Recon: Vertex Destroyed 8,000 Packs of Orkambi During UK Pricing Standoff; NY AG Sues Sackler Family

• NY attorney general targets Sackler family with allegations tied to Purdue Pharma (STAT) (NYTimes) (CNBC)
• FDA Chief Lays Out Vision for New Pain Pills to Replace Opioids (Bloomberg)
• The ‘venture creation’ model is picking up speed as a way to fuel biotech (STAT)
• Local jurisdictions pay the price for nation’s opioid crisis (AP)
• Bristol-Myers Squibb turns to an AI startup to accelerate cancer research (STAT)
• Hospital pharmacists face dozens of drug shortages yearly (Reuters) (JAMA)
• Trump says he can produce a better healthcare plan than Obamacare (Reuters)
• US performs world's first organ transplants from living donors who have HIV (NBC)
• Sarepta to seek speedy approval of third DMD drug (BioPharmaDive)
• Investors are starting to bet big on psychedelic medicine (CNBC)
• House E&C Subcommittee Advances 5 Bills Related to Generic Competition (Focus)

• Germany warns of medical products shortage if Brexit chaotic: paper (Reuters)
• Months after Imfinzi combo flops, AstraZeneca wins NICE endorsement as lung cancer monotherapy (Endpoints) (Pharmafile)
• Take over pharma to create new medicines, says top adviser (BBC) (The Guardian)
• Vertex destroyed nearly 8,000 packs of Orkambi in 2018 (Pharmafile) (The Guardian) (Endpoints) (Fierce)
• The world must wake up to the threat of latest Ebola outbreak (Financial Times)
• AstraZeneca to help build new life science research cluster in China (Fierce)
• Big Pharma accused of 'endless talk, no action' on antibiotic threat (Reuters)
• EMA Decides Fast-Track Fate Of Masitinib And Anthrax Antitoxin (Pink Sheet-$)
• NICE recommends MSD’s diabetes drug Steglatro (PMLive)
• Merck KGaA injecting €150M into biologics site where it makes immunotherapies (Fierce)

• Speaking on Rare Disease Day 2019 (NIH Director’s Blog)
• CREATES Act Has a Penalty Problem (Pink Sheet-$)
• FDA Takes First Steps to Modify TIRF REMS Program (Focus)
• FDA Finalizes Guidance on Pediatric Information in Drug Labels (Focus)
• How pharma companies can benefit from the FDA’s digital health approach (PWC)
• Is Personalized Medicine Doomed Worldwide if Biosimilars Fail in the U.S.? (Biocentury)
• Tadalafil Launches In US Follow Teva's 180-Day Expiry (Generics Bulletin)
• FDA Center Chiefs Weigh Priorities That Are Suitable For Partnerships (IHP-$)
• Gottlieb's Greatest Strength As US FDA Commissioner? Stability (Pink Sheet-$)
• Norman Sharpless Will Arrive At US FDA With Many Challenges Awaiting (Pink Sheet-$)
• Gottlieb Leaves FDA Feeling Good About Generic Approvals, But Concerned About Innovative Competition (Pink Sheet-$)
• Orphan Drug Designation Requests and Designations Dipped in 2018, But Orphan Approvals Are Up Again! (FDA Law Blog)
• IPEC Wants FDA To Clear Up Elemental Impurity Confusion (Pink Sheet-$)
• Combination Pricing Solution As Elusive As Ever (Pink Sheet-$)
• After a 33-year odyssey, Jeffrey Bluestone grabs a ringside seat to watch his drug teplizumab go back into the clinic (Endpoints)
• Sure Hervé Hoppenot took a big cut in compensation after a pipeline disaster. But he still outscored the only woman on the list (Endpoints)
• Illicit drugs are making some big advances in R&D, and Thiel partners at ATAI get a $43M bankroll to fuel drive on magic mushrooms, Special K (Endpoints)
• Promising to match more NSCLC patient with targeted drugs, Cambridge spinout Inivata readies US launch of liquid biopsy (Endpoints)
• As AI permeates clinical analytics, Perceptive Advisors bets $40M into a storied player in the field (Endpoints)
• Sofinnova, NEA power autoimmune startup Polyneuron to A round (Fierce)
• Elicio Therapeutics aims to sneak cancer vaccines into the lymph nodes, with $30M to launch (Fierce)
• Ichor Medical Systems pens AstraZeneca plasmid DNA delivery pact (Fierce)
• Advisory Committee; Cellular, Tissue and Gene Therapies Advisory Committee, Renewal (FDA)

