Recon: AbbVie, Allergan Divest Two Drugs; More Than 80 Deaths From Wuhan Coronavirus as Infections Climb

• AbbVie and Allergan divestitures are in, and an old AstraZeneca drug comes home (Endpoints) (Press)
• Novartis, GBT sickle cell drugs too expensive, draft US report says (Reuters) (Fierce) (ICER)
• Trump’s dispute with Azar gives new life to drug pricing plan (Politico)
• Call For FDA To Withdraw Preterm Birth Drug Divides Doctors and Insurers (KHN)
• Life Sciences IPOs Target Collective Raise of More Than $600M This Week (Xconomy)
• FDA OKs Dificid for C difficile Infection in Children as Young as 6 Months (Medscape) (Press)
• Pfizer seeking to dent market share with trio of discounted biosimilars (BioCentury) (BioPharmaDive)
• When Insurance Won't Cover Drugs, Americans Make 'Tough Choices' About Their Health (NPR)
• J&J scientific officer ‘pretty confident’ they can create coronavirus vaccine as outbreak widens (CNBC)
• California considers declaring Tylenol’s key ingredient a carcinogen (LA Times)
• Wither New Biotech Startups? (LifeSciVC)

• China's President Xi holds politburo meeting on curbing virus outbreak (Reuters)
• Deaths climb above 80 as China records thousands of new cases. (NYTimes) (Reuters)
• WHO chief says he is on way to China to confer on virus, boost response (Reuters)
• China testing HIV drug as treatment for new coronavirus, AbbVie says (Reuters)
• Boris Johnson to unveil ‘talent visa’ for high-flying scientists (PMLive)
• Brussels wants to tailor pharma incentives to patients’ needs (Politico Pro-$)
• AZ makes case for use of blood thinner Brilinta in stroke patients (Endpoints) (PMLive) (Press)
• NICE shuns Novo Nordisk's obesity med Saxenda, citing CV questions (Fierce)
• Merck KGaA matches lofty R&D goals with €250M investment into a new clinical manufacturing site in Switzerland (Endpoints)

• Why big pharma sees a remedy in data and AI (Financial Times)
• FDA decision nears on Aimmune's contested peanut allergy drug (BioPharmaDive)
• Long Hot Summer For Novel Drug Reviews Forecast At US FDA (Pink Sheet-$)
• US FDA’s 2020 Approvals: A Deep Pipeline, And More Of The Expected (Pink Sheet-$)
• Gene Therapy Approvals By US FDA Could Double In 2020 (Pink Sheet-$)
• After a brief break, AstraZeneca is back at divesting — handing off hypertension meds for $350M (Endpoints)
• By Any Means Necessary: How Allergan Gamed the System to Raise Drug Prices and Flood the Country with Pills (Public Citizen)
• A Biotech VC’s Prescription For What Ails Pharma (Forbes)
• Industry says voluntary plan to curb antibiotic pollution is working, but critics want regulation (Science Mag)
• The suburbs are cheaper, but they don’t have what Kendall Square has for biotechs: serendipity (STAT)
• GSK hands TB vaccine to Gates Foundation's nonprofit biotech (Fierce)
• An RNA vaccine drives expansion and efficacy of claudin-CAR-T cells against solid tumors (Science)
• Saying ‘diabetes doesn’t discriminate,’ Gov. J.B. Pritzker signs measure limiting out-of-pocket cost of insulin to $100 for 30-day supply (Chicago Tribune)
• Oncology loses top spot in Series A biopharma investment, report finds (MedCity)
• Summit Therapeutics loses R&D president after BARDA funding boost (Fierce)
• Sorrento shrugs off an anonymous private equity group’s $1B offer to buy the company (Endpoints)
• Bruce Booth and Samantha Truex's latest venture aims just above Humira (Endpoints)
• The Pharmacist Is Out: Supermarkets Close Pharmacy Counters (WSJ)
• Pink Sheet Roundtable: Experts Advise On How To Prepare For DSCSA In 2020 (Pink Sheet-$)
• How The DSCSA Is Designed To Work (RxTrace)

