Recon: Lilly, Avidity Team up on Immunology Drugs; FDA Approves Keytruda Combo for Kidney Cancer

• Merck's Keytruda wins FDA approval as combination therapy for kidney cancer (Reuters) (Endpoints) (FDA)
• Lilly, Avidity to Partner on Immunology Drugs in Up-to-$440M Collaboration (GEN) (BioPharmaDive) (Endpoints)
• Poseida Therapeutics Raises $142 Million in Series C Financing (Reuters) (Fierce) (Endpoints) (Press)
• Second death in Novartis gene therapy trials under investigation (Reuters) (Endpoints)
• MD Anderson ousts 3 scientists over concerns about Chinese conflicts of interest (Houston Chronicle) (Endpoints) (MD Anderson)
• The Giants at the Heart of the Opioid Crisis (NYTimes)
• When a Treatment Costs $450,000 or More, It Had Better Work (The Atlantic)
• In lawsuit, United Therapeutics is accused of unfairly blocking generic rival (Pittsburgh Post-Gazette)
• How does Biogen move beyond its Alzheimer’s drug blowup? Listen for the clues (STAT)
• Coming today: HHS to announce new payment pilots (Politico)
• What Can the U.S. Health System Learn From Singapore? (NYTimes)
• Amid Opioid Prescriber Crackdown, Health Officials Reach Out To Pain Patients (NPR)
• The Search for a Biomarker for Early Autism Diagnosis (NYTimes)

• China draws up tighter rules on human gene and embryo trials (Reuters) (Xinhua)
• New MDCG guidance on timelines and legacy devices in Eudamed (Emergo)
• Revamp at Silence does little to improve investors’ wellbeing (Financial Times)
• We ignore the disaster in the antibiotics market at our peril (Financial Times)
• Congo's Ebola response threatened by conspiracy theories, rumors (NBC)
• ICH To Partner For Training Of Regulators, Industry On Key Guidelines (Pink Sheet-$)
• Not all who received Johnson & Johnson hip implants may get damages (Economic Times)
• Canada finally opens up data on new drugs and devices (BMJ)
• Hope For China’s Academic Spinouts (BioCentury)
• WHO Invites Comments on Drug Shelf Life Policies (FDANews-$)

• Priority Review Vouchers And Access To Drugs Targeting Neglected Diseases (Forbes)
• FDA Moves to Modernize Drug Review Process (PharmTech)
• Life After FDA: Rachel Sherman To Tackle Real World Evidence, Clinical Trial Efficiency (Pink Sheet-$)
• With some tweaks, CAR-T cancer therapy could be made safer — and more widely available — study suggests (STAT)
• CAR-Ts can beat back some cancers. Researchers are trying to adapt them to work in other diseases (STAST)
• Jeff Aronin’s startup incubator scoops ex-Alkermes exec Jim Robinson for new president/COO role (Endpoints)
• Tonix loses Army R&D contract, gains chance to retain FDA breakthrough status (Fierce)
• Seattle Genetics CEO Clay Siegall’s comp package soars to $18.1M, rivaling Big Pharma chiefs (Endpoints)
• Meet The 'Wonder Drug' Drawing FDA Fire (Law360-$)
• Experts Seek Alignment of Standards Recognition Across FDA’s CDER, CBER, CDRH (Focus)
• Singapore Firm Draws Warning for Unapproved Drug, Quality Violations (FDANews-$)
• Alvogen recalls mismarked fentanyl patches over overdose concerns (Fierce) (FDA)

• Aura Biosciences to Present Two Year Phase 1b/2 Clinical Data for AU-011 at the Association for Research in Vision and Ophthalmology (ARVO) 2019 Annual Meeting (Press)
• European Investment Bank (EIB) Extends Financing Agreement to €24 Million Total in Support of BiondVax's Universal Flu Vaccine Ongoing Pivotal Phase 3 Clinical Trial (Press)
• Novus Therapeutics Announces Results of Two Single-Dose OP0201 Phase 1 Clinical Trials (Press)
• FDA Approves Merck’s KEYTRUDA® (pembrolizumab) in Combination With Inlyta® (axitinib) as First-Line Treatment for Patients With Advanced Renal Cell Carcinoma (RCC) (Press)

• NeuroSigma wins FDA nod for ADHD device (MassDevice) (FDA)
• Not a Moonshot, But Not a Fizzle Either − FDA’s Proposed Regulatory Framework for AI/Machine Learning Medical Devices Is A First Step Toward Total Product Lifecycle Regulation (Drug & Device Law)
• Nipro’s Infraredx wins expanded FDA nod for Makoto intravascular imager (MassDevice) (Press)
• Intuitive Falls Short of Expectations in 1Q19 (MDDI)
• No More Patent Drama Between Neovasc and Edwards? (MDDI)

• Federal Right to Try: Where Is It Going? (Hastings Center)
• Hospitals Stand to Lose Billions Under ‘Medicare for All’ (NYTimes)
• More Ill-conceived Remedies from Congress Regarding Prescription Drug Costs (Patent Docs)
• Answers To AI Patent Questions May Be Found In Biotech (Law360-$)
• Three New York parents face $1,000 fines for failing to vaccinate children (The Hill)

• FDA Advisory Committee Calendar
• Circulatory System Devices Panel of the Medical Devices Advisory Committee – 19-20 June 2019
• Patient Perspectives on the Impact of Rare Diseases: Bridging the Commonalities – 29 April 2019

• CDSCO to regulate all non-notified medical devices in phased manner to ensure patient safety (Pharmabiz)
• Novartis picks Sanjay Murdeshwar of AstraZeneca to lead its India business (Economic Times)
• Alembic Pharma gets USFDA nod for 2 generic products (Economic Times)
• Torrent Pharma recalls over 10.78 lakh bottles of hypertension drug from US (Economic Times)
• CDSCO releases data of SQ drugs along with NSQ drugs to boost the image of Indian drug manufacturers (Pharmabiz)
• Health ministry to amend D&C Rules to make QR code on packs of APIs mandatory to regulate quality (Pharmabiz)
• NPPA directs state drug controllers to expedite setting up of PMRUs for effective price compliance (Pharmabiz)

• US records 71 new measles cases in week as outbreak spreads (Reuters)