Recon: FDA Rejects Heron Postoperative Pain Drug, Nabriva’s UTI Antibiotic

• Trump, Democratic leaders to meet on drug prices soon: White House (Reuters)
• Heron Therapeutics plunges as FDA delays decision on postoperative pain NDA (PharmaLetter-$) (Endpoints) (Press)
• FDA declines to approve Nabriva's antibiotic for urinary tract infections (Reuters) (Endpoints)
• FDA approves first treatment for all genotypes of hepatitis C in pediatric patients (FDA)
• Allergan shareholders vote down proposal to split chairman, CEO roles (BioPharmaDive) (Endpoints)
• Biotech Amgen reveals earnings beat in face of rising competition (Financial Times)
• Merck & Co. to close plants, cut jobs in $1.2B manufacturing squeeze (Fierce)
• US drugmakers buoyed by growth in China and new products (Financial Times)
• Mallinckrodt shares drop after US joins cases over expensive drug (Reuters)
• Eisai buys Purdue stake in insomnia drug as PDUFA date nears (Fierce)
• Crispr Babies Vs. ‘Bubble Boy’: Only One Was About the Patient (Bloomberg)
• Perrigo's tax bill approaches $3B as U.S. joins Ireland in demanding back payment (Fierce)
• The French solution to US drug prices (CNN)
• Samsung Bioepis Sued Regarding Its Recently-Approved Etanercept Biosimilar (Big Molecule Watch)

• GSK dumps universal flu vaccine after interim data readout (Fierce)
• GSK's Shingrix skyrockets toward the £1 billion mark as HIV meds falter (Fierce)
• Generic Advair hits GSK revenues hard (BioPharmaDive)
• MHRA More Likely Than Other Regulators to Issue a Safety Advisory, Research Finds (Focus)
• US-EU Mutual Recognition Expands to Bulgaria, Cyprus (Focus)
• MHRA’s Director of Devices to Step Down (Focus)
• ABPI response to packaging changes for opioid medicines (ABPI)
• In the Leadup to EU Elections, Biosimilar and Generics Group Calls for Sustainable Market Policies (Center for Biosimilars)
• NHS Will 'Bend Over Backwards' To Fund Top Value Innovation In UK (Pink Sheet-$)
• WHO Invites HIV Drugmakers to Submit Applications for Prequalification Program (WHO)
• China makes headway on trade secret reform (BioCentury)

• CEOs in Health Care Discuss Challenges of Working With Artificial Intelligence (WSJ)
• If pharma looks slow to adopt AI, it's got good reason, expert says (Fierce)
• FDA Adds Boxed Warnings to Insomnia Medicines Following Injuries, Deaths (Focus)
• 5 questions for Gilead’s rookie CEO on his Wall Street debut (STAT)
• Gilead's CFO and Executive Vice President to depart in 2020 (Pharmafile) (Endpoints)
• Groups Urge Acting FDA Commissioner to Push for OTC Monograph Reform (Focus)
• With nanobots and rare viruses, scientists work to solve CRISPR’s delivery problem (STAT)
• Emtora Biosciences Turns Sights on Rare Genetic Disease, New Funding (Xconomy)
• Pfizer prospects for tafamidis market (BioPharmaDive)
• New Experimental Therapy CAR NKT-Cells Tested In Cancer Patients For The First Time (Forbes)
• ‘Sophisticated’ cyberthieves hacked into Charles River Labs and made off with clients’ drug data (Endpoints)
• Federal health officials urge some adults to get revaccinated against measles amid worst outbreak in 25 years (CNBC)
• Exceptions and Alternative Procedures Approved Under 21 CFR 640.120 (FDA)
• 173 to 1: Bristol-Myers chief Caforio picked up a $19.4M compensation deal after leading the charge for $74B Celgene buyout (Endpoints)
• Share price blitzed, analysts in an uproar after lead PhIII drug implodes — and Biogen unveils a $2.5M raise for the CEO (Endpoints)
• Utilizing real-world evidence to improve oncology care (Medcity)