• Daiichi Sankyo starts mirogabalin trial in spinal injury pain (PMLive)
• Little Proteon shares crash into penny stock territory as lead drug flops in PhIII (Endpoints)
• Acadia to Move Experimental Pediatric Rett Syndrome Drug to Phase 3 (Xconomy)
• Imbrium Therapeutics Announces U.S. FDA Orphan Drug Designation for Tinostamustine for the Treatment of T-cell Prolymphocytic Leukemia (Press)
• Stealth BioTherapeutics Announces Dosing Of First Patient In Phase 2 Study Of Elamipretide For The Treatment Of Dry AMD (Press)
• Velicept Therapeutics Announces Positive Top-Line Phase 2b Results for Solabegron in the Treatment of Overactive Bladder (OAB) (Press)
• Key bladder cancer data pave way for Seattle Genetics to submit marketing application for armed antibody (Endpoints) (Press)
• Positive Phase 2 Study Results of Trofinetide in Pediatric Rett Syndrome Published in Neurology, the Medical Journal of the American Academy of Neurology (Press)

• Continuous Learning: FDA Looks to Wider Adoption (Focus)
• FDA Proposes Major Changes to Mammography Regulations (Focus)
• Osiris shareholders sue to block $660m merger with Smith & Nephew (MassDevice)
• Philips buys Direct Radiology (MassDevice)
• LivaNova’s CMS vagus nerve depression device trial must include sham arm (MassDevice)
• Eurofins Subsidiary Gets New York State Approval for Addition of Y Chromosome Screen to NIPT Test (GenomeWeb)

• U.S. judge blocks Medicaid work requirements in Kentucky, Arkansas (Reuters)
• Medicaid work requirements: What's next? (Politico)
• J&J settles three mesothelioma talc cases-plaintiffs' lawyer (Reuters)
• New Jersey jury finds J&J not liable in talc cancer trial; company settles three other cases (Reuters)
• U.S. jury says Bayer must pay $80 million to man in Roundup cancer trial (Reuters)
• BIO Urges USTR To Take Action on Growing IP Barriers in Overseas Markets (BIO)
• Breaking News − Defense Sweep In Eliquis MDL (Drug & Device Law)

• FDA Advisory Committee Calendar
• Annual Public Meeting; Reagan-Udall Foundation for the Food and Drug Administration – 2 May 2019

• Meetings of MDCG and subgroups – 2019 (EC)
• EU Regulatory Roundup: EU Drafts Guidance on Assessing the Benefits and Risks of Phthalates (Focus)
• EU MedTech Industry Signals Need for Harmonized Approach to Cybersecurity (Focus)

• Japanese court orders public health campaigner to pay ¥3.3 million to anti-vaccine researcher (Pharmafile)

• NCLT sees violation of Sec 29(A) in Sterling Biotech case (Economic Times)
• Clinical trial industry hails recently notified New Drugs & Clinical Trial Rules as well balanced and focused on patient rights & safety (PharmaBiz)
• PvPI releases list of 9 drugs with previously unknown AEs; list includes Tramadol, Ofloxacin, Amikacin, Bedaquiline, etc (PharmaBiz)

• Health Product InfoWatch – March 2019 (Health Canada)

• Amid ruined lives, Mozambique's cyclone survivors face cholera, diarrhea (Reuters)

• The case of a woman who feels almost no pain leads scientists to a new gene mutation (STAT)
• Flu Tied to Heart Failure Worsening (NYTimes)