Recon: FDA Warns of Breathing Problems With Gabapentinoids; Merck’s Ebola Vaccine Wins FDA Approval

• Merck receives FDA approval for Ebola vaccine (Reuters) (STAT) (FDA) (Press)
• Gilead submits an NDA for its big blockbuster hopeful (Endpoints) (Fierce) (Press)
• Novartis wins Medicaid approval for new sickle cell drug in key US states (Reuters)
• Behind the Biotech Stock Rally: New Deals and Easing Political Worries (WSJ)
• House Passes North American Trade Pact With Bipartisan Support (WSJ) (Law360-$) (AP)
• FDA warns of breathing risks with popular nerve drugs (AP) (Medpage) (FDA)
• Some ways importation could falter (Politico)
• In a shift toward venture capital fundraising, FORMA Therapeutics brings in $100 million (STAT)
• 2019 was supposed to be the year Washington lowered drug prices. What happened? (STAT)
• Lawmakers seek to loosen US FDA drug approval requirements to allow early access (S&P Global)
• The new FDA commissioner appears to have deleted nearly 10,000 tweets by his predecessor (Politico)

• Stealth BioTherapeutics' neuromuscular disorder drug fails late-stage study (Reuters) (Endpoints)
• J&J gets EU approval for depression nasal spray Spravato (PMLive)
• Rinvoq gains EU approval for rheumatoid arthritis (PharmaTimes)
• Galderma Acne treatment receives approval from Europe (Pharmafile)
• Fampyra recommended in Wales after positive results in MS (PharmaTimes)
• Israel avoids health crisis with last-minute new drug budget (Reuters)
• First Ebola relapse recorded in Congo outbreak, WHO says (Reuters)
• Mundipharma fined for misleading advertising of opioids to health professionals (TGA)
• EMA Management Board: highlights of December 2019 meeting (EMA)

• Doctors Prescribe More of a Drug If They Receive Money from a Pharma Company Tied to It (ProPublica 1, 2)
• FDA takes efforts to improve quality of compounded drugs from outsourcing facilities through collaboration and education as part of new Center of Excellence (FDA)
• Cigna’s Express Scripts And Big Blue Cross PBM In Major Deal To Tame Drug Costs (Forbes)
• Top 10 surprises for biopharma in 2020? Cowen's biotech team offers a few ideas to chew on (Endpoints)
• Many pregnant women with HIV prescribed treatment that does not meet federal guidelines (NIH)
• NIH-developed Zika vaccine improves fetal outcomes in animal model (NIH)
• A hospital staffer diverted drugs, which gave me hepatitis C. That happens more often than you think (STAT)
• Kinnate jumps onto the biotech stage with $74.5M and a fledgling cancer drug pipeline (Endpoints)
• Biogen makes cautious bet on dry AMD as partner Catalyst Bio moves anti-C3 drug toward the clinic (Endpoints)
• Alkermes' head of early R&D jumps ship to newly created Harvard role (Endpoints)
• Bill Lundberg takes over the reins at Merus; Former Akcea COO Jeffrey Goldberg takes the helm of Immunitas (Endpoints)
• Tessa Therapeutics to build commercial-scale facility for VST therapies (Fierce)
• New leader at FDA, new philosophy? (Fierce)
• Industry faces new safety worries from old drugs and wider testing in 2020 (Fierce)
• Will we see the world's first approved NASH drug in 2020? (Fierce)
• Election 2020: What will it mean for R&D? (Fierce)
• Drugmakers rebranding around oncology, rare diseases could provide 2020 preview (Fierce)
• Looking ahead to a new year and a new decade (Fierce)
• Is there a future for pharma in neuro? (Fierce)
• Personalized Medicine for Primary Treatment of Serous Ovarian Cancer (NEJM)
• Injecting Safety into Supplements — Modernizing the Dietary Supplement Law (NEJM)
• Paratek wins US contract to develop anthrax treatment (BioPharmaDive)
• Biogen and the desperation of a need for Alzheimer's drugs (Fierce)
• Charles River Labs to buy HemaCare for $380M, expanding in cell therapy (BioPharmaDive)
• Bispecifics Could Be A Threat To CAR-Ts, But Efficacy May Trump Convenience (Scrip-$)

