Recon: Merck to Spin Off Women’s Health, Biosimilar Business; GSK Plans Consumer Health Split

• Merck to spin off women's health and biosimilar drugs, focus on Keytruda (Reuters) (STAT) (Financial Times) (Endpoints)
• Trump calls for bipartisan bill to 'dramatically' lower drug prices (The Hill)
• On Drug Pricing, The President’s Numbers Are Still Off (KHN)
• Democrats chant in support of House drug pricing bill during State of the Union (The Hill) (Vox)
• Former executive of Taro Pharmaceutical indicted in US for price-fixing (Reuters) (DOJ)
• Armed with Nestlé cash, Aimmune grabs experimental food allergy drug from Xencor (Fierce) (Endpoints)

• GSK outlines plan to split as earnings fall short (Financial Times) (Reuters) (Endpoints)
• Pharma execs argue new Canadian regulations for setting drug prices will hurt the country (STAT)
• WHO: 'no known effective' treatments for new coronavirus (Reuters)
• WHO calls for improved data-sharing on virus, says sending team to China (Reuters)
• US$675 million needed for new coronavirus preparedness and response global plan (WHO)
• Measles vaccine drive aims to protect 45 million children in Africa, Asia (Reuters)
• New drugs drive Novo Nordisk despite insulin price pressures (PMLive)

• Watch: Top FDA official talks bringing the agency into a new age (STAT)
• January price increases confirm slowing drug inflation (BioPharmaDive)
• Drug pricing reform expected to be biggest drag on biopharma in 2020; Beam upsizes IPO offering (Endpoints)
• New ‘real world evidence’ company leverages medical societies to produce data for pharma (STAT)
• This biotech just bought three failed drugs. Here’s why (STAT)
• Active Biotech is back, with one last bid for the failed MS drug Teva discarded (Endpoints)
• Predicting The User Fee Reauthorization Schedule (Pink Sheet-$)
• PDUFA VII: Will Gene Therapy's Rise Influence Talks? (Pink Sheet-$)
• GDUFA III: How Much Of A Fee Increase Can Industry Stomach? (Pink Sheet-$)
• BsUFA III: Could Regulatory Science Research Emerge With Other Tweaks? (Pink Sheet-$)
• US Embassy Slams Dutch Compounding Policy (Pink Sheet-$)
• FDA continues to ride Lupin over plant failings (Fierce)
• $750M Fund Looks to Software Sector to Drive Future of Biotech (Xconomy)
• Gilead CEO O'Day feels 'sense of urgency' on dealmaking as Kite writedowns add up (Fierce) (Endpoints)
• Gilead Writes Down Kite Buy As Yescarta Sales Flatten Out (Scrip-$)
• MaaT bags €18M to test microbiome modulators in cancer patients (Fierce) (Endpoints)
• Dentists commonly over-prescribe opioids (Reuters)
• Agency Information Collection Activities; Proposed Collection; Comment Request; Health Care Providers' Understanding of Opioid Analgesic Abuse Deterrent Formulations (FDA)
• Public Health Alert Concerning Dietary Supplements Containing Cesium Salts (FDA)

• Emtora Biosciences Presents Phase Ib Data in Low Grade Prostate Cancer Patients at the 2020 ASCO-SITC Clinical Immuno-Oncology Symposium (Press)
• Moleculin to Seek Accelerated FDA Approval and Plans for Pivotal Phase 2 AML Trial (Press)

• Boston Scientific posts mixed bag Q4 results (MassDevice)
• Titan Medical’s Cash Crunch Stalls Plans to Get Surgical Robot to FDA (Xconomy)
• Abbott wins breakthrough tag for fully implantable LVAD system, following Medtronic (MedtechDive)
• Zimmer's Rosa robot drives Q4 growth, restructuring set (MedtechDive)
• Abbott, SynCardia requests prompt CMS to reconsider heart device coverage (MedtechDive)
• FDA Expands Clearance for OTC Pain Device (Medscape)
• GE Healthcare respiratory analyzer recall is Class I (MassDevice)
• Teleflex recalls certain Arrow epidural catheterization kits in Europe (MassDevice)

• Trump goes big on health care at State of the Union (Politico)
• Fed. Circ. Mulls Reviving Fight Over Opioid Blocker Patent (Law360-$)
• FDA Didn't Vet Enviro Impact Of GMO Salmon, Group Claims (Law360-$)
• Insys Execs Say Assumptions Don't Equal $300M Restitution (Law360-$)
• US government experts, industry spar over asbestos testing in talc (Reuters)
• FTC Takes Action to Stop Anti-Aging “Cure-All” Marketers From Making Baseless Health Claims (FTC)
• Walgreens Will Pay $7.5 Million to Settle Unlicensed-Pharmacist Claims (NYTimes)
• The Zombie Apocalypse of Patent Eligibility Reform and a Possible Escape Route (Patent Docs)
• Court Keeps Child Custody/Support Issues Out of Hip Implant Case (Drug & Device Law)

• FDA Advisory Committee Calendar
• Prescription Drug User Fee Act of 2017; Electronic Submissions and Data Standards; Public Meeting – 22 April 2020

• The EU Medical Device Regulation: What’s Next? (National Law Review)
• Brexit happened. EU MDR looms. 3 key questions on medtech's future in Europe (MedtechDive)
• t:slim X2 insulin pump – discard or destroy defective mains (A/C) power adapters (MDA/2020/005) (MHRA)

• Health ministry releases Draft DMR Amendment Bill, 2020 (Pharmabiz)

• In Coronavirus, China Weighs Benefits of Buffalo Horn and Other Remedies (NYTimes)
• Chatbots are screening for the new coronavirus — and turning up cases of the flu (STAT)
• Novel coronavirus 2019-nCoV exposes a flaw in the Nagoya Protocol (STAT)
• In the race to develop a coronavirus treatment, Regeneron thinks it has the inside track (STAT)
• Bill And Melinda Gates Donate $100 Million To Coronavirus Vaccine Research (Forbes)
• China lab seeks patent on use of Gilead's coronavirus treatment (Reuters)
• Even Without Symptoms, Wuhan Coronavirus May Spread, Experts Fear (NYTimes)
• US may stage additional evacuation flights in China's virus-hit Wuhan on February 6 (Reuters)
• Russia's Putin proposes stripping pharmacy licences for raising anti-virus mask prices (Reuters)
• About 350 US evacuees from virus-hit Chinese city land at California air base: local media (Reuters)
• British scientist makes breakthrough in race for coronavirus vaccine: Sky (Reuters)
• Taiwan to suspend entry for Chinese citizens to control virus (Reuters)
• Hong Kong testing over 1,800 passengers on cruise ship for coronavirus (Reuters)
• Passengers face two weeks on virus-hit cruise ship off Japan (Reuters)
• Japan prepares ferry to be used for quarantine as virus spreads (Reuters)

• Mary Lou Valdez appointed as PAHO/WHO Deputy Director (PAHO)