| PPD Confirms Takeda Receives NDA Approval of NESINA® (Alogliptin) from Japanese Ministry of Health, Labour and Welfare (Business Wire) WILMINGTON, N.C.----PPD, Inc. today confirmed that Takeda Pharmaceutical Company Limited’s new drug application for NESINA® , a highly selective DPP-4 inhibitor for the treatment of type 2 diabetes, was approved by the Japanese Ministry of Health, Labour and Welfare on April 16. us.rd.yahoo.com |
Novartis: Gilenia Clears Latest Regulatory Hurdle With Ease EP Vantage submits:The phrase "medical breakthrough" is often overused and misplaced, but in Gilenia’s (fingolimod) case this is truly appropriate as it is on the verge of becoming the first oral drug to treat MS patients, up to 40% of whom are estimated to delay or refuse initial treatment with currently available injectable agents.An FDA advisory committee yesterday issued a surprisingly unanimous recommendation to approve the Novartis (NVS) drug, although the Swiss group is likely to keep celebrations on ice until formal approval is granted in September given the regulator’s recent unpredictability; InterMune’s (ITMN) experience with pirfenidone bears testimony to this. The committee votes were surprising, given safety concerns with the drug and the fact that approval as a first line therapy was also strongly endorsed (Event – Gilenia’s safety the main focus of advisory committee, June 7, 2010). Novartis’ shares gained 3% today to SFr55.55 as multiple analysts announced major upgrades to their Gilenia forecasts, current consensus for which sits at $952m by 2016.Complete Story » seekingalpha.com |
Buyout Shops Swap MultiPlan in $3.1 Billion LBO In one of the year's largest leveraged buyouts, BC Partners and Silver Lake Partners have agreed to purchase health-care company MultiPlan. online.wsj.com |
Cypress Risks Deepening Disquiet With Another Spending Spree EP Vantage submits:One could be forgiven for thinking it rather provocative that a board under fire for an apparently misguided license deal should go straight out and strike two more. Perhaps a sign of single mindedness is exactly the message that Cypress Bioscience (CYPB) is trying to send to its activist hedgefund shareholder, Ramius.After Cypress’ share price halved in value to $2.16 in the wake of a licensing deal over BioLineRx’s antipsychotic CYP-1020 (BL-1020) in June, Ramius ramped up its vociferous calls for change and offered to buy the company for $4 per share, rather than see more money wasted (Ramius fires warning shot across Cypress’s bow, July 20, 2010). Rather than negotiate, Cypress has bought rights to two early-stage projects, Alexza Pharmaceuticals’ (ALXA) Staccato nicotine drug delivery platform, and autism drug carbetocin from Marina Biotech. Some analysts reckon these deals signal Cypress’ intention to press ahead unabated. The question for shareholders is whether this is a viable vision for the future.Complete Story » seekingalpha.com |
Sanofi Blood-Vessel Drug Fails Trial French drug maker Sanofi-Aventis said its experimental blood-vessel medicine NV1FGF failed to meet its target in a late stage clinical trial. online.wsj.com |