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

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• FDA Advisory Committee Calendar

• 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)

• Scott Kelly Spent a Year in Orbit. His Body Is Not Quite the Same. (NYTimes)
• CBD Lures Stressed-Out Parents Looking to Unwind (NYTimes)