Pharmaceutical News

RSS

FDA grants marketing approval for EnzySurge's new SilverStream solution for prescription use

EnzySurge Ltd. (EnzySurge), a provider of innovative solutions for the advanced chronic wound management market, announced today that it has received clearance from the U.S. Food and Drug Administration (FDA) to market its new SilverStream(TM) solution for prescription use. The FDA also cleared DermaSept, an Over-the-Counter version of the SilverStream product.

15 Dec 2009

UNITAID to launch patent pool for HIV/AIDS drugs by mid-2010

The international drug procurement agency UNITAID on Monday unveiled plans to create a patent pool for HIV/AIDS medications to help increase access to generic versions of newer drugs at lower prices for low- and middle-income countries, Agence France-Presse reports. The patent pool "will create a common space for patent holders to license their technology in exchange for royalties" and is "scheduled to begin operating in mid-2010," AFP reports (12/14).

15 Dec 2009

Pfizer to co-promote Actos with Tianjin Takeda Pharmaceuticals in China

Takeda Pharmaceutical Company Limited (“Takeda”) and Pfizer Inc. (“Pfizer”) announced that they have entered into an agreement under which Pfizer in China will co-promote Takeda’s Actos® (pioglitazone HCl) with Tianjin Takeda Pharmaceuticals in China.

15 Dec 2009

Genocea Biosciences to develop Chlamydia trachomatis vaccine with UPMC grant

Genocea Biosciences, a leading vaccine discovery and development company, today announced it has been awarded a grant from the University of Pittsburgh Medical Center’s (UPMC) Sexually Transmitted Infections (STI) Cooperative Research Center for the development of vaccines for Chlamydia trachomatis.

15 Dec 2009

Prescription drug import amendment divides Senate Democrats

The Senate is battling over a proposed amendment that would allow prescription drugs to be imported from other countries where prices are lower.

15 Dec 2009

Novartis submits JOULFERON MAA to the EMEA

Human Genome Sciences, Inc. today announced that Novartis has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMEA) for approval to market JOULFERON® (albinterferon alfa-2b, known in the United States as ZALBIN™) for the treatment of chronic hepatitis C. In November 2009, HGS submitted a Biologics License Application (BLA) for ZALBIN to the FDA in the United States.

15 Dec 2009

Jazz Pharmaceuticals announces submission of JZP-6 NDA for treatment of fibromyalgia

Jazz Pharmaceuticals, Inc. announced it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration for JZP-6 (sodium oxybate oral solution) for the treatment of fibromyalgia.

15 Dec 2009

CHPA comments on NIDA's Monitoring the Future survey

Following is a statement by Linda A. Suydam, D.P.A., president of the Consumer Healthcare Products Association (CHPA), regarding today's release of the National Institute on Drug Abuse's (NIDA's) Monitoring the Future survey:

15 Dec 2009

Bend Research makes available Type V DMF for HPMCAS concerning FDA regulatory filings

Bend Research Inc. announced today that its clients may now reference a key safety file for HPMCAS, an excipient used in technologies developed by the firm to enhance the oral bioavailability of clients' low-solubility drugs.

15 Dec 2009

CDC has distributed 3,177,900 doses of H1N1 flu vaccine to Pennsylvania till date

The federal Centers for Disease Control and Prevention, or CDC, has allocated a total of 3,177,900 doses of H1N1 flu vaccine to Pennsylvania to date, the state Department of Health said today.

15 Dec 2009

Antidepressant and anti-anxiety medications linked to increased risk of cardiovascular events and death

Women with suspected coronary artery disease (CAD) who report taking antidepressant and anti-anxiety medications have an increased risk of cardiovascular events, including heart attacks and strokes, and death compared to women not taking these medications, according to researchers at the Uniformed Services University of the Health Sciences (USU).

15 Dec 2009

Study to determine link between insulin glargine and cancer

Type 2 diabetes and obesity are linked to an increased risk of certain cancers. Recently published studies suggested that insulin glargine (a synthetic insulin preparation marketed under the trade name Lantus), may be associated with a higher risk of certain cancers than other insulins or oral glucose lowering medications. However, these studies were unable to control for important factors such as obesity that may have driven the association.