• With eye on winning over FDA in the wake of RTF, Zogenix publishes new Fintepla data (Endpoints)
• Sunovion Announces FDA Filing Acceptance of Resubmitted New Drug Application for Apomorphine Sublingual Film (Press)
• Arrowhead Pharmaceuticals Doses First Patient in AROAAT2002 Open Label Phase 2 Study of ARO-AAT for Treatment of Alpha-1 Liver Disease (Press)
• Poxel passes 3rd straight Phase III diabetes trial in Japan, but what's going on with US/EU partner Roivant? (Endpoints) (Press)
• Concert Pharmaceuticals Successfully Completes Open Label Trial of CTP-543 in Patients with Alopecia Areata (Press)

• CDRH Case for Quality Voluntary Improvement Pilot Collaboration Shows Impressive Results for Device Manufacturers (IPQ)
• Rethinking manufacturing and distribution networks in medtech (McKinsey)
• Medical Device Recalls Were Way Up in 2019 (MDDI)
• LivaNova Recalls VNS Therapy SenTiva Generator Due to Reset Error (FDA)
• Smiths Medical ASD, Inc. Recalls Medfusion® 4000 Syringe Pumps Due to Malfunctioning Alarms and Potential Interruption of Therapy (FDA)
• Forward Science Receives FDA Clearance for Orapeutic for Opioid Free Oral Pain Management (Press)
• Guardant Health Liquid Biopsy Test Gets Expanded Medicare Coverage for Solid Tumors (GenomeWeb)
• What Does 2020 Have in Store for Medtech? (MDDI)

• US vaping-related deaths rise to 54, hospitalizations to 2,506 (Reuters)
• Bayer Drops Trade Secret Suit Against Fired Scientist (Law360-$)
• Roche Wants Russian Drug Co. Sanctioned In Antitrust Fight (Law360-$
• PTAB Blocks Pharma Co.'s Repetitive Challenge To Iron Patent (Law360-$)
• Senate Passes $1.4T Spending Package To Avert Shutdown (Law360-$)
• Sweet And Low In Chicago (Drug & Device Law)
• FDA targets e-cigs that hook teens but don't help smokers quit (NBC)
• Sackler Family Members Fight Removal of Name at Tufts, Calling It a ‘Breach’ (NYTimes)

• FDA Advisory Committee Calendar

• EU Evaluation Of Orphan & Pediatric Legislation Nears Completion (Pink Sheet-$)
• Bristol-Myers Squibb Receives European Commission Approval for Revlimid® (lenalidomide) in Combination with Rituximab for the Treatment of Adult Patients with Previously Treated Follicular Lymphoma (Press)

• Merck’s KEYTRUDA® (pembrolizumab) Approved in Japan for Three New First-Line Indications Across Advanced Renal Cell Carcinoma (RCC) and Recurrent or Distant Metastatic Head and Neck Cancer (Press)

• Natco launches cut price versions of cancer drug ibrutinib in India (Economic Times)
• Lupin gets USFDA nod to market skin ointment (Economic Times)
• NPPA fixes price of 2 inhaler devices under DPCO (Pharmabiz)

• Canada health minister proposes bans on vaping product advertising (Reuters)

• Australian TGA publishes Uniform Recall Procedure update (Emergo)
• Consultation: Proposed amendments to the Poisons Standard - ACCS, ACMS and Joint ACMS/ACCS meetings, March 2020 (TGA)

• CDC Links Deadly Listeria Outbreak to Hard-Boiled Egg Plant in Georgia (NYTimes)