Recon: FDA Approves Bayer's Hemophilia Drug Jivi; Alnylam's Onpattro Wins EU Approval

• Bayer's hemophilia A drug gets FDA approval (Reuters) (MarketWatch) (Press)
• Mislabeling leads to recall of popular blood pressure medicine (NBC) (Fortune) (CBS)
• Widely Used Diabetes Drug Can Cause Flesh-Eating Genital Infection (Bloomberg) (Reuters) (FDA)
• Biotech Boom Built Wall Street’s $3 Million Analyst (WSJ) (Endpoints)
• Vaccine tied to drop in HPV cases still not reaching half of US kids (Reuters)
• Study finds multiple sclerosis drug slows brain shrinkage (NIH) (NEJM)
• Groupon Cofounder's Health Startup Hits $2 Billion Valuation With Latest Funding Round (Forbes)
• Why Amazon Could Have A Hard Time Getting Into Pharmacy (Forbes)
• ICER says Alnylam’s Onpattro should cost 90%-95% less (PMLive)
• Sophiris eyes phase 3 after clearing patient death from its lead study (Fierce)
• Pfizer Terminates Trials of Domagrozumab to treat DMD (Press)

• Congo Ebola outbreak not yet stabilized: WHO chief (Reuters)
• Germany tells drugmakers to check supply chains for no-deal Brexit risks (Reuters)
• No-deal Brexit: Plan to maintain medicine supplies 'could cost £2bn' (The Guardian) (PMLive)
• Alnylam Receives Approval of ONPATTRO (patisiran) in Europe (Press)
• EMA’s Request For Extra Staff Rebuffed As Losses ‘Worsen Dramatically’ (Pink Sheet-$)
• EU approves AZ’ Bydureon BCise device (PharmaTimes) (Pharmafile)
• EU expands use of Amgen’s Blincyto (PharmaTimes)
• GSK’s Nucala approved for younger asthma patients (PharmaTimes)
• Vertex invests in Genomics plc as the firms sign research deal (PharmaTimes)
• Europe ready to cash in on cheap copies of AbbVie biotech drug (Reuters)
• UK advertising watchdog bans contraception app's Facebook ad following investigation (mobihealthnews) (Pharmafile)
• Pharmacy2U could face fresh investigation into advertising claims (Pharmaceutical Journal)
• Grünenthal extends gout portfolio with second EU approval (PharmaLetter-$)
• Kenya: Big Mark Ups Obscure Patient Savings From Local Production (Pink Sheet-$)

• Spurred by opioid epidemic, new pain drugs may lower the risk of overdose and addiction (Science)
• Why Jeff Bezos is backing this Silicon Valley scientist who is working on a cure for aging (CNBC)
• With PBMs gaining power, pharma and ad agencies zero in on payer marketing (Fierce)
• Scientists unpick how cannabis component may fight psychosis (Reuters)
• Evolus back on track with Botox rival that was sidelined by manufacturing CRL (Fierce)
• Women’s health firm KaNDy raises $32M for menopause study (Fierce)
• FDA Clarifies Path To Submission For Ultragenyx's Rare Disease Therapy (BioCentury)
• An elite team of young, transpacific scientists out of Harvard and MIT starts plowing next-gen cell therapy tech field (Endpoints)
• Closely allied with (both) Mercks and Celgene, Sutro CEO Bill Newell is laying out all his cards in a new IPO (Endpoints)
• Amgen vet Laura Hamill takes commercial reins at Gilead amid executive shakeup (Endpoints) (Fierce)
• Tempus Raises $110M Series E (BioCentury)
• FDA Reopens Comment Period on Shared REMS Draft Guidance (Federal Register)
• Product Quest Manufacturing LLC Recalls All Nasal Products and Baby Oral Gels Manufactured at Florida Facility Due to Possible Microbial Contamination (FDA)
• Hellolife, Inc. Issues Voluntary Worldwide Recall of Neuroveen, Respitrol, Thyroveev and Compulsin due to Possible Microbial Contamination (FDA)

• U.S. Food and Drug Administration Accepts Bristol-Myers Squibb’s Application for Sprycel (dasatinib) in Pediatric Patients with Newly Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Press)
• Positive phase III results for Roche’s Hemlibra for haemophilia A without factor VIII inhibitors published in New England Journal of Medicine (Press)
• Actelion Submits Application to EMA Seeking Approval of OPSUMIT (macitentan) for the Treatment of Chronic Thromboembolic Pulmonary Hypertension (CTEPH) (Press)
• Xenon’s epilepsy drug clears phase 1b, setting stage for trial in patients (Fierce)

• Merck’s latest digital diabetes coach aims to fill education and support gaps (Fierce)
• ISO 80369: Frequently Asked Questions, Answered (MDDI)
• Ceterix Ortho wins expanded FDA nod for NovoStitch Pro (MassDevice)
• Atlantic Therapeutics touts muscle stimulation device for urinary incontinence (MassDevice)
• SynCardia responds to FDA note warning of high rates of stroke, mortality risk with TAH-t C2 Driver (MassDevice)
• ivWatch wins CE Mark for continuous IV site monitor (Drug Delivery)
• Protecting and Enforcing the Intellectual Property Behind Medical Diagnostics (MDDI)
• Taking a Deeper Look at Device Certification and Recertification (MDDI)

• How Medicare Wastes $4.6 Billion A Year On Long-Term Care Hospitals (Forbes)
• First Circuit Eye Drop Decision Gets Preemption Right (Drug & Device Law)
• Allergan, Shire Spar Over Pfizer-J&J Antitrust Ruling (Law360-$)
• Fed. Circ. Impeding Biopharma Innovation, Justices Told (Law360-$)
• J&J Hip Implant Plaintiffs Get $245M Judgment After Trial (Law360-$)

• FDA Advisory Committee Calendar

• Medicines and Healthcare products Regulatory Agency GPC spending over £500: 2018 – 2019 (MHRA)
• Celltrion Plans EU Filing For Remsima SC As Phase III Completed (SCRIP-$)
• Persistent peddler jailed for dealing dodgy sex drugs (MHRA)
• Boehringer begins construction at €85m tablet manufacture plant (InPharmaReporter)

• Sequoia China Leads Seed Round For Next-Gen T Cell Therapy Play (BioCentury)

• Domestic pharmaceutical players eye Bharat Serums acquisition (Economic Times)

• Advisory Committee on Medicines Scheduling to consider upscheduling to 'Pharmacist Only' (TGA)
• Consultation: Referral of proposed amendment to the current Poisons Standard to the meeting of the ACMS, March 2019 (TGA)
• About Australian recall actions (TGA)

• Posters Suggesting That Women Can Drink While Pregnant Stir Backlash (NYTimes)
• Despite evidence, skeptics try to cast doubt on CTE-football link (NBC)