Sanofi and Regeneron creep toward PCSK9 finish line; Boehringer's Pradaxa antidote comes through in trial;

@FierceBiotech: Agios offers another glimpse of 'exciting' early data for a leukemia drug. Report | Follow @FierceBiotech

@JohnCFierce: Lots of discussion about this one -- Average cost of drug R&D? Try $2.9B on for size. Editor's Corner | Follow @JohnCFierce

@DamianFierce: Knight Therapeutics found a buyer for its FDA priority review voucher, selling it to $GILD for $125M. Release | Follow @DamianFierce

> Sanofi ($SNY) and Regeneron ($REGN) unveiled the full results from their 6-trial Phase III effort to develop alirocumab, a treatment designed to lower LDL cholesterol by blocking a protein called PCSK9. The antibody met its primary endpoint of slashing LDL levels in patient populations including those with high cardiovascular risks, statin intolerances and genetic disorders. The two companies expect to submit alirocumab for FDA approval by year's end, racing with Amgen ($AMGN) to commercialize the first PCSK9 inhibitor. News (PDF)

> In a small study, Boehringer Ingelheim's in-development antidote to Pradaxa helped reverse the effects of the drug in healthy volunteers and boosted the production of the clotting mechanism fibrin, making it the first such reversal treatment to do so, the company said. The drug, idarucizumab, is in the midst of a Phase III study and has received the FDA's breakthrough therapy designation. More

Medical Device News

@FierceMedDev: ICYMI yesterday: Brain tumor treatment device gets early trial halt for efficacy as a combo with chemo. Story | Follow @FierceMedDev

@EmilyWFierce: Shaq is back for $SNY's latest marketing campaign. Release | Follow @EmilyWFierce

> St. Jude's CardioMEMS could help hospitals avoid Affordable Care Act readmission penalties. More

> Baird Capital closes $185M technology, healthcare fund. Item

> Alfred Mann's Second Sight prices $32M IPO for 'bionic eye.' Story

Pharma News

@FiercePharma: Ranbaxy fights FDA for killing its approval to make generic Nexium. FiercePharmaManufacturing story | Follow @FiercePharma

@CarlyHFierce: AirFluSal Forspiro won approval in my two favorite countries, Ireland & Czech Republic, which is inconsequential to me but fun nonetheless. | Follow @CarlyHFierce

> Novartis seeks tech partners for brave new beyond-the-pill world. More

> Solo Shire moves 500 to Boston as it pushes ahead with reorg. Story

> NICE asks Novartis to pony up more information on Xolair for hives. Report

Drug Delivery News

> Cynapsus releases clinical trial data about its sublingual thin-film strip for Parkinson's. Item

> Catalent buys particle engineering outfit Micron Technologies. News

> RNAi masking technique allows more efficient delivery. Story

> Medical marijuana company licenses RapidMist device for buccal delivery. Report

> NSF funds further research into only FDA-cleared catheter for rectal delivery. Article

Diagnostics News

> Precision Therapeutics ropes in $60M for corporate overhaul. More

> Cepheid snags $3.3M to roll out rapid Ebola test. Report

> Roche nabs FDA clearance for quick strep test. News

> Illumina, Sequenta partner up on next-gen cancer diagnostic. Article

> Enterome teams up with AbbVie to create molecular Dx for Crohn's disease. Item

Pharma Marketing News

> Payers' hep C delay tactics work: Coverage hurdles may be dampening Harvoni script growth. Article

> How to prep for a 'megablockbuster' launch? Novartis lines up cost-savings data. Report

> Valeant and Allergan's wining-and-dining shows docs still hold the script reins. More

> Painkiller marketing secrets? Check Chicago's unredacted suit against Endo, Purdue, Cephalon, et al. Story

> Sanofi tags newly OK'd MS drug Lemtrada at $158K, ready to tout head-to-head Rebif data. Article

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