Recon: NICE Backs Novartis’ Gene Therapy Luxturna; Stryker Enters $500M Bid for Mobius Imaging

• US judge orders big drug companies to face opioid trial (Reuters) (The Hill) (Endpoints) (Bloomberg)
• California advances crackdown on bogus vaccine exemptions (AP)
• Stryker bolsters robotics play with $500m offer for Mobius Imaging (MassDevice)
• New York City Declares Measles Outbreak Over (WSJ)
• Get Vaccinated or Leave School: 26,000 NY Children Face a Choice (NYTimes)
• GDUFA II User Fees: They Saved Paradise and Put Up a Parking Lot (FDA Law Blog)
• 7 things to know about Aimmune’s peanut allergy therapy ahead of a pivotal FDA meeting (STAT)
• Here are the biopharma companies that launched the most drugs over the past decade (STAT)
• It worked in biotech. But can this trade group turn Boston into a hub for digital health? (STAT)
• Vertex buys the top spot on the list of the biggest preclinical M&A deals. Were they robbed or was it a steal? (Endpoints)
• Trump Administration Announces $1.8 Billion in Funding to States to Continue Combating Opioid Crisis (HHS)

• UK cost watchdog recommends Novartis' blindness therapy Luxturna (Reuters) (PMLive)
• AstraZeneca's Tagrisso gets China OK for type of lung cancer (Reuters)
• J&J's Stelara OK'd in Europe for ulcerative colitis (Seeking Alpha) (Press)
• Keytruda scores EU approval in combination with Inlyta for first-line advanced renal cell carcinoma (Pharmafile) (Press)
• EC Would Back Limited Expansion Of Products Covered By MDR Grace Period (Medtech Insight-$)
• ABPI launches NHS, industry partnership guideline (PharmaTimes)
• Korean drugmaker buys large Vietnamese plant (Fierce)
• Korean biopharma executive indicted for allegedly conducting illegal trials on company researchers (Endpoints)
• Doctors Without Borders criticizes the Gavi coalition over access to pneumonia vaccines (STAT)
• Lupin signs second partnership for its oncology pipeline, this time with German drug maker BI (Economic Times)

• George Scangos heads back to Wall Street. And he’s bringing along some of the best connections in biotech (Endpoints)
• FDA OPDP Research – A Foggy Window into Future Thinking on Digital Media (Eye on FDA)
• Pfizer’s chessmaster: How a top scientist helped invigorate a lumbering drug giant (STAT)
• Activist Investor Seek Four Board Seats at Amag Pharmaceuticals (Bloomberg)
• The FDA Is Restricting Access to the Easiest, Safest Form of Abortion (Vice)
• Enough with the me-too drugs. New treatments should be worthy of the people who invest their lives in clinical trials (STAT)
• Evidence Supporting US Food and Drug Administration Drug Safety Communications (JAMA)
• The Public Health Urgency of a Temporary FDA Moratorium on New Opioid Approvals (JAMA)
• Novel Machine Learning Technique Identifies Populations of Stimulated Mesenchymal Stromal Cells with Immunosuppressive Activity (CBER)
• Stem Cells: FDA Warns Company for Selling Unapproved Products, Puts Others on Notice (Focus)
• That Pill Is Watching You - Privacy And Hackability Of Ingestible Electronic Sensors (Forbes)
• Medication can lower some women's risk of breast cancer (Reuters)
• Plotting clinical entry, James Wilson's gene therapy startup brings in billionaire for $110M Series B (Endpoints)
• Bristol-Myers is scouting new company startups; AbbVie and Idera team up to evaluate combination for HNSCC (Endpoints)
• Cancer drugs' share of new FDA approvals doubled this decade thanks to smarter R&D: report (Fierce)
• FDA Singles Out 9 More Drug Substances Not for Compounding (Focus)
• Deep-learning AI technique helps scientists see more clearly inside the cell (STAT)
• PDUFA Workload Sets Records, But Inflation Generates More Revenue (Pink Sheet-$)
• Bellus hopes to fuel up on IPO cash as it squares off with giant Merck on a rival drug (Endpoints)
• Nkarta maps out clinical, manufacturing plans for CAR-NK following $114M round led by Samsara (Endpoints)
• Key legal considerations in accelerating pharma using artificial intelligence (Pharmafile)
• Endo Announces Approval of First Generic Orfadin in U.S. (Press)
• Vir Bio Plans IPO to Fund Clinical Trials of Infectious Disease Drugs (Xconomy)
• Versant's Repare raises $82M to trial synthetic lethality drugs (Fierce)
• AstraZeneca to adopt Schrödinger's molecule-modeling platform for drug discovery (Fierce)
• Bristol-Myers teams with BioMotiv to build and buy biotechs (Fierce)

