Eli Lilly ($LLY) and research partner Incyte ($INCY) released positive new data from the RA-BEACON Phase III trial showing its investigational rheumatoid arthritis pill baricitinib met its primary endpoint of improved ACR 20 response when compared with placebo at week 12. ACR 20 represents at least a 20% improvement across selected measures of disease activity. The data, published in the NEJM, comes as the drug is moving along the FDA regulatory path, which the companies hope will find an approval this year. This follows a series of positive results for the drug in recent years, which analysts believe will hit peak sales of $1.5 billion. Release
@FierceBiotech: Jazz Pharma's much delayed rare liver disease drug finally wins FDA approval. News | Follow @FierceBiotech
@JohnCFierce: PureTech startup sets out to develop new tech for controversial 'vaginal seeding.' Article | Follow @JohnCFierce
> The FDA has accepted Dynavax Technologies Corporation's ($DVAX) Biologics License Application for its hepatitis B vaccine Heplisav-B, with a final PDUFA decision expected on Sept. 15. Release
> Spanish biopharma PharmaMar met its primary endpoint in a Phase III study of its investigational anti-cancer drug plitidepsin in combination with dexamethasone--versus dexamethasone alone--in patients with relapsed/refractory multiple myeloma. The drug showed a 35% reduction in the risk of progression or death over the comparator. Statement
> The private, CA-based biotech ArmaGen has dosed the first patient with its enzyme replacement therapy AGT-181 in a Phase II proof-of-concept clinical trial treating pediatric patients with the hereditary neurological condition Hurler syndrome in Brazil. Release
Medical Device News
@FierceMedDev: ICYMI: Theranos slammed again after new study points to testing flaws. Article | Follow @FierceMedDev
@EmilyWFierce: Forgot how much I liked the word "torrent" until I read this lead $VRX. More from the NYT | Follow @EmilyWFierce
> Swiss team designs robotic exoskeleton that mimics human knee stability. Report
> Massachusetts General Hospital Philips' digital pathology tools to clearance of the tech as a diagnostic. Item
> Qiagen to pony up $100M+ for Danish molecular diagnostics outfit Exiqon. Article
Pharma News
@FiercePharma: Keryx anemia med Auryxia trounces placebo in study aimed at big new use. More from FiercePharmaMarketing | Follow @FiercePharma
@EricPFierce: Construction begins on Novo Nordisk's first US, API plant and first outside of Denmark. FiercePharmaManufacturing article | Follow @EricPFierce
@CarlyHFierce: FDA falls short on safety monitoring, delaying public communications, report says. Report | Follow @CarlyHFierce
> Have the feds gone soft on pharma? Shrinking fines suggest it's yes, Public Citizen says. More
> With deal scouts knocking, Medivation hires JPMorgan to man the door. Report
> FTC digs deeper into Pfizer's proposed combo with Allergan. Article
Pharma Manufacturing News
> Anuh Pharma plant savaged in EMA report. Report
> Dr. Reddy's recalling injected drug manufactured by Gland Pharma. More
> Citing microbial growth, B. Braun issues dextrose injection recall. Story
> Catalent issues lead to CRL for OPKO. Article
> Japan's Daiichi Sankyo closing Japan plant with 150 workers. Item
CRO News
> Rho seeks 30 new hires after bumper year. More
> Snapdragon Chemistry announces extended partnership, lab space, and a new leader. News
> Alten Calsoft Labs looks to extend U.S. reach, reporting services with PVR Technologies buy. Report
> Former GSK staffers launch new Canadian CRO. Story
> Quintiles named 'best CRO in Asia' again. Article
Pharma Asia News
> AZ approval for Tagrisso in Japan a big change to NSCLC treatment options in Asia. Item
> Australian pharma firms splashed AU$43M to docs, with lunches, Vienna trips raising eyebrows. Report
> Big Pharma finds second chance for failed drugs in China. More
> GSK pumps $29M into infectious disease R&D hub in Beijing. Story
> India's local rotavirus vaccine launched to combat death linked to diarrhea. Article