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Regulatory Focus™ > News Articles > 2019 > 9 > Recon: Vertex Buys Semma for $950M; Insilico AI Study Yields Drug Candidates in Just 21 Days

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

Posted 03 September 2019 | By Michael Mezher 

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

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • 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)
In Focus: International
  • 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)
Pharmaceuticals & Biotechnology
  • 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)
Pharmaceutical & Biotechnology: Study Results, Filings & Designations
  • 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)
Medical Devices
  • 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)
US: Assorted & Government
  • 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-$)
Upcoming Meetings & Events Europe
  • BSI certifies first product to the Medical Devices Regulation (BSI)
  • Civil Society representatives: Call for expressions of interest for the EMA PDCO Committee (EC)
  • EMA’s Antibiotic Plans Could Hinder Trial Recruitment, Says Industry (Pink Sheet-$)
  • 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)
General Health & Other Interesting Articles
  • 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)
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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