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FDA warning letter to Genzyme related to the Allston facility

BioMarin Pharmaceutical Inc. has announced that the FDA warning letter issued to Genzyme addressing deficiencies related to Genzyme's Allston Landing manufacturing facility during an inspection performed in September and October 2008 has no foreseeable impact on the supply of Aldurazyme.

2 Apr 2009

FDA provides positive review of InNexus Biotechnology development plan for lead preclinical candidate

InNexus Biotechnology Inc. has announced the United States Food & Drug Administration (FDA) has completed its comprehensive review of the development plans for InNexus' lead preclinical candidate, DXL625 (CD20) for the prospective treatment of Non-Hodgkin's Lymphoma (NHL) and/or Chronic Lymphocytic Leukemia (CLL).

2 Apr 2009

FDA clears Cellectar's IND application for drug candidate

Cellectar, Inc., a privately held radiopharmaceuticals company that designs and develops products to detect, treat and monitor human cancers, has announced that the U.S. Food and Drug Administration (FDA) has cleared the Company's Investigational New Drug (IND) application for its (131)I-CLR1404 drug candidate for testing in patients with advanced solid malignancies.

2 Apr 2009

Teva receives approval for generic Yaz (Drospirenone and Ethinyl Estradiol) tablets

Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration has granted approval for the Company's Abbreviated New Drug Application (ANDA) to market its generic version for Bayer Healthcare Pharmaceuticals' oral contraceptive Yaz® (Drospirenone and Ethinyl Estradiol) Tablets.

1 Apr 2009

FDA approves generic Topamax tablets (topiramate)

The U.S. Food and Drug Administration has approved the first generic versions of Topamax tablets (topiramate) to prevent seizures.

1 Apr 2009

Branding still overshadows critical fine print on nonprescription medications

Medicine packages barrage consumers with information, some required to be "prominent" and "conspicuous."

1 Apr 2009

House subcommittee to conduct hearing to discuss strategies to end agreements between brand-name, generic drugmakers, limit number of plans

A House Energy and Commerce subcommittee on Tuesday is scheduled to conduct a hearing on the issue of ending agreements under which brand-name pharmaceutical companies pay generic drugmakers to delay the launch of less costly versions of top-selling medications, the Wall Street Journal reports.

31 Mar 2009

World Heart Federation, Daiichi Sankyo and Lilly Partner to improve cardiovascular health

The World Heart Federation, Daiichi Sankyo Company, and Eli Lilly announced today that they have partnered to improve cardiovascular health internationally. The organizations made the announcement at the 58th Annual Scientific Session of the American College of Cardiology in Orlando, Florida.

31 Mar 2009

Basilea Pharmaceutica expands potential commercial availability of Toctino in Europe

Basilea Pharmaceutica Ltd. has announced the submission of a Marketing Authorization Application (MAA) for Toctino (alitretinoin) in 13 additional European Union (EU) Member States as well as in Norway and Iceland. Toctino is a new once-daily oral treatment for adults with severe chronic hand eczema (CHE) unresponsive to potent topical corticosteroids.

31 Mar 2009

Mylan's Matrix receives tentative FDA approval under PEPFAR for generic Truvada

Mylan Inc. has announced that Matrix Laboratories Limited, its India-based subsidiary in which it holds a 71.2% controlling interest, has received the first 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 Emtricitabine and Tenofovir Disoproxil Fumarate Tablets, 200 mg/300 mg.

30 Mar 2009

Intercell receives FDA approval of IXIARO, novel vaccine for Japanese encephalitis

Intercell AG (VSE: ICLL) today announced that the U.S. Food and Drug Administration (FDA) approved IXIARO(R), a new vaccine for the prevention of Japanese Encephalitis (JE).

30 Mar 2009

Court of Appeal for Saskatchewan allows Merck's appeal

Merck Frosst Canada Ltd. has learned that the Court of Appeal for Saskatchewan has issued a decision allowing Merck's appeal and quashing an order of the Court of Queen's Bench that had certified a class proceeding on behalf of Canadian residents of all provinces except Quebec who purchased or ingested VIOXX.

