Recon: Vertex Buys Semma for $950M; Insilico AI Study Yields Drug Candidates in Just 21 Days

• Big Pharma Sinks to the Bottom of US Industry Rankings (Gallup) (The Hill)
• Drug pricing looms large on Congress' September agenda (Politico)
• Vertex’s next act: a billion-dollar bet on a cure for type 1 diabetes (STAT) (Endpoints) (Press)
• A Molecule Designed By AI Exhibits 'Druglike' Qualities (Wired) (Endpoints) (Nature Biotechnology)
• Medimmune-born Viela files $150m IPO, eyes first product launch (PMLive)
• Sacklers vs. States: Settlement Talks Stumble Over Foreign Business (NYTimes) (Washington Post)
• Ohio attorney general sues to stop upcoming opioid trials (Washington Post)
• US records 19 new cases of measles as of last week (Reuters)
• Allergan to Pay $5 Million to Settle Ohio Opioid Suit (WSJ)
• ‘The nightmare everyone is worried about’: HIV cases tied to opioids spike in West Virginia county (Politico)

• Novartis, Lonza deepen biosimilars push with MS, arthritis drug deals (Reuters) (BioProcessIntl) (Press)
• Roche's Tamiflu follow-up Xofluza scores in flu-spreading study (Fierce) (Press)
• Roche’s flu drug Xofluza scores phase 3 primary endpoint (PMLive) (Press)
• Roche mum on FTC, CMA reviews as $4.3B Spark deal faces yet another delay (Endpoints) (Press)
• UK biotech secures £100m funding for lung cancer trials (Financial Times) (Fierce)
• China says has only 'limited' cooperation with US on fentanyl (Reuters)
• China expands drug bulk-buy program, puts pressure on pharma firms (Reuters)
• UK No-Deal Medicines Regulation Under Threat As Brexit Chaos Grows (Pink Sheet-$)
• UniQure stays a step ahead in hemophilia B (BioPharmaDive)
• AZ’s Farxiga heart failure results wow the ESC (PMLive) (Endpoints) (Press)
• AstraZeneca presents strong Phase 3 Brilinta data for reducing CV risk (Pharmafile) (Press)
• WHO Director-General calls on world leaders to support Universal Health Coverage high-level meeting (WHO)

• The FDA and Sarepta: a window into the real world of drug regulation (STAT)
• Cell therapy results ‘very promising’ in children with cancer (Financial Times)
• Bayer hires former J&J executive for more pharma deals (Reuters) (Fierce) (Press)
• New Sanofi CEO wants to tap digital technology to improve drug research and sales (STAT)
• Biosimilars In US Drug Pricing Debate: Second Chance – Or Maybe Last Chance (Pink Sheet-$)
• Chinese scientists came to the US to pursue their dreams. Under tighter scrutiny, many are returning home (STAT)
• With FDA’s Eye on JAK Drugs, Concert Pharma Moves One Ahead For Hair Loss (Xconomy)
• NIH launches novel nationwide search for neuroprotective stroke therapies (NIH)
• Completed BsUFA II Deliverables (FDA)
• HHS Purchases Smallpox Vaccine to Enhance Biodefense Preparedness (HHS)
• Xarelto™ 2.5 mg plus aspirin recommended for patients at high risk of heart attacks, strokes and death due to chronic coronary syndromes (Press)
• CDER Ties Monthly Novel Approval Record With Nourianz Green Light (Pink Sheet-$)
• South Korean CDMO consolidates, plants flag in California (Fierce)
• DuoCAR-T cells eliminate HIV (Nature)
• Orphan GPCR exhibits anti-opioid activity (Nature)
• RIKEN and Astellas Enter into Worldwide Exclusive Licensing Agreement for Artificial Adjuvant Vector Cell Technology in Oncology (Press)
• MedCo's PCSK9 challenger steals the show at ESC with winning data (Fierce) (Press)
• Clean safety and efficacy data tee Medicines Company up for PCSK9 scrap (Fierce)
• As Genfit hopes to get its liver drug on the market, founding CEO makes way for new blood (Fierce)
• Once again Novartis’ cardio team looks to beat the odds using sketchy data and a familiar argument (Endpoints)
• RA Capital-backed cell therapy player in the neoantigen game grabs a $121M megaround to fund first human studies (Endpoints)
• Syncona dives deep into dry AMD R&D, upping Gyroscope bet to $100M (Endpoints)
• VeraSci's Virtual Reality Functional Capacity Assessment Tool (VRFCAT) Accepted into the FDA's Clinical Outcome Assessment (COA) Qualification Program (Press)
• Pacifico National, Inc. dba AmEx Pharmacy Issues Voluntary Nationwide Recall for all Lots of Bevacizumab (FDA)

