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News Breaks
January 29, 2014
05:34 EDTSNYSanofi, Transgene launch construction phase of new bioproduction platform
Sanofi and Transgene SA announced that they have launched the construction phase of the manufacturing platform dedicated to the production of viral vectors, such as Transgene’s MUC1 targeted cancer immunotherapy, TG4010. In March 2013, the companies announced a long-term collaboration agreement to build the unit, which is to be constructed on the Genzyme Polyclonals site in Lyon, an important French biopharmaceutical cluster. The companies together will invest approximately EUR 10M in the production unit over an expected two-year timeframe, of which Transgene's share will be approximately EUR 5M. This dedicated platform will be Sanofi’s exclusive property and will enable to produce a new breakthrough class of APIs.
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April 23, 2014
06:54 EDTSNYCambridge Healthtech Institute to hold a conference
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06:54 EDTSNYGlobal Technology Community to hold a summit
7th Annual Diabetes Summit is being held in Cambridge, MA on April 23-25.
06:53 EDTSNYFood & Drug Law Institute to hold a conference
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06:16 EDTSNYPharmaceutical companies narrowing focus, WSJ reports
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April 21, 2014
11:33 EDTSNYAward of $16M to Sanofi, Abbott for damages upheld on appeal
The Court of Appeals for the Federal Circuit affirmed a lower court ruling that Glenmark Pharmaceuticals infringed a patent related to the antihypertension drug Tarka that is owned by or exclusively licensed to Sanofi (SNY), Abbott Labs (ABT), and their related companies. In the prior case, Glenmark admitted infringement and the jury awarded $15.2M in lost profits and about $800K in price erosion damages. The appeals court affirmed the district court's jurisdiction in the matter, as well as its judgment and related rulings. Reference Link
08:36 EDTSNYAastrom announces definitive agreement to acquire Sanofi's CTRM business
Aastrom Biosciences (ASTM) announced that it has entered into a definitive agreement to acquire Sanofi's (SNY) Cell Therapy and Regenerative Medicine, or CTRM, business for a purchase price of $6.5M, with $4M payable in cash at closing and $2.5M payable in the form of a promissory note. The acquisition is subject to customary closing conditions and is scheduled to close in approximately three weeks. Through the CTRM acquisition, Aastrom is acquiring global commercial rights to three marketed autologous cell therapy products. Aastrom will also acquire global manufacturing and production centers located in the United States and Denmark.
08:32 EDTSNYAastrom announces definitive agreement to acquire Sanofi's CTRM business
07:21 EDTSNYFDA Pediatric Advisory Committee to hold a meeting
The Committee discusses pediatric-focused safety reviews including MDT's Activa Dystonia Therapy, (BAX's Advate and Tisseel, NVS' Famvir, Tibotec's (JNJ subsidiary) Intelence, UCB Pharma's Keppra, MRK's Maxalt, BAYRY's Natazia, Digestive Care's Pertzye, JNJ's Prezista, BMY's Reyataz, SNY's Sklice, PFE's Torisel, Aptalis' Ultresa, and GILD's Viread in a meeting being held in Bethesda, Maryland on April 21 at 8 am. Webcast Link
April 16, 2014
09:15 EDTSNYImpax launches generic Renvela for kidney disease licensed from Sanofi
Impax Laboratories (IPXL) is commencing shipment of authorized generic Renvela 800 mg tablets, through Global Pharmaceuticals, Impax's generics division. Renvela is indicated for the control of serum phosphorus in patients with chronic kidney disease on dialysis. Under the terms of a settlement agreement, Sanofi (SNY) company Genzyme agreed to grant Impax a license to sell an allotment of a specified number of bottles of an authorized generic version of Renvela tablets commencing on April 16. Impax continues to pursue approval of its pending Abbreviated New Drug Application for generic Renvela with the FDA.
April 15, 2014
06:32 EDTSNYPatients paying much more for specialty drugs, NY Times says
The amount that patients with certain diseases must pay for specialty drugs has increased significantly, a research firm reported, according to The New York Times. Meanwhile, consumers' use of health care increased in 2013 for the firm time in three years, the newspaper quoted the firm, the IMS Institute for Healthcare Informatics, as saying. Publicly traded drug makers include AstraZeneca (AZN), Bristol-Myers (BMY), Eli Lilly (LLY), GlaxoSmithKline (GSK), Johnson & Johnson (JNJ), Merck (MRK), Novartis (NVS), Pfizer (PFE), Roche (RHHBY) and Sanofi (SNY). Publicly traded health insurers include AMERIGROUP (AGP), Aetna (AET), Centene (CNC), Cigna (CI), Health Net (HNT), Healthspring (HS), Humana (HUM), Molina Healthcare (MOH), UnitedHealth (UNH), WellCare (WCG) and WellPoint (WLP).Reference Link
April 11, 2014
07:06 EDTSNYVIVUS announces avanafil clinical data presentation
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