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Regulatory Focus™ > News Articles > 2019 > 5 > Recon: China Approves Third Domestic PD-1 Drug; Fosun Rethinking US Deals Amid Trade Tensions

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

Posted 31 May 2019 | By Michael Mezher 

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

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • 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)
In Focus: International
  • 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)
Pharmaceuticals & Biotechnology
  • 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)
Pharmaceuticals & Biotechnology: Study Results, Filings & Designations
  • 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)
Medical Devices
  • 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)
US: Assorted & Government
  • 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-$)
  • Darknet Fentanyl Dealer Indicted in Nationwide Undercover Operation Targeting Darknet Vendors Who were Selling to Thousands of US Residents (DoJ)
  • Justice Department Requires Amcor to Divest Medical Flexible Packaging Assets in Order to Proceed with Bemis Acquisition (DoJ)
  • New Jersey sues Sackler family for alleged role in opioid epidemic (The Hill)
  • HP&M Shares Experience with 16 Externally-Led Patient-Focused Drug Development Meetings; Summarizes Commonalities in Rare Disease Patient Perspectives in Comment to FDA (FDA Law Blog)
  • Should The Learned Intermediary Rule Apply To Prescription Marijuana? (Drug & Device Law)
Upcoming Meetings & Events Europe
  • EU Regulatory Roundup: Swissmedic Sees Surge in Inquiries as Safety Scares, Brexit Fuel Questions (Focus)
  • Novartis and Sumitomo Dainippon agree diabetes deal in Japan (PharmaLetter-$)
  • 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)
General Health & Other Interesting Articles
  • Scientists Genetically Modify Fungus To Kill Mosquitoes That Spread Malaria (NPR)
Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory news stories from around the globe. Each weekday morning, we aim to bring you the latest highlights of new approvals, meetings, legal and political developments, regulations and guidance, and the latest trends with the potential to impact regulatory affairs professionals and the industry in which they work.
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