Recon: BMS Withdraws Application for Opdivo-Yervoy Lung Cancer Combo

• In disappointment, Bristol pulls FDA application for Opdivo combination in lung cancer (STAT) (CNBC) (Endpoints)
• Bristol-Myers Shares Slide as Cancer-Drug Race Intensifies (Bloomberg)
• PhRMA blasts Trump’s plan to tie U.S. drug prices to other countries’ — but some of its criticisms don’t hold up (STAT)
• Trump plan to force drug makers to advertise prices might work, but not if pharma gets its way (STAT)
• FDA forces troubled Advaxis to halt enrollment on its PhIII study for lead drug axalimogene (Endpoints) (Press)
• Vertex Pharmaceuticals Fires Executive for Conduct Violation (WSJ) (Endpoints)
• FDA's opioids adviser accuses agency of having 'direct' link to crisis (The Guardian) (Endpoints)
• Has Abbott's Miles White Made His Last Big Deal? (Forbes)
• Botox-Maker Allergan in Patent Spat Over Next-Wave Wrinkle Fixer (Bloomberg)
• Vertex sharpens focus on gene-editing in licensing deal with Merck KGaA (Endpoints)
• Bristol-Myers Squibb Reports Fourth Quarter and Full Year Financial Results (Press)

• Pregnancy reported in the first known trial of ‘three-person IVF’ for infertility (STAT)
• How to Stop Rogue Gene-Editing of Human Embryos? (NYTimes) (Forbes)
• China clones gene-edited monkeys for sleep disorder research (Reuters) (Endpoints)
• China to crack down on health care violations: state media (Reuters)
• ChemoCentryx pulls conditional approval filing to rejig regulatory plan (Fierce) (Press)
• South Africa’s drug ATMs offer formula to treat chronic illness (Financial Times)
• Parents' vaccine side effects fear 'fuelled by social media' (BBC)
• How to pay for very high cost, curative drugs? ICER and NICE put their heads together (PMLive)
• Novo Nordisk stockpiling over double usual amount ahead of Brexit (PharmaTimes)
• TimesUK biotech doubles investment but offers few IPOs (Financial Times)
• Congo records one-day record for confirmed Ebola cases (Reuters)
• Deadly Ebola Virus Is Found in Liberian Bat, Researchers Say (NYTimes)
• Korean Gene Therapies On Horizon, But Slow Regulatory Changes A Drag (Scrip-$)
• Dutch hospitals warn no-deal Brexit will put patients in danger (Reuters)
• UK Seeks Smooth 'Grandfathering' Of EU Centrally Approved Drugs In Event Of No-Deal Brexit (Pink Sheet-$)
• Neglected-disease research funding hits record high (Nature) (Policy Cures Research)
• The World Health Organization says cancer drug prices are ‘impairing’ access to treatment (STAT) (KEI) (IPWatch)

• PDUFA Funds Likely to Run Out in February (Focus)
• Speed approval of ‘biosimilar’ drugs (The Post & Courier)
• Assessing the Effectiveness of REMS: FDA Drafts Two New Guidances (Focus)
• Merck KGaA chief Oschmann 'absolutely certain' a biopharma major will rise from China (Fierce)
• Medical advice on the pill was wrong for 60 years. How convenient to blame the pope (The Guardian)
• Helping to accelerate cures: Regulating the rapidly evolving field of cell and gene therapies (McKinsey)
• How FDA Drug Review Contributed to the Opioid Epidemic (The Regulatory Review)
• California Doctors Alarmed As State Links Their Opioid Prescriptions to Deaths (NPR)
• Basilea teams up with Roche to test bladder cancer combination (Fierce)
• Putting 2018 medicine approvals in context (PhRMA)
• What’s up with all the buzz about Gilead’s PhIII NASH drug selonsertib? (Endpoints)
• Shutdown thrusts Gossamer Bio onto a rarely used path for fixed-price IPO (Endpoints)
• ICER Aims To Define HTA Approach To Gene Therapies (BioCentury)
• Alexander Hardy tapped to head back to South San Francisco as the next CEO at Genentech (Endpoints)
• Immunogenicity Testing: FDA Finalizes Guidance on Assay Development and Validation (Focus)
• Physicians’ Favorable Views of FDA Drug Approval Standards Underscore ‘Disconnect,’ Survey Finds (Focus)

