Recon: Amgen Takes 20.5% Stake in BeiGene; Novartis Cosentyx Fails to Top Humira in Head-to-Head Trial

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

In Focus: US

• FDA is modernizing its technology to prepare for a new wave of therapies (Politico)
• Google takes on wearables giants with $2.1 billion Fitbit deal (Reuters) (WSJ)
• Realizing the Dream of Molecularly Targeted Therapies for Cystic Fibrosis (NEJM) (NIH) (NYTimes)
• AbbVie Earnings, Revenue Beat in Q3 (Yahoo) (Press)
• AbbVie says multiple parties vying for assets related to Allergan deal approval (Reuters)
• White House distances itself from Pelosi plan to lower drug prices (The Hill)
• Neglected Sickle Cell Patients Finally Get a Break and New Drugs (Bloomberg)
• US vaping-related deaths climb to 39, Illinois reports third death (Reuters)

In Focus: International

• Amgen takes 20.5% stake in BeiGene to sell cancer drugs in China (Reuters) (STAT) (Endpoints)
• Novartis arthritis drug falls short in challenge to global bestseller (Reuters) (Endpoints) (Press)
• Novo dumps proposed Rybeslus successor for newer model (Endpoints)
• Novo Nordisk nudges up 2019 sales outlook as new drugs excel (Reuters) (PMLive) (Press)
• German pharma experiencing a ‘Brexit boost’; report (PMLive) (CPhI)
• Lupin looks to sell Japanese arm Kyowa for $600 million (Economic Times)
• Pfizer Licenses TB Drug Sutezolid To Medicines Patent Pool (Pink Sheet-$)
• First patient dosed with Chiesi’s Holoclar (PharmaTimes)
• European agency highlights blood clot risks from Pfizer's arthritis drug (Reuters)
• England's antibiotic use is down, but antibiotic-resistant infections spreading, report warns (Pharmafile) (GOV.UK)

Pharmaceuticals & Biotechnology

• AI will revolutionize drug discovery — but only if experts are involved (STAT)
• Giving vouchers to pharma to develop antibiotics could be a costly move (STAT)
• Infection amnesia: Measles 'destroys immune system memory' (Reuters) (NYTimes)
• Why Developing New Antibiotics is a Losing Battle (Medpage)
• Sometimes Drug Prices Are Too Low (WSJ)
• FDA Revises Draft Guidance on Implementing GDUFA II (Focus)
• Opinion Split Over ICH Proposal To Limit Safety Data Collection (Pink Sheet-$)
• Chronic Hepatitis D: FDA Drafts Drug Development Guidance (Focus)
• Researchers Publish Results Of Biosimilar-Switching Studies (Big Molecule Watch)
• Vik Bajaj unveils Foresite's new incubator, looking to hatch future giants crossing tech and healthcare (Endpoints)
• Data suggest gene, cell therapy trial initiations in Europe lag behind North America — here's why (Endpoints)
• AMAG’s Makena: Did Accelerated Approval Kill The Confirmatory Trial? (Pink Sheet-$)
• Merck's Ebola Vaccine Will Get US FDA Decision Before March Review Deadline (Pink Sheet-$)
• US FDA Hoping To Solve Drug-Software Issues With Digital Health Working Group (Pink Sheet-$)
• Next Billion-Dollar Startups: Truepill’s Dose Of Digital Disruption To The $400 Billion Pharmacy Industry (Forbes)
• ImmunoGen Reports Recent Progress and Third Quarter 2019 Financial Results (Press)
• FDA to consider new evidence, risks behind fecal matter transplants for C. diff treatment (STAT)
• Patient Advocacy Groups – Pharma in Disguise? (Harvard Bill of Health)
• Bristol-Myers Squibb Company Announces Extension of the Expiration Date for Exchange Offers for Celgene Corporation Notes (Press)
• Paratek's top antibiotic fails to clear a key competitive hurdle in head-to-head studies (Endpoints)
• Dogs help Eli Lilly scientists identify new osteoarthritis target (Fierce)
• Gilead's ex-investor relations chief takes CFO job at Sangamo; Former GE Healthcare exec takes the helm at Vectura Group (Endpoints)
• AstraZeneca spinout Entasis nabs Shire exec as CMO (Fierce)
• Stem Cell Agency Approves Funding for Clinical Trials Targeting Parkinson’s Disease and Blindness (CIRM)
• Determination That MEXITIL (Mexiletine Hydrochloride) Capsules, 150 Milligrams, 200 Milligrams, and 250 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness (FDA)
• Research Misconduct Finding: Erin N. Potts Kant (ORI)

