FDA delays decision on Gilead's HIV drug; Amgen drug flunks late-stage CKD study

@FierceBiotech: Merck Serono staffers mull strike as budget ax hovers over Geneva HQ. Item | Follow @FierceBiotech

@RyanMFierce: Hi all, we're about to launch FierceBiotech's Fierce 15 biotech search. Countdown from 10... Survey | Follow @RyanMFierce

> BioSante preps for two more PhIII LibiGel trials. News

> ADA roundup: J&J's diabetes pioneer edges out Januvia in Phase III. More

> Gilead Sciences says the FDA has delayed its decision on whether it will allow Truvada to be sold as a guard against HIV infection. Report

> Amgen ($AMGN) says Sensipar failed a late stage study among chronic kidney disease patients. The drug failed to significantly reduce the risk of death and cardiovascular incidents. Report

> Sanofi says it has filed for approval of its diabetes drug lixisenatide in Japan. Story

> Newton, MA-based Chiasma says it has raised $3 million in debt financing. Story

Pharma News

@FiercePharma: J&J to pay up to $2.2bn in Risperdal settlement, Bloomberg says. Close to Pfizer's record $2.3bn deal. More | Follow @FiercePharma

> Now it's generic versions of Pfizer's ($PFE) blockbuster cholesterol pill Lipitor that are seeing sales erosion--from other generics. News

> Roche ($RHHBY) isn't planning to make a second run at Illumina, the gene-sequencing company it tried to buy earlier this year, and plans to look at smaller deals instead. Report

> Novartis ($NVS) announced new data suggesting that its Gilenya multiple-sclerosis pill was effective at reducing relapses and reducing the loss of brain volume in MS patients, with a "consistent safety profile." Story

> Germany's new drug-pricing system is keeping new medicines out of patients' hands, a European pharma association contends. Item

> Mylan ($MYL) and Teva Pharmaceutical Industries ($TEVA) came to an agreement over generic Provigil, in a deal that allows Mylan to launch its version Aug. 10, before Teva's 180-day exclusivity period expires. Article

> GlaxoSmithKline ($GSK) told the World Anti-Doping Agency that its experimental anti-anemia drug could also be used by athletes as a performance enhancer. More

> Japan's Astellas Pharma launched Dificlir, a treatment for Clostridium dificile infections, in the European market. Report

> Clinigen Group, a U.K.-based drugmaker that licenses pharma's mature or end-of-lifecycle drugs, is looking to sell itself or go public, Sky News reports. News

> FDA approves Roche's pricey new Herceptin partner, Perjeta. Story

Medical Device News

@FierceMedDev: Get your nominations in for the 15 fiercest private medical device developers while there is still time. Survey | Follow @FierceMedDev

> ECG-maker AliveCor pulls in $10.5M. More

> ConforMIS, an orthopedics implant maker, seeks $68M. Article

> Boston Sci closes $150M deal for Cameron, new ICD. News

> J&J's Animas will advance a second artificial pancreas trial. Story

Biotech IT News

> Biogen vet tapped as CIO of Harvard Med School. News

> Pharma rocks many Twitter handles for many reasons. More

> Novartis predicts drug side effects with computers. Report

> Lilly leads docs to cancer drug trials with iPad app. Item

And Finally… A team of UCLA stem cell scientists say that a purified subset of stem cells found in fat tissue was able to form bone that was better and faster than current methods produce. Release

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