• Ultragenyx-GeneTx Get Orphan Drug Status for GTX-102 From FDA (Press)
• Roche to present pivotal data for satralizumab in neuromyelitis optica spectrum disorder and six-year OCREVUS data in multiple sclerosis at ECTRIMS (Press)
• Ra Pharmaceuticals Receives Orphan Drug Designation from the U.S. FDA for Zilucoplan for the Treatment of Myasthenia Gravis (Press)
• Magenta Therapeutics Announces FDA Regenerative Medicine Advanced Therapy (RMAT) Designation Granted to MGTA-456 for the Treatment of Inherited Metabolic Disorders (Press)
• Tricida Announces Submission of New Drug Application for Veverimer for the Treatment of Metabolic Acidosis in Patients with Chronic Kidney Disease (Press)
• FDA Grants Orphan Drug Designation to Puma Biotechnology’s NERLYNX® for the Treatment of Breast Cancer Patients with Brain Metastases (Press)
• Astex Pharmaceuticals Announces That Its Novel, Oral Hypomethylating Agent ASTX727 Has Been Granted Orphan Drug Designation for the Treatment of Myelodysplastic Syndromes (Including Chronic Myelomonocytic Leukemia) by the US FDA (Press)
• Impel NeuroPharma Announces Last Patient Enrolled In Phase 3 Trial Evaluating INP104 For The Treatment Of Acute Migraine (Press)
• Synlogic Presents Data from Phase 1/2a Study of SYNB1618 at the Annual Symposium of the Society for the Study of Inborn Errors of Metabolism (SSIEM) (Press)
• Tiziana Life Sciences Reports Positive Phase 2a Clinical Data Exhibiting Positive Clinical Activity with Milciclib Monotherapy in Advanced Sorafenib-refractory or -intolerant Patients with Unresectable or Metastatic Hepatocellular Carcinoma (Press)
• Ribon Therapeutics Announces Dosing of First Patient in Phase 1 Clinical Trial of RBN-2397, a First-In-Class PARP7 Inhibitor (Press)
• Rocket Pharmaceuticals Announces Registration-Enabling Phase 2 Plans for RP-L102 Gene Therapy for Fanconi Anemia Following a Supportive End-of-Phase 1 FDA Meeting (Press)
• Disarm Therapeutics Announces First Subject Enrolled in EPIPHANY Natural History Study of Chemotherapy-Induced Peripheral Neuropathy (CIPN) (Press)

• Co-founded by Versant, NEA investors, new medtech VC firm kicks off inaugural fund with $225M bounty (Endpoints)
• Mexican regulators to require online submission of medical device import permit applications (Emergo)
• FDA sets meeting on EO sterilization (MassDevice)

• Federal judge enters consent decree against Tennessee drug, dietary supplement and device distributors, Basic Reset and Biogenyx, for drug, device and dietary supplement violations (FDA)
• Prescription Opioids: Patient Options for Safe and Effective Disposal of Unused Opioids (GAO)
• Capital Rx To Inject Transparency In Prescription Drug Prices (Forbes)
• Virginia Democrats bet on Obamacare to win statehouse (Politico)
• Pharma Group Fights Injunction For Blacklisted Pricing Site (Law360-$)
• CDC Awards New Funds to Stop Drug Overdoses, Deaths (CDC)
• Stryker Gets Ax Of Ex-NFL Player's Pain Pump Claims (Law360-$) (MassDevice)
• C.D. Illinois Rejects Spoliation Claim for Lack of Special Relationship (Drug & Device Law)
• iNO Therapeutics LLC v. Praxair Distribution Inc. (Fed. Cir. 2019) (Patent Docs)

• FDA Advisory Committee Calendar
• Accelerating Drug Development for Polyarticular Juvenile Idiopathic Arthritis (pJIA) – 2 October 2019

• Infographic: Europe’s biotech hot spots (McKinsey)
• Ireland Allows More Time To Iron Out Glitches In Medicines Verification System (Pink Sheet-$)

• Asia Regulatory Roundup: China Releases UDI Rules as Pilot Progresses (Focus)

• Sterling Biotech case: Far-reaching NCLAT order sets new bankruptcy precedent (Economic Times)

• Health Canada’s Public Release of Drug, Device Clinical Data Picks Up Steam (Focus)

• Consultation: Proposed clarification that goods are therapeutic goods - goods containing folate substances in certain circumstances (TGA)
• TGA laboratories testing report: Survey of microwavable heat packs (TGA)