Feds Hit Glaxo for $3 Billion; Alexza Announces Adasuve™ PDUFA Goal Date Print E-mail
By Staff and Wire Reports   
Thursday, 05 July 2012 19:25
Below is a look at some of the headlines for companies that made news in the healthcare sector on July 5, 2012.

The Department of Justice hit GlaxoSmithKline (NYSE:GSK) with what it billed as the “largest health care fraud settlement in U.S. history” that is “unprecedented in both size and scope.” Glaxo’s $3 billion in fines and other penalties tops the $2.3 billion Pfizer (NYSE:PFE) paid in 2009, not to mention the $1.5 billion levied against Abbott Labs (NYSE:ABT) in May.

Glaxo sold Paxil to treat depression in kids under 18, despite a lack of pediatric approval. It also promoted depression drug Wellbutrin to treat weight loss and sexual dysfunction, among other things.

But a quick check of corporate annual reports shows that in the past decade, those two drugs alone brought in more than seven times the amount of this settlement. Paxil brought in close to $14 billion, Wellbutrin $8.5 billion.

These are just rough figures. The release also mentions Advair, Lamictal, Zofran, Imitrex, Lotronex, Flovent and Valtrex, and we’ll let you add up the numbers for those. But it’s clear that even a $3 billion settlement isn’t going to scare companies much. Paying the Department of Justice settlements are apparently just a cost of the drug business.


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Alexza Pharmaceuticals, Inc. (NASDAQ:ALXA)
announced the U.S. FDA has accepted the Company's resubmitted ADASUVE New Drug Application (NDA) as a complete, class 2 response to the FDA's action letter, with an indicated Prescription Drug User Fee Act (PDUFA) goal date of December 21, 2012.

On June 22, 2012, Alexza announced that it had resubmitted the ADASUVE NDA, which seeks marketing approval for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults.



Also Thursday:




Acorda Therapeutics, Inc. (Nasdaq: ACOR)
today announced that Jane Wasman, Chief, Strategic Development and General Counsel, will present at the JMP Healthcare Conference on Thursday, July 12, 2012 at 2:30 pm ET at the Peninsula Hotel in New York.

Arena Pharmaceuticals, Inc. (NASDAQ: ARNA)
announced today the promotion of Craig M. Audet to the position of Senior Vice President, Operations and Head of Global Regulatory Affairs. In his new role, Audet will serve as an executive officer of the company.

ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA)
today announced that it will present at the seventh annual JMP Securities Healthcare Conference being held at the Peninsula Hotel in New York City.

Biogen Idec (NASDAQ:BIIB)
and Swedish Orphan Biovitrum (STO:SOBI) today announced the initiation of two global pediatric clinical trials of the companies’ long-lasting recombinant Factor VIII and Factor IX Fc fusion proteins (rFVIIIFc and rFIXFc) in hemophilia A and B.

BIOQUAL (Pinksheets: BIOQ)
has received notice from the National Cancer Institute (NCI) that the NCI will not be exercising its option to renew the contract “Facility for Breeding, Housing, and Handling Genetically Manipulated and Chimeric Mice” for the sixth option year of six possible options, which would have extended the contract for the period from September 16, 2012, to September 15, 2013, and that any remaining work under the contract will be taken over by NCI.

Biogen Idec Inc. (NASDAQ:BIIB)
today announced it will report second quarter 2012 financial results on Tuesday, July 24, 2012, before the financial markets open.

Hi-Tech Pharmacal Co., Inc. (NASDAQ: HITK)
announced that the Company will release results for its fourth quarter of Fiscal Year 2012 ended April 30, 2012, prior to the market opening on Tuesday July 10, 2012 and will hold a conference call to discuss its financial results at 10 a.m. Eastern Time.

InspireMD, Inc. (OTC BB: NSPR)
, a medical device company focusing on the development and commercialization of its proprietary stent platform technology for use in patients with Acute Myocardial Infarctions, announced today that Craig Shore, Chief Financial Officer, will present at the 7th Annual JMP Securities Healthcare Conference on July 12th in New York City.

MannKind Corporation (Nasdaq: MNKD)
, focused on discovering, developing and commercializing treatments for diabetes and cancer, announced today that it will present at the JMP Securities 7th Annual Healthcare Conference on Thursday, July 12, 2012 at 2:30 PM (ET) at The Peninsula Hotel in New York.

MDxHealth SA (NYSE Euronext: MDXH)
, a leading molecular diagnostic company that develops and commercializes epigenetic tests to support cancer treatment, announced today that it has expanded its collaboration with Merck KGaA, Darmstadt, Germany.

Rite Aid Corporation (NYSE: RAD)
today announced sales results for June.

Sucampo Pharmaceuticals, Inc. (NASDAQ: SCMP)
today announced that it will webcast its corporate presentation from The Seventh Annual JMP Securities Healthcare Conference on Thursday, July 12, 2012, at 4:30 pm Eastern.

Sucampo Pharmaceuticals, Inc. (NASDAQ: SCMP)
(SPI) and Abbott (NYSE:ABT) today announced that Sucampo Pharma, Ltd., a wholly owned subsidiary of SPI, has received approval from the Ministry of Health, Labor and Welfare in Japan for AMITIZA® (lubiprostone), a prescription medicine for the treatment of chronic constipation (excluding constipation caused by organic diseases).

Synta Pharmaceuticals Corp. (NASDAQ: SNTA)
today announced that the Company will be presenting at the 7th Annual JMP Securities Healthcare Conference on Friday, July 13 at 11:30 a.m. (ET) in New York.



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