Recon: China Approves Third Domestic PD-1 Drug; Fosun Rethinking US Deals Amid Trade Tensions

• Grail, a deep-pocketed startup, shows ‘impressive,’ if early, results for cancer blood test (STAT) (Fierce) (Press)
• Turning Point Therapeutics drug shows benefits for patients with rare lung cancer gene (STAT) (Endpoints)
• Epizyme seeks early approval for drug to treat ultra-rare tumors (STAT)
• US drugmaker charged in generics price-fixing investigation (Financial Times)
• Iovance reports progress with its custom cell therapies for solid tumors (STAT) (Endpoints)
• Right to try: Congress wants a single ALS patient to get therapy never tested in humans (STAT)
• Kite and Humanigen link up to trial Yescarta with lenzilumab (PharmaLetter) (Press)
• Cannabis Companies Push FDA to Ease Rules on CBD Products (NYTimes) (STAT)
• Former FDA chief Gottlieb says some CBD can get you high — even though many think it can’t (CNBC)
• Acting FDA chief says regulators don’t know much about CBD despite ‘explosion of interest’ (CNBC) (NPR) (FDA)
• The drugs with the biggest price hikes don’t treat depression or diabetes — they’re for erectile dysfunction (CNBC)
• Getting To Yes: Areas Of Bipartisan Agreement On Drug Pricing And Access Reform (Health Affairs)
• No end in sight to rising drug prices, study finds (NBC)
• Measles cases hit 27-year high (Politico) (Reuters) (NYTimes) (CDC)

• Trade Tensions Have a Chinese Giant Rethinking US Deals (Bloomberg) (Fierce) (Endpoints)
• Fast moving Chinese regulators wave third homegrown PD-1 to market (Endpoints)
• Spanish NB Bows Out Ahead of EU MDR (Focus)
• Invossa Fallout: Call For Review Of All Korea-Approved Cell Therapies (Pink Sheet-$)
• Pakistan’s Largest Ever Pharma Deal in Advanced Talks (Bloomberg)
• As Bristol-Myers merger marches ahead, what's BeiGene's plan for Celgene-partnered PD-1? (Fierce)
• Mitsubishi pulls EU application for ALS drug, citing 'unwarranted' data request (BioPharmaDive)
• Teva shares hit 19-year low after opioid settlement, analyst downgrades (Fierce)
• NICE issues guidance revision for depression (PharmaTimes)
• It Looked As Though Millions Of Babies Would Miss Out On A Lifesaving Vaccine (NPR)
• Children under five dying at higher rate in Congo Ebola epidemic: WHO (Reuters)

• Fighting the Gender Stereotypes That Warp Biomedical Research (NYTimes)
• I have spinal muscular atrophy. Critics of the $2 million new gene therapy are missing the point (STAT)
• ASCO 2019: What to watch for, including Keytruda, Lynparza, KRAS and more (Fierce)
• ASCO 2019 preview: Big Pharmas looking for cancer R&D revival as we hit next-gen crossroads (Fierce)
• Record number of cancer drugs launched in 2018, says report (PharmaTimes)
• Biogen trumpets safety data for Tecfidera follow-up (PMLive)
• San Diego Entrepreneur Launches First "Medical Defense" Company (Forbes)
• PE firm nabs Vibalogics, banking on demand for complex viral products (BioPharmaDive)
• Bye bye, blockbuster? AstraZeneca's Faslodex gets U.S. generic on heels of record sales year (Fierce)
• Troubled microbiome startup uBiome to lay off some employees, refund payments from federal insurers (STAT)
• OPDP Issues Second Untitled Letter of 2019 (Focus)
• Partnered with Genentech and Microsoft, this biotech believes it can leverage its knowledge of the immune system into a $230M-plus IPO (Endpoints)
• Aslan doubles down on CSL drug, plots longshot rivalry with Dupixent in atopic dermatitis (Endpoints) (Fierce)
• Dr Dietmar Berger returns to big pharma (Pharmafile)
• Luck and unicorns? Who needs that? Santé Ventures’ new $250M fund is looking for biotech upstarts (Endpoints)
• FDA’s New Opioid Packaging Plan is Meant to Limit Overprescribing (Focus)
• Right to Try One Year Later: Limited Patient Involvement but More FDA Clarity Coming (Focus)
• Alnylam promotes longtime exec Kevin FitzGerald to CSO; Intellia Therapeutics brings on Laura Sepp-Lorenzino (Endpoints)

