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FDA places Geron Corporation's IND for spinal cord injury on clinical hold

Geron Corporation (Nasdaq:GERN) today announced that its IND (Investigational New Drug application) for GRNOPC1, a cell therapy for neurologically complete, subacute spinal cord injury, has been placed on clinical hold by the FDA pending the agency’s review of new nonclinical animal study data submitted by the company. A clinical hold is an order that the FDA issues to a sponsor to delay a proposed trial or to suspend an ongoing trial.

19 Aug 2009

Amira Pharmaceuticals submits IND for inflammatory and allergic disease treatment candidate

Amira Pharmaceuticals, Inc. announced today the submission of an Investigational New Drug application (IND) of AM461, its internally-discovered, oral drug candidate for the treatment and control of inflammatory and allergic disease linked to the arachidonic acid pathway, to the U.S. Food and Drug Administration.

19 Aug 2009

Gloucester Pharma announces FDA Advisory Committee Meeting to discuss Romidepsin NDA

Gloucester Pharmaceuticals will discuss the New Drug Application for romidepsin to treat patients with cutaneous T-cell lymphoma (CTCL) at the Oncologic Drugs Advisory Committee (ODAC) meeting on September 2, 2009.

18 Aug 2009

Labopharm comments on outcome of patent-infringement litigation initiated by Purdue Pharma

Labopharm Inc. today commented on the outcome of patent-infringement litigation initiated by Purdue Pharma Products L.P. against Par Pharmaceutical Companies, Inc. relating to Ultram(R) ER (tramadol hydrochloride extended-release tablets). The patents-in-suit are owned by Purdue and are licensed to Ortho-McNeil, Inc., the marketer of Ultram(R) ER.

18 Aug 2009

Par Pharmaceutical wins in Ultram ER litigation

Par Pharmaceutical Companies, Inc. today announced that the U.S. District Court for the District of Delaware has ruled in favor of Par in its challenge of Purdue's patents relating to extended-release tramadol, which are listed in the Orange Book for Ortho-McNeil's Ultram(R) ER product.

18 Aug 2009

Synco Bio to manufacture Versartis type 2 diabetes drug candidate

SynCo Bio Partners, a Netherlands based biopharmaceutical contract manufacturer, and Versartis, Inc. today announced a strategic partnership to produce Versartis' lead drug candidate VRS-859, a novel GLP-1 analog for monthly dosing to treat type 2 diabetes Under the agreement, SynCo will further develop the Versartis existing production process for VRS-859 and optimize the manufacturing process to increase yields for the forthcoming cGMP production.

18 Aug 2009

Boehner blasts Phrma on deal with White House

The drug industry’s decision to agree to $80 billion in concessions to the White House was short-sighted, will hurt drug manufacturers and their customers, and "has all the markings of a deal gone sour," House Minority Leader John Boehner wrote Monday to his former colleague, Billy Tauzin, who now heads the Pharmaceutical Research and Manufacturers of America.

17 Aug 2009

FDA approves Helixate FS for routine prophylaxis in children with hemophilia A

CSL Behring announced today that Helixate® FS, Antihemophilic Factor (Recombinant), has been approved by the U.S. Food and Drug Administration (FDA) for routine prophylaxis in children with hemophilia A who are 16 years old or younger and do not have pre-existing joint damage.

17 Aug 2009

Alpharx completes lyophilization process for Zysolin

AlphaRx Inc. has announced that it has completed the lyophilization process for Zysolin(TM), allowing the company to proceed to clinical batch material manufacturing for human trials. This process has been solely developed by AlphaRx's scientists and the resulting formulations have been successfully tested in animal studies conducted by the U.S. Army under a Material Transfer Agreement.

17 Aug 2009

GSK starts testing H1N1 vaccine; Opinion piece addresses U.S. role in helping developing countries procure vaccine

"GlaxoSmithKline has started testing its pandemic H1N1 swine flu vaccine in humans, and expects to start giving the results to government agencies next month, the drugmaker said on Friday," Reuters reports. The company "plans to conduct 16 different trials of the vaccine and to test 9,000 people in total across Europe, Canada and the United States," according to the news service (Deighton, 8/14).

17 Aug 2009

FDA approves Extavia for multiple sclerosis

The US Food and Drug Administration (FDA) has approved Extavia(R) (interferon beta-1b), the first in a new planned portfolio of multiple sclerosis (MS) medicines from Novartis to help patients manage this devastating disease.

17 Aug 2009

Astronauts test nutritional supplement formulas in space

After nearly four years of joint research of Houston-based AmeriSciences and NASA / Johnson Space Center (JSC), a senior NASA medical officer has confirmed that two of the resulting nutritional supplement formulas were used and tested in space by the astronauts of mission STS-125 of May 11, 2009 and the mission STS-127 of July 15, 2009 and are now in use and testing aboard the International Space Station.

