@FiercePharma: UPDATED: It's confirmed: 'No signal' of heart failure risk with Merck's Januvia. More | Follow @FiercePharma
@CarlyHFierce: ICYMI yesterday: No change in CV risk for ACS patients on Sanofi's Lyxumia. Item | Follow @CarlyHFierce
> Alexion Pharmaceuticals ($ALXN) won final European approval for two of its drugs for ultrarare diseases, Kanuma, which treats lysosomal acid lipase deficiency, and Strensiq, a treatment for children with pediatric-onset hypophosphatasia. Report
> Sun Pharmaceutical has wrapped up its buyout of GlaxoSmithKline's ($GSK) opiates business in Australia. Report
> Chinese pharma companies have started recruiting senior scientists from Indian drugmakers to beef up their expertise in formulations, rather than bulk drug ingredients. Report
> Teva Pharmaceutical ($TEVA) said its migraine-relief patch Zecuity is now available in the U.S. Release
> Zeltia said its cancer drug Yondelis won a recommendation for approval in Japan. Report
Medical Device News
@FierceMedDev: Exact Sciences wins CMS panel vote for Cologuard pricing. FierceDiagnostics story | Follow @FierceMedDev
@VarunSaxena2: Quanterix and Banyan Biomarkers forge ahead with brain injury diagnostic tech. Article | Follow @VarunSaxena2
@EmilyWFierce: Social media spin mistress @KimKardashian mops up Duchesnay's marketing mess. More from FiercePharmaMarketing | Follow @EmilyWFierce
> Germany's coramaze receives $5M in Series A to develop transcatheter mitral valve repair device. Article
> CeQur reels in $100M for insulin infusion smart patch device. News
Biotech News
@FierceBiotech: ICYMI: Sanofi buys into Google's biotech future, pairing up in diabetes. Article | Follow @FierceBiotech
@JohnCFierce: Just wondering how Valeant's reps plan to market brodalumab. Suicidal thinking? No worries, mate. Story | Follow @JohnCFierce
@DamianFierce: "Valeant is acquiring __________ for $__________, touting the drug's __________ despite serious concerns about ___________." | Follow @DamianFierce
> Alexion wins a pair of EU approvals to build out its rare disease ranks. Story
> Gene therapy upstart Audentes bags a new program in buyout. More
> CRISPR player Intellia looks IPO-ready after $70M round. Article
Pharma Manufacturing News
> Three pharmaceutical company owners in India busted for distributing pseudoephedrine. Item
> Regis Technologies opens new facility for manufacturing highly potent APIs. Report
> Mega Lifesciences to expand in Indonesia on partnership with Sydna Farma. More
> AMRI, Saneca Pharma team to produce a range of opium-based APIs. Story
> Mayne Pharma to spend $65M on expansion of North Carolina facility. Article
Pharma Asia News
> Two dengue treatments slated for PhII in Singapore next year. Report
> Japan's MHLW gives nods for Remicade, VFend, Tracleer, INOflo new indications. Item
> Another recall by Indian drugmakers as U.S. FDA notes troubles. More
> Executive shakeup with Guilder out at Taiwan's TWi. Story
> Shanghai Pharmaceutical raises funds for online-to-offline sales push with eye on ethical products. Article
Drug Delivery News
> Surefire picks up FDA clearance for Precision cancer drug delivery tool. More
> MicroRNA specialist aims for $81M IPO amid market downturn. Report
> Teva makes only approved migraine patch available in the U.S. Story
> Intraoperative radiation therapy proving divisive among oncologists. Item
> Titan Pharma submits opioid addiction-fighting subdermal implant for FDA approval. Article
And Finally... New guidelines from the American Society of Clinical Oncology aim to help doctors make sense of newly available genetic testing. Report