• ViiV submits NDA for first long-acting, injectable HIV combo (PharmaTimes)
• Triumvira Submits Investigational New Drug (IND) Application to the FDA and Clinical Trial Application (CTA) to Health Canada to Evaluate TAC01-CD19, a T Cell Antigen Coupler Therapy, in Ph 1/2 TACTIC-19 Trial (Press)
• Tetra Discovery Partners Initiates Phase 2 Clinical Trial of BPN14770 in Patients with Early Alzheimer’s Disease (Press)
• Sinovant Sciences Announces Approval of Derazantinib’s Clinical Trial Application by the China National Medical Products Administration (Press)

• Medtronic wins FDA nod for quadripolar Attain Stability left heart lead (MassDevice) (Press)
• Texas Firm Draws FDA Warning Over Adulterated Device (Focus)
• Spring 2019 medical device regulatory recap: Brazil (Emergo)
• Final Guidance on UDI Labeling for Convenience Kits Brings Additional Clarity (FDA Law Blog)
• Pulse Biosciences slides on FDA setback, Q1 miss (MassDevice)
• LivaNova slides on Q1 misses, slashed outlook (MassDevice)
• CryoLife gains on Street-beating Q1 sales, confirmed outlook (MassDevice)
• Imperative Care wins FDA nod for Zoom brain thrombectomy system (MassDevice)
• InDevR Gets FDA 510(k) Clearance for Influenza Assay (GenomeWeb)

• West Virginia Hospitals Sue Opioid Companies; Want Damages (NYTimes)
• House Judiciary Committee Advances Four Bills Targeted at Generic Competition (Focus)
• What to expect from CBO’s single payer analysis (Politico)
• H.R. 965, CREATES Act of 2019 (CBO)
• Pallone Remarks At Medicare Drug Payment Hearing (House E&C)
• Pharmaceutical Company Agrees to Pay $17.5 Million to Resolve Allegations of Kickbacks to Medicare Patients and Physicians (DoJ)
• US Trade Office Signals Growing Drug Counterfeiting Problem (Pink Sheet-$)
• Another big private insurer just vowed to fight ‘Medicare for All’ plans in Washington (CNBC)
• When is a Period Not a Period? The Curious Case of Ivabradine and Pediatric Exclusivity (FDA Law Blog)
• FDA permits sale of Philip Morris IQOS tobacco-heating alternative to cigarettes (Reuters)
• House Subcommittee Approves $2B Boost to NIH Funding (GenomeWeb)
• New Naloxone Laws Seek to Prevent Opioid Overdoses (Pew)

• FDA Advisory Committee Calendar
• Development of Antiviral Drugs for the Treatment of Adenoviral Infection in Immunocompromised Patients – 8 August 2019
• Preparation for International Cooperation on Cosmetics Regulation Thirteenth Annual Meeting; Public Meeting – 5 June 2019
• Perspectives on In Vitro Diagnostic Devices Regulated by the Office of Blood Research and Review; Public Workshop – 15-16 June 2019
• NPC Headliners Luncheon: Former FDA Commissioner Scott Gottlieb – 10 May 2019

• Hoists: Molift Mover 180/205 mobile hoist and Molift Air ceiling hoist - all sizes of 2-point sling bars – risk of fracture of hooks in use (MDA/2019/020) (MHRA)
• New NICE guideline will help doctors recognise and refer people with suspected neurological conditions  (NICE)

• Donkeys Are Dying Because China Wants Their Hides For A Traditional Remedy (NPR)

• Johnson & Johnson hip implants: Drug regulator orders compensation for 2 more patients (Economic Times)
• China’s Fosun International group in talks to acquire Medall Healthcare (Economic Times)
• Pharma may see a price war in good news for diabetics (Economic Times)

• Medicine Shortages in Australia: Reporting obligations and the TGA's compliance framework (TGA)
• Webinar: How to apply to list a medicine using permitted indications (TGA)

• Keytruda - Notice of Compliance with Conditions - Qualifying Notice (Health Canada)

• His Symptoms Pointed to M.S. Then He Had a Strange Personality Shift. (NYTimes)