Regulatory Focus™ > News Articles > 2019 > 2 > Recon: Starboard Value Takes Stake in BMS; GenSight's Vision Loss Gene Therapy Fails Phase III Study

Recon: Starboard Value Takes Stake in BMS; GenSight's Vision Loss Gene Therapy Fails Phase III Study

Posted 04 February 2019 | By Michael Mezher 

Recon: Starboard Value Takes Stake in BMS; GenSight's Vision Loss Gene Therapy Fails Phase III Study

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Trump health chief presses Congress to pass drug discount plan (The Hill)
  • Wall St set for $1bn fee bonanza from pharma mega-deal (Financial Times)
  • GenSight’s second LHON gene therapy PhIII stumbles out of the gate — just like the first time (Endpoints) (Fierce) (Press)
  • Starboard Value Is to Take Stake in Bristol-Myers Squibb (Bloomberg) (CNBC) (Endpoints)
  • Still Unclear What Starboard Wants from Bristol-Myers (Audio) (Bloomberg)
  • Policing Big Pharma’s Influence Over Doctors’ Treatment Guidelines (Undark)
  • Trump to call for end to HIV epidemic in America (Politico)
  • For CRISPR enzymes, the gold rush is on (STAT)
  • FDA approves cheaper Botox rival to treat frown lines (Reuters) (Endpoints)
  • Top US insurer to cover Amgen, Eli Lilly migraine drugs, exclude Teva (Reuters)
  • FDA declines to approve Alkermes opioid-based depression drug (Reuters)
  • McKinsey Advised Purdue Pharma How to ‘Turbocharge’ Opioid Sales, Lawsuit Says (NYTimes)
  • Clash of Giants: UnitedHealth Takes On Amazon, Berkshire Hathaway and JPMorgan Chase (NYTimes)
  • Zika still a threat in Puerto Rico, but government stopped tracking it (AHCJ)
  • Lawmaker: Measles vaccine is not about "parental rights" (CBS)
  • Editorial: Why You Should Be Careful About 23andMe’s Health Test (NYTimes)
  • NY Times, Why Are You So Worried About 23andMe's Genetic Tests? (Forbes)
In Focus: International
  • WHO and vaccine group back 'critical' cervical cancer shots (Reuters)
  • Editorial: The Guardian view on new drugs: high hopes, higher prices (The Guardian)
  • Calls for action on patients denied £100,000 cystic fibrosis drug (The Guardian)
  • How 2019 Milestones Could See Aslan Benefit From Its 2012 Strategy Shift (BioCentury)
  • Brexit Relief For Ireland In New Joint Labeling Plans (Pink Sheet-$)
  • Chugai unveils new three-year business plan (PharmaLetter-$)
  • EMA Updates Brexit Guidance (Focus)
  • Indivior to offload Chinese opioid treatment drug in $123m deal (Financial Times)
  • WHO Invites Drugmakers to Submit Interest for HIV Drug Prequalification (WHO)
  • Three steps to better cancer outcomes (EFPIA)
Pharmaceuticals & Biotechnology
  • Shakeup at the Top of FDA’s Biosimilars Division (Focus)
  • The list of shame no biopharma wants to join (Evaluate)
  • ‘We’re still waiting’: As cystic fibrosis drugs deliver new hope, not everyone is being swept up by scientific progress (STAT)
  • Focusing on Cures (BioCentury)
  • After Trump’s election, long-acting contraceptive use jumped among women with private insurance (STAT)
  • Opinion: Don’t Blame Drug Prices on ‘Big Pharma' (WSJ)
  • Winners And Losers Under Bold Trump Plan To Slash Drug Rebate Deals (KHN)
  • Rebates To The Dustbin Of History? (Forbes)
  • Remarks to the AcademyHealth Conference (HHS)
  • Chairman Alexander Supports Trump Administration Proposal on Drug Rebates (Alexander)
  • Cigna sinks on investor worries about Trump drug rebate rule change (CNBC)
  • A stem-cell-derived eye patch for macular degeneration (Nature)
  • FDA Partially Grants Keryx’s Exclusivity Requests for Auryxia (FDANews-$)
  • Peter Diamandis’ right hand man Sergey Young wants to reverse aging via his $100M Longevity Vision Fund (Endpoints)
  • ANDA Review: Moving From Tentative To Final Approval Could Require 10 Months Or More (Pink Sheet-$)
  • Pharma, we have a problem: New drugs can’t cover the cost of Big Pharma’s failures (Endpoints)
  • Keto in a pill? Jim Mellon debuts anti-aging joint venture with the Buck dedicated to inducing ketosis (Endpoints)
  • Effect of Adding Azithromycin to Seasonal Malaria Chemoprevention (NEJM)
  • Use of Valium and Xanax for pain rising in US (Reuters)
  • Anti-rejection drug rapamycin shows promise in liver cancer (Fierce)
  • Sosei spins out 2 CNS companies with help from Medicxi (Fierce) (Endpoints)
  • Orange You Glad We Didn’t Make an Orange Book Pun? (FDA Law Blog)
