U.S. FDA Delays Decisions Due to Sandy; J&J Drug Wins Wider Approval Print E-mail
By Staff and Wire Reports   
Friday, 02 November 2012 18:54
Below is a look at some of the headlines for companies that made news in the healthcare sector on November 2, 2012.

U.S. health regulators will delay decisions on some drugs for up to two days because of the massive storm Sandy, which closed the federal government.

The Food and Drug Administration said on Friday that the delay in meeting regulatory timelines for prescription drugs, medical devices and biosimilar drugs would apply to those with target dates around Oct. 29 and 30, when offices were closed.

For those drugs with target dates on Oct. 31 or later, the agency will consider whether a delay is warranted, but it will not exceed two days.

Sandy hit the East Coast late on Monday. The U.S. government closed ahead of the storm, and again on Tuesday due to widespread power outages and transit issues.

The FDA has set times to review drugs under a user fee program that manufacturers help fund in return for the agency's meeting certain performance goals. For instance, it must review a certain percentage of drug applications within a set time.

New drug application target approval dates under the Prescription Drug User Fee Act, or PDUFA, are closely watched because they indicate when companies will be able to start selling their new products.

The Biosimilar User Fee Act - which applies to a new generation of generic biotech treatments - and the Medical Device User Fee Act also have approval schedules.

The FDA also said that applications submitted while it was closed might have adjusted timelines. (Reporting by Caroline Humer; Editing by Lisa Von Ahn)



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U.S. regulators on Friday said they had approved expanded use of Johnson & Johnson's (NYSE:JNJ) Xarelto blood thinner, to treat blood clots in the legs and lungs and to reduce the risk of such clots recurring after initial treatment.

The pill is already approved to reduce the risk of such leg clots, called deep vein thrombosis, and lung clots, following knee or hip replacement surgery. It is also already approved to prevent strokes in patients with an irregular heartbeat called atrial fibrillation.

"Xarelto is the first oral anti-clotting drug approved to treat and reduce the recurrence of blood clots since the approval of warfarin 60 years ago," the FDA said in a release.



Also Friday:



Amgen (NASDAQ: AMGN)
will present data from four Phase 2 trials of AMG 145, an investigational fully human monoclonal antibody directed against PCSK9, a protein that reduces the liver's ability to remove low density lipoprotein cholesterol (LDL-C), or "bad" cholesterol from the blood, at the upcoming American Heart Association (AHA) Scientific Sessions 2012.

Antares Pharma, Inc. (NASDAQ: ATRS)
today announced it will release its third quarter 2012 financial results before the market opens on Wednesday, November 7, 2012, and host a conference call shortly thereafter at 8:30 a.m. ET (Eastern Time) to discuss the results.

Assisted Living Concepts, Inc. (NYSE: ALC)
reported a net loss of $4.0 million in the third quarter of 2012 as compared to net income of $5.8 million in the third quarter of 2011.

Bristol-Myers Squibb Company (NYSE: BMY)
and Pfizer Inc. (NYSE: PFE) today announced that a large number of data presentations sponsored by the companies on ELIQUIS® (apixaban) and the treatment of atrial fibrillation will be presented at the American Heart Association 2012 Scientific Sessions, November 3-7, 2012, in Los Angeles, California.

Celsion Corporation (NASDAQ: CLSN)
, a leading oncology drug development company, today announced that it would hold a conference call to discuss third quarter 2012 results at 11:00 a.m. ET on Monday, November 12, 2012.

China Biologic Products, Inc. (NASDAQ: CBPO)
, a leading fully integrated plasma-based biopharmaceutical company in China, today announced that the Company plans to release third quarter 2012 financial results on Thursday, November  8, 2012 after the market closes.

Corgenix Medical Corporation (OTC BB: CONX)
, a worldwide developer and marketer of diagnostic test kits, will host a conference call on Tuesday, November 13, 2012, at 4:00 p.m. EST to discuss the Company’s financial and operating performance for its quarter ended September 30, 2012, and the status of the Company’s product development and marketing activities.

Cubist Pharmaceuticals, Inc. (NASDAQ: CBST)
today announced that company management will discuss Cubist’s business activities and financial outlook at investor conferences during November 2012.

Dendreon Corporation (Nasdaq: DNDN)
today reported results for the quarter ended September 30, 2012.

Enzo Biochem Inc. (NYSE:ENZ)
reported yesterday that the jury in the Enzo action entitled Enzo Biochem, Inc. et al. vs. Applera Corp. and Tropix Inc. in New Haven, CT Civil Action No. 3:04cv929 (JBA), has rendered its verdict that Applera Corp., now Life Technologies, Inc. (NASDAQ:LIFE), infringed Enzo’s patents covering pioneering technologies relating to compounds used in DNA sequencing systems to read the genetic code.

Lannett Company, Inc. (NYSE MKT: LCI)
, today announced that the company will release its fiscal 2013 first quarter financial results on Thursday, November 8, 2012 after the market closes.

Novadaq® Technologies Inc. (TSX:NDQ) (NASDAQ:NVDQ)
, a developer of clinically-relevant fluorescence imaging solutions for use in surgical procedures, today announced financial results for its third quarter ended September 30, 2012.

Orthofix International N.V., (NASDAQ:OFIX)
(the Company) announced today that the Company’s Global Vice President of Research and Development, Chuck Jaggers, will be a speaker at the first annual Texas Medical Device Symposium today at the University of Texas at Dallas.



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