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Avanir Rises on Faster Development for New Drug
June 6, 2013 8:10 am | News | CommentsShares of Avanir Pharmaceuticals Inc. rose Wednesday after the company said the Food and Drug Administration will allow it to speed research on a newer version of its drug Nuedexta. Avanir said the FDA agreed to a faster development process for its experimental drug AVP-786 and will allow the company to use some data from studies of Nuedexta in its applications for AVP-786.
Actavis Confirms Generic Safyral Patent Challenge
June 6, 2013 8:07 am | News | CommentsActavis, Inc. today confirmed that it has filed an Abbreviated New Drug Application with the FDA seeking approval to market Drospirenone/Ethinyl Estradiol/Levomefolate Calcium Tablets And Levomefolate Calcium Tablets. Actavis' ANDA product is a generic version of Bayer's Safyral, which is approved to prevent pregnancy in women who elect to use an oral contraceptive, and to provide a daily dose of folate supplementation.
Endo to Explore Options on Two Business Units, Cut Jobs
June 5, 2013 6:39 pm | by The Associated Press | News | CommentsEndo Health Solutions Inc. on Wednesday partially reversed course on several years of expansion, saying it will explore strategic options for two businesses and eliminate almost 700 jobs. The company said it will consider options for its HealthTronics urology business and for its branded drug...
Table-Top Twin-Screw Extruder
June 5, 2013 3:39 pm | Product Releases | CommentsThe PTSE 12/36 EC is a table-top 12mm pharmaceutical twin screw extruder suitable for hot melt extrusion, early formulation development and preparation of samples for clinical studies. It offers all necessary technical requirements for small scale formulation development and meets the needs of minimal amounts of expensive API.
Stainless Steel Floor Scale
June 5, 2013 3:26 pm | Product Releases | CommentsThe stainless steel ProDec is available in a combination of sizes and capacities, and the fully stainless steel floor scale is ideal for environments that require strict sanitation. The new platform scale is based on the company’s industry-recognized ProDec model.
Handheld Raman Spectrometer
June 5, 2013 11:08 am | Product Releases | CommentsThe NanoRam handheld Raman spectrometer is an analyzer for material identification and verification within cGMP compliant facilities. It is the only one of its kind due to its high-brightness OLED touch screen display and intuitive software for both technical and non-technical users.
Impax Labs Cuts 110 Manufacturing and Sales Jobs
June 5, 2013 10:33 am | by The Associated Press | News | CommentsGeneric drugmaker Impax Laboratories Inc. said Wednesday it eliminated 110 jobs, or about 10 percent of its workforce, partly because of delays in approval of an important product. Impax said most of the cuts were made at its manufacturing facility in Hayward, where 176 employees worked at the...
What New Diagnoses Could Mean for Pharma Industry
June 5, 2013 8:48 am | Videos | CommentsChanges to the DSM-5, the updated manual of psychiatric illnesses released earlier this month, include 15 new disorders. The Wall Street Journal’s Jen Wieczner looks at how these new disorders could spell new market opportunities for Big Pharma.
Smart Drugs. Too Good to be True?
June 5, 2013 8:38 am | Videos | CommentsIf there was a pill to make you smarter would you take it? A new generation of so-called “smart” drugs is being used by people looking for an edge, but doctors warn of serious potential side effects. Dr. Jeffrey Lieberman of Columbia University Medical Center offers his perspective.
Obesity Surgery-Diabetes Study Shows Pros and Cons
June 5, 2013 8:22 am | by LINDSEY TANNER,AP Medical Writer | News | CommentsObesity surgery worked much better at reducing and even reversing diabetes than medication and lifestyle changes in one of the most rigorous studies of its kind. But the researchers and others warn that possible serious complications need to be considered.
First Manhattan Seeks to Replace Vivus Directors
June 5, 2013 8:12 am | News | CommentsOne of Vivus Inc.'s biggest stockholders is asking shareholders to vote for its slate of board nominees, continuing its push for new leadership at the company. First Manhattan has criticized Vivus for the failed launch of weight loss drug Qsymia. The Food and Drug Administration approved Qsymia in July, and Vivus started selling the drug in September.
Rigel Slumps as AstraZeneca Ends Fostamatinib Deal
June 5, 2013 8:05 am | News | CommentsShares of Rigel Therapeutics Inc. fell to an all-time low Tuesday after its partner AstraZeneca decided not to file for marketing approval of fostamatinib, a rheumatoid arthritis drug Rigel developed. AstraZeneca said earlier studies of fostamatinib were promising, but the company reported results from late-stage studies Tuesday and said they did not measure up.
Judge Halts Royalty Pharma's Bid for Elan Stock
June 5, 2013 7:59 am | by The Associated Press | News | CommentsElan Corp.'s fight against a takeover bid by Royalty Pharma has spilled into U.S. federal court, where a judge has issued a temporary restraining order preventing Royalty from completing its offer to buy the Irish drugmaker. Royalty is a privately held New York company that buys royalty interests in drugs and late-stage drug candidates. It made an offer to buy Elan last month for $12.50 per share, or about $7.5 billion.
Bayer Completes Offer for Conceptus Shares
June 5, 2013 7:54 am | by The Associated Press | News | CommentsBayer AG has acquired a majority stake in birth control maker Conceptus Inc. and expects its $1.1 billion purchase of the California company to be completed soon. Bayer said Wednesday that more than 96 percent of the company's outstanding shares were validly tendered and not withdrawn during an offer period that expired Tuesday.
Bristol-Myers, AstraZeneca Get Faster FDA Review
June 4, 2013 1:50 pm | by The Associated Press | News | CommentsBristol-Myers Squibb Co. and AstraZeneca PLC said Tuesday the Food and Drug Administration will conduct an accelerated review of their lipid disorder drug metreleptin. The companies want to market metreleptin as a treatment for metabolic disorders associated with rare forms of a condition called...
