Recon: Canadian Fund Buys Keytruda Rights from UK's LifeArc for £1B

• Gates-backed Schrödinger raises $110m for new drug push (Financial Times) (Fierce)
• Exit Of No. 2 At Amazon’s Haven Keeps Walmart Employee Health Strategy In Lead (Forbes) (STAT)
• Dana-Farber prevails in immunotherapy dispute over patents behind blockbuster drug (STAT) (Endpoints)
• Commentary: We need to make sure new drug cures don’t widen income gap for the poor (CNBC)
• Biotech Startups And The Hard Truth Of Innovation (LifeSciVC)
• Google’s AI improves accuracy of lung cancer diagnosis, study shows (STAT)
• Allergan wins a novel case over false ads by a compounder, but gets just $48,500 for its trouble (STAT)
• After forced sale, PatientsLikeMe founder frets that U.S. policy could chill collaboration in biotech (STAT)
• House bundles CREATES with measures that Trump won’t sign (BioCentury)
• Seeking to contain drug costs, CMS may have ‘killed’ a PBM billing practice (STAT)
• Why Missouri’s The Last Holdout On A Statewide Rx Monitoring Program (KHN)
• Recalled defibrillator among exemptions in FDA's hidden database (CNN)
• Millions Take Gabapentin for Pain. But There’s Scant Evidence It Works. (NYTimes)
• A Rare Genetic Mutation Leads to Cancer. The Fix May Already Be in the Drugstore. (NYTimes)
• Citrus Farmers Facing Deadly Bacteria Turn to Antibiotics, Alarming Health Officials (NYTimes)

• UK medical research lands £1bn from cancer drug sale (Financial Times) (Reuters) (Fierce) (Endpoints)
• Breast cancer drug Verzenio could have serious side effects on lungs, Japan's health ministry warns (Japan Times)
  Modi’s jobs deficit: J&J’s largest India plant idle three years after completion (Reuters)
• South Africa's Aspen sells Australian prescription portfolio to Mylan (Reuters)
• Industry steps up interest in developing world, fueling doubling of R&D pipeline (Fierce)
• Sandoz is first multinational to secure generic approval under new Chinese guidelines (Pharmafile)
• Pushing China to the forefront: When a first-in-China regulatory strategy makes sense (BioCentury)
• Takeda's Entyvio beats Humira for remission in ulcerative colitis, exploratory data show (Pharmafile)
• Europe responding to gene therapy challenge, but picture remains fragmented (PMLive)
• Dr Reddy's to spend upto $ 300 million on R&D in FY2020 (Economic Times)
• ‘So Far So Good’: EMA Talks Relocation, Staff Retention, Teleworkers And More (Pink Sheet-$)
• WHO Calls for GMPs to Limit Wastewater-Driven Superbugs (FDANews-$)

• Price Transparency: Why Are Drug Prices Such A Bitter Pill to Swallow? (Forbes)
• A Waste of 1,000 Research Papers (The Atlantic)
• Genetically engineered immune cells fight off deadly virus in mice (Science)
• The Impact of the Orphan Drug Act on FDA-Approved Therapies for Rare Skin Diseases and Skin-Related Cancers (JAAD)
• AstraZeneca's Fasenra offers severe asthma patients 2 years of benefits: analysis (Fierce)
• Some of the best connected players in the San Diego hub organize launch round for another biotech with an eye on trial data (Endpoints)
• Friends, Parker Institute call for more flexibility in early T cell therapy development (BioCentury)
• Boehringer Ingelheim, UCB venture arms seed hearing loss newco Rinri (BioCentury)
• Long-term inclisiran data suggest The Medicines Company/Alnylam drug will flourish in pivotal study, disrupt ‘bad’ cholesterol market (Endpoints)
• TRC Capital’s mini-tender offer irritates a flustered Biogen (Endpoints)
• New insight into a struggling AstraZeneca anti-VEGF drug could expand its use in cancer (Fierce)
• MorphoSys posts positive data for lymphoma drug, but will it compete with CAR-Ts? (MedCity)
• AbbVie's discounting Humira to aid Skyrizi's launch—and a price war could follow: analyst (Fierce)
• CSL Behring poaches top manufacturing exec from struggling Biogen (Fierce)
• ICER releases new tools to facilitate use of its reports (PharmaLetter-$)
• The Role of Quality Culture in Data Integrity Is Getting More Attention as Regulator and Industry DI Guidances Evolve (IPQ)
• Eisai lures Novartis exec to its US Oncology Unit (PharmaLetter-$)
• Exploring The Link Between Inflammation And Depression: Study Suggests Women Are Affected The Most (Forbes)
• MedCo Touts New Data for Long-Lasting Heart Drug as Reckoning Looms (Xconomy)
• EU Proposal To Ban Microplastics In Pharmaceutical Ingredients Has US Excipient Industry On Edge (Pink Sheet-$)
• AuroMedics Pharma LLC Issues Voluntary Nationwide Recall of Levofloxacin in 5% Dextrose 250mg/50mL Due to Presence of Visible Particulate Matter Tentatively Identified as Mold (Focus)
• Bayer Issues Voluntary Recall of Alka-Seltzer Plus® Products (FDA)

