Recon: Monthly Injection of ViiV, J&J HIV Combo Successful in Two Phase III Studies

• Monthly shots control HIV as well as pills in 2 big studies (AP) (Financial Times) (Endpoints) (Press)
• FDA experts gun down a big part of Sanofi’s pitch for their controversial vaccine (Endpoints) (STAT) (Fierce)
• FDA Rescinds Two Breakthrough Therapy Designations (Focus)
• FDA Reverses Course, Decides Not to Add Suffixes to Older Biologics’ Nonproprietary Names (Focus)
• Years after it was OK’d, AMAG’s drug for preventing preterm births fails badly in long-awaited confirmatory trial (Endpoints)
• Biotech shares continue to fall on FDA uncertainty (CNBC)
• Facebook Announces Plan to Curb Vaccine Misinformation (NYTimes)
• Hedge Fund Tosses Family That Controls Maker of OxyContin (WSJ)
• Anthem Promises a New Type of Drug Plan After PBM Scrutiny (Bloomberg)
• Mylan's Advair generic pressures GSK with strong launch (BioPharmaDive)
• Gilead shares early clinical data on HIV capsid inhibitor (Fierce)
• Martin Shkreli Steers His Old Company From Prison—With Contraband Cellphone (WSJ) (Endpoints)
• Medical device tax repeal bill reintroduced in US Senate (MassDevice)
• Trump Will Get Legislation On His Desk This Year To Lower Drug Prices, Predicts Senator Susan Collins (Forbes)

• Roche gets European approval for Tecentriq combo vs. lung cancer (Reuters) (Press)
• EMA validates Bavencio for review in advanced RCC (PharmaTimes)
• EU Committee Urges No-deal Brexit Transition Period for Medical Devices (Focus)
• NICE updates high blood pressure guidelines (PharmaTimes)
• Merck gives King’s College London, Wellcome Trust up to $340M in deal to develop non-opioid painkillers (Endpoints)
• As polio goal nears, Pakistan pushes against vaccine misinformation (Reuters)
• "Our children are forgotten": Zika's devastating impact lingers 3 years later (CBS)
• Without vaccine, hundreds of children die in Madagascar measles outbreak (Reuters)
• Dutch join backlash at expensive drugs by making their own (Reuters)
• ‘We can’t’: Jeff Leiden stands his ground as MPs grill Vertex on pricing disagreement with NHS (Endpoints) (BioCentury)
• The Battle Against One of the Worst Ebola Epidemics Ever Is in Trouble (NYTimes)

• Amy Abernethy For FDA Commissioner (Forbes)
• BeiGene Puts Up $10M to Use Ambrx’s Drug Development Technology (Xconomy)
• An Antibody-Inspired Small Molecule Could Make For A Better Flu Treatment (NPR)
• Briggs Morrison’s little biotech Syndax concedes 2 key trial setbacks for its lead drug, as shares shrivel some more (Endpoints)
• A Gulp Of Genetically Modified Bacteria Might Someday Treat A Range Of Illnesses (NPR)
• Suven plans to buy US-based Rising Pharmaceuticals' assets (Economic Times)
• American Health Packaging Issues Voluntary Nationwide Recall of Valsartan Tablets Due to the Detection of NDEA (N-Nitrosodiethylamine) Impurity (FDA)

• FDA to undertake priority review of Dupixent® (dupilumab) for adults with inadequately controlled severe chronic rhinosinusitis with nasal polyps (Press)
• Forbius Announces First Patient Dosed in Phase 2a Squamous Cell Carcinoma of the Head and Neck (SCCHN) Trial of AVID100, a Novel Anti-EGFR ADC (Press)
• Alexion Announces Publication of Interim Data from Phase 3 Open-Label Extension Study Supporting Long-Term Efficacy and Safety of SOLIRIS® (Eculizumab) in Adult Patients with Generalized Myasthenia Gravis in Muscle & Nerve (Press)
• Positive Interim Analysis in Pivotal IsoConDa Phase III Study (Press)
• Cerebral Therapeutics Raises Series A Extension Financing to Advance Clinical-Stage Drug Device Combination Therapy to Phase 3 Readiness for Adult Refractory Epilepsy (Press)
• Arena Pharmaceuticals Presented New Phase 2 Data for Etrasimod and Olorinab at the 14th Congress of European Crohn's and Colitis Organisation (Press)
• Galderma Presented Final Results from Phase 2b Study of Nemolizumab in Patients with Moderate-to-Severe Atopic Dermatitis at the 2019 American Academy of Dermatology Annual Meeting Late-Breaking Session (Press)

• MITA Raises Questions With Pre-Cert Software Pilot (Focus)
• Experts Question FDA Proposal to Conduct Manufacturing Inspections for De Novo Reviews (Focus)
• Omni sold to U.K. ortho company Corin Group (MassDevice)
• ZEISS Receives FDA Clearance for Epithelial Thickness Mapping for CIRRUS HD-OCT, Enabling More Detailed Assessment of Refractive Surgery Patients (Press)
• Ocular Therapeutix posts mixed Q4 results (MassDevice)

• Every State But Missouri Has An Opioid Database. Will That Change? (KCUR)
• As Hospitals Post Price Lists, Consumers Are Asked To Check Up On Them (KHN)
• Ex-Pharma Sales Rep Gets 4 Years For $3.5M Rx Scheme (Law360-$)
• Justices Urged To Turn Down PTAB Tribal Immunity Case (Law360-$)
• Eleventh Circuit Holds Off-Label Marketing Claim Preempted under Buckman, Even When Disguised as “Negligent Marketing” Claim (Drug & Device Law)
• USDA and FDA Announce a Formal Agreement to Regulate Cell-Cultured Food Products from Cell Lines of Livestock and Poultry (FDA)

• FDA Advisory Committee Calendar

• UK’s NIBSC Updates on No-Deal Brexit Plans (Focus)
• EU Regulatory Roundup: UK Talks Up Prospect of No-Deal Brexit Accelerating Access to New Medicines (Focus)
• Compulsory licenses in Germany: a tool for licensing negotiations? (EPR)
• Bayer submits European marketing authorization application for darolutamide (Press)
• Expert Advisory Group set-up to review paclitaxel drug-coated balloon catheters and drug-eluting stents (MHRA)
• enFlow® IV fluid and blood warmer - risk of unsafe levels of aluminium leaching from the device (MDA/2019/015) (MHRA)

• Digital therapeutics startup Akili Interactive inks deal with Japanese pharma company (MedCity)

• Prices of 390 non-scheduled cancer medicines slashed by up to 87 per cent (Economic Times)
• Whistleblower says Sun Pharma gave doctors gifts through a subsidiary (Economic Times)

• Public submissions on scheduling matters referred to the ACMS #25, ACCS #23 and Joint ACMS-ACCS #20 meetings held in November 2018 (TGA)