FDA Approves Avanir and Forest Labs Treatments for PBA and Bacterial Infections

FDA Ends October With Drug Approvals

BOSTON (TheStreet) -- U.S. regulators ended October with two drug approvals, clearing an antibiotic from Forest Labs(FRX_) and a first-time treatment for a neurological disorder developed by Avanir Pharmaceuticals(AVNR).

Investors are still waiting on the fate of Biodel's (BIOD) fast-acting insulin Linjeta. The U.S. Food and Drug Administration was expected to issue an approval decision Friday, but the news could come Monday.

October was a busy but tough month for new drug approvals at the FDA. Regulators rejected seven new drugs, including a diabetes drug from Amylin Pharmaceuticals (AMLN) and weight-loss drugs from Arena Pharmaceuticals (ARNA) and Vivus (VVUS), respectively.

The FDA approved four drugs: the two mentioned above plus drugs from Questcor Pharmaceuticals(QCOR) and Alkermes (ALKS).

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The Forest Labs (FRX) injectable antibiotic Teflaro approved Friday will be used to treat patients with pneumonia and bacterial skin infections, including methicillin-resistant Staphylococcus aureu, or MRSA.

Battling Deadly Diseases--13 Antibiotic Makers

Image via Wikipedia

Top Antibiotic Makers:

Trius Therapeutics--(TSRX)
Forest Labs--(FRX)
Optimer Pharmaceuticals--(OPTR)

These stocks haven't necessarily done extremely well this year, but the high cost of Clinical Trials leads to debt.  Once the clinical trials are approved and these antibiotics go on the market these should have noticeable gains.  I think these could have potential to invest in the long term futures.

Another company of note is SIGA Technologies (SIGA).  SIGA makes bioweapons vaccines for the government and recently announced a government contract for small pox treatment.  From Marketwatch:  SIGA soars on government contract. 
 
Hope In The Grim Fight Against Drug-Resistant Germs

Bristol-Myers Acquires ZymoGenetics

Image via Wikipedia Healthcare Sector Breaking News for Tuesday, September 07, 2010

Bristol-Myers Squib to merge with ZymoGenetics

After the bell Tuesday, Bristol-Myers Squibb Company (NYSE:BMY) and ZymoGenetics, Inc. (NASDAQ: ZGEN) announced today that the companies have signed a definitive agreement providing for the acquisition of ZymoGenetics by Bristol-Myers Squibb, for $9.75 per share in cash.

Forest Labs FDA Panel Review and Phase II Clinical Trial Results

Chemical Structure of Ceftaroline This just in to marketwatch today.

Forest-Gedeon Richter drug misses overall goal

TEL AVIV (MarketWatch) -- Forest Laboratories Inc. FRX 29.56, +0.37, +1.27%) and Gedeon Richter PLC said Monday that in a Phase II study of cariprazine, a potential treatment for bipolar depression, the overall result for patients taking the drug was not statistically different from that of the patients taking placebo. In higher doses, however, the antipsychotic drug did show "evidence of a clinically relevant treatment effect," the drugmakers, based respectively in New York and Budapest, said. The primary endpoint was the scores on the Montgomery Asberg Depression Rating Scale, they said. The companies are mulling whether to do another Phase II study of the drug to examine a wider range of doses. Meantime, the drug is in Phase III trials for, separately, schizophrenia and bipolar mania

News concerning Tomorrow's FDA decision. This is an antibiotic up for approval up for review tomorrow Sept. 7th, 2010.

FDA Panel Alert: Forest Labs

Comprehensive List of Drug Approvals From 2009

Image by boodoo via Flickr I found a nice list of all the drugs approved in 2009 and their respectable companies.

Those of note were Glaxo SmithKline (GSK) with HPV vaccine, H1N1, seasonal flu vaccine, renal carcinoma, and lymphocyte leukemia.

Novartis (NVS) for H1N1, seasonal flu vaccine, MS, malaria, and schizophrenia.

Schering-Plough, now Merck (MRK) , for schizophrenia. Schering was bought out for their extensive drug pipeline of numerous upcoming drugs.

Sanofi-Aventis (SNY) had an antiarrhythmic drug, along with another flu vaccine for elderly patients. Sanofi is getting snuffed out with the Genzyme takeover bid but the bidding could still continue.

Others included Takeda Pharmaceuticals (TKPHF), Cypress Biosciences/Forest Labs, Allos Therapeutics, Lilly/Daiichi Sankyo, Gloucester Pharmaceuticals, and Theravance.

Forest Labs Antibiotic Seems Effective FDA Notes Revealed

Image via Wikipedia FDA staff back safety, efficacy of ceftaroline

* Advisory panel to review drug on Tuesday
* Forest shares up 5.4 pct in afternoon
* Nearly $361 million in ceftaroline sales seen in 2014 (Revises first sentence, adds analyst comment, updates shares)
By Lisa Richwine

WASHINGTON, Sept 2 (Reuters) - A Forest Laboratories Inc (FRX.N) antibiotic appears effective with risks similar to current options, U.S. drug reviewers said in an analysis that raised hopes for the medicine's approval.

Shares of Forest, which needs new medicines to offset looming patent expirations on its major drugs, were up $1.49 or 5.4 percent at $29.14 on the New York Stock Exchange after the Food and Drug Administration released its preliminary review on Thursday.

Analysts expect nearly $361 million in sales in 2014 for the potential new antibiotic called ceftaroline, according to Thomson Reuters forecasts.