FDA Expands Use of Approved Breast Cancer Drug

The U.S. Food and Drug Administration today approved Tykerb (lapatinib) in combination with Femara (letrozole) to treat hormone positive and HER2-positive advanced breast cancer in postmenopausal women for whom hormonal therapy is indicated.
HER2 is a protein involved in normal cell growth. It is found on some types of cancer cells, including breast cancer cells. In [...]

FDA Approves Once-A-Day Lamictal(R)XR(TM) as Add-On Epilepsy Therapy for Primary Generalized Tonic-Clonic Seizures

GlaxoSmithKline announced today that the U.S. Food and Drug Administration has approved Lamictal®XR™ (lamotrigine) Extended-Release Tablets as once-a-day, add-on therapy for epilepsy in patients ages 13 years and older with primary generalized tonic-clonic seizures.  This is an expanded label, as Lamictal XR is approved for partial onset seizures (with or without secondary generalization) for patients [...]

Watson Completes Acquisition of Eden Biodesign

Watson Pharmaceuticals, Inc. today announced that it has completed the acquisition of Eden Biopharm Group Limited for approximately $15 million.  Eden is a biopharmaceutical development and contract manufacturing company located in Liverpool, UK.  As a result of the acquisition of the Arrow Group in December 2009, Watson had previously acquired approximately 36 percent of Eden.  [...]

Repligen Announces Long Term Supply Agreement with GE Healthcare for Recombinant Protein A

Repligen Corporation announced today that it has extended its longstanding relationship with GE Healthcare Bio-Sciences AB by entering into a five-year supply agreement for recombinant Protein A, a consumable used in the manufacture of monoclonal antibodies, a highly successful class of biopharmaceutical.  Repligen is the world’s leading supplier of recombinant Protein A and has manufactured [...]

Merck Receives European Approval for ELONVA(R)

Merck & Co., Inc., which operates outside the U.S. and Canada as MSD, today announced the European Commission (EC) approval of ELONVA® (corifollitropin alfa injection). 
ELONVA is indicated for controlled ovarian stimulation (COS) in combination with a GnRH antagonist for the development of multiple follicles in women participating in an assisted reproductive technology program.
With the EC approval, [...]

FDA Authorizes Peramivir for H1N1

Washington, DC – In response to a request from the U.S. Centers for Disease Control and Prevention, The Food and Drug Administration has issued an emergency use authorization for the intravenous (IV) investigational antiviral drug Peramivir, to be used in certain adult and pediatric patients with confirmed or suspected 2009 H1N1 influenza infection who are [...]

Amneal Expands Generic Portfolio

Hauppauge, NY – Amneal Pharmaceuticals announces the availability of its Alprazolam Extended Release Tablets in strengths of 0.5 mg, 1 mg, 2 mg and 3 mg.  The company also announces the availability of its Benazepril HCl Tablets in strengths of 5 mg, 10 mg, 20 mg and 40 mg.
Alprazolam ER is an anti-anxiety Schedule-IV controlled [...]

Alabama Supreme Court Overturns Verdict Against Novartis

EAST HANOVER, N.J., – The Alabama Supreme Court today overturned a jury verdict against Novartis Pharmaceuticals Corporation (NPC), and directed entry of judgment in favor of NPC.
The State of Alabama had claimed prices provided by NPC to reporting services resulted in overpayment to pharmacists and doctors in the Alabama State Medicaid system, and a Montgomery [...]

Benign Paroxysmal Positional Vertigo

 For Robert, a 54 year old sales executive, effective treatment for his Benign Paroxysmal Positional Vertigo (BPPV) was a long time in coming. His story, typical of those who suffer from BPPV, shows how frustrating this treatable, recurrent condition can be for patients and physicians, and highlights the need for improved access to the right [...]

Amicus Therapeutics Announces Preliminary Results of Phase 2 Study with Plicera(TM) for Gaucher Disease

CRANBURY, N.J., Oct. 2 — Amicus Therapeutics (Nasdaq: FOLD) today announced preliminary results from its Phase 2 randomized, open-label study to assess the safety, tolerability and preliminary efficacy of its investigational drug, Plicera(TM) (afegostat tartrate), in treatment-naive adult patients with type 1 Gaucher disease. Two dose regimens of Plicera (225 mg three days on/four days [...]

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