FDA

Cephalon, Inc. (Nasdaq: CEPH) filed a lawsuit in U.S. District Court in Delaware against Teva Pharmaceuticals USA, Inc. (Nasdaq: TEVA) for infringement of U.S. Patent Nos. 7,132,570, 7,297,346 and RE37,516 for the Cephalon product NUVIGIL Tablets.

The lawsuit is based upon an Abbreviated New Drug Application (ANDA) filed by Teva seeking FDA approval for a generic equivalent of armodafinil to be sold in the United States. Teva alleges that the above NUVIGIL patents are invalid, unenforceable and/or will not be infringed by Teva's manufacture, use or sale of the product described in its ANDA.

"We believe that our NUVIGIL patents, approved by the US Patent & Trademark Office, are valid, enforceable and are infringed by the proposed Teva ANDA product ," said Jerry Pappert, Executive Vice President and General Counsel. "

Needham & Co lifted theier price targete on Dyax Corp. (Nasdaq: DYAX) to $8 from $6, following FDA approval of KALBITOR for the treatment of acute attacks of hereditary angioedema in patients 16 years of age and older. The firm's Buy rating was maintained.

Analyst Mark Monane states "We are encouraged by KALBITOR label for treatment in HAE regardless of anatomic location and note that KALBITOR represents the only approved treatment option for life-threatening laryngeal attacks. The Company is working on a pediatric development plan for KALBITOR with the EMEA, and while the US KALBITOR label did not include an indication in patients 12-15 years old, we expect off-label use in this population due to multiple similarities with adults, yet limited use in patients 9-12 years old. As we expected, KALBITOR use, although given SQ, is limited at this time to the ER or medical office area: future studies are planned to optimize use of KALBITOR in further outpatient or home settings."

Novo Nordisk (NYSE: NVO) said today that the U.S. Food and Drug Administration (FDA) has approved a 10 mcg dose formulation of Vagifem (estradiol vaginal tablets) for the treatment of atrophic vaginitis due to menopause - a condition experienced by up to 75 percent of postmenopausal women. This approval makes Vagifem 10 mcg the lowest local estrogen therapy (LET) dose commercially available in the U.S. It will be available in pharmacies in the first quarter of 2010.

Atrophic vaginitis, commonly referred to as vaginal atrophy, is directly related to the loss of estrogen associated with menopause. It is caused by the resulting thinning and shrinking of vaginal tissues and the decreased lubrication of the vaginal walls, which can lead to vaginal dryness, soreness, vaginal and or vulvar itching and irritation, painful sexual intercourse and light bleeding after intercourse.

AEterna Zentaris Inc. (NASDAQ: AEZS) announced that the FDA has granted Fast Track designation for the Company's PI3K/Akt pathway inhibitor compound, perifosine (KRX-0401), for the treatment of relapsed/refractory multiple myeloma.

Keryx Biopharmaceuticals, Inc. (Nasdaq: KER), is AEterna Zentaris' partner and licensee for perifosine in the United States, Canada and Mexico.

The Fast Track program of the FDA is designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. Fast Track designated drugs ordinarily qualify for priority review, thereby expediting the FDA review process.

Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX) said the FDA has granted Fast Track designation for KRX-0401 (perifosine), the Company's novel, potentially first-in-class, oral anti-cancer agent that inhibits the phosphoinositide 3-kinase (PI3K)/Akt pathway, for the treatment of relapsed/refractory multiple myeloma.