|Watson Receives FDA Approval for Generic Actos; Forest Labs in Settlement Pact|
|By Staff and Wire Reports|
|Friday, 26 October 2012 18:42|
Watson Pharmaceuticals, Inc. (NYSE: WPI) announced Watson has launched a generic version of Actos® (Pioglitazone Hydrochloride 15mg, 30mg and 45mg tablets) after receiving final approval today from the U.S. FDA. Watson began shipping the product immediately.
On August 15, 2012, Watson announced that it had filed suit against the FDA challenging the Agency's decision regarding Watson's entitlement to shared exclusivity for its generic version of Actos®. Mylan Pharmaceuticals, Inc. subsequently intervened as a defendant in the action. On October 22, 2012, the U.S. District Court for the District of Columbia granted summary judgment in favor of Watson and ordered the FDA to approve Watson's ANDA. Mylan appealed the judgment to the U.S. Court of Appeals for the District of Columbia Circuit. The Court of Appeals has denied Mylan's motion for a stay of the judgment pending the appeal.
Forest Laboratories, Inc. (NYSE: FRX) and Forest Laboratories Holdings, Ltd. (collectively, “Forest”) announced they have entered into a settlement agreement with Hetero Labs Ltd. and Hetero USA Inc. (collectively, “Hetero”) in patent infringement litigation brought by Forest in response to Hetero's ANDA seeking approval to market generic versions of Forest's BYSTOLIC® (nebivolol) tablets. Specifically, under the terms of the settlement agreement and subject to review of the settlement terms by the U.S. Federal Trade Commission, Forest will provide a license to Hetero that will permit it to launch its generic version of BYSTOLIC® as of the date that is the later of (a) three calendar months prior to the expiration of U.S. Patent No. 6,545,040, including any extensions and/or pediatric exclusivities or (b) the date Hetero receives final FDA approval of its ANDA, or earlier in certain circumstances.
Similar patent infringement litigation brought by Forest against Alkem Laboratories, Ltd., Indchemie Health Specialties Pvt. Ltd., Glenmark Generics Inc., Watson Pharmaceuticals Inc., Torrent Pharmaceuticals Ltd., Amerigen Pharmaceuticals Ltd., and related companies and subsidiaries, remains pending in a multidistrict litigation established in the U.S. District Court for the Northern District of Illinois.
Advanced Cell Technology, Inc. (“ACT”; OTCBB: ACTC), a leader in the field of regenerative medicine, announced today that chairman and CEO Gary Rabin will present at the 2012 Stem Cell Meeting on the Mesa’s Investor and Partnering Forum, Oct. 29 and 30 in La Jolla, California.
AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) today announced it will report unaudited consolidated financial results for the quarter ended September 30, 2012 before the U.S. financial markets open on Thursday, November 1, 2012.
Columbia Laboratories Inc. (Nasdaq: CBRX) today confirmed that the U.S. Food and Drug Administration (FDA) has denied Watson Pharmaceuticals’ (NYSE:WPI) Formal Dispute Resolution Request (FDRR) related to its New Drug Application (NDA 22-139) for Prochieve for the prevention of preterm birth in women with a short cervical length.
Cytori Therapeutics, Inc. (NASDAQ: CYTX) will give a company presentation at the 2012 Stem Cell Meeting on the Mesa’s Investor and Partnering Forum on Tuesday, October 30.
Galectin Therapeutics (NASDAQ: GALT), the leading developer of therapeutics that target galectin proteins to treat fibrosis and cancer, today announced that it will present at the American Association for the Study of Liver Disease (AASLD) Annual Meeting on November 12, 2012, in Boston, MA.
ImmunoGen, Inc. (Nasdaq: IMGN), a biopharmaceutical company that develops anticancer products using its Targeted Antibody Payload (TAP) technology and antibody expertise, today reported financial results for the three-month period ended September 30, 2012 – the first quarter of the Company’s 2013 fiscal year – and provided an update on the Company.
InSite Vision Incorporated (OTCBB:INSV) announced today that it will report financial results for the third quarter ended September 30, 2012 on Thursday, November 8, 2012.
Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced financial results for the third quarter of 2012.
mPhase Technologies, Inc. (OTCBB: XDSL) announced today that the mPower Jump introduced yesterday is a full powered, portable, rechargeable jump starter that features fast recharge times and fits in a glove box.
NuVasive, Inc. (NASDAQ: NUVA), a medical device company focused on developing minimally disruptive surgical products and procedures for the spine, today announced that the U.S. Food and Drug Administration (FDA) has granted Premarket Approval (PMA) for the PCM® Cervical Disc System.
Rapid Fire Marketing (PINKSHEETS: RFMK) ("the Company") a developer, producer and of vapor inhaler products, announced today that its wholly-owned subsidiary, Medical Cannabis Management (MCM), is proud to announce that it has appointed attorney, Michael Levinsohn, to serve on the Advisory Board of the Company effective immediately.
Repligen Corporation (NASDAQ:RGEN) today announced that it will report financial results for the third quarter of 2012 before the NASDAQ Global Market opens on Thursday, November 8.
RTI Biologics Inc. (RTI) (Nasdaq: RTIX), the Florida-based processor of orthopedic, dental, surgical specialties and other biologic implants, is launching a new biologic implant for use in sports medicine, orthopedic and spine surgeries.
Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) announced today that the U.S. Food and Drug Administration (FDA) approved SYNRIBO (omacetaxine mepesuccinate) for Injection to treat adult patients with chronic phase (CP) or accelerated phase (AP) chronic myeloid leukemia (CML) with resistance and/or intolerance to two or more tyrosine kinase inhibitors (TKIs).