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Regulatory Focus™ > News Articles > 2020 > 1 > Recon: Novartis, NHS Reach Deal on Yet-to-Be Approved Heart Drug Inclisiran; Roche Aims to Undercut

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

Posted 14 January 2020 | By Michael Mezher 

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

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • 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)
In Focus: International
  • 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)
Pharmaceuticals & Biotechnology
  • 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)
Pharmaceutical & Biotechnology: Study Results, Filings & Designations
  • 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)
Medical Devices
  • 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 $45M Financing (MDDI)
  • Carestream Digital Tomosynthesis Receives FDA Clearance (Press)
  • TransEnterix Announces Submission of 510(k) to FDA for First Machine Vision System in Robotic Surgery (Press)
US: Assorted & Government
  • Health care questions for tonight's Democratic debate (Politico)
  • 2020 in Washington: another shot at drug pricing legislation, user fees and 21st Century Cures 2.0 (BioCentury)
  • Supreme Court Takes Pass on Clarifying Patent Eligibility, Disappointing BioPharma (Pink Sheet-$) (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-$) (AP)
  • Team Trump Says Administration’s Action On Health Care ‘Is Working.’ Is It? (KHN)
  • Lanham Act Claim Dismissed as Usurping FDA Authority (Drug & Device Law)
  • The Evolving Legality Of Lesser-Known Cannabis Compounds (Law360-$)
Upcoming Meetings & Events Europe
  • 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)
General Health & Other Interesting Articles
  • Artificial Intelligence Speeds Brain Tumor Diagnosis (NIH)
Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe.
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