Pharmaceutical & Biotechnology: Study Results, Filings & Designations

• Phase 3 Results from Two Studies of TRIKAFTA (elexacaftor/tezacaftor/ivacaftor and ivacaftor) Triple Combination Treatment for Cystic Fibrosis Concurrently Published in The New England Journal of Medicine and The Lancet (Press)
• New England Journal of Medicine Publishes Results from Astellas' Phase 3 ADMIRAL Trial of XOSPATA® (gilteritinib) in Adult Patients with FLT3 Mutation-Positive Relapsed/Refractory Acute Myeloid Leukemia(1) (Press)
• Promentis Pharmaceuticals Announces Positive Results for Phase 2A Study of SXC-2023 Targeting Novel Glutamatergic Mechanism and Completion of Enrollment for Phase 2 Trichotillomania Study (Press)
• IDEAYA Biosciences Reports End‑of‑Phase 1 Meeting with FDA for IDE196 Confirms Acceptability of Single-Arm Trial Design for Potential Phase 2 Registration-Enabling Study in Metastatic Uveal Melanoma (Press)

Medical Devices

• FDA clears Xact's hands-free, robotic needle surgery system (Fierce)
• Abiomed targets 'TAVR-like' adoption for protected PCI (MedtechDive)
• Internal probe finds major problems at Ra Medical (MassDevice)
• Endologix defends AFX stent grafts after FDA warning (MassDevice)

US: Assorted & Government

• Senate Committee Advances OTC Monograph Reform Bill (Focus)
• Elizabeth Warren Releases $20.5 Trillion Plan to Pay for ‘Medicare for All’ (NYTimes) (Reuters)
• Obamacare open enrollment begins with new lower rates and same legal uncertainty (CNBC)
• The Trump Administration Cracked Down on Medicaid. Kids Lost Insurance. (ProPublica)
• Altria confirms FTC investigation of Juul as agency scrutinizes role in executive shake-up at vaping company (CNBC)
• Arizona's Purdue Suit Violates Ch. 11 Law, High Court Told (Law360-$)
• Georgia seeks to remake insurance market (Politico)
• Research Misconduct Finding: Erin N. Potts Kant (ORI)
• Removed to Federal Court? Not So Fast, Unless You’re Faster! (Drug & Device Law)
• Federal Circuit Holds APJs Are Principal Officers (Patent Docs)

Upcoming Meetings & Events

• Office of Minority Health and Health Equity Public Meeting on Strategies To Improve Health Equity Amidst the Opioid Crisis; Public Meeting – 21 November 2019

Europe

• Current drugs are "poisoning" elderly patients due to insufficient trial data, House of Lords committee hears (Pharmafile)
• Updated: Make a payment to MHRA (MHRA)

Asia

• China Effectively Bans Online Sales of E-Cigarettes (NYTimes)

India

• TB Alliance seeks clinical trial waiver for Pretomanid drug (Economic Times)

Australia

• Advertising guidance for providers of disease education activities (TGA)
• Advertising guidance for businesses involved with medicinal cannabis products (TGA)

General Health & Other Interesting Articles

• Cardiac rehab after heart valve surgery tied to better outcomes (Reuters)
• Minority cancer patients less often see 'culturally competent' doctors (Reuters)

Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory news stories from around the globe. Each weekday morning, we aim to bring you the latest highlights of new approvals, meetings, legal and political developments, regulations and guidance, and the latest trends with the potential to impact regulatory affairs professionals and the industry in which they work.

Need to contact the editor of Regulatory Reconnaissance? Email us at news@raps.org.

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.