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January 8, 2020
by Michael Mezher

Recon: AbbVie to Split Allergan Cosmetics Into Separate Unit; Pharmacy Chains Sue Prescribers in Opioid Spat

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • AbbVie to house Allergan Botox business in separate unit (BioPharmaDive)
  • Less Is More for Big Pharma in 2020 (WSJ)
  • Why Humira’s price keeps rising despite FDA approval of generic competition (Washington Post)
  • At 2020 deadline, progress in Patrick Soon-Shiong’s ‘cancer moonshot’ is hard to find (STAT)
  • Pharmacies say prescribers bear opioid crisis responsibility (ABC) (Washington Post)
  • Cancer Death Rate in US Sees Sharpest One-Year Drop (NYTimes) (STAT) (WSJ)
  • Drugmakers won't replace opioids anytime soon (Politico)
  • Federal Investigators Can Intervene In Perrigo Takeover Row (Law360-$)
  • A new biotechnology and pharmaceutical industry commitment to patients and the public (STAT)
  • Arena Pharma CEO Targets Brain Diseases as Next Drug Frontier (Bloomberg)
  • Can a Drug's $500,000 Price Withstand Competition? (Bloomberg)
In Focus: International
  • Sun Pharma eyes China, Japan markets (Economic Times)
  • Almirall eyes $62m takeover of multicytokine specialist Bioniz (PMLive)
  • WuXi-backed Adagene scores $69M round led by General Atlantic to push antibodies where Bristol-Myers struggled (Endpoints)
  • Anger over UK's failure to ban breast implants linked to 61 cancer cases (The Guardian)
  • Serum Institute of India Pvt Ltd has achieved WHO prequalification for Pneumosil (Press)
  • Eight Chinese sufferers of unidentified virus released from hospital (Reuters)
  • WHO Drafts Policy on Designating Regulators as Listed Authorities (Focus)
  • Asia Regulatory Roundup: India Gives Device Manufacturers Another Year to Meet Drug Regulations (Focus)
Pharmaceuticals & Biotechnology
  • Verastem pens KRAS-focused drug licensing deal with Chugai (Fierce)
  • A New Approach to Cancer Treatment Draws Lessons From Darwin (WSJ)
  • FDA Updates Compliance Guide on Pre-approval Inspections for Drugs (Focus)
  • Novartis' AveXis opens Zolgensma plant in Colorado with 350 employees (Fierce)
  • Just how big is the biopharma dealmaking world? In 2019 we saw megabillions in cash change hands, and that's just the tip of the iceberg (Endpoints)
  • Miracle drugs can’t help if they aren’t affordable (Baltimore Sun)
  • n-Lorem Foundation launches to develop individualized therapies for ultra-rare diseases (C&EN) (Endpoints)
  • Millennium Health Donates Data to Help Fight the Drug Overdose Crisis (HHS)
  • FibroGen names Lilly veteran as new CEO (Pharmafile)
  • New recommendations could get innovative treatments to cancer patients quicker (PharmaTimes)
  • A Fine Balance: Report Aims to Combat Opioid Epidemic, Manage Pain (Medscape)
  • Pear Therapeutics licenses voice biomarkers for dementia and psychiatric disorders (STAT)
  • Mirati Adds Execs With Commercial Experience at Spark, Bristol-Myers (Xconomy)
  • Galen completes acquisition of healthcare company POA Pharma (PMLive)
  • Patients push limits for clues to chronic fatigue syndrome (STAT)
  • NorthSea raises $40M to wrap up phase 2b NASH trial (Fierce) (PMLive) (Press)
  • Xencor, Verastem ink new deals; Scynexis' lead drug scores again (Endpoints)
  • Mark Alles begins his post-Celgene career on the board of a US-China biotech led by a former colleague (Endpoints)
  • Aim for the brain: RA Capital bets on Colorado biotech to reformulate epilepsy drug for refractory patients (Endpoints)
  • Mayo Clinic helps tech-enabled R&D shop nference to $60M B round (Fierce) (Endpoints)
  • Bristol-Myers' ex-chief scientific officer joins Fred Hutchinson as president (Fierce) (Endpoints)
  • Analysts weigh in on what to expect in biopharma this year (MedCity)
