RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

Regulatory Focus™ > News Articles > 2020 > 1 > Recon: China Says New Coronavirus Can Spread From Human to Human; GSK, 23andMe Seek First Drug Targe

Recon: China Says New Coronavirus Can Spread From Human to Human; GSK, 23andMe Seek First Drug Target

Posted 20 January 2020 | By Michael Mezher 

Recon: China Says New Coronavirus Can Spread From Human to Human; GSK, 23andMe Seek First Drug Target

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • Despite US law, many clinical trial results go unreported (Reuters) (The Lancet)
  • FDA delays decision on Intercept's NASH drug by three months (PMLive) (BioPharmaDive)
  • Patients Still Struggle To Balance High Costs Of MS Treatment, Despite Generic (NPR)
  • Judge slashes $8B Risperdal award against J&J to $6.8M (Reuters) (NYTimes)
  • Medicare’s Part D Doughnut Hole Has Closed! Mostly. Sorta. (NYTimes)
  • Supreme Court to hear Trump appeal in Obamacare contraception fight (Reuters)
  • US to screen passengers for new China coronavirus at three airports (Reuters)
In Focus: International
  • China Confirms New Coronavirus Spreads From Humans to Humans (NYTimes)
  • Virus spreads to more Chinese cities, President Xi says containment is priority (Reuters)
  • China’s plan to slash health care costs sees global pharmaceutical firms crowded out of market (SCMP)
  • WHO Warns That Pipeline for New Antibiotics Is Running Dry (NYTimes)
  • EPO officially cancel the Broad Institute's CRISPR patent (BioNews) (GenomeWeb)
  • GSK and gene profiling group 23andMe seek first drug target (Financial Times)
  • Heart failure market could surpass ‘$22bn by 2028’ (PharmaTimes)
  • UK records 178 medicine shortages in 2019, say reports (EPR)
  • What ails India's pharmaceutical sector? (Economic Times)
Pharmaceuticals & Biotechnology
  • Deciphering a cancer treatment’s dark side (Science)
  • Could a drug for arthritis in dogs also fight cancer in people? (Boston Globe)
  • After big year, RNAi drugmakers compete to prove what comes next (BioPharmaDive)
  • JPM: Glaxo's cancer unit, in commercial 'building mode,' gets choosy with M&A (Fierce)
  • JPM: Biotech, VC execs on where the industry should look beyond cancer (Fierce)
  • Your heartburn drug has been recalled. Now what? (NBC)
  • Moffitt Cancer Center details links of fired scientists to Chinese talent programs (Science)
  • US-China trade deal fails to address opioids (AEI)
  • Merck looks to CMOs to help ease vaccine supply bottleneck (Outsourcing Pharma)
  • FDA Panels Show Little Love for New Painkillers (Medpage)
  • Unapproved Drug for Babies? Ethics Experts Weigh In (Medpage)
  • Biosimilars for Rheum Disease: Failure to Launch (Medpage)
  • FDA Harnesses Technology and Collaboration to Support Rare Disease Product Development (FDA)
  • Strides arm receives EIR for its US facility (Economic Times)
  • Revolution Med shoots for $100M+ IPO — and divulges some secrets about that Warp Drive buyout (Endpoints)
  • At #JPM20, two CEOs, two radically different therapies, and a fight to chase down sickle cell (Endpoints)
  • Edible security tag for drugs developed to combat counterfeits (EPR)
  • FUSION IV Pharmaceuticals, Inc dba. AXIA Pharmaceutical Issues Voluntary Nationwide Recall of All Sterile Drug Products Within Expiry Due to A Lack of Assurance of Sterility (FDA)
Pharmaceutical & Biotechnology: Study Results, Filings & Designations
  • J&J pushes to expand Imbruvica label after clinical success (PMLive) (Press)
  • AstraZeneca Announces Positive FDA Updates on Cancer Drugs (Press)
  • AZ’s Imfinzi scores orphan drug status in liver cancer (PMLive)
  • Bridge Biotherapeutics Announces FDA IND Clearance for BBT-176, an EGFR TKI for NSCLC (Press)
  • Medivir's Phase II Study of MIV-711 in Patients With Osteoarthritis Published in Annals of Internal Medicine (Press)
Medical Devices US: Assorted & Government
  • Boston Scientific to appeal order to finish failed $275M merger (MassDevice)
  • Breaking News – Supreme Court Personal Jurisdiction Certiorari Grants (Drug & Device Law)
  • Plaintiffs Win – The Public Loses (Drug & Device Law)
  • BioDelivery Sciences International, Inc. v. Aquestive Therapeutics, Inc. (Fed. Cir. 2020) (Patent Docs)
  • High Court ERISA Case Has States, Pharmacies On Edge (Law360-$)
Upcoming Meetings & Events Europe
  • Information for all Swiss manufacturers of medical devices Third country compliance for all products (MDR and MDD) from 26 May 2020 is currently the realistic «worst case scenario» (Swiss Medtech)
  • Zydus & CMS enter pact for Desidustat in Greater China (Economic Times)
  • Report of the PMDA-ATC GMP Inspection Seminar 2019 (PMDA)
  • Pain for big Indian pharma companies continue warns CRISIL, as FDA woes remains unresolved (Economic Times)
  • Biocon Bengaluru unit pre-approval inspection by USFDA concludes with zero observations (Economic Times)
  • Lupin gets 5 observations from USFDA for its Vizag facility (Economic Times)
  • Cipla announces closure of USFDA inspection at Patalganga facility (Economic Times)
  • DoP rejects Sun Pharma’s review petition on ciprofloxacin hydrochloride injection (PharmaBiz)
  • Consultation: Fees and charges proposal 2020-21 (TGA)
  • New science strategy prepares regulatory scientists for the future (TGA)
Other International
  • Paraguay braces for deadly Dengue fever outbreak (Reuters)
General Health & Other Interesting Articles
  • Epic Systems, a major medical records vendor, is warning customers it will stop working with Google Cloud (CNBC)
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 news@raps.org.
A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.

Regulatory Focus newsletters

All the biggest regulatory news and happenings.