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FDA approves Amneal Pharmaceuticals' Tramadol/APAP tablets

Amneal Pharmaceuticals is pleased to announce that it received U.S. FDA approval to manufacture combination Tramadol HCl in 37.5 mg strength and Acetaminophen in 325 mg strength (Tramadol/APAP) in tablet form effective December 9, 2009. Amneal’s generic is an AB-rated, therapeutically equivalent alternative to Ultracet® (a licensed trademark of Ortho-McNeil Janssen). U.S. sales of Tramadol/APAP were $61 MM according to June 2009 IMS Health market data.

8 Feb 2010

QIAGEN acquires global licence for PI3K gene to develop real-time-PCR and endpoint PCR assays

QIAGEN today announced that its wholly owned subsidiary DxS has acquired the global and exclusive licence for biomarker PI3K from Johns Hopkins University to develop real-time-PCR and endpoint PCR assays.

From QIAGEN Manchester Limited 8 Feb 2010

Anthera Pharmaceuticals reaches agreement with the FDA on SPA for VISTA-16 clinical study

Anthera Pharmaceuticals, Inc., a privately held biopharmaceutical company developing drugs to treat serious diseases associated with inflammation, announced today that it reached an agreement with the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) for the Phase 3 clinical study named VISTA-16 (Vascular Inflammation Suppression to Treat Acute Coronary Syndrome - 16 Weeks) for its lead product candidate, A-002, an oral sPLA2 inhibitor, in combination with HMG-CoA reductase inhibitor, or statin, therapy for short-term (16-week) treatment of patients experiencing an acute coronary syndrome.

8 Feb 2010

AMRI announces fourth-quarter and full-year 2009 results

AMRI today reported financial and operating results for the fourth quarter and full year ending December 31, 2009.

8 Feb 2010

3SBio announces Nephoxil collaboration and license agreement with Panacor Bioscience

3SBio Inc., a leading China-based biotechnology company focused on researching, developing, manufacturing and marketing biopharmaceutical products, today announced a collaboration and license agreement with Panacor Bioscience Ltd. to develop and commercialize its Nephoxil(R) pharmaceutical product for the treatment of hyperphosphatemia in China.

8 Feb 2010

LPC Pharma Group outsources pharmacovigilance/drug safety operations to APCER Pharma

APCER Pharma announced that LPC Pharma Group is outsourcing its pharmacovigilance/drug safety operations to APCER.

8 Feb 2010

Novavax to discontinue collaboration agreement with ROVI Pharmaceuticals

Novavax, Inc. announced today that the company has decided to discontinue negotiations in its pursuit of the previously announced collaboration with ROVI Pharmaceuticals to develop Novavax's virus-like-particle (VLP)-based vaccines against influenza in the country of Spain.

8 Feb 2010

Babson Executive Education offers program for bio-pharma professionals

Babson Executive Education is offering Bio-Pharma: Mastering the Business of Science, which will help you contribute more to your company by strengthening your understanding of strategy, finance, marketing, and leadership in the biotechnology and pharmaceutical industries.

6 Feb 2010

HTDS announces recent business developments

Hard to Treat Diseases (HTDS; http://www.htdsmedical.com/) brings attention to a certain previously released news announcements namely January 7 2009, November 19, 2009, Dec 15, 2009 January 12,2010, and January 22, 2010.

6 Feb 2010

Teva Pharmaceutical Industries reaches settlement in principle to resolve claims under federal, state False Claims Acts

Teva Pharmaceutical Industries Ltd. announced today that several of its subsidiaries in the United States reached a settlement in principle to resolve claims brought by Ven-A-Care of the Florida Keys, Inc. on behalf of the United States, Texas, Florida, and California under federal and state False Claims Acts.

6 Feb 2010

Breakthrough research could lead to new potential treatments for malaria

Groundbreaking research done at Singapore's Nanyang Technological University's (NTU) School of Biological Sciences (SBS) could lead to the development of more potent drugs or a vaccine for malaria, which is transmitted to humans by infected mosquitoes and kills up to three million people each year.

6 Feb 2010

AMAG Pharmaceuticals releases safety update on Feraheme Injection

AMAG Pharmaceuticals, Inc., a biopharmaceutical company focused on the development and commercialization of a therapeutic iron compound to treat anemia and novel imaging agents to aid in the diagnosis of cancer and cardiovascular disease, today provided a safety update on Feraheme® (ferumoxytol) Injection for intravenous use.

6 Feb 2010

Health bill stall creates uncertainty for drug makers

"With the possible demise of health care legislation, getting back to business as usual may not be the best thing for the nation's drug makers," The New York Times reports. "After all, in return for the prospect of tens of millions of newly insured customers and a large degree of regulatory certainty, the pharmaceutical industry had agreed to pay a relatively small price: $8 billion a year in discounts and fees.