  • Appco Pharma LLC Issues Voluntary Nationwide Recall of Ranitidine Hydrochloride Capsules 150 mg and 300 mg Due to an Elevated Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA) (FDA)
Pharmaceutical & Biotechnology: Study Results, Filings & Designations
  • NANOBIOTIX Announces Plan for Global Phase III Head and Neck Cancer Registration Trial Along With Overall Development Update (Press)
  • Promethera® Announces Initiation of Phase 2b DHELIVER Study of HepaStem™ in Patients with Acute-on-Chronic Liver Failure (ACLF) (Press)
  • SCYNEXIS Announces Positive Results from the Second Interim Analysis of Ongoing Phase 3 FURI Study, Demonstrating Oral Ibrexafungerp's Ability to Treat Severe Fungal Infections in the Hospital Setting (Press)
  • PellePharm Initiates Phase 2 Clinical Trial of Patidegib Topical Gel for People With High Frequency Basal Cell Carcinoma (Press)
  • Certara Partners with Galderma in Advancing Modeling and Simulation Technology to Attain FDA Approval of AKLIEF® Topical Acne Cream (Press)
  • Catabasis Pharmaceuticals and Duchenne UK Announce Partnership to Evaluate Edasalonexent in a Phase 2 Non-Ambulatory Duchenne Muscular Dystrophy Trial (Press)
Medical Devices
  • A Q&A with FDA’s Amy Abernethy on how the agency is grappling with digital health regulation (STAT)
  • US FDA issues updates to classification regulations, hires verification services (Emergo)
  • FDA OKs alternative to open heart surgery for Abbott's HeartMate 3 pump (MedtechDive)
  • OrthoPediatrics sells Vilex assets in preparation for more M&A (MedtechDive)
  • Digital health M&A flatlines in 2019, but IPO activity promising (MedtechDive)
  • Bio-Rad Laboratories appoints new head of clinical diagnostics group (MassDevice)
US: Assorted & Government
  • 'Burner' phones and Ariad secrets: Goldman Sachs banker pleads guilty for his role in global insider trading ring (Endpoints)
  • Allergan Accused Of Playing Dirty In Breast Implant MDL (Law360-$) (MassDevice)
  • 'Opioid Babies' Seek Class Cert. In MDL (Law360-$)
  • Whistleblower Fights Safeway's Bid To End Drug Price Suit (Law360-$)
  • Sarepta Investors Sue In Delaware Over Drug Risk Disclosures (Law360-$)
  • Fed. Circ. Partially Revives Amgen's Sensipar Patent Fight (Law360-$)
  • Constitutional Limitations on Product Liability? (Drug & Device Law)
  • AAM Statement on "The Unintended Economics of the BLOCKING Act" Report (AAM)
  • NCPA Available for Comment on Potential SCOTUS PBM Case (NCPA)
  • Focus Needed Not Just On Drugs But Hospital Expenses To Impact Healthcare Costs (Forbes)
  • Largest study yet offers no clear talc link to ovarian cancer (Reuters)
Upcoming Meetings & Events Europe
  • Examining the issue formerly known as Brexit (Emergo)
  • Spain's Esteve sells a plant then buys one as it refocuses on specialty drugs (Fierce)
  • Walgreens Boots Alliance confirms that 28 Boots stores have been closed (Pharmaceutical Journal)
Asia
  • China court jails founder of traditional medicine firm over pyramid scheme (Reuters)
  • Avacta and Daewoong form cell and gene therapies JV (PharmaLetter-$)
India
  • Cabinet gives ex-post-facto nod to MoC between health department, Gates Foundation (Economic Times)
  • Punjab FDA gets 13 drug inspectors and 12 drug analysts; DCA proposes to create post of DDCs (PharmaBiz)
Australia
  • Variations to prescription medicines - excluding variations requiring evaluation of clinical or bioequivalence data, Appendix 1: Variation types - chemical entities (TGA)
Other International
  • New Guidance Explains How Regulators Can Begin the Process to Join PIC/S (Focus)
General Health & Other Interesting Articles
  • Analysis of commercial DNA tests finds inconsistent coverage (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 [email protected].
 
A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.
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