Recon: FDA Approves Two Formulations of Pfizer’s Tafamidis for Cardiomyopathy

• Pfizer gets US approval for $225,000 a year heart drug (Reuters) (Endpoints) (Press) (FDA)
• Cytokinetics pushes ahead with ALS drug despite negative clinical trial outcome (STAT) (Endpoints)
• Most AbbVie shareholders are unfazed that the CEO’s bonus is tied to high prices for Humira (STAT)
• The health care votes that Democrats are planning this week (Politico)
• Here’s who will lose their insurance if Obamacare is overturned (CNBC)
• FDA Approving Oncology Drugs Off Trials With Weak Controls? (Medpage) (JAMA)
• UK's Vectura wins patent infringement case against GlaxoSmithKline in US (Reuters) (Law360-$)
• 80,000 Deaths. 2 Million Injuries. It’s Time for a Reckoning on Medical Devices. (NYTimes)
• FDA to End Alternative Summary Reporting for Devices (Focus) (KHN)
• US measles count rises to 764, driven by New York outbreaks (NBC)
• Rogue Stem Cell Clinics Hawking Untested Treatments Irk FDA (Bloomberg)
• Roche's breast cancer hopes get a boost from postsurgery Kadcyla approval (Fierce) (Press) (FDA)
• Amid US measles outbreak, who needs an additional dose of the vaccine? (Reuters)

• The top 50 biotechs by market cap — and what their CEOs’ compensation deals tell us about biopharma (Endpoints)
• Lundbeck strikes $250M Abide buyout, bagging Tourette's drug (Fierce) (Endpoints)
• Working together for safe medicines in the EU Share (EMA)
• EMA Discusses Pivotal Role Of RWE For Six Drugs (Pink Sheet-$)
• Sun Pharmaceuticals to set up an ethics committee to oversee corporate governance-related matters (Economic Times)
• Cipla is undergoing a big transformation and is doing something it once eschewed (Economic Times)
• Indian pharma sees US as complementary partner in the wake of US-China trade war (PharmaBiz)
• China's war on healthcare costs lures India's biggest drugmaker (Economic Times)
• With potential launches nearing, Zai taps investors for $200M (BioCentury)
• Opinion: Big pharma can only see the benefit of R&D for wealthy markets (The Guardian)
• GHTC delivers statement on access to medicines at HHS WHA listening session (GHTC)

• FDA Explains Why it Waived a Shared REMS for Letairis Generics (Focus)
• FDA Drafts Guidance for Developing Drugs to Treat ADHD (Focus)
• US FDA Biosimilars Acting Director Yim ‘Not A Great Fan’ Of Suffix-Based Naming Policy (Pink Sheet-$)
• Keeping Checkpoint Inhibitors in Check (JAMA)
• Microbes called extremophiles might combat superbugs, biowarfare agents (Washington Post)
• New Zolgensma data suggest comparable efficacy to Spinraza — analysts (Endpoints) (Fierce)
• An Encyclopedia Of Advice For Startup Boards (LifeSciVC)
• Potential Governing Body Emerges For DSCSA Tracing Of US-Marketed Drug Packages (Pink Sheet-$)
• Few at risk for opioid overdose get potentially life-saving naloxone (Reuters)
• Gene Therapy Policies Can Strike An Ethical Balance (Law360-$)
• Paying For Gene Therapy: Medicaid Will Be ‘Canary In Coal Mine’ (Pink Sheet-$)
• After A Big Failure, Scientists And Patients Hunt For A New Type Of Alzheimer's Drug (NPR)
• Delivery Might Be Key to Gene Therapy’s Orphan Status, CBER Official Says (FDANews-$)
• Half of People Miss Benefits of Statins (NYTimes)
• Bill Haney’s Skyhawk spears another marquee alliance for its work drugging RNA in Takeda neuro pact (Endpoints)
• Pioneering mRNA CEO Stéphane Bancel bags an eye-popping $58M compensation deal in wake of record IPO (Endpoints)
• Study highlights challenges in using artificial intelligence to personalize cancer treatment (STAT)
• Scientists see hope in a rare disease drug Wall Street has all but written off (STAT)
• FDA Chief Counsel's Remarks to the 2019 FDLI Policy Conference (FDA)

