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News Breaks
November 25, 2013
07:04 EDTSNY, ALNYAlnylam earns $7M payment for patisiran Phase II 'success'
Alnylam (ALNY) announced that it has earned a $7M payment from its partner Genzyme, a Sanofi (SNY) company, for achieving Phase II "success" with patisiran. Alnylam recently presented positive Phase II results which showed that multiple doses of patisiran led to robust and statistically significant knockdown of serum TTR protein levels of up to 96%, with mean levels of TTR knockdown exceeding 85%. Knockdown of TTR, the disease-causing protein in ATTR, was found to be rapid, dose dependent, and durable, and similar activity was observed toward both wild-type and mutant protein. In addition, patisiran was found to be generally safe and well tolerated in this study. Alnylam has also recently initiated its APOLLO Phase III trial of patisiran in ATTR patients with FAP, with the study now open for enrollment. Alnylam plans to develop and commercialize the ALN-TTR program in North and South America, Europe, and rest of the world.
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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
13:51 EDTALNYAlnylam COO critical of big pharma, FierceDrugDelivery reports
After Novartis (NVS) decided to end its RNAi research, Alnylam COO Barry Greene told FierceDrugDelivery that big pharma has "never been able to innovate." Greene attributes the recent sell-off in Alnylam shares to "generally bearish sentiment on Wall Street regarding biotech stocks in particular." Reference Link
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
07:35 EDTALNYAlnylam outlook not affected by Novartis decision, says JMP Securities
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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 14, 2014
14:42 EDTALNYAlnylam slips after Novartis reportedly cuts back RNAi development
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April 11, 2014
07:06 EDTSNYVIVUS announces avanafil clinical data presentation
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