15 Dec 2009

Supplements boost immune system and offer protection against seasonal flu

Accompanied by a chorus of coughs and sniffles, the winter season has arrived. "Protecting your health during this year's winter season should be a top priority for people," said Tom Tolworthy, CEO and Chief Health Enthusiast for The Vitamin Shoppe. "Many of our customers are being proactive in boosting their immune systems this time of year."

15 Dec 2009

INS cites FDA-approved Totect antidote for anthracycline extravasations

The third edition of Infusion Nursing: An Evidence-Based Approach, published by the Infusion Nurses Society (INS), includes Totect(®), the only FDA-approved treatment for anthracycline extravasation. Anthracyclines are a group of chemotherapy medications including daunorubicin, doxorubicin, idarubicin and epirubicin that have been used in the treatment of various types of cancer since the early 1970s.

15 Dec 2009

FDA publishes cGMPs for PET drugs

The U.S. Food and Drug Administration (FDA) announced publication of a final regulation on current good manufacturing practices (cGMPs) for the production of positron emission tomography (PET) drugs, as well as a guidance document describing acceptable approaches that would enable PET drug producers to meet the requirements in the proposed regulation.

15 Dec 2009

Health hazards of BPA: Call for FDA to make its announcement before Christmas

Environmental health advocates hope that U.S. FDA will make its promised announcement about health hazards of bisphenol A (BPA), a synthetic sex hormone linked to cancer, behavioral changes, reproductive harm and other illnesses, in time for Christmas.

15 Dec 2009

Study compares status of health care systems in U.S. and UK

The well-worn notion that patients in the United States have unfettered access to the most expensive cancer drugs while the United Kingdom's nationalized health care system regularly denies access to some high-cost treatments needs rethinking, a team of bioethicists and health policy experts says in a report out today.

15 Dec 2009

USPTO issues Notice of Allowance to Transcept Pharmaceuticals for Intermezzo claims

Transcept Pharmaceuticals, Inc. today announced that it has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for claims under U.S. patent application no. 11/060,641, which covers the composition and use of Intermezzo® (zolpidem tartrate sublingual tablet), the lead Transcept product candidate.

15 Dec 2009

Decision Resources: Atrial fibrillation drug market to increase more than sevenfold

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that, owing to the launches of several new agents, the atrial fibrillation drug market will increase more than sevenfold from $790 million in 2008 to $6.1 billion in 2018 in the United States, France, Germany, Italy, Spain, the United Kingdom and Japan.

15 Dec 2009

New program to help maintain bone health in men with prostate cancer on ADT announced

Watson Pharmaceuticals, Inc. today announced a new program encouraging health professionals to help maintain the bone health of prostate cancer patients who are on long-term androgen deprivation therapy (ADT).

15 Dec 2009

Pharmaceutical News

FDA grants marketing approval for EnzySurge's new SilverStream solution for prescription use

UNITAID to launch patent pool for HIV/AIDS drugs by mid-2010

Pfizer to co-promote Actos with Tianjin Takeda Pharmaceuticals in China

Genocea Biosciences to develop Chlamydia trachomatis vaccine with UPMC grant

Prescription drug import amendment divides Senate Democrats

Novartis submits JOULFERON MAA to the EMEA

Jazz Pharmaceuticals announces submission of JZP-6 NDA for treatment of fibromyalgia

CHPA comments on NIDA's Monitoring the Future survey

Bend Research makes available Type V DMF for HPMCAS concerning FDA regulatory filings

CDC has distributed 3,177,900 doses of H1N1 flu vaccine to Pennsylvania till date

Antidepressant and anti-anxiety medications linked to increased risk of cardiovascular events and death

Study to determine link between insulin glargine and cancer

Supplements boost immune system and offer protection against seasonal flu

INS cites FDA-approved Totect antidote for anthracycline extravasations

FDA publishes cGMPs for PET drugs

Health hazards of BPA: Call for FDA to make its announcement before Christmas

Study compares status of health care systems in U.S. and UK

USPTO issues Notice of Allowance to Transcept Pharmaceuticals for Intermezzo claims

Decision Resources: Atrial fibrillation drug market to increase more than sevenfold

New program to help maintain bone health in men with prostate cancer on ADT announced

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

Latest News