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by Michael Manns, Senior Equity Analyst & Jason McGorman, Equity Analyst, Bloomberg Industries China is now the world‘s second largest market for medical equipment, behind the U.S. Hospitals have purchased imaging and diagnostic equipment in compliance with the 2009 health reform that included a $124 billion stimulus package to build medical clinics in every village [...]
Pfizer’s novel rheumatoid arthritis drug (RA) Xeljanz has had a strong launch in the U.S. Initial analysis of prescription data from Symphony Health Solutions suggests that Xeljanz use will not be limited to patients who have an inadequate response to TNF inhibitors, which currently dominate the market. Additional data on a higher dose and use [...]
Lexicon may be able to secure a partner for diabetes drug LX4211 following the favorable review of Johnson & Johnson’s Invokana by a panel that met to advise the FDA ahead of its decision on approval. The company has said it wants to seal a partnership for the drug before launching Phase III trials, which [...]
By Jason M. Brocks, Bloomberg Law A recent opinion issued by the United States Court of Appeals for the Fourth Circuit raises the pleading standard in cases alleging False Claims Act (FCA) violations by drug companies for off-label use of their drugs resulting from their own marketing practices. According to the court, a claim alleging [...]
NuPathe may gain approval for its first commercial product Zecuity, a transdermal migraine patch, this week. The company received a Prescription Drug User Fee Act (PDUFA) date of Jan.17 from the FDA. Click here to continue reading.
Allergan’s supplemental biologics license application (sBLA) for a Botox label expansion to idiopathic overactive bladder (OAB) may receive a final decision this month. The application has a PDUFA date in January, according to estimates by Bloomberg Industries, which are based on the company’s submission in both the U.S. Click here to continue reading.
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Several key presentations will be made at the American Society of Hematology (ASH) annual meeting in Atlanta, Georgia on Dec. 8-11. On Dec. 11, Celgene will present progression free survival (PFS) and overall survival (OS) data from the MM-003 study, a pivotal Phase III trial that tested pomalidomide in refractory resistant multiple myeloma. The drug [...]
The new drug application (NDA) for Zogenix/Alkermes/Paladin Labs’ Zohydro ER (hydrocodone bitartrate extended-release capsules) will be reviewed by a panel advising the FDA this week. To continue reading click here: To subscribe to the full newsletter please contact us at: Annie Gustavson Bloomberg Briefs email@example.com 212-617-0544
Chris Garabedian, President and Chief Executive Officer of Sarepta, told Bloomberg Brief: Healthcare Finance’s Elizabeth Krutoholow that the results seen with lead drug eteplirsen for Duchenne Muscular Dystrophy (DMD) have provided proof-of-concept to support the company’s phosphorodiamidate morpholino oligomer technology. He said the company will focus on DMD and eventually other rare genetic diseases. Sarepta [...]