• UCB announces NAYZILAM® (midazolam) nasal spray now approved by FDA to treat intermittent, stereotypic episodes of frequent seizure activity in people living with epilepsy in the U.S. (Press)
• Can-Fite’s Phase II Liver Cancer Data Selected for Presentation at a Leading Liver Cancer Scientific Forum (ILCA) (Press)
• Compugen Doses First Patient in COM701/Opdivo® (Nivolumab) Combination Arm of Phase 1 Study in Patients With Advanced Solid Tumors (Press)
• SpringWorks Therapeutics Announces Initiation of Phase 3 Trial (DeFi) of Nirogacestat in Adult Patients with Desmoid Tumors (Press)
• ACADIA Pharmaceuticals to Present Phase 2 CLARITY Results for Pimavanserin as an Adjunctive Treatment in Major Depressive Disorder at the 2019 American Psychiatric Association Annual Meeting (Press)
• Categorical Response and Clinical Relevance as Assessed in a Phase III Study of HP-3070 (Asenapine) Transdermal Patch for the Treatment of Schizophrenia to be Presented at the American Psychiatric Association 172nd Annual Meeting (Press)

• Patient Use of Unapproved Diabetes Management Devices Poses Insulin Dosing Risks, FDA Warns (Focus) (Bloomberg)
• MagStim wins FDA nod, launches StimGuide TMS navigation system (MassDevice)
• Results from Spatz Medical FDA clinical trials confirm that Spatz3, the only Adjustable Gastric Balloon, delivers the highest success rates of all gastric balloons (Press)
• J&J’s Auris touts prelim data from first-in-man study of Monarch platform (MassDevice)
• Cook Medical partners with Ambu A/S to distro single-use duodenoscope pending FDA approval (MassDevice)
• QIAGEN Gains 510(k) Clearance by FDA for QIAstat-Dx in the U.S. and Launches System as Next Generation Platform for Syndromic Insights (Press)
• Body Vision Medical Receives FDA Clearance for LungVision 2.0 System, a Part of LungVision Platform, Demonstrated at ATS 2019 (Press)

• AP fact check Trump’s miscues on trade and drug prices (PBS)
• Further Thoughts on the Proposed DTC Advertising Drug Pricing Rule (Drug & Device Law)
• Cutting through the noise: the handful of pricing proposals the Trump administration or Congress may enact (BioCentury)
• In an Unusual Administrative Law Development, DOJ’s OLC States That FDA Has No Regulatory Authority Over Articles Used in Lawful Executions (FDA Law Blog)
• Opioid Prescriptions Drop Sharply Among State Workers (KHN)
• FDA official clarifies position on CBD-related ‘enforcement discretion’ (Natural Product Insider)
• FTC Must Tackle Anti-Competitive Drug Rebate Practices (Law360-$)
• IRS Should Use Tax Law To Combat The Opioid Epidemic (Law360-$)
• How Supreme Court Conservatives Have Shaped The FCA (Law360-$)
• How Might we Approach Discussions on the Implications of Using Genetic Data from a Human Rights or Social Justice Perspective? (Harvard Bill of Health)

• FDA Advisory Committee Calendar
• Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments – 7 June 2019

• As UK biotech gains steam, Syncona launches new Treg player while Cambridge spinout expands Series A (Endpoints)
• Deadlines for submission of applications for orphan medicinal product designation to the EMA and corresponding COMP timetable for valid applications (EMA)

• NGOs demand withdrawal of India-Japan MoU on PPH on fast-tracking of patents examination (PharmaBiz)
• NPPA reduces prices of nine non-scheduled anti-cancer medicines by 30 to 60% (PharmaBiz)
• CDSCO classifies 12 new notified medical devices based on intended use and associated risks (PharmaBiz)
• CDSCO declares 31 samples as NSQ and 1064 samples as SQ in random sampling for April (PharmaBiz)
• DCGI warns of stern action against cos which change contents of formulations without changing existing brand names (PharmaBiz)
• Civil Society Organisations urge WHO to update Guideline on the Evaluation of Similar Biotherapeutic Products (PharmaBiz)

• Countries move towards the elimination of mother-to-child transmission of HIV, syphilis, hepatitis B and Chagas disease (Paho)
• Brazil: The Anvisa 2019 Pilot Report (RxTrace)