Recon: Sanofi Reportedly Weighing Sale of Consumer Health Unit; J&J Loses Australian Pelvic Mesh Suit

• Pricing Tactics Slow Uptake of Generic Drugs by Medicare Plans (Bloomberg)
• Gilead CEO Daniel O’Day says company is in an ‘acquisitive mode’ (STAT)
• Hospitals Push Back on Price-Disclosure Rule (WSJ)
• Trump, senators push for drug price disclosures despite setbacks (The Hill)
• Where top 2020 Democrats stand on drug pricing (The Hill)
• Charity to pay $4 million to resolve US pharma kickback probe (Reuters) (STAT)
• FDA Nominee Hahn Faces Limited Opposition From Senate Committee  (Focus) (NYTimes)
• Alnylam's rare genetic disorder drug priced at $575,000 per year (Reuters)
• BMS completes Celgene merger after FTC okay (PMLive) (Press)

• Sanofi Is Said to Mull Options for $30 Billion Consumer Arm (Bloomberg BNN) (Reuters)
• Private equity-led group to buy UK life sciences company for £3bn (Financial Times)
• Johnson & Johnson loses pelvic mesh class action in Australia (Reuters) (BuzzFeed)
• Takeda sees cell, gene therapy in its future. Is it too late? (Endpoints)
• Industry Pricing Tactics Are Driving Europe’s Cross-Country Backlash (Pink Sheet-$)
• ABPI calls for increased investment in UK clinical research (Fierce)
• Cancer Research UK spinoff raises $41M+ in Series B injection (Endpoints)
• MSD’s Keytruda scores another EU okay, in head and neck cancer (PMLive)
• Novartis, Bayer, Longwood back genomics startup to speed search for immunotherapy targets (Endpoints)

• Fall Regulatory Agenda: FDA Delays Release of Several Proposed Rulemakings (Focus)
• Biopharma Execs Remain Optimistic Despite Political Headwinds (Xconomy)
• NASEM Committee Calls to Expand Mutual Agreements Between Drug Regulators (Focus)
• From Molecule to Patient: A Biotech Perspective (Clinical Pharmacology & Therapeutics)
• No Safety Switch: How Lax Oversight Of Electronic Health Records Puts Patients At Risk (KHN)
• The triple crown in biotech: An all-or-nothing bet on an FDA approval of 3 drugs over 16 months starts today (Endpoints)
• This Pharma Startup Could Transform How Chronic Diseases Are Treated (Forbes)
• The patent landscape of inflammasome modulators (Nature)
• FDA Drafts Guidance on Transdermal and Topical Drug Delivery Systems (Focus)
• ‘The industry has earned it’: Three CEOs own up to biopharma’s bad reputation (STAT)
• Gene therapy pioneer says the field is behind — and that delivery technology is ‘embarrassing’ (STAT)
• Signant Health joins the Association of Clinical Research Organizations (PMLive)
• Amgen juices up sales outlook amid high hopes for Celgene castoff Otezla (Fierce)
• The hemophilia gene therapy race faces a critical year in 2020 (BioPhamaDive)
• Managing the challenge of drug-induced liver injury: a roadmap for the development and deployment of preclinical predictive models (Nature)
• AbbVie scoops up option to license Harpoon's BCMA drug for $50M upfront as biotech partner preps PhI/II trial (Endpoints)
• US FDA's Marks: Gene Therapy Success Could Hinge On Regulatory Convergence (Pink Sheet-$)
• Scientists find promising drug combination against lethal childhood brain cancers (NIH)
• Efforts To Move The Needle On Flu Shot Rates Get Stuck (KHN)
• A Reflection On BTD And RMAT Designations (Pink Sheet-$)
• Remote Decentralized Clinical Trials Could Solve RCT Problems (Pink Sheet-$)
• Accelerator reaches out to rare disease patient groups (PharmaLetter-$)
• Brii bags rights to tuberculosis drug to further antibiotic push (Fierce) (Endpoints)
• Pivoting from clinical to commercial, MorphoSys loses chief scientist (Fierce)
• A new generation of tools and standards for biologic medicine quality (USP)
• FDA Issues Draft Guidance Reflecting Expansion of PMR Authority (FDA Law Blog)
• Astellas and Welldoc Enter into Strategic Alliance for Digital Therapeutics - Develop and commercialize digital health solutions globally for multiple therapeutic areas, including in Japan for diabetes patients (Press)

• Pivotal data from Phase 3 study of sutimlimab in cold agglutinin disease to be presented at ASH 2019 late-breaking session (Press)
• MC2 Therapeutics Announces FDA Acceptance of its New Drug Application for Wynzora™ Cream for Treatment of Plaque Psoriasis (Press)
• Pivotal data from Phase 3 study of sutimlimab in cold agglutinin disease to be presented at ASH 2019 late-breaking session (Press)
• FORMA Therapeutics’ Olutasidenib Demonstrates Positive Phase 1b/2 Results, including Blood-Brain Barrier Penetration and Stable Disease in Patients with IDH1-mutated Glioma (Press)
• Clover Biopharmaceuticals Doses First Patient in Phase I Study of SCB-313 in Australia for Malignant Pleural Effusions (MPE) (Press)
• Inotrem Announces Enrollment of First Patient in its Phase IIb ASTONISH Trial for Nangibotide in the Treatment of Septic Shock (Press)
• Arakoda™ (Tafenoquine) Tablets, First Prescription Drug Approved for Malaria Prevention by US FDA in Over 18 Years, Now Available in US (Press)