• Breast cancer approval in tow, AstraZeneca, Daiichi armed antibody scores in key gastric cancer study (Endpoints)
• NeoImmuneTech Received U.S. FDA Clearance of IND Application for Phase 1b/2a Study of Hyleukin-7™ (NT-I7) and KEYTRUDA® (Pembrolizumab) in Relapsed/Refractory Advanced Solid Tumors (Press)
• Genentech Submits Supplemental Biologics License Application to the FDA for Tecentriq in Combination With Avastin for the Most Common Form of Liver Cancer (Press)
• AVEO Oncology and Biodesix Announce Results from Phase 1b Study of Ficlatuzumab, Gemcitabine and Nab-paclitaxel in Advanced Pancreatic Cancer (Press)
• Phase 2 DESTINY-Gastric01 Trial of DS-8201 Versus Chemotherapy Met Primary Endpoint (Press)
• Epygenix Therapeutics Successfully Completes EPX-100 Phase I, Placebo-Controlled, Double-Blind, 2-Period Study and Ready to Phase 2 Studies (Press)

• Imricor Medical Systems ablation catheter wins CE mark (MassDevice)
• Strata Skin Sciences wins FDA clearance for excimer laser platform (MassDevice)
• Abbott wins expanded indication for Infinity DBS system (MassDevice)

• HELP and SFRC Leadership Statement on Novel Coronavirus Outbreak Briefing (Senate HELP)
• FDA Regulation of Cannabidiol (CBD) Consumer Products: Overview and Considerations for Congress (CRS)
• Special Diabetes Programs Expire in FY2020: Policy Considerations and Extension Proposals (CRS)
• Opioid Use Disorder: Barriers to Medicaid Beneficiaries' Access to Treatment Medications (GAO)
• Coming Thursday: Medicaid block grants (Politico)
• Sanofi, Mylan Spar Over Surescripts Ruling In EpiPen Fight (Law360-$)
• After criticism, federal officials to revisit policy for reviewing risky virus experiments (Science Mag)
• GOP senator calls for public health emergency over new coronavirus (The Hill)
• Remand Denied, but for “Improper,” Not Fraudulent, Joinder (Drug & Device Law)
• U.S. and China Approve Trade Agreement: Part 1 (Patent Docs)
• An antiquated system makes it hard for the FDA to find source of food-borne illness outbreaks quickly (NBC)
• Bayer Roundup cancer trial postponed to continue settlement talks (Reuters)

• FDA Advisory Committee Calendar
• John Wilkinson to chair the Global UDI and Master Data Forum, Berlin, Germany 21-23 April 2020

• Pharma Has High Hopes Of Pilot On Simultaneous Advice From EU Countries (Pink Sheet-$)
• Fimea Helsinki office has moved to new premises at Tilkanmäki (FIMEA)
• The Decade In Review: The UK, The EU And Brexit (Pink Sheet-$)
• Dutch Hospital Resumes Own Manufacture Of Leadiant’s Costly Drug (Pink Sheet-$)
• After Real-World Data Row, AZ Looks To NHS England For Tagrisso Deal (Scrip-$)
• Ondansetron: small increased risk of oral clefts following use in the first 12 weeks of pregnancy (MHRA)

• USFDA issues Form 483 with 5 observations to Biocon's Bengaluru facility (Economic Times)
• Industry raises concern over incorporation of strict WHO, ICH Guidelines in Schedule M (Pharmabiz)

• China will ensure ample supplies to Wuhan's markets, ensure price stability, Premier Li says (Reuters)
• Did China downplay the coronavirus outbreak early on? (Vox)
• Coronavirus (In The Pipeline)
• Officials confirm five U.S. cases of coronavirus after China travel (Reuters)
• China virus remains severe, medical supplies very tight: provincial official (Reuters)
• China bans wildlife trade nationwide due to coronavirus outbreak (Reuters)
• Japan confirms third case of Wuhan virus (Reuters)
• Japan to arrange charter flight for Japanese in Wuhan as early as Tuesday: Kyodo (Reuters)
• Coronavirus contagion rate makes it hard to control: studies (Reuters)
• Wuhan suspends visa, passports services for Chinese citizens until January 30: government statement (Reuters)
• Malaysia confirms fourth case of coronavirus infection (Reuters)
• Cambodia confirms first case of coronavirus -health minister (Reuters)
• Australia confirms fifth coronavirus case from last flight out of Wuhan (Reuters)
• Hong Kong bans entry of visitors from China virus province (Reuters)
• France confirms first three cases of coronavirus in Europe (Reuters)
• France to evacuate citizens from Wuhan by air (Reuters)

• 7th Invitation to manufacturers of medicinal products for treatment of Neglected Tropical Diseases (NTDs), to submit an Expression of Interest (EOI) for product evaluation to the WHO Prequalification Unit (WHO)

• Something Far Deadlier Than The Wuhan Virus Lurks Near You (KHN)
• These 10 startups acquired by Alphabet reveal a health care play centered on surveillance (STAT)