• Milestone achieved in J&J’s investigational HIV study (PharmaTimes)
• FDA breakthrough therapy designation granted for Bayer’s Aliqopa (PharmaTImes)
• FDA Approves Supplemental New Drug Application Adding Overall Survival Data for XOSPATA® (gilteritinib) (Press)
• Merck’s KEYTRUDA® (pembrolizumab) Demonstrates Improved Overall Survival as First-Line Treatment of Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma at Final Analysis of Pivotal Phase 3 KEYNOTE-048 Trial (Press)
• Gamida Cell Announces Data for Omidubicel Presented at the International Society for Cellular and Gene Therapy 2019 Annual Meeting (Press)
• Alnylam Doses First Patient in Phase 1 Study of ALN-AGT, an Investigational RNAi Therapeutic for the Treatment of Hypertension (Press)
• Vigeo Therapeutics Presents Preliminary Results from Its Phase 1 Open Label Trial of VT1021 in Patients with Advanced Solid Tumors at ASCO (Press)
• Tolero Pharmaceuticals Advances Investigational Agent TP-0903 into Phase 1b Expansion Stage of Study in Patients with Advanced Solid Tumors (Press)
• Innovent Provides Update on Phase Ib Study of Sintilimab in Combination with Chemotherapy for First-line Advanced or Metastatic Non-small Cell Lung Cancer (Press)
• SFA Therapeutics to Present Human Psoriasis Data for Microbiome-based Drug (SFA002) at the Global Biotech Entrepreneur Forum and the BIO International Convention (Press)

• More Than Half Of Surgical Stapler Malfunctions Went To Hidden FDA Database (KHN)
• Israeli startup gets FDA nod for neuromodulation device to treat migraines (MedCity)
• FDA Clears DiaSorin Molecular Meningitis, Encephalitis Assay (GenomeWeb)
• Roche and GE Healthcare launch NAVIFY Tumor Board with medical imaging capabilities to enable more personalised treatment decisions in cancer care (Press)

• Minnesota tries an unusual approach to make drugmakers, wholesalers pay for the opioid crisis (STAT)
• NJ AG Latest To Go After Sacklers Over Opioid Crisis (Law360-$)
• Pharma Co., Founder To Pay $7M Over Aspirin Drug Fraud (Law360-$) (DoJ)
• Hatch-Waxman Presuit Considerations For Generics: Part 2 (Law360-$)
• Darknet Fentanyl Dealer Indicted in Nationwide Undercover Operation Targeting Darknet Vendors Who were Selling to Thousands of US Residents (DoJ)
• Justice Department Requires Amcor to Divest Medical Flexible Packaging Assets in Order to Proceed with Bemis Acquisition (DoJ)
• New Jersey sues Sackler family for alleged role in opioid epidemic (The Hill)
• HP&M Shares Experience with 16 Externally-Led Patient-Focused Drug Development Meetings; Summarizes Commonalities in Rare Disease Patient Perspectives in Comment to FDA (FDA Law Blog)
• Should The Learned Intermediary Rule Apply To Prescription Marijuana? (Drug & Device Law)

• FDA Advisory Committee Calendar

• EU Regulatory Roundup: Swissmedic Sees Surge in Inquiries as Safety Scares, Brexit Fuel Questions (Focus)

• Novartis and Sumitomo Dainippon agree diabetes deal in Japan (PharmaLetter-$)

• How ethical dilemmas tailed Sun Pharma’s rise (LiveMint)
• HC asks J&J to pay Rs 25 L to 67 patients who had revision surgery for faulty hip implants (Economic Times)
• Lupin's Goa facility may face regulatory action, says USFDA (Economic Times)
• Natco, Onyx settle cancer drug patent litigation (Economic Times)

• Second Industry Forum on Good Manufacturing Practice – GMP (TGA)

• Scientists Genetically Modify Fungus To Kill Mosquitoes That Spread Malaria (NPR)