Recon: White House Proposes Taking the Food out of FDA

• White House proposes a narrowing of FDA’s mission — and a new name (STAT) (Endpoints)
• Johnson & Johnson hits the Big Apple with latest JLabs site (MassDevice) (Endpoints) (BioSpace)
• Bristol-Myers clears another hurdle in Merck lung cancer showdown — but big challenges remain (Endpoints) (PharmaTimes) (The Pharma Letter-$) (Fierce)
• Nanobiotix soars as late-phase cancer trial hits endpoint (Fierce) (Endpoints) (BioSpace)
• Shire plasma center gets first FDA approval (The Pharma Letter-$) (Fierce)
• Key marijuana drug approval looms as cannabis goes mainstream (Reuters)

• James Sabry takes over global partnering for Roche (Fierce) (PMLiVE) (Endpoints) (BioSpace)
• Boehringer invests $268M to further build out biologics (BioPharma Dive) (Endpoints)
• Next-Generation CAR-T Company Raises €130M on NASDAQ IPO (Labiotech.eu) (Fierce)
• NICE u-turn backs Roche’s Ocrevus for multiple sclerosis (PharmaTimes) (Fierce)
• Access extended for investigational DMD drug in UK (The Pharma Letter-$) (PharmaTimes)
• Sanofi's Dupixent scores NICE recommendation after price cut (Fierce) (PharmaTimes) (PMLiVE)
• Will WHO grant boost Strides Shasun? (The Hindu Business Line) (Pharmabiz)
• PATH partners with SD Biosensor to advance diagnostic test for malaria (Pharmabiz) (Fierce)
• Latest ranking of top research institutions show China coming on strong — with significant implications for biotech (Endpoints)
• Afatinib push back K-RAS-positive lung cancer (European Biotechnology)
• The Mutual Recognition Agreement Rolls Along – But Where is Germany? (FDA Law Blog)

• What Is Ailing the Drug Industry? (The Wall Street Journal)
• Tesaro stock rockets as rumours of Roche takeover abound (pharmaphorum)
• Opioids don’t have to be addictive – the new versions will treat pain without triggering pleasure (The Conversation)
• VR Art Reduces Need For Opioids in NY Hospital (Forbes)
• We need more answers about immunotherapy for the elderly (STAT)
• ‘Living Legos’ form blood vessels to simulate heart disease and test drugs (STAT-$)
• Can biotech keep its breathless IPO pace? A look at the numbers (STAT-$)
• Up and down the ladder: The latest comings and goings (STAT-$)
• To save money, my insurance company forced me to try drugs that didn’t work (The Verge)

• Naturally-Derived Cancer Drugs Provide Clues As To How Microbiome May Cause Chemotherapy Resistance (Forbes)
• Acurx Pharma's antibiotic product candidate, ACX-362E gets US FDA qualified infectious disease product status (Pharmabiz)
• Alligator Bioscience presents positive additional preclinical data from ATOR-1017 to treat metastasizing cancer at WPC meeting (Pharmabiz)
• Harmony Biosciences Makes Headway on Narcolepsy Drug Involving Histamine (BioSpace)
• Impel NeuroPharma Announces FDA Clearance of IND for Pivotal Phase 3 Study of INP104 for Acute Treatment of Migraine (Press)
• Adamas Presents New Data Analysis Demonstrating that GOCOVRI Reduces Transitions between Dyskinesia and OFF Episodes Throughout the Day (Press)
• Optinose Announces Publication of Pivotal Efficacy and Long-Term Safety Data for XHANCE in Peer Reviewed Journals (Press)

• Nerve stimulation device maker electroCore goes public with $78M IPO (Fierce)
• Smith & Nephew Wants Hip MDL Slashed Over Time Bar (Law360-$)
• GPB Capital puts $21m into CardioFocus for HeartLight catheter launch (MassDevice)
• No new trial for Bard in $4m vena cava filter loss (MassDevice)
• Purdue University researchers develop glucose-monitoring contact lens (MobiHealthNews)
• Masimo, Thermomedics team up to launch Bluetooth, contactless thermometer (MobiHealthNews)
• Abbott Receives FDA Clearance for Afinion HbA1c Dx for Diagnosing Diabetes (Press)
• Tenon Medical, Inc. Receives FDA Clearance For Sacroiliac Joint Fusion System (Press)
• LUTRONIC Announces U.S. FDA Clearance for 1.8 GW Picosecond Laser (Press)
• Tandem Diabetes Care Announces FDA Approval of t:slim X2 Insulin Pump with Basal-IQ Technology (Press)
• Siemens Healthineers launches Acuson Sequoia to address industry challenges in ultrasound imaging (Press)

• How Trump's ACA case differs from Obama's (Axios)
• Allscripts offering buyouts (Politico)
• FDA mustn't interfere with dying patients' right to experimental treatments (Washington Examiner)
• CVS Health CEO Larry Merlo: Confident Aetna deal will close later this year (CNBC)
• Lyft Is Offering Free Rides to Cancer Patients in Major U.S. Cities (Fortune)
• Head of new U.S. corporate health plan cites surgery as biggest cost (Reuters)
• FDA shouldn’t allow politics to hurt women suffering miscarriage (STAT)
• How life sciences companies are using AI — and how to separate hope from hype (STAT-$)
• Trump Administration Resumes Approving Young Doctor Visas (Forbes)
• Sanofi Judge Skeptical She Was Wrong To Toss Antitrust Suit (Law360-$)
• PBMs, Insurers Back Anthem, Express Scripts In Pricing Suit (Law360-$)

• FDA Advisory Committee Calendar

• Ireland urgently needs access to new drugs, says pharma body (Irish Times)
• How much does big pharma make from animal antibiotics? (The Guardian)
• Pharma expert: Combination vaccines reduce the cost of outbreaks and treatments (EURACTIV)
• Industry urges EU to scrap national HTA bodies (pharmaphorum)
• Brexit and the medical devices industry: coping with uncertainty (Lexology-$)
• Stada Arz recovers selling rights to Parkinson's drug (The Pharma Letter)
• Impersonation of MHRA staff (MHRA)
• LumiThera LT-300 Device For Treating Dry Advanced Macular Degeneration Granted CE Mark (Press)

• Israel's UroGen to start mid-stage bladder cancer trial (Reuters)
• Korean pharmaceuticals enter schizophrenia therapy market (Korea Biomedical Review)
• ‘Long-term aspirin use can lower gastric cancer risks’ (Korea Biomedical Review)
• Jiao Hong,CNDA Commissioner meets UNAIDS Executive Director Michel Sidibe (CFDA)

• Government may scrap trials for some IVD devices (Livemint)
• APAC Biotech and Diakonos collaborate on immunotherapy technology for India (The Pharma Letter) (Press)
• Astrazeneca Pharma sweetens after securing permission (Business Standard)

• Three babies and young adult given donor tissue from cancer patient (The Guardian)
• Inaugural Industry Forum on Good Manufacturing Practice (GMP) (TGA)
• Metronidazole intravenous infusion 500 mg/100 mL bag (TGA)

• Proposed Amendments to Regulations Define Health Care Institutions’ Pharmaceutical and Medical Device Adverse Event Reporting Obligations (Lexology-$)
• List of Drugs for an Urgent Public Health Need (Health Canada)

• Many psychiatric conditions have the same genes in common (New Scientist)
• Researchers Just Printed Sensors Onto Gummi Candies (Forbes)
• Lifestyle changes can help obese women improve fertility (Reuters)
• Targeting cancer cells' escape vehicles to stop tumor metastasis (Fierce)
• Will launching plants into orbit yield new medicines? (STAT)