Recon: FDA Approves Novartis’ SMA Gene Therapy With $2.1M Price Tag

• $2.1 million drug to treat rare genetic disease approved by FDA (NBC) (STAT) (FDA)
• JPMorgan cuts ties with OxyContin maker Purdue Pharma (Reuters) (CBS) (NBC)
• McKinsey No Longer Consulting for Purdue, Ends Opioid Work (Bloomberg)
• Trump Administration Preparing Executive Order on Health-Cost Disclosure (WSJ)
• Senate bill to cut health costs, targets FDA tweaks (Focus) (STAT)
• FTC Finds Dwindling Number of Anticompetitive Reverse Payment Deals (Focus) (STAT) (Law360-$)
• US Crackdown On Foreign Biotech Investment Makes Us Poorer, Not Safer (Forbes)
• Oklahoma takes on drugmakers J&J, Teva in landmark opioid trial (Reuters)
• RICO Offers a Powerful Tool to Punish Executives for the Opioid Crisis (NYTimes)
• American Pain Society considers bankruptcy under the weight of opioid lawsuits (STAT)
• Trump-Pelosi fight threatens drug pricing talks (The Hill)
• In Midst Of Opioid Crisis, FDA May Block New Addiction Drug From Market (NPR)

• WHO drug pricing talks may fail to end secrecy, activists fear (Reuters)
• GSK's shingles vaccine approved for use in China in adults aged 50 and above (Reuters)
• China says making progress on African swine fever vaccine (Reuters)
• EMA facilitates early engagement with medicine developers to combat antimicrobial resistance (EMA)
• Vertex and UK agency make competing proposals as logjam over cystic fibrosis meds continues (STAT) (Pink Sheet-$)
• WuXi Biologics building dedicated facility to supply 'global vaccine leader' (BioPharmaDive)
• Evotec to buy Just Biotherapeutics for up to $90M (BioPharmaDive)
• AZ’ HER2 drug hits mid-stage trial endpoints (PharmaTimes)
• NHS to undergo ‘ambitious’ tech overhaul (PharmaTimes)
• Final NICE guidance issued for Akcea’s Tegsedi (PharmaTimes)
• WHO Consults On Good Practices For Medical Product Supply (Pink Sheet-$)

• Use Of Buprenorphine To Treat Opioid Addiction Proliferates In California (KHN)
• Blink Health Taking On Big Pharma To Democratize Drug Prices (Forbes)
• Samsung Bioepis Data Suggest Clinical Impact From Herceptin Product Quality Drift (Pink Sheet-$)
• Project Snow White: Internal probe reveals former MiMedx C-suite spied on employees, lied to regulators and misled investors (Endpoints)
• Bristol-Myers Squibb Company Announces Extension of the Expiration Date for Exchange Offers for Celgene Corporation Notes (Press)
• Stoke files for $86M IPO to take Dravet drug from preclinical to phase 3 (Fierce)
• Ideaya wraps $50M IPO to fuel clinical drive on synthetic lethality (Endpoints)
• Cipla Claims Pricing Advantage For Albuterol In US (Scrip-$)
• Life sciences fund raises €118M for its next round of bets; Gilead scraps Alpine alliance (Endpoints)
• Novocure bags mesothelioma nod for electric fields cancer therapy with some limitations (Endpoints)
• A new interleukin target for NASH spawns Singaporean biotech steered by well known players (Endpoints)
• Ed Kaye is taking his fledgling biotech to Wall Street, looking for a new injection of cash (Endpoints)
• Sobered by mounting costs, Dynavax looks to unload I/O, slash jobs and circle wagons around Heplisav (Endpoints) (Fierce)

• NeoImmuneTech Announces that the FDA has Allowed the Center for Cancer Research, National Cancer Institute to Proceed with an Investigational New Drug Application to Initiate a Clinical Trial for Hyleukin-7 with Vaccines in Elderly Cancer Survivors (Press)
• Aimmune to Present AR101 Data at European Academy of Allergy and Clinical Immunology 2019 Congress (Press)
• Knopp Biosciences Presents Positive Preclinical Data for Lead Neonatal Epilepsy Drug Candidate at 2019 Antiepileptic Drug and Device Trials XV Conference (Press)
• Accelerated Approval Submission On The HORIZON For Oncopeptides’ Melflufen (Pink Sheet-$)
• New Investigational Clinical Data for Ipsen’s Oncology Products in 11 Solid Tumor Types to Be Presented at 2019 ASCO Annual Meeting (Press)

• FDA Clears New Tests for Chlamydia, Gonorrhea, Zika Virus and Prosthetic Joint Infections (Focus)
• FDA alerts hospitals, laboratories and health care professionals about recall of Beckman Coulter blood test analyzers due to risk of inaccurate platelet analyzing results (FDA)
• UPDATE On Risk of Cross-Contamination From 24-Hour Multi-Patient Use Endoscope Connectors - Letter to Health Care Providers and Staff at Health Care Facilities Performing Gastrointestinal Endoscopy Procedures (FDA)
• Edwards Lifesciences LLC Recalls EV1000 Clinical Platforms Due to Electrical Short Circuit Which May Cause the Device to Stop Working or Catch Fire (FDA)
• FDA Cites Defibrillator Battery Maker for Quality Violations (MDDI)
• Boston Scientific study to compare Watchman FLX with anticoagulant drugs (MassDevice)
• FDA approves Novocure’s NovoTTF-100LTM plus chemo for mesothelioma (MassDevice) (Press)
• Neovasc surges on two-year Reducer results (MassDevice)
• THINK Surgical Submits to the U.S. FDA for Clearance to Market its Active Robot for use in Total Knee Replacement Procedures (Press)
• Determination of Regulatory Review Period for Purposes of Patent Extension; EDWARDS INTUITY ELITE AORTIC VALVE (FDA)

• House Mark-up for FY 20 Very Pleasing (Alliance for a Stronger FDA)
• Senate Proposal for Section 101 Reform: Effect on Biotech/Pharma Inventions (Patent Docs)
• Setting Reasonable Expectations for FDA’s Public Hearing on Cannabis (FDA Law Blog)
• Justice Department Wants Closer Examination Of Centene-WellCare Deal (Forbes)
• Florida Finally Does Daubert (Drug & Device Law)
• What's Ahead For FDA Regulation Of Dietary Supplements (Law360-$)

• FDA Advisory Committee Calendar

• When a Retweet is Considered Promotional, MHRA Takes Action (Focus)
• Experts Examine Impact of EU GDPR, CCPA on MedTech Sector (Focus)
• Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 21-22 May 2019 (EMA)

• Korea Pledges Broad Innovation, Policy Support As It Eyes Global Stage (Pink Sheet-$)

• CCI approves GSK, Pfizer consumer healthcare JV formation (Economic Times)

• Ontario first Canadian province to pay for Venclexta (PharmaLetter-$)
• Notice of Consultation on the Prescription Drug List: Vitamin D (Health Canada)
• Health Canada approved Mylan and Biocon’s Ogivri, trastuzumab biosimilar, for the treatment of HER2-positive breast and gastric cancers (Biosimilar News)