Recon: Purdue Reaches $270M Settlement in Oklahoma Opioid Case

• OxyContin maker Purdue reaches $270 million settlement in Oklahoma opioid case: source (Reuters) (NYTimes) (Washington Post) (Bloomberg)
• Oklahoma top court clears way for Purdue, J&J, Teva to face opioid trial (Reuters)
• House Democrats to Unveil Plan to Expand Health Coverage (NYTimes) (House Energy & Commerce)
• Trump's new legal position: Scrap all of the ACA (Politico)
• With an experimental NASH treatment, NGM aims to be the next billion-dollar biotech (STAT)
• Purdue Pharma, maker of OxyContin, settles opioids lawsuit in Oklahoma (AP)
• FTC demands more info from Bristol-Myers, Celgene on psoriasis drugs, signaling a potential hitch for $74B deal (Endpoints) (SEC)
• Women at Breast Implant Hearing Call for Disclosure of Safety Risks (NYTimes) (The Hill)
• Museums Cut Ties With Sacklers as Outrage Over Opioid Crisis Grows (NYTimes)
• Duke University to Pay $112.5 Million to Settle Claims of Research Misconduct (NYTimes)
• White House touts progress in opioid crisis, but health researchers are skeptical (CNBC)
• Tracking Federal Funding to Combat the Opioid Crisis (Bipartisan Policy Center)
• BIO Submits Comments to SEC on Earning Releases and Quarterly Reports (BIO)

• Data suggest US, UK universities fall woefully short on reporting clinical trial results (Endpoints)
• Bluebird plays down report of EU gene therapy approval (PMLive) (Scrip-$)
• Medtronic launches Shanghai-based medtech incubator (MassDevice) (Press)
• Indian Government notifies new rules for drugs and clinical trials (Economic Times)
• EMA IT systems unavailable from 30 March to 1 April 2019 (EMA)
• AbbVie's immunology blockbuster-to-be Skyrizi picks up first global approval (Fierce)
• Oxford BioMedica Notes Kymriah Cancer Treatment's Approval In Japan (Morningstar) (PharmaLetter-$)
• Masthercell adds to global gene and cell manufacturing frenzy with EU facility (Fierce)
• What Now After Brexit Delay? UK BioIndustry Association Asks (Pink Sheet-$)
• Progress in Peril: Stagnant Funding Could Lengthen the TB Elimination Timeline (PLOS)

• Genome engineers made more than 13,000 CRISPR edits in a single cell (MIT Technology Review)
• Bluebird opens manufacturing facility as it moves gene therapies forward (Fierce)
• Novel drug targets in 2018 (Nature)
• Approval Time Data Won’t Look Good Until the Oldies Are Cleared Out (Lachman)
• Updating Labels for Generic Oncology Drugs (National Cancer Policy Forum)
• Pre-approval Promotion: Corporate Communications May Draw US FDA Scrutiny (Pink Sheet-$)
• The top 10 Alzheimer’s deals tell us a lot about a big change of direction for a disaster-prone field (Endpoints)
• Biotech’s newborn unicorn Sana grabs Harvard tech aimed at slipping engineered stem cells past the immune system (Endpoints)
• Proteostasis shares shattered as weak triplet data inspires a scorching backlash (Endpoints)
• Alexion chief registers $16.5M in pay after a solid year, with a relatively low 74-to-1 ratio compared to a well paid staff (Endpoints)
• Analysts: Proteostasis Data Are No Boost vs. Vertex in Cystic Fibrosis (Xconomy)
• Contending for CD47 throne, Arch Oncology scores $50M as it ramps up PhI studies (Endpoints)
• iTeos brings on Sanofi cancer VP as CMO as it wades deeper into the clinic (Fierce)

• Janssen Submits Application for DARZALEX (daratumumab) Combination Therapy to U.S. FDA for Newly Diagnosed, Transplant Eligible Patients with Multiple Myeloma (Press)
• FDA Denies Recro Pharma’s Intravenous Meloxicam A Second Time (FDA News-$)
• Tiziana submits IND for Foralumab oral formulation in NASH (PharmaTimes)
• Aldeyra's eye drug meets main goal in late-stage study, shares surge (Reuters) (Endpoints) (Press)
• Israeli biotech flunks PhII liver cancer study, but it insists drug Can-Fite disease in subset of patients (Endpoints)
• Lipella Pharmaceuticals Received FDA IND Approval for Phase-2a Oncology Supportive Care Drug Study (Press)
• Buyout vote looming, Celgene files for ozanimod OK (again), with a multibillion-dollar bet riding on every step (Endpoints) (Press)
• Selvita Announces FDA Acceptance of Investigational New Drug Application to Commence Clinical Development of SEL120 in the Treatment of Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome (Press)
• Fina Biosolutions’ Licensee Successfully Completes a Phase 3 Study and Enters World Health Organization (WHO) Registration for Pneumosil (Press)
• Hansa Biopharma Receives Ethics and Regulatory Clearance to Start Phase 2 Study of Imlifidase in Acute Antibody Mediated Rejection in Kidney Transplantation (Press)
• Breath Therapeutics Announces Initiation of Global Phase 3 Trials for the Treatment of Bronchiolitis Obliterans Syndrome (Press)
• Eiger BioPharmaceuticals Announces Oral Presentation of Phase 