6 Feb 2010

Strativa Pharmaceuticals' Zuplenz NDA: FDA issues complete response letter

Strativa Pharmaceuticals announced today that the U.S. Food and Drug Administration (FDA) issued a complete response letter regarding the new drug application (NDA) for Zuplenz® (ondansetron) oral soluble film for the prevention of nausea and vomiting associated with highly- and moderately-emetogenic chemotherapy, radiotherapy and surgery.

6 Feb 2010

CREON effective in improving CFA and CNA in pediatric patients with EPI due to CF

Solvay Pharmaceuticals, Inc. announced that Phase IIIb data published in the January issue of Clinical Therapeutics confirm that CREON® (pancrelipase) Delayed-Release Capsules significantly improves a key measure of fat absorption in children aged 7-11 years who have exocrine pancreatic insufficiency (EPI) due to cystic fibrosis (CF), EPI is a condition resulting from a deficiency in the production and/or secretion of pancreatic enzymes that are necessary to digest nutrients in food.

5 Feb 2010

Biotechnology: The next medical revolution

A recent article in the Scandia Journal reported that biotechnology is helping to improve our knowledge of many devastating illnesses, and has armed patients and their doctors with exciting new diagnostics and treatments to battle disease.

5 Feb 2010

Centerphase Solutions and Mayo Clinic collaborate to speed up clinical trials for new medical treatments

Centerphase has entered into a collaboration with Mayo Clinic to speed the introduction of new medical treatments developed by the biopharmaceutical industry. The Company addressed the root causes historically plaguing the clinical trials process: the lack of a systematic, structured approach for evaluating and optimizing protocols and the tremendous burdens associated with trial start-up administration.

5 Feb 2010

Pharma IQ to organize 4th Improving Solubility conference at The Park Hyatt in Philadelphia

Organized by Pharma IQ, a division of IQPC, the 4th Improving Solubility conference will be held March 29-31, 2010 at The Park Hyatt in Philadelphia, PA. This forum brings together pharmaceutical researchers and scientists to uncover advances in enhancing solubility, amorphous forms, bioavailability & lipid-based formulation of drugs.

From IQPC Ltd 5 Feb 2010

ABC Laboratories expands offering to include comprehensive support for large molecule development

Recognizing an increased industry need for outsourced biopharmaceutical drug development services, Analytical Bio-Chemistry Laboratories (ABC) has expanded its offering to include comprehensive support for large molecule development.

5 Feb 2010

Access Pharmaceuticals initiates Cobalamin technology program for targeted delivery of siRNA therapies

ACCESS PHARMACEUTICALS, INC. announced today that it initiated an internal pre-licensing program to confirm the utility of its proprietary Cobalamin (vitamin B12) platform technology for targeted delivery of siRNA therapies. The program is considered important because, despite the widely publicized potential of RNA therapy, researchers up to now have been stymied in their efforts to design a pharmaceutical product that efficiently transports siRNA therapeutics into the cells they are designed to inhibit or kill.

5 Feb 2010

Pharmaceuticals News and Research

FDA approves Amneal Pharmaceuticals' Tramadol/APAP tablets

QIAGEN acquires global licence for PI3K gene to develop real-time-PCR and endpoint PCR assays

Anthera Pharmaceuticals reaches agreement with the FDA on SPA for VISTA-16 clinical study

AMRI announces fourth-quarter and full-year 2009 results

3SBio announces Nephoxil collaboration and license agreement with Panacor Bioscience

LPC Pharma Group outsources pharmacovigilance/drug safety operations to APCER Pharma

Novavax to discontinue collaboration agreement with ROVI Pharmaceuticals

Babson Executive Education offers program for bio-pharma professionals

HTDS announces recent business developments

Teva Pharmaceutical Industries reaches settlement in principle to resolve claims under federal, state False Claims Acts

Breakthrough research could lead to new potential treatments for malaria

AMAG Pharmaceuticals releases safety update on Feraheme Injection

Health bill stall creates uncertainty for drug makers

Strativa Pharmaceuticals' Zuplenz NDA: FDA issues complete response letter

CREON effective in improving CFA and CNA in pediatric patients with EPI due to CF

Biotechnology: The next medical revolution

Centerphase Solutions and Mayo Clinic collaborate to speed up clinical trials for new medical treatments

Pharma IQ to organize 4th Improving Solubility conference at The Park Hyatt in Philadelphia

ABC Laboratories expands offering to include comprehensive support for large molecule development

Access Pharmaceuticals initiates Cobalamin technology program for targeted delivery of siRNA therapies

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