) for the treatment of Generalised Anxiety Disorder (GAD).</p><p>The positive...

GlaxoSmithKline Workers Warned of Job Losses

Employees at GlaxoSmithKline's plant in Montrose have been warned to expect redundancies. A review of its activities is under way as the firm tries to save 700m a year by 2010 across its global operations. There are currently about 450 permanent and temporary staff at the pharmaceutical factory in Angus.

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Welcome

Your success. At Excel Life Sciences (ELS) that’s our commitment to you. To navigate today’s rapidly changing operating and regulatory environment, you need a partner with the experience necessary to understand your needs and help you achieve your goals. As the leading Trial Management Organization in India and through our trusted partnerships worldwide, we have the capabilities and bandwidth to take on any project large or small. And with offices and executive leadership based in the United States, you can be sure that we’re available when you are. Our extensive expertise comes from:

  • 125 years combined experience in Clinical Medicine, Pharmaceutical Medicine and Biometrics
  • 45 years of regulatory experience and top US and India senior regulatory executives on the ELS advisory board
  • 225 successfully conducted clinical trials at over 500 sites
  • 120 IND approvals and contribution to 20+ NDA approvals in US, Europe and Asia
What's New at ELS
 

ELS Welcomes Industry Veteran Wayne Pines to Board of Directors

ELS has added regulatory affairs and drug development industry veteran Wayne Pines to its Board of Directors. Pines is an internationally-known consultant on regulatory issues, advertising and promotion, media strategies and crisis management involving pharmaceuticals, biological products and medical devices. Click here (links to press release page with full release text) to learn more, or visit our What’s New page to read about other exciting developments at ELS.  Read More