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February 7, 2020
by Michael Mezher

Recon: AbbVie Boosts 2020 Outlook; Novacyt Seeks Emergency Authorization for Coronavirus Test

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • First US attempt at CRISPR gene editing in cancer appears safe (Reuters) (Science Mag) (Science) (Endpoints)
  • Scott Gottlieb adds one more high-profile board seat to the post-FDA resume. And it’s another plum assignment (Endpoints) (Press)
  • Biotech company Novacyt seeks emergency approval for coronavirus test (Reuters)
  • AbbVie boosts 2020 outlook despite competition from generic drugs (Financial Times)
  • AbbVie touts Humira defense strategy abroad as a positive sign for forthcoming US battle (Fierce)
  • Takeda Beats Rivals' Challenge To Diabetes Drug Patent (Law360-$)
  • Chiesi launches new rare disease R&D division in Boston (PMLive) (Fierce) (Press)
  • Jury orders Johnson & Johnson to pay $750 million in New Jersey talc case (Reuters)
In Focus: International
  • China Begins Testing an Antiviral Drug in Coronavirus Patients (NYTimes)
  • Mainland China reports 73 new coronavirus deaths on February 6, toll rises to 636 (Reuters)
  • A lottery like no other offers up a cutting-edge medicine — with lives on the line (STAT)
  • Lonza resuming production as coronavirus spread threatens manufacturers (BioPharmaDive)
  • Novo Nordisk investing $117.4M in manufacturing site in Denmark (Fierce)
  • Drug Prices ‘Not On The Table’ In UK-US Trade Deal Talks (Pink Sheet-$)
  • UK Urged To Fund Rare Disease Treatments Immediately (Pink Sheet-$)
  • Pharma companies must adhere to marketing norms during conferences: Indian Govt (Economic Times)
Pharmaceuticals & Biotechnology
  • Just a few hundred prescribers responsible for half of US opioid doses (Reuters)
  • Time to Ban Heritable Genome Editing (Harvard Bill of Health)
  • Use of CAR-Transduced Natural Killer Cells in CD19-Positive Lymphoid Tumors (NEJM)
  • Drugmaker BioMarin Seeks New CFO Amid Coming Release Of Potentially Costliest Drug In The World (Forbes)
  • Weak pipeline? Why, Sanofi execs are suddenly over the moon about their prospects (Endpoints)
  • 85% of patients see benefit in clinical trials, but 43% were never given the option to participate, report finds (Pharmafile)
  • AAM Announces 2020 Board of Directors (AAM)
  • Sonoma Bio Launches With $40M to Take Cell Therapy Beyond Cancer (Xconomy)
  • Another Takeda/Shire R&D exec jumps ship as Pharvaris nabs Peng Lu as its new CMO (Fierce)
  • Sanofi C-suite explains Regeneron deal 'simplification,' ramping up its pipeline (Fierce)
  • Biologics Consortium Plans Collaborative Approach To Rapid Methods Validation (Pink Sheet-$)
  • Record levels of VC financing and R&D boom left biopharma companies clamoring for space. How bad is it? (Endpoints)
  • From mice to dogs, and someday man: George Church's gene therapy cocktail for aging-related diseases (Endpoints)
  • Craig Basson tells us why he leapt from NIBR to Boston Pharma; Ex-BMS Partner CytomX finds new CMO in Allison Hannah (Endpoints)
  • Diffusion CSO and co-founder Gainer set to resign next month (Fierce)
Pharmaceutical & Biotechnology: Study Results, Filings & Designations
  • So close, yet so far: Zogenix LGS trial succeeds, but results underwhelm (Endpoints) (Press)
  • Elios Therapeutics Presents New Phase IIb Data for Personalized Cancer Vaccine in High-Risk Melanoma Patients at the 2020 ASCO-SITC Clinical Immuno-Oncology Symposium (Press)
Medical Devices
  • GE Healthcare recalls nearly 3,600 anesthesia systems (MassDevice) (FDA)
  • Snapshot: How medtech earnings season is shaping up (MedtechDive)
  • Longtime Myriad CEO resigns amid another steep earnings miss, guidance cut (MedtechDive)
  • Verily, Santen do a JV for ophthalmological devices (MassDevice)
  • I was fortunate to get post-23andMe genetic counseling. Everyone should have that option (STAT)
  • Life Spine Announces FDA 510(k) of the Steerable PLATEAU® Ti System (Press)
US: Assorted & Government
  • Dueling It Out with FDA over NCE Exclusivity (FDA Law Blog)
  • Burning health care questions for tonight’s Democratic debate (Politico)
  • A closer look at Bernie Sanders’ plans to upend pharma and lower drug prices (STAT)
  • Patients Stuck With Bills After Insurers Don’t Pay As Promised (KHN)
  • Pay-For-Delay Ban Risks 'Endless Litigation,' 9th Circ. Told (Law360-$)
  • FDA Begins Crackdown On Illegally Marketed E-Cigarettes (Law360-$)
  • A Judge Rules That the FDA’s Cigar Box Warning Label Requirement Is Unconstitutional (Yahoo)
  • Bayer Can't Seal Internal Essure Docs, Judge Says (Law360-$)
  • Ending four years of legal fight, ARCH-backed synthetic DNA maker settles lawsuit with CEO's former employer (Endpoints)
  • FNC Won’t Let Mass Litigation Tourism Be (Drug & Device Law)
Upcoming Meetings & Events Europe
  • CJEU Confirms 'Pay For Delay' Settlements Can Break EU Law (Pink Sheet-$)
  • EU Regulatory System Attacked Over Quality Of Approvals (Pink Sheet-$)
  • Irish patients ‘wait three times longer for medicines’ (PharmaLetter-$)
India
  • Strides to acquire 18 abbreviated new drug applications from Pharmaceutics International, Inc (Economic Times)
Australia
  • Microbiological quality of medicinal cannabis products (TGA)
  • Warning about products claiming to treat or prevent the novel coronavirus (TGA)
Coronavirus Outbreak
  • WHO says too early to say coronavirus peaking in China (Reuters)
  • WHO warns of global shortage of coronavirus protective equipment (Reuters)
  • 'Light a candle': Death of Chinese doctor sparks mourning, anger (Reuters) (NBC) (NYTimes)
  • China anti-corruption body to probe 'issues' related to Li Wenliang (Reuters)
  • Experts scramble, but new virus vaccine may not come in time (AP)
  • Brazil's Bolsonaro signs into law bill on quarantine rules for coronavirus (Reuters)
  • Italy denies 'groundless' China assertion on resuming flights (Reuters)
  • Singapore lifts virus alert to SARS level, sparking panic buying (Reuters)
  • Coronavirus screening leads Royal Caribbean to delay cruise from N.J., 4 taken to hospital (NBC)
  • Coronavirus cases on cruise ship marooned off Japan rise to 61 (Reuters)
General Health & Other Interesting Articles
  • Five new measles cases reported in Los Angeles area (The Hill)
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.
 
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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