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Regulatory Focus™ > News Articles > 2019 > 4 > Recon: Gilead, Novo Nordisk Team up to Test NASH Combo

Recon: Gilead, Novo Nordisk Team up to Test NASH Combo

Posted 12 April 2019 | By Michael Mezher 

Recon: Gilead, Novo Nordisk Team up to Test NASH Combo

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • Novo Nordisk and Gilead team up to test fatty liver disease treatment (Reuters) (Endpoints) (Fierce) (Press)
  • FDA expands Keytruda label to include stage 3 and 4 non-small cell lung cancer (Pharmafile) (Press)
  • Bristol-Myers shareholders back the big Celgene buyout. What happens now? (Endpoints) (Celgene) (BMS)
  • Many employers would like to eliminate those controversial rebates on drugs (STAT)
  • Lawmakers ask the Trump administration to investigate PBM pricing practices (STAT)
  • Florida House approves drug imports from Canada (Tampa Bay Times)
  • Opioid Sales Reps Swarmed New York at Height of Crisis (NYTimes)
  • The Perils Of Value-Based Pricing For Prescription Drugs (Washington Post)
  • Oklahoma judge, not jury, to decide case against drugmakers (AP) (The Oklahoman)
  • Herbal supplement kratom is tied to more US deaths (AP)
  • Ketamine May Relieve Depression By Repairing Damaged Brain Circuits (NPR) (NIH)
  • Health spending growth continues to lag GDP increases (Politico)
In Focus: International
  • Novartis Doesn’t Rule Out Further Deals in NASH Treatments (WSJ)
  • Why you’re more likely to die of cancer in Europe than America (Politico)
  • Health experts discuss rise in Ebola, to decide if emergency: WHO (Reuters)
  • Disease outbreaks feared in Libya, as supplies stretched: WHO (Reuters)
  • No-deal risk recedes, but new Brexit delay adds to uncertainty (PMLive) (PharmaTimes)
  • European Commission Says Majority of Drugs, Devices Compliant Ahead of Postponed Brexit (Focus)
  • EMA confirms path for Diurnal's Chronocort despite trial failure (PharmaTimes)
  • Update of EU recommendations for 2019/2020 seasonal flu vaccine composition (EMA)
  • Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 April 2019 (EMA)
  • New humanitarian discount policy increases access to expensive pneumonia vaccines (MSF)
  • China's Ant Financial amasses 50 million users, mostly low-income, in new health plan (Reuters)
  • This Chinese pharma filed for an IPO last September. Seven months and a $283M investment later, they are back at the HKEX (Endpoints)
  • Egypt’s fast-track medical device registration pathway reducing market access timeframes (Emergo)
  • Teva Canada announces the approval of Truxima, the first biosimilar to Rituxan (Biosimilar News)
Pharmaceuticals & Biotechnology
  • Going viral? J&J tries to spark a Twitterstorm for the latest data on its HIV med (Endpoints)
  • Of Risk and Gene Drives (Harvard Bill of Health)
  • How Are Gene Therapies Going To Get Paid For? (Forbes)
  • Generic Labeling Problems Targeted In US FDA Budget Request (Pink Sheet-$)
  • The Return Of The “Specialty” Drug Pricing Debate In The US (Pink Sheet-$)
  • Lack Of Harmonization In ICH Q12 Draft Guideline Draws Fire In US (Pink Sheet-$)
  • Wave delays key data readout for Huntington's therapy (BioPharmaDive)
  • FDA Finalizes Rule on OTC Hand Sanitizers (Focus)
  • Janssen's Symtuza around 90% effective in achieving undetectable HIV-1 viral loads, when used immediately following diagnosis (Pharmafile)
  • GW Pharma announce Darren Cline as company's new Chief Commercial Officer (Pharmafile)
  • Still preclinical, but this Flagship upstart recruited a Big Pharma exec with a $4.3M compensation package and an IPO plan (Endpoints)