• Medtronic Drug-Coated Balloon Receives U.S. FDA Approval to Treat Arteriovenous Fistula Lesions (Press)
• Pulmonary hypertension common in MitraClip patients, increasing mortality risk: JAMA Cardiology (MedtechDive)
• Genapsys finally unveils vaunted sequencer, but can it dent Illumina? (Endpoints)
• Liquid Biopsy Firm Lucence Plans Bay Area Buildout With $20M in Tow (Xconomy)
• LivaNova pulls the plug on transcatheter mitral valve repair device (MassDevice)
• Hologic to sell Cynosure medical aesthetics business for $205m (MassDevice)
• Congressional task force to press EPA on ethylene oxide emissions standards (MassDevice)
• Rare medical device ban, OTC hearing aids make FDA year-end to-do list (MedtechDive)
• Transcatheter device to treat heart failure gets breakthrough designation (MedtechDive)
• South Korean MFDS reduces submission requirements for high-risk medical devices (Emergo)
• Medica 2019 report: MDR readiness checklist ahead of May 2020 deadline (Emergo)
• T2 Biosystems Gets CE Mark for Direct-From-Blood Antimicrobial Resistance Panel (GenomeWeb)
• FDA Clears Siemens Healthineers SOMATOM X.cite CT Scanner With Intelligent User Interface Concept (Press)

• White House: Vaping rules not stalled, Trump plans Friday meeting (Reuters)
• US Shelves Plan to Sharply Cut Nicotine in Cigarettes (Bloomberg)
• Debate skimps on 'Medicare for All' moments (Politico)
• Medicare Add-On Payments For New Dialysis Drugs Limited To ‘Innovative’ Products (Pink Sheet-$)
• Amgen and Accord End Filgrastim, Pegfilgrastim Biosimilar Litigation (BigMoleculeWatch)
• J&J now has to fight thousands more Risperdal claims, thanks to Pennsylvania's high court (Fierce)
• AbbVie Investors Fight Bid To Toss Humira Kickbacks Suit (Law360-$)
• The FDA Knew the Bottled Water Was Contaminated. The Public Didn't. (Consumer Reports)
• Why the FDA was unable to prevent a crisis of vaping among kids (STAT)
• House committee approves landmark bill legalizing marijuana at the federal level (CNBC)
• Severance of Misjoined Claims–Why Not More Often? (Drug & Device Law)
• CRISPR Motions Day at the PTAB: Broad Files Its Substantive Motion No. 3 (Patent Docs)

• FDA Advisory Committee Calendar
• Dermatologic and Ophthalmic Drugs Advisory Committee; Notice of Meeting – 13 December 2019
• Anesthetic and Analgesic Drug Products Advisory Committee; Notice of Meeting – 16 January 2020

• EU Regulatory Roundup: Swissmedic Creates Signal Notification Form in Change to 2020 Requirements (Focus)
• MHRA drug alert: recalls for 13 over-the-counter Ranitidine medicines (MHRA)
• Class 2 Medicines recall: Ranitidine 75mg Tablets, (Various Liveries) (EL(19)A/37) (MHRA)
• Yellow fever vaccine: stronger precautions in people with weakened immunity and in those aged 60 years or older (MRHA)
• Carfilzomib (Kyprolis▼): risk of reactivation of hepatitis B virus (MHRA)
• Medical Device Alerts issued in October 2019 (MHRA)
• Letters and drug alerts sent to healthcare professionals in October 2019 (MHRA)
• Drug Safety Update: monthly PDF newsletter (MHRA)
• Aerie Pharmaceuticals Receives European Commission Approval for Rhokiinsa® (netarsudil ophthalmic solution) 0.02% (Press)

• China, Gates Foundation sign MoU on tuberculosis prevention, control (Xinhua)
• Eisai to launch Newron’s Xadago in Japan via deal with Meiji Seika (PharmaLetter-$)

• Chinese strategy: Dr Reddy's outsources part manufacturing to local parties (Economic Times)
• Laurus Labs gets 3 observations from USFDA for Visakhapatnam facility (Economic Times)
• Zydus Cadila gets USFDA nod for Isosorbide Dinitrate tablets, Desonide Cream (Economic Times)
• Indian pharma industry to achieve 11-12% growth over the next 10 years: Sudarshan Jain (Pharmabiz)
• Pharma cos to start operations at MIHAN bulk drugs park in Nagpur soon following land allocation (Pharmabiz)

• Canadian teen developed 'popcorn lung' type injury from vaping: report (Reuters)

• Brazilian Regulator Wins Place On ICH Management Committee (Pink Sheet-$)