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FDA launches pilot program to improve drug safety and active drug ingredients produced outside U.S.

The U.S. Food and Drug Administration today announced the launch of a voluntary pilot program that would help promote the safety of drugs and active drug ingredients produced outside the United States.

14 Jan 2009

Oncolytics Biotech issued new U.S. patent

Oncolytics Biotech Inc. has announced that it has been granted its 31st U.S. Patent, # 7,476,382, entitled "Reovirus for the Treatment of Neoplasia." The patent includes claims to pharmaceutical compositions containing reovirus.

13 Jan 2009

New folate antagonists selectively target pathway important in rheumatoid arthritis

Methotrexate (MTX), a folate antagonist that blocks folic acid activity, is the most widely used disease-modifying antirheumatic drug (DMARD) for rheumatoid arthritis.

13 Jan 2009

Wyeth and Santaris Pharma to collaborate on RNA-based medicines

Wyeth Pharmaceuticals, a division of Wyeth, and Santaris Pharma have announced that the companies have entered into a worldwide strategic alliance to discover, develop and commercialize new medicines based on Santaris Pharma's proprietary Locked Nucleic Acid (LNA) drug platform, which allows specific targeting and regulation of microRNAs (miRNAs) and messenger RNAs (mRNAs) as a means to affect gene expression mediated by the targeted RNAs.

12 Jan 2009

Pfizer joins URMC initiative for safety of experimental drugs

Pfizer Inc. has agreed to provide the University of Rochester Medical Center (URMC) with a unique set of electrocardiographic data that will help researchers develop new methods to ensure the safety of experimental drugs.

12 Jan 2009

GSK and XenoPort resubmit NDA for Solzira in restless legs syndrome

GlaxoSmithKline and XenoPort, Inc. announced today that GSK has resubmitted the New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) requesting approval of Solzira(TM) (gabapentin enacarbil) Extended Release Tablets for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS).

12 Jan 2009

FORMA Therapeutics to collaborate with Novartis on inhibitors

FORMA Therapeutics has announced that it has entered into a license and option agreement through the Novartis Option Fund.

12 Jan 2009

First artemisinin based malaria drug may meet resistance, expert says

This year, the U.S. Food and Drug Administration is expected to approve the first malaria drug to contain artemisinin, a wormwood derivative from China that has proven effective for malaria in Africa and Asia.

8 Jan 2009

New drugs have longer clinical development times despite faster FDA review

While the U.S. Food and Drug Administration Drug has quickened review and approval of new medicines, the complex nature of diseases for which new therapeutics are being developed has resulted in longer clinical development times, according to the Tufts Center for the Study of Drug Development.

8 Jan 2009

Sun Pharmaceutical extends tender offer for Taro

Sun Pharmaceutical Industries Ltd. today announced its subsidiary, Alkaloida Chemical Company Exclusive Group Ltd. (Alkaloida), has extended the Expiration Date of the Tender Offer for the purchase of all outstanding Ordinary Shares of Taro Pharmaceutical Industries Ltd. (Taro).

7 Jan 2009

Sun Pharmaceutical receives FDA approvals for 4 generics

Sun Pharmaceutical Industries Ltd. announced that together with its subsidiaries, it has received final approval from U.S. FDA for several Abbreviated New Drug Applications (ANDA).

7 Jan 2009

Codexis announces licensing agreement with Teva Pharmaceutical Industries

Codexis, Inc. today announced a licensing agreement with Teva Pharmaceutical Industries Ltd., to produce an important publicly-undisclosed generic product, using a proprietary Codexis biocatalyst.

7 Jan 2009

Sequella, Inc. drug compound SQ109 selected for phase 1B clinical trial program

Sequella, Inc., a clinical-stage biopharmaceutical company focused on diseases of epidemic potential, announced today that SQ109, its lead drug candidate for the treatment of tuberculosis (TB), was the first drug approved for evaluation in a newly awarded clinical program contract to Dynport Vaccine Company LLC and Quintiles Transnational.

6 Jan 2009

Onyx Pharmaceuticals acquires license option on novel JAK2 inhibitors from S*BIO

Onyx Pharmaceuticals, Inc. has announced that it has acquired an option to license rights to SB1518, an orally available, potent, and selective inhibitor of Janus Kinase 2 (JAK2), and SB1578, also a JAK2 inhibitor, from S*BIO Pte Ltd based in Singapore.

6 Jan 2009

Phase III studies of EXPAREL (DepoBupivacaine) from Pacira complete enrollment

Pacira Pharmaceuticals, Inc., an acute care specialty pharmaceutical company, announced today that enrollment has been completed in two pivotal Phase III SIMPLE trials to evaluate the safety and efficacy of a single intraoperative administration of EXPAREL(TM) (DepoBupivacaine) for prolonged postoperative analgesia.

6 Jan 2009

New hope for leptin as a solution to obesity

The discovery more than a decade ago of leptin, an appetite-suppressing hormone secreted by fat tissue, generated headlines and great hopes for an effective treatment for obesity.

6 Jan 2009

Indevus Pharmaceuticals enters merger agreement with Endo Pharmaceuticals

Indevus Pharmaceuticals, Inc. has announced that it has entered into a definitive merger agreement under which Endo Pharmaceuticals Holdings, Inc.

5 Jan 2009

Endo Pharmaceuticals to acquire Indevus Pharmaceuticals

Endo Pharmaceuticals (NASDAQ:ENDP) and Indevus Pharmaceuticals, Inc. (NASDAQ: IDEV) announced today that they have entered into a merger agreement under which Endo will commence a tender offer to acquire 100 percent of the outstanding shares of Indevus for approximately $370 million, or $4.50 per Indevus share, in cash, and up to an additional approximately $267 million, or $3.00 per Indevus share, in cash payable in the future upon achievement of certain regulatory and sales milestones.

5 Jan 2009

Cylene Pharmaceuticals starts CX-4945 trial - first-in class inhibitor of CK2

Cylene Pharmaceuticals announced today that it has initiated a Phase I clinical trial of its oral CK2 protein kinase inhibitor, CX-4945, in patients with advanced solid tumors, Castleman's disease, or multiple myeloma.

5 Jan 2009

PDL BioPharma and Alexion Pharmaceuticals resolve patent dispute

PDL BioPharma, Inc. and Alexion Pharmaceuticals, Inc. today jointly announced that the companies have entered into a definitive license agreement and settlement agreement that resolve the legal disputes between them relating to Alexion's humanized antibody, Soliris (eculizumab) and PDL's patents known as the Queen et al. patents.

5 Jan 2009