UCB (BE) - Cimzia, the only PEGylated anti-TNF, approved in Europe and available in a syringe designed in partnership with OXO Good Grips

UCB announced today that the European Commission (EC) approved Cimzia®, in combination with MTX, for the treatment of moderate to severe active RA in adult patients inadequately responsive to disease-modifying antirheumatic drugs (DMARDs) including MTX.

The details can be read here.

Allos Therapeutics Announces U.S. Availability of FOLOTYN (pralatrexate injection)

Oct 5, 2009 - Allos Therapeutics, Inc. today announced that FOLOTYN™ (pralatrexate injection) is now available for commercial sale in the United States. The U.S. Food and Drug Administration (FDA) granted accelerated approval for FOLOTYN for use as a single agent for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL) on September 24, 2009.

The details can be read here.

License to Market Kremezin (drug for chronic renal failure) in Japan

Oct. 5, 2009--KUREHA CORPORATION and Mitsubishi Tanabe Pharma Corporation have entered into an agreement, effective on November 1, 2009, under which KUREHA shall grant Mitsubishi Tanabe a license to market Kremezin® in Japan, a drug for chronic renal failure developed by KUREHA.

The details can be read here.

Vivaldi Biosciences Inc. Announces Issuance of US Patent for Influenza Vaccines

Oct 5, 2009 - Vivaldi Biosciences Inc. (Vivaldi), a biotechnology company focused on development of vaccines for influenza, today announced that the United States Patent and Trademark Office has issued US Patent 7,588,768 covering live attenuated influenza vaccines (LAIVs) with modifications to the viral NS1 gene, and methods for producing the vaccines in cell culture systems.

The details can be read here.

Impax Laboratories Receives Tentative FDA Approval for Generic FLOMAX 0.4mg Capsules

Oct 5, 2009 - Impax Laboratories, Inc. today confirmed that the U.S. FDA has granted tentative approval of the Company's Abbreviated New Drug Application (ANDA) for generic version of FLOMAX® (tamsulosin hydrochloride) 0.4mg capsules.

The details can be read here.

Addrenex Pharmaceuticals Files sNDA Submission for Clonicel to Treat ADHD

Oct 1, 2009 - Addrenex Pharmaceuticals and Sciele Pharma, Inc., a Shionogi company today announced that Addrenex has submitted a supplemental New Drug Application (sNDA) to the United States Food and Drug Administration (FDA) for Clonicel (modified-release clonidine) to treat attention deficit hyperactivity disorder (ADHD).

The details can be read here.

Avodart (dutasteride) Regulatory Update

Oct. 1, 2009--GlaxoSmithKline (GSK) announced today that it has filed a supplemental New Drug Application (sNDA) for Avodart® (dutasteride) with the US Food and Drug Administration (FDA) for prostate cancer risk reduction among men at increased risk of developing the disease. EU filings also are underway via the European Mutual Recognition Variation Procedure, with Sweden acting as the Reference Member State.

Astellas and Theravance Announce Approval of Vibativ (telavancin) in Canada

October 1, 2009 - Astellas Pharma Canada, Inc. and Theravance, Inc. announced today that Health Canada has approved VIBATIV™ (telavancin) for the treatment of adult patients with complicated skin and skin structure infections (cSSSI) caused by susceptible Gram-positive bacteria, including Staphylococcus aureus, both methicillin-resistant (MRSA) and methicillin-susceptible (MSSA) strains.

The details can be read here.

FDA Approves New Indication For Mirena to Treat Heavy Menstrual Bleeding in IUD Users

Bayer HealthCare Pharmaceuticals, Inc., announced today that the U.S. Food and Drug Administration (FDA) approved a new indication for Mirena® (levonorgestrel-releasing intrauterine system) for the treatment of heavy menstrual bleeding in women who choose to use intrauterine contraception as their method of contraception.

The details can be read here.

Nutra Pharma Announces Manufacturing Release of Cobroxin, a Treatment for Chronic Pain

Oct 2, 2009 - Nutra Pharma Corp., a biotechnology company that is developing treatments for Adrenomyeloneuropathy (AMN), HIV and Multiple Sclerosis (MS), has announced today that it has completed manufacturing the first commercial batch of Cobroxin and has successfully released it for final distribution.

The details can be read here.

Impax Laboratories Commences Shipment of Generic Adderall XR Capsules

Oct 1, 2009 - Impax Laboratories, Inc. today announced that it is commencing shipment of its authorized generic version of Adderall XR® (Amphetamine and dextroamphetamine mixed salts) Capsules, 5mg, 10mg, 15mg, 20mg, 25mg and 30mg, through Global Pharmaceuticals, Impax's generic division.

The details can be read here.

Actavis (IS) - Actavis' clients launch first generic Atorvastatin in Spain

1 October 2009 -- Actavis Group, the international generic pharmaceuticals company, today announced that its third-party sales division, Medis, has delivered 30 million tablets of Atorvastatin to its clients in Spain. This is the first generic version of the blockbuster molecule to reach the Spanish market.


The details can be read here.

Mylan Receives FDA Approval for Generic Version of Parkinson's Treatment Sinemet

Mylan Inc.today announced that its subsidiary Mylan Pharmaceuticals Inc. has received approval from the U.S. FDA for its Abbreviated New Drug Application (ANDA) for Carbidopa and Levodopa Tablets USP, 10mg/100mg, 25mg/100mg and 25mg/250 mg.

The details can be read here.

Hospira Acquires Worldwide Rights to Biogeneric Version of Filgrastim

Hospira, Inc., a global specialty pharmaceutical and medication delivery company, today announced the acquisition of worldwide rights to a biogeneric version of filgrastim and an affiliated European manufacturing facility from PLIVA Hrvatska d.o.o. (Zagreb, Croatia) , a move that will help extend Hospira's reach and vertical integration in biogenerics. Financial terms of the agreement were not disclosed.

The details can be read here.

Labopharm receives notice of ANDA submission with paragraph IV certification for generic of Ryzolt

Labopharm Inc. today announced it has received notice from Sun Pharma Global FZE advising that Sun has submitted an Abbreviated New Drug Application (ANDA) to the U.S. FDA for approval to market 100, 200 and 300 mg generic versions of Ryzolt(TM) (tramadol hydrochloride extended-release 100, 200 and 300 mg tablets) in the United States.

The details can be read here.