  • Determination That ESBRIET (Pirfenidone) Film Coated Tablets, 534 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness (FDA)
  • Dr. Reddy's Laboratories Continues its Voluntary Nationwide Recall of Levetiracetam in 0.54% Sodium Chloride Injection 1500mg/100mL Due to Mislabeling (FDA)
Pharmaceuticals & Biotechnology: Study Results, Filings & Designations
  • Aimmune Therapeutics to Present AR101, OIT and Peanut Allergy Data at 2019 AAAAI Annual Meeting (Press)
  • BioArctic Announces That Eisai Will Initiate Phase 3 Confirmatory Study With BAN2401 in Early Alzheimer's Disease (Press)
  • Eisai and Purdue Pharma Present Efficacy and Safety Data from Second Pivotal Phase 3 Study at the Sleep Research Society's Conference: Advances in Sleep and Circadian Science (Press)
  • Verseon Reports First Dosing in Phase 1 Trial on New Precision Oral Anticoagulant (Press)
  • FDA grants orphan drug designation to BL-8040 for pancreatic cancer (Healio)
Medical Devices
  • FDA warns patients and doctors about recall of home-use test strips used with device to monitor blood thinner warfarin, not authorized for sale in U.S. (FDA) (Recall)
  • Stryker Launches Voluntary Field Action for Specific Units of the LIFEPAK® 15 Monitor/Defibrillator (FDA)
  • Ensuring that Plastic Devices Can Withstand Rigorous Disinfecting Procedures (MDDI)
  • Boston Sci joins cyber-physical R&D collaborative (MassDevice)
  • Acquisition Expands Medical Packaging Options Globally (MDDI)
  • Magnolia Medical Captures $20M to Reduce Blood Culture Contamination (Xconomy)
  • Will AI Play a Large Role for Edwards in 2019? (MDDI)
  • Sirakoss wins CE Mark for Osteo3 bone graft substitute (MassDevice)
  • Boston Scientific launches Spectra WaveWriter SCS in Europe (MassDevice)
  • Wright Medical inks $112m refinancing deal (MassDevice)
US: Assorted & Government
  • Shutdown: Members’ Questions Are Still Flowing In (Alliance for a Stronger FDA)
  • Dana-Farber heads to court to add researcher on immunotherapy patents (STAT)
  • Allergan Deal Gets Compounder To Say Drugs Not FDA-OK'd (Law360-$)
  • As Democrats Talk Single Payer, Private Medicare Advantage Soars (Forbes)
  • Fed. Circ. Says PTAB Right To Uphold Epilepsy Drug Patent (Law360-$)
  • AGs Want To Unlock Redacted Generic Price-Fixing Complaint (Law360-$)
  • We’re missing the true point of hospital price transparency (STAT)
  • Calif. Judge Axes Suits Alleging Pradaxa Warnings Inadequate (Law360-$)
  • Transparent Hospital Pricing Exposes Wild Fluctuation, Even Within Miles (KHN)
  • States In Driver's Seat On Healthcare Reform (Forbes)
  • FTC Returns More Than $6 Million to Consumers Who Bought Deceptively Marketed Health Products from Tarr, Inc. (FTC)
  • U.S. judge throws out Maryland bid to protect Obamacare law (Reuters)
  • JHL Biotech And Genentech Duke It Out Over Allegedly Stolen Trade Secrets (BioCentury)
  • Baxter cleared from DoJ antitrust saline probe (MassDevice)
Upcoming Meetings & Events Europe
  • BSI Urges Migration of CE Certificates Ahead of Brexit (Focus)
  • Summary of Direct Healthcare Professional Communications (DHPCs) issued in January 2019 (HPRA)
  • Class 4 defect information: Amoxicillin 500mg Capsules BP (MDR 92-12/18) (MHRA)
Asia
  • China’s NMPA Cites Overseas Device, IVD Companies (Focus)
  • How A New Shanghai Exchange Board Could Compete For Biotech Listings (Biocentury)
  • China Resources, Charoen Pokphand Launch $300m Life Science Fund (Biocentury)
India
  • DCGI instructs state FDAs to ensure digitization of manufacturing sites & formulation data on Sugam portal (PharmaBiz)
  • 42 new pharma plants to be commissioned in Gujarat in 3 months as part of Vibrant Gujarat (PharmaBiz)
  • Union govt’s recent guidance on LVPs for drugs coming under Form 28D or 28DA facilitates faster approvals for exports (PharmaBiz)
  • Sub-committee on 'compensation related to faulty devices' recommends amendments in MD Rules on par with D&C Act (PharmaBiz)
  • Govt may tighten fluoroquinolone labelling regulations further as US FDA issues warning over aortic rupture risk (PharmaBiz)
  • Rupee payment pact to help Indian pharma firms boost exports to Iran; tie-ups with Philippine companies in offing (PharmaBiz)
General Health & Other Interesting Articles
  • Obesity Tied to Higher Cancer Rates in Younger People (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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