  • Sonde wants to listen for disease — M Ventures heard the Boston biotech, and led a $16M round to supercharge research (Endpoints)
  • Chutes & Ladders—Shire R&D chief jumps ship to Ironwood spinout amid Takeda megamerger (Fierce)
  • SD Import Issues Voluntary Nationwide Recall of Aphrodisiac Capsules Due to Presence of Undeclared Sildenafil (FDA)
  • Determination of Regulatory Review Period for Purposes of Patent Extension; SYMPROIC (FDA)
Pharmaceuticals & Biotechnology: Study Results, Filings & Designations
  • Mallinckrodt Completes Full Enrollment of its Phase 3 Clinical Trial for StrataGraft® Regenerative Skin Tissue (Press)
  • Horizon Pharma plc to Present Results from its Phase 3 Teprotumumab Trial (OPTIC) at the 2019 American Association of Clinical Endocrinologists (AACE) Scientific and Clinical Congress (Press)
  • Cirius Therapeutics Announces Presentation of Interim Data from Phase 2b Clinical Study of MSDC-0602K at The International Liver Congress 2019 (Press)
Medical Devices
  • Third Party Review Organization Performance Report (FDA)
  • FDA Reclassifies Certain Device Accessories to Class I (Focus) (FDA)
  • Smith & Nephew expands robotics R&D footprint in Pittsburgh (MassDevice)
  • Medical Devices; Anesthesiology Devices; Classification of the Ventilatory Electrical
  • Impedance Tomograph (FDA)
US: Assorted & Government
  • President Trump’s impossible health care dream (Boston Globe)
  • The false promise the PROTECT Act makes on preexisting conditions (LA Times)
  • The Issue Of Medicare For All Is Dominating The 2020 Democratic Field (NPR)
  • De Blasio defends vaccination mandate from planned legal challenge (The Hill)
  • Bayer says to comply with court mediation order in glyphosate case (Reuters)
  • 'Pharma Bro' Shkreli Can't Duck Kidney Drug Antitrust Suit Yet (Law360-$)
  • Who Can Be A Defendant In Biosimilar Patent Litigation? (Law360-$)
  • Drug Pricing and Intellectual Property Law: A Legal Overview for the 116th Congress (CRS)
  • AbbVie, Shire investors agree to settle lawsuit over scuttled tax-inversion deal (Fierce)
  • Advertising Laboratory Tests: Change on the Way in Maryland (FDA Law Blog)
  • Pennsylvania Still Flailing Away in The Jurisdictional Deep End (Drug & Device Law)
  • Pennsylvania appeals court upholds $14m plaintiff win in Ethicon mesh case (MassDevice)
Upcoming Meetings & Events Europe
  • EMA Officials Debate Going Beyond Safe and Effective Determinations for New Drugs (Focus)
  • EuroBiotech Report—Bayer boosts US research workforce, Poxel sees diabetes success and Kymab turns to Merck KGaA for next CEO (Fierce)
  • UK Legislators Get Involved In NICE’s Methods Review (Pink Sheet-$)
  • Japanese pharma market set for strong growth in 2019 (EPR)
  • FiercePharmaAsia—PD-1 royalty dispute; Takeda Latam asset sale; Chinese genomics investor in US (Fierce)
  • J&J doubles bedaquiline donation in India to 20,000 courses for timely access to TB patients (Pharmabiz)
  • DCGI directs state DCs to ask manufacturers of 7 drugs to incorporate newly identified ADRs in package insert of drugs (Pharmabiz)
  • Can I import a medicine for personal use? (TGA)
  • Fluoroquinolone antibiotics and risk of aortic aneurysm/dissection (TGA)
General Health & Other Interesting Articles
  • Scott Kelly Spent a Year in Orbit. His Body Is Not Quite the Same. (NYTimes)
  • CBD Lures Stressed-Out Parents Looking to Unwind (NYTimes)
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.

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