• GenSight Biologics Announces Presentation of 72-Week Data from the REVERSE Phase III Trial of GS010 at the Annual Meeting of the American Academy of Neurology (AAN) (Press)
• Savara Announces Molgradex Received Fast Track Designation by FDA for Treatment of Autoimmune Pulmonary Alveolar Proteinosis (Press)
• Connect Biopharma Reports Positive Phase 1 Data and Announces Initiation of Phase 1b Study in Patients with Atopic Dermatitis for Novel IL-4Rα Antibody CBP-201 (Press)
• OnKure Announces FDA IND Regulatory Clearance to Start Phase 1 Trials for OKI-179 (Press)
• UroGen Delivers Updated Complete Response (CR) and Durability Data from the UGN-101 Phase 3 OLYMPUS Trial (Press)
• SpringWorks Therapeutics Announces Initiation of Phase 1b Clinical Trial of MEK Inhibitor PD-0325901 in Combination with BeiGene’s RAF Dimer Inhibitor Lifirafenib in Advanced or Refractory Solid Tumors (Press)
• Can-Fite Announces Preparation for End-of-Phase II Meeting with FDA to Initiate the Phase III Liver Cancer Study for Namodenoson (Press)
• Initial Data for Alterity Therapeutics Phase 1 Clinical Trial Released at American Academy of Neurology Annual Meeting (Press)
• Xencor Doses First Patient in Phase 1 Study of XmAb®23104 for the Treatment of Patients with Advanced Solid Tumors (Press)
• Axonics® Announces ARTISAN-SNM Pivotal Study Results Presented at the American Urological Association Annual Meeting (Press)
• Shattuck Labs, Inc. Announces Initiation of Phase 1 Clinical Trial of SL-279252 (PD1/OX40L) (Press)
• Medicines360 and Allergan Present Six-Year Clinical Data from Largest Ongoing Phase 3 Study of an Intrauterine System in the U.S. (Press)
• GlycoMimetics, Inc. Announces Enrollment Completed for Phase 3 Clinical Trial Evaluating Rivipansel in Sickle Cell Disease (Press)
• AMO Pharma Presents Statistical Analysis of Results of Phase 2 Study of AMO-02 in Adolescents with Autism Spectrum Disorder (Press)

• CDRH Remains Bullish on 510(k) Modernization (Focus)
• Boston Scientific wins FDA approval for Vici peripheral venous stent (MassDevice)
• RTI Surgical shares rise on Q1 earnings beat (MassDevice)
• Bausch Health slashes Q1 losses, raises outlook (MassDevice)
• Axonics touts results from pivotal FDA IDE r-SNM urinary dysfunction trial (MassDevice)
• FDA Grants IDE Approval for Almac Diagnostic Services' CDx for Use in Cancer Drug Study (GenomeWeb)
• USP Volunteers Develop Standard that Improves Test Critical to Cellular Transplant Care (USP)

• Setting Precedent, A Federal Court Rules Jail Must Give Inmate Addiction Treatment (NPR)
• Hi-Tech Sues to Save DMHA (FDA Law Blog)
• Update to Our 2011 Post on When Counsel Can Confer with Their Own Witnesses During Depositions (Drug & Device Law)
• Obviousness Analysis Trends In Pharma Patent Cases (Law360-$)
• Supplement Co. Says FDA Crackdown On Stimulant Unlawful (Law360-$)

• FDA Advisory Committee Calendar
• Implementing the 21st Century Cures Act: Making Electronic Health Information Available to Patients and Providers, Part II – 7 May 2019
• Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee – 20 June 2019

• Pharmaceuticals: Commission launches new version of the Union Register (EC)
• EC Explains What UDI Information to Provide for Eudamed (Focus)
• European Commission Approves Palynziq® (pegvaliase injection) for Treatment of Phenylketonuria (PKU) in Patients Aged 16 Years or Older (Press)
• European Union (EU) International Organisation for Standardization (ISO) for identification of medical products (IDMP)/Substance, Product, Organisation and Referential (SPOR) data Task Force meeting Share (EMA)

• Rush To Produce, Sell Vaccine Put Kids In Philippines At Risk (NPR)

• Dr Reddy's launches generic testosterone gel in US market (Economic Times)
• Lupin, Zydus Pharmaceuticals recall products in the US (Economic Times)
• NPPA fixes retail prices of 22 formulations under DPCO, 2013 (PharmaBiz)

• Webinar: An update on the consultation for the Regulation of Software, including Software as a Medical Device (SaMD) (TGA)
• TGA presentation: ARCS Australian Pharmacovigilance Regulatory Requirements and Risk Management Plans Summit, 27 March 2019 (TGA)

• Breast cancer ad campaign banned from Facebook for violating nudity guidelines (CBS)