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

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• FDA Advisory Committee Calendar
• Fiscal Year 2019 Generic Drug Regulatory Science Initiatives; Public Workshop – 1 May 2019
• Vaccines and Related Biological Products Advisory Committee – 6 March 2019

• 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)

• 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)

• 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)

• Obesity Tied to Higher Cancer Rates in Younger People (NYTimes)