• Amgen And Allergan Announce Positive Top-Line Results From Phase 1/ Phase 3 Study Of ABP 798, Biosimilar Candidate To Rituximab (Press)
• FDA approves use of 0.5 mL dose of Fluzone® Quadrivalent (influenza vaccine) in children as young as 6 months of age (Press)
• Amerigen Announces U.S. FDA Approval For Generic Mixed Amphetamine Salts, Extended-Release Capsules (Press)
• X-Rx Announces FDA Acceptance of IND Application for X-165 (Press)
• MGB Biopharma - FDA and Health Canada Clear IND/CTA Applications for MGB-BP-3, a Novel, Potent Bactericidal Antibiotic Targeting Clostridium difficile-Associated Diarrhoea (CDAD) (Press)
• Ironwood Pharmaceuticals Initiates Phase 1 Trial of IW-6463, the First CNS-penetrant sGC Stimulator to Enter Clinical Trials (Press)
• Navitor Pharmaceuticals Commences Phase 1 Clinical Evaluation of NV-5138, a Novel mTORC1 Activator in Patients with Treatment-Resistant Depression (Press)
• Concert Pharmaceuticals Initiates Phase 1 Single-Ascending Dose Trial of CTP-692 as an Adjunctive Treatment for Schizophrenia (Press)

• CDRH Outlines Next Steps to Implement New Safety and Performance Based Pathway (Focus)
• FDA permits marketing of first test to aid in the diagnosis of a sexually-transmitted infection known as Mycoplasma genitalium (FDA)
• New Liquid Biopsy Test Detects Brain Cancer, But It Doesn't Use Blood (Forbes)
• FDA Issues Final Rule on Medical Device Classification Procedures (FDA Law Blog)
• Applied Tissue Technologies’ negative-pressure dressing gets FDA nod (Medical Design & Outsourcing)
• Human Factors Engineering and Usability: What you should know about diary studies (Emergo)
• Perspectum wins FDA nod for biliary duct mapping software (MassDevice)
• Hologic M. Genitalium Assay Gets FDA De Novo Clearance (GenomeWeb)

• Furloughed federal workers may lose some health benefits: US senators (Reuters)
• Texas wants to repeal the ACA, but doesn't have a replacement (Politico)
• UnitedHealth sues former executive for stealing trade secrets and taking them to Amazon joint health venture (CNBC)
• Jamie Dimon says Americans have 'some of the worst outcomes' in health care despite the best system (CNBC)
• Pharma Co. Can't Sue FDA Over Rival's Opioid Approval (Law360-$)
• Merck Can't Arbitrate Antitrust Suit Over Vaccine Bundles (Law360-$)
• Boston Scientific's Del. Merger Trial Still A Go For April (Law360-$)
• After Falling Under Obama, America’s Uninsured Rate Looks to Be Rising (NYTimes)
• HIV care is threatened by proposed changes to Medicare Part D (STAT)
• No Mulligans in the Law (Drug & Device Law)
• Trump Zeroes In On Surprise Medical Bills In White House Chat With Patients, Experts (KHN)

• FDA Advisory Committee Calendar

• Irish Pfizer employees to launch industrial action ballot over pensions scheme (Pharmafile)
• EMA Updates on Priorities Ahead of Netherlands Move (Focus)
• EMA: No New Patients Should Start Treatment With Lilly’s Lartruvo (Focus)
• EFPIA On How To Make Cross-Country Collaborations Work (Pink Sheet-$)
• MHRA recalls more blood pressure and heart medication from pharmacies as a precaution (MHRA)

• Glenmark gets USFDA nod for generic Derma-Smoothe Topical Oil (Economic Times)

• Israel cabinet expected to approve medical cannabis exports (Reuters)

• Spinal Fractures Can Be Terribly Painful. A Common Treatment Isn’t Helping. (NYTimes)
• Even Modest Blood Pressure Elevation in Young Adults May Take a Toll on the Brain (NYTimes)