17 Aug 2009

Mylan Pharmaceuticals receives final FDA report on Morgantown, W.Va., manufacturing facility

Mylan Inc. (Nasdaq: MYL) today announced that the U.S. Food and Drug Administration (FDA) has released its official and final report regarding the agency's review of allegations made in a July newspaper article concerning the company's Morgantown, W.Va., manufacturing facility.

14 Aug 2009

CVS Caremark announces results of 2009 Health IQ study

CVS Caremark (NYSE: CVS) announced today the results of its 2009 Health IQ study which examined consumer attitudes and behaviors around health care and prescription usage. Among its findings, the study underscores the need for expanded health care coverage along with cost savings realized by improving health care delivery.

13 Aug 2009

Sigma-Aldrich offers customizable synthetic extracellular matrix (ECM) for stem cell research

Sigma-Aldrich (Nasdaq: SIAL) today announced an agreement with Glycosan BioSystems for the sale of HyStem(TM), a fully customizable synthetic extracellular matrix (ECM) for stem cell research. HyStem offers researchers flexibility to tailor microenvironments for their cultured cells that mimic natural in vivo conditions, optimizing stem cell proliferation and differentiation. HyStem was developed by Glycosan BioSystems and will be sold by Sigma-Aldrich under a non-exclusive distribution agreement.

13 Aug 2009

Stanford researchers want FDA to require drug makers to state how new medications compare with similar, existing treatments

The labeling information that comes with prescription drugs tells you what’s known about the medication, but researchers from the Stanford University School of Medicine think it’s high time that the labeling tell you what isn’t known.

13 Aug 2009

Dynavax announces European development strategy for investigational adult hepatitis B vaccine in Europe

Dynavax Technologies Corporation (Nasdaq:DVAX) today announced that it has met with the European Medicines Evaluation Agency (EMEA) to discuss its plans for continued clinical development of HEPLISAVTM Phase 3 investigational adult hepatitis B vaccine in Europe.

12 Aug 2009

Bristol-Myers Squibb announces Hart-Scott-Rodino Review period for Medarex acquisition expired

Bristol-Myers Squibb Company (NYSE: BMY) announced today that the Hart-Scott-Rodino (HSR) review period for its tender offer for Medarex, Inc. (NASDAQ: MEDX) has expired.

12 Aug 2009

Nanoviricides herpes study discussed on CBS News report

NanoViricides, Inc. (OTC BB: NNVC.OB), reported today that the CBS affiliate TV station WBRZ interviewed Professor K. Gus Kousoulas , PhD, in which he explained the potential implications of the Company’s nanoviricides™ anti-Herpes drug candidates.

12 Aug 2009

Health Canada approves Multaq (Dronedarone) for atrial fibrillation

Sanofi-aventis Canada announced today that Multaq (dronedarone, 400 mg tablets) has received Health Canada approval for the treatment of patients with a history of, or current atrial fibrillation to reduce their risk of cardiovascular hospitalization due to this condition.

12 Aug 2009

Pharmaceutical News

FDA places Geron Corporation's IND for spinal cord injury on clinical hold

Amira Pharmaceuticals submits IND for inflammatory and allergic disease treatment candidate

Gloucester Pharma announces FDA Advisory Committee Meeting to discuss Romidepsin NDA

Labopharm comments on outcome of patent-infringement litigation initiated by Purdue Pharma

Par Pharmaceutical wins in Ultram ER litigation

Synco Bio to manufacture Versartis type 2 diabetes drug candidate

Boehner blasts Phrma on deal with White House

FDA approves Helixate FS for routine prophylaxis in children with hemophilia A

Alpharx completes lyophilization process for Zysolin

GSK starts testing H1N1 vaccine; Opinion piece addresses U.S. role in helping developing countries procure vaccine

FDA approves Extavia for multiple sclerosis

Astronauts test nutritional supplement formulas in space

Mylan Pharmaceuticals receives final FDA report on Morgantown, W.Va., manufacturing facility

CVS Caremark announces results of 2009 Health IQ study

Sigma-Aldrich offers customizable synthetic extracellular matrix (ECM) for stem cell research

Stanford researchers want FDA to require drug makers to state how new medications compare with similar, existing treatments

Dynavax announces European development strategy for investigational adult hepatitis B vaccine in Europe

Bristol-Myers Squibb announces Hart-Scott-Rodino Review period for Medarex acquisition expired

Nanoviricides herpes study discussed on CBS News report

Health Canada approves Multaq (Dronedarone) for atrial fibrillation

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

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