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Link between widely used osteoporosis drugs and heart problems probed

New research at Wake Forest University School of Medicine evaluated the link between a common class of drugs used to prevent bone fractures in osteoporosis patients and the development of irregular heartbeat.

6 Apr 2009

Zosano Pharma presents positive results for needle-free osteoporosis therapy

Zosano Pharma, Inc., a privately held pharmaceutical company developing products using a novel transdermal delivery technology, has presented positive results from its phase 2 study of the ZP-PTH rapid delivery patch for the treatment of osteoporosis at the 8th International Symposium on Osteoporosis in Washington, D.C.

6 Apr 2009

Taro receives final FDA approval for Carbamazepine extended-release tablets

Taro Pharmaceutical Industries Ltd. has reported that it received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application ("ANDA") for Carbamazepine Extended-Release Tablets USP, 100 mg, 200 mg and 400 mg ("carbamazepine extended-release tablets").

6 Apr 2009

U.S. FTC requests more information on Pfizer's proposed acquisition of Wyeth

Pfizer has announced that it has received a request for additional information from the U.S. Federal Trade Commission ("FTC") with respect to its previously announced proposed acquisition of Wyeth.

6 Apr 2009

Fluorescent anesthetic compound brings new avenues for drug discovery

A collaboration of University of Pennsylvania and University of Wisconsin chemists and anesthesiologists have identified a fluorescent anesthetic compound that will assist researchers in obtaining more precise information about how anesthetics work in the body and will provide a means to more rapidly test new anesthetic compounds in the search for safer and more effective drugs.

6 Apr 2009

Most psychiatrists who wrote clinical guidelines had financial ties to drug companies, study shows

Most of the psychiatrists on the American Psychiatric Association panels who wrote the newest clinical guidelines for how to treat depression, bipolar disorder and schizophrenia had financial ties to drug companies, according to a study by Boston researchers scheduled to be published this month in the journal Psychotherapy and Psychosomatics, the Boston Globe reports.

5 Apr 2009

Canadian Senator proposes process to expedite export of low-cost drugs for HIV, other diseases

Canadian Sen. Yoine Goldstein earlier this week proposed a bill that would reform Canada's Access to Medicines Regime by expediting the process of exporting generic drugs for diseases such as HIV to developing countries, the Ottawa Citizen reports.

5 Apr 2009

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

Pharmaceutical News

Link between widely used osteoporosis drugs and heart problems probed

Zosano Pharma presents positive results for needle-free osteoporosis therapy

Taro receives final FDA approval for Carbamazepine extended-release tablets

U.S. FTC requests more information on Pfizer's proposed acquisition of Wyeth

Fluorescent anesthetic compound brings new avenues for drug discovery

Most psychiatrists who wrote clinical guidelines had financial ties to drug companies, study shows

Canadian Senator proposes process to expedite export of low-cost drugs for HIV, other diseases

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

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