30 Mar 2009

Wal-Mart in talks with several companies to expand prescription drug discount program for employees

Wal-Mart on Friday announced that it is in negotiations to expand to several other companies a generic drug purchasing pilot program it currently runs with Caterpillar, the Chicago Tribune reports.

30 Mar 2009

FDA approves Afinitor oral tablets (everolimus) for advanced form of kidney cancer

The U.S. Food and Drug Administration today approved Afinitor oral tablets (everolimus) for the treatment of patients with advanced kidney cancer whose disease has progressed after treatment with other cancer therapies.

30 Mar 2009

FDA approves IXIARO for Japanese encephalitis

The U.S. Food and Drug Administration has approved IXIARO, a vaccine to prevent Japanese encephalitis (JE) which is caused by a mosquito-transmitted virus found mainly in Asia. IXIARO will be the only vaccine for JE available in the United States.

30 Mar 2009

Senate measure would allow generic versions of biotechnology drugs after five years

Sens. Charles Schumer (D-N.Y.) and Susan Collins (R-Maine) on Thursday introduced legislation (S 726) that would allow FDA to approve generic versions of biotechnology drugs after a five-year period of brand-name patent exclusivity, the New York Times reports.

30 Mar 2009

Takeda expands into Canada

Takeda Pharmaceutical Company Limited and its wholly-owned subsidiary, Takeda Pharmaceuticals North America, Inc. today announced the establishment of Takeda Canada Inc., expanding the company's North American presence into the world's eighth largest pharmaceutical market.

29 Mar 2009

Salk Institute forms strategic alliance agreement with sanofi-aventis

The Salk Institute has announced that it has signed a strategic alliance agreement with sanofi-aventis, establishing a joint program that supports cutting-edge research and promotes an exchange of discoveries focused on scientific advances and therapeutic applications.

29 Mar 2009

Mylan confirms four first-to-file challenges

Mylan Inc. has announced that it and/or a subsidiary have been sued in connection with four separate "first-to-file" Abbreviated New Drug Applications (ANDA) filed with the U.S. Food and Drug Administration (FDA).

29 Mar 2009

Sagent Pharmaceuticals receives FDA approval of Azithromycin for injection

Sagent Pharmaceuticals, Inc. has announced U.S. Food and Drug Administration (FDA) approval of azithromycin for injection, a semi-synthetic, macrolide antibiotic that is used to treat a wide variety of bacterial infections. Sagent will offer azithromycin in a 500 mg vial for intravenous use.

26 Mar 2009

Pharmaceutical News

FDA warning letter to Genzyme related to the Allston facility

FDA provides positive review of InNexus Biotechnology development plan for lead preclinical candidate

FDA clears Cellectar's IND application for drug candidate

Teva receives approval for generic Yaz (Drospirenone and Ethinyl Estradiol) tablets

FDA approves generic Topamax tablets (topiramate)

Branding still overshadows critical fine print on nonprescription medications

House subcommittee to conduct hearing to discuss strategies to end agreements between brand-name, generic drugmakers, limit number of plans

World Heart Federation, Daiichi Sankyo and Lilly Partner to improve cardiovascular health

Basilea Pharmaceutica expands potential commercial availability of Toctino in Europe

Mylan's Matrix receives tentative FDA approval under PEPFAR for generic Truvada

Intercell receives FDA approval of IXIARO, novel vaccine for Japanese encephalitis

Court of Appeal for Saskatchewan allows Merck's appeal

Wal-Mart in talks with several companies to expand prescription drug discount program for employees

FDA approves Afinitor oral tablets (everolimus) for advanced form of kidney cancer

FDA approves IXIARO for Japanese encephalitis

Senate measure would allow generic versions of biotechnology drugs after five years

Takeda expands into Canada

Salk Institute forms strategic alliance agreement with sanofi-aventis

Mylan confirms four first-to-file challenges

Sagent Pharmaceuticals receives FDA approval of Azithromycin for injection

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