• Findings Released from NAXOS, a French Real-World Data Analysis and the Largest Real-World Data Analysis on Oral Anticoagulant Effectiveness and Safety in Europe Among Patients with Non-Valvular Atrial Fibrillation (Press)
• Ardelyx's lead drug tenapanor scores in second hyperphosphatemia study, shares leap (Endpoints)
• Inotrem Announces Fast Track Designation Granted by U.S. FDA to Nangibotide Development Program for the Treatment of Septic Shock (Press)
• Boehringer Ingelheim and Zealand Pharma Advance Dual-Acting GLP-1/glucagon Agonist BI 456906 to Phase 2 Clinical Testing in Obesity/Diabetes (Press)
• Alnylam Pharmaceuticals Provides Perspective on Positive Complete Results from ORION-11 Phase 3 Study of Inclisiran (Press)
• CARsgen Therapeutics Receives US FDA Orphan Drug Designation For Fully Human Anti-BCMA (B Cell Maturation Antigen) Autologous Chimeric Antigen Receptor (CAR) T Cells For The Treatment Of Multiple Myeloma (Press)
• A PhII flop triggers an ugly rout for micro-cap biotech Aridis; Genfit CEO passes baton to successor (Endpoints)
• Armed with promising alopecia PhII, Concert edges forward with modified JAK inhibitor — but safety will still be key (Endpoints)
• OBI Pharma Announces U.S. FDA Clearance of IND Application for a Phase 1/2 Study of its Antibody-Drug Conjugate (ADC) targeted cancer therapy, OBI-999 (Press)
• Allegro Ophthalmics to Present the Results of Its Phase 2 Risuteganib Intermediate Dry Age-Related Macular Degeneration Study at the 19th EURETINA Congress and The Retina Society 2019 Annual Meeting (Press)
• Aridis Pharmaceuticals Reports Phase 2 Clinical Trial Results of AR-105 for the Treatment of Ventilator-Associated Pneumonia Caused by Pseudomonas Aeruginosa (Press)
• Akebia Therapeutics Announces Full Enrollment of its Global Phase 3 Program of Vadadustat for the Treatment of Anemia Due to Chronic Kidney Disease (Press)

• FDA Probe Into Patient Infections Over Contaminated Duodenoscopes Hits Turning Point (Focus)
• Oklahoma hospital used dirty gastroscopes on almost 1,000 patients; no infections reported (Reuters)
• Smart devices are moving from fitness tracking to monitoring patients with chronic illnesses (CNBC)
• Fresenius recalls dialysis tubes due to dangerous, undetectable leaks (MassDevice)
• FDA requires more postmarket data to keep certain devices on the market (MassDevice)
• Concept Medical Inc. Granted 'Breakthrough Device Designation' From the FDA for Its MagicTouch AVF Sirolimus Coated Balloon (Press)

• Litigation alone cannot heal the opioid epidemic (Financial Times)
• That Beloved Hospital? It’s Driving Up Health Care Costs (NYTimes)
• Reining in drug spending: What states can learn from one another (STAT)
• As Congress considers lowering drug costs, pharma CEOs target key senators with campaign cash (STAT)
• Telemedicine and the Learned Intermediary Rule (Drug & Device Law)
• Rx Info Site Fights To Get Off Pharma Groups' Web Blacklists (Law360-$)
• Drugmaker Fine Shows SEC's Renewed Disclosure Focus (Law360-$)

• FDA Advisory Committee Calendar
• General Hospital and Personal Use Panel of the Medical Devices Advisory Committee – 6-7 November 2019

• BSI certifies first product to the Medical Devices Regulation (BSI)
• Civil Society representatives: Call for expressions of interest for the EMA PDCO Committee (EC)
• EMA’s Antibiotic Plans Could Hinder Trial Recruitment, Says Industry (Pink Sheet-$)
• Global drugmakers look set for better protection of their legal rights in Russia (PharmaLetter-$)
• Russian plans to establish production of orphan drugs (PharmaLetter-$)

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

• India to contribute USD 2,00,000 for WHO SEARO health emergency fund: Harsh Vardhan (Economic Times)
• Water leak fixed with zip ties indicative of Dr. Reddy's sterile plant failings (Fierce)
• USFDA issues response letter for new drug application for insulin glargine: Biocon (Economic Times)
• Leprosy drug to treat cancer? Doctors hunt for new uses of old medicines (Economic Times)
• Lava bags order from GE to make medical devices (Economic Times)

• Therapeutic Goods Amendment (Permissible Ingredients) Determination (No. 1) 2019 (TGA)
• High-moderate risk changes to permissible ingredients – Caffeine (TGA)
• Consumer fact sheet: recall of Allergan Biocell breast implants (TGA)
• The TGA launches new tool to help sponsors find information on registering prescription medicines (TGA)
• Ingredients in therapeutic goods (TGA)

• Cancer overtakes heart disease as biggest rich-world killer (Reuters)
• Tuberculosis rates down in most US children, but still high in some groups (Reuters)
• Weight-Loss Surgery May Reduce Heart Risks in People With Type 2 Diabetes (NYTimes)