Recon: Novartis, NHS Reach Deal on Yet-to-Be Approved Heart Drug Inclisiran; Roche Aims to Undercut Rivals With SMA Drug Pricing

• All talk, no M&A makes for a down JPM Day (STAT) (Pink Sheet-$)
• Roche aims to 'underwhelm' on SMA drug price to challenge rivals (Reuters) (Endpoints)
• GlaxoSmithKline CEO expects to get ‘at least’ six drug approvals from the FDA in 2020 (CNBC)
• Eyeing more data, Livongo will integrate continuous glucose monitor into diabetes coaching program (STAT)
• FDA's tech overhaul is underway (Politico)
• Eli Lilly to launch half-priced versions of two more insulin treatments (Reuters) (Press)
• Oklahoma attorney general sues distributors of opioids (AP) (The Hill) (Law360-$)
• Appeals court skeptical of Trump rule on TV drug ads (The Hill) (Law360-$)
• Drugmakers Test New Ways to Pay for Six-Figure Treatments (WSJ)
• Big Pharma looks to stem losses after trade deal defeat (The Hill)
• NIH extends reporting mandate to more clinical trials, but obscures their policing (Science)

• Novartis to speed access to $10 billion heart drug via NHS deal (Reuters) (CNBC) (Endpoints) (Financial Times) (ABPI) (GOV.UK)
• Life Sciences Industrial Strategy Update (GOV.UK)
• Urgent health challenges for the next decade (WHO)
• Astellas teams with Adaptimmune to create CAR-T, TCR therapies (Fierce) (Endpoints) (Press)
• Amgen CEO expects 25% of growth to come from Asia in next decade (Reuters)
• Genomics England, Illumina join forces on whole genome sequencing (PharmaTimes)
• Zytiga, Ajovy among latest SMC decisions (PharmaTimes)
• WHO says new China coronavirus could spread, warns hospitals worldwide (Reuters)
• EU-China Working Group to Address API Manufacturing Concerns (Focus)

• Do FDA’s Reforms Need Reforming? Report Looks Back on 4 Decades (Focus)
• OND Reorganization Slightly Delayed as Woodcock Outlines 2020 Priorities (Focus)
• ‘Clinical Superiority’: FDA Finds Diazepam Nasal Spray Deserves Orphan Exclusivity (Focus)
• Prescription Drug Shortages Could Plague The 2020’s (Forbes)
• Prescription drug overload: Critics fighting to curb an epidemic of medication side effects (Boston Globe)
• BMS expands collaboration with Nektar, sending shares soaring (PMLive)
• Alexion's neuro bet, Rubius' trial troubles and biotech's gene therapy milestones (BioPharmaDive)
• BioMarin sets gene therapy sights beyond hemophilia (BioPharmaDive)
• Mind the Gap: Bridging the ‘Valley of Death’ for U.S. Biomanufacturing (NIST)
• Trump restrictions on fetal tissue research unsettle key studies and scientists (Washington Post)
• FDA places Innate cancer trial on partial clinical hold over CMO issue (Outsourcing Pharma)
• At JPM, a debate on Alzheimer’s disease, some family drama in oncology, and a beaten-down biotech (STAT)
• JPM: Alnylam CEO looks to action-packed 2020 on the heels of Givlaari approval (Fierce)
• JPM: Roche, Illumina unveil 15-year cancer diagnostic tie-up (Fierce) (Press)
• #JPM20: Biogen CEO Michel Vounatsos offers a 'smile of confidence' as he presents aducanamab (Endpoints)
• JPM: Bristol chief says one-third of Celgene cost cuts will hit in 2020 (Fierce)
• JPM: With new ethics plan, Novartis chief puts his money where his mouth is (Fierce)
• Daré Bioscience Inks Deal With Bayer for Non-Hormonal Contraceptive (Xconomy) (PMLive)
• Horizon enlists Mammoth in CRISPR move (PharmaTimes)
• EUSA Pharma and BeiGene ink deal for two orphan drugs (PharmaLetter-$)
• The war against cancer (The Hill)
• Express Scripts vs. CVS Health: Five Lessons From the 2020 Formulary Exclusions and Some Thoughts on Patient Impact (Drug Channels)
• FDA Drug Reviews Could Benefit From Insights Into What Payers Want, OND Chief Says (Pink Sheet-$)
• US FDA’s Precision Medicine Efforts Turn Towards Adverse Events (Pink Sheet-$)
• NeoGenomics Nabs Human Longevity’s Oncology Division for $37M (Xconomy)
• Innovation in biotech R&D: New resources offer new hope (STAT)
• A forerunner in ‘smart pills’ adopts a new tack as key pharma partnership unravels (STAT)
• Eli Lilly ditches NextCure pact (Fierce)
• Gates vets at Adjuvant back Codagenix's software-driven approach to recoding RSV, flu, oncolytic viruses and more (Endpoints)
• Ex-Merck Serono CMO takes up medical role at struggling Ipsen in its evolving C-suite (Fierce)
• Improving immunotherapy (Nature)
• Sorafenib analogue combats MRSA (Nature)

• AbbVie's Skyrizi hangs Novartis' Cosentyx out to dry in head-to-head psoriasis study (Endpoints)
• NantKwest and ImmunityBio Announce Complete Response in Metastatic Pancreatic Cancer in the First Patient to Receive PD-L1 Tumor-Targeted Natural Killer Cells (PD-L1.t-haNK) Combined with N-803 IL-15 Fusion Protein (Press)
• Alexion Announces Planned Initiation of Pivotal Phase 3 Study of ULTOMIRIS® (ravulizumab) in ALS (Press)
• Cerevel Therapeutics Initiates Phase 3 Program of Tavapadon for the Treatment of Parkinson’s Disease (Press)
• GNT Pharma's Anti-dementia Drug 'crisdesalazine' Demonstrates Efficacy in Phase III Clinical Study with Companion Dogs with Dementia (Press)

• A thoroughly average year for medtech mergers (Evaluate)
• Stryker Petition Pushes FDA to Exempt Powered Wheel Stretchers From 510(k) Requirements (Focus)
• MGI Receives CE Mark, Regulatory Clearance in Asia-Pacific Countries for Several Sequencers (GenomeWeb)
• Dexcom's G6 to integrate with Livongo (mobihealthnews)
• Medtronic Wins CE Mark for Rechargeable Sacral Neuromodulation Tech (MDDI)
• Abbott Kicks in for Bigfoot's $45M Financing (MDDI)
• Carestream Digital Tomosynthesis Receives FDA Clearance (Press)
• TransEnterix Announces Submission of 510(k) to FDA for First Machine Vision System in Robotic Surgery (Press)

• Health care questions for tonight's Democratic debate (Politico)
• 2020 in Washington: another shot at drug pricing legislation, user fees and 21st Century Cures 2.0 (BioCentury)
• Supreme Court Takes Pass on Clarifying Patent Eligibility, Disappointing BioPharma (Pink Sheet-$) (Law360-$) (Patent Docs)
• FDA Slams Theranos Execs' 'Unprecedented' Doc Bid (Law360-$) (The Recorder)
• FTC Approves Final Order Requiring Bristol-Myers Squibb Company and Celgene Corporation to Divest Psoriasis Drug Otezla as a Condition of Acquisition (FTC)
• Ex-Insys Exec Gets Nearly 3 Years For Opioid Kickbacks (Law360-$)
• Insys Judge Wonders If Potential Punishment Is Too Harsh (Law360-$)
• FDA’s Juul Inquiry Found Consumers Had 2,600 Health Complaints (Bloomberg)
• AmerisourceBergen Loses Bid To Shield Opioid Docs (Law360-$) (AP)
• Team Trump Says Administration’s Action On Health Care ‘Is Working.’ Is It? (KHN)
• Lanham Act Claim Dismissed as Usurping FDA Authority (Drug & Device Law)
• The Evolving Legality Of Lesser-Known Cannabis Compounds (Law360-$)

• FDA Advisory Committee Calendar

• Pharmacist sentenced for supplying drugs on the black market (MHRA)
• UK Multiple Myeloma Patients Allowed Early Access To Sanofi’s Isatuximab (Pink Sheet-$)
• Class 4 Medicines Defect Information: Advanz Pharma Zapain 30mg/500mg Tablets (Codeine Phosphate /Paracetamol), PL12762/0034, (EL(20)A/01) (MHRA)

• Asia Regulatory Roundup: TGA Clears Pharmacies to Advertise Salbutamol Inhalers During Fires (Focus)
• Korea 2020 Outlook: Hopes Of Turnaround Amid Potential Deals, Biosimilar Launches, Biologics Law (Scrip-$)
• Biosimilar and Biologic Updates in China: Bevacizumab, Etanercept, Tislezumab, Infliximab, Eculizumab, Adalimumab (Big Molecule Watch)

• Govt to come up with financial assistance for fighting rare diseases (Economic Times)
• Pharma cos may face Rs 10-lakh penalty, 2-year jail term for deceptive drug ads (Economic Times)
• Maharashtra FDA lab investigations reveal only 232 NSQ drug samples found in 2019 (Pharmabiz)

• Notice of recommendations to prepare a document in substitution for the current Poisons Standard - New Chemical Entities (NCEs) (TGA)
• Notice of final decision to amend (or not amend) the current Poisons Standard: Risankizumab (TGA)

• Notice: Product Monograph Implementation Plans (Health Canada)
• Health Canada Approves Astellas' XOSPATA® (gilteritinib) for Patients with Relapsed or Refractory Acute Myeloid Leukemia with a FLT3 Mutation (Press)

• Artificial Intelligence Speeds Brain Tumor Diagnosis (NIH)