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FDA grants orphan drug designation to hGH-CTP for treating growth hormone deficiency

PROLOR Biotech, Inc., a company developing next generation biobetter therapeutic proteins, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to hGH-CTP, PROLOR's longer-acting version of human growth hormone for the treatment of growth hormone deficiency.

5 Oct 2010

FDA grants Matrix tentative approval under PEPFAR for Atazanavir Sulfate Capsules ANDA

Mylan Inc. today announced that its subsidiary Matrix Laboratories Limited has received tentative approval from the U.S. Food and Drug Administration (FDA) under the President's Emergency Plan for AIDS Relief (PEPFAR) for its Abbreviated New Drug Application (ANDA) for Atazanavir Sulfate Capsules, 150 mg and 300 mg. This product will be eligible for purchase outside the U.S. in certain developing countries.

5 Oct 2010

FMCNA offers annual flu vaccine to patients and clinical staff

Beginning in mid-October, Fresenius Medical Care North America will offer all of its patients and clinical staff an annual flu vaccine, which protects against both seasonal flu and H1N1 this year. The Centers for Disease Control (CDC) cautions that it is likely that H1N1 will continue to spread along with seasonal viruses this flu season.

5 Oct 2010

Researchers complete first studies of mephedrone drug ban in Northern Ireland

Researchers at Queen's University Belfast have completed one of the first studies of mephedrone use in Northern Ireland since the drug was outlawed earlier this year. They found that the ban did not deter those mephedrone users surveyed from taking the substance.

5 Oct 2010

Octapharma USA launches wilate replacement therapy Web site for von Willebrand Disease

Octapharma USA has launched a comprehensive Web site for wilate® at www.wilateusa.com to provide von Willebrand disease healthcare professionals and patients with easily accessible information, news and updates. The U.S. Food and Drug Administration (FDA) has granted orphan drug exclusivity for wilate® (von Willebrand Factor/Factor VIII Concentrate, Human), the first replacement therapy developed specifically for von Willebrand Disease (VWD).

5 Oct 2010

Tasly, ProteoTech to co-develop Exebryl-1(R) medication for Alzheimer's disease treatment

Tasly Pharmaceutical Co., Ltd. and ProteoTech, Inc. today announced an agreement to co-develop ProteoTech's novel small molecule therapeutic, Exebryl-1(R), for the treatment of mild-to-moderate Alzheimer's disease.

5 Oct 2010

Researchers call for sustained funding to move HIV vaccine R&D ahead

At the AIDS Vaccine 2010 conference last week in Atlanta, researchers emphasized the need for sustained funding for vaccine research and development in order to further progress toward an HIV vaccine, SciDev.Net reports.

5 Oct 2010

Novo Nordisk announces $73M expansion of Clayton insulin delivery systems manufacturing facility

Novo Nordisk, a global healthcare company and leader in diabetes care, today announced a $73 million expansion of its Clayton, NC manufacturing facility to accommodate increased production capacity for the Company's insulin delivery devices.

5 Oct 2010

HGS receives Complete Response Letter from FDA for ZALBIN drug

Human Genome Sciences, Inc. today announced that, as expected, it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the Company's Biologics License Application (BLA) for 900-mcg ZALBIN (albinterferon alfa-2b, known in Europe as JOULFERON®) dosed every two weeks for the treatment of chronic hepatitis C.

5 Oct 2010

Merck to appeal against jury verdict in retrial of federal FOSAMAX case

Merck & Co., Inc. today said it will appeal a decision by the U.S. District Court for the Southern District of New York that reduced the jury verdict from $8 million to $1.5 million but denied Merck's request for judgment in its favor or a new trial in the case of Boles v. Merck, a retrial of a federal FOSAMAX case.

5 Oct 2010

CPS recommends all Canadian babies should be vaccinated against rotavirus

All Canadian babies should be vaccinated against rotavirus, according to a new statement by the Canadian Paediatric Society. The CPS is also calling for public funding of the vaccine, which is not currently covered by provincial or territorial health plans.

5 Oct 2010

FDA approves Food Contact Notification for CDG Solution 3000

The FDA notified CDG Environmental, LLC on September 29th of its approval of Food Contact Notification FCN 001011 for CDG Solution 3000 effective October 28, 2010.

5 Oct 2010

Aeras Global receives FDA grant to develop biomarkers for TB vaccine

The Aeras Global TB Vaccine Foundation is pleased to announce receipt of a grant from the United States Food and Drug Administration (FDA) to develop new biological and immunological biomarkers for TB vaccine development. The FDA grant, which supports the coordination of a multi-investigator project with researchers from the United States, the United Kingdom and South Africa, will provide $362,102 in the first year of funding.

5 Oct 2010

FDA awards $2.9 million to support tuberculosis research projects

The U.S. Food and Drug Administration today announced the award of $2.9 million to support six research projects that will help with the diagnosis, treatment, and prevention of tuberculosis (TB).

5 Oct 2010

Australian reimbursement committee is set to consider Novo Nordisk's type 2 diabetes treatment

In its November meeting, the Pharmaceutical Benefits Advisory Committee (PBAC) will consider Novo Nordisk's second-to-market glucagon-like peptide-1 (GLP-1) agonist Victoza for reimbursement, which would be essential in order for the drug to compete effectively with Eli Lilly's Byetta. However, its chances of success are uncertain, considering that it took three years to get Byetta on the Pharmaceutical Benefits Scheme (PBS).

4 Oct 2010

NY Times: DEA crackdown means delays for some patients in need of pain meds

The New York Times: Increased scrutiny by the Drug Enforcement Administration may be causing painful delays for patients who need narcotic drugs. "Roland Lorenz has surgical screws in his back and neck and a pin in his upper leg, and when his pain reared up one recent weekend, he knew he needed something strong.

4 Oct 2010

Decision Resources: NSCLC drug market to grow from $4 billion in 2009 to over $6.5 billion in 2019

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues finds that the non-small-cell lung cancer (NSCLC) drug market will increase from approximately $4 billion in 2009 to more than $6.5 billion in 2019 in the United States, France, Germany, Italy, Spain, United Kingdom and Japan.

4 Oct 2010

VIVUS announces divestiture of MUSE to Meda

VIVUS, Inc. today announced that it has entered into an asset purchase agreement with Meda - an international specialty pharma company - for MUSE®, transurethral alprostadil, for the treatment of erectile dysfunction (ED). Under the agreement, Meda will acquire the MUSE assets including the United States and foreign MUSE patents, existing inventory and the manufacturing facility located in Lakewood, New Jersey.

4 Oct 2010

FDA clears Orthovita's VITOMATRIX Bone Graft Substitute for dental procedures

Orthovita, Inc., an orthobiologics and biosurgery company, announced that it received 510(k) clearance from the U.S. Food and Drug Administration to market VITOMATRIX Bone Graft Substitute as a bone grafting material in certain dental procedures.

4 Oct 2010

J&JPRD receives FDA Complete Response Letter for tapentadol ER tablets NDA

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) announced today that it received a Complete Response letter from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for tapentadol extended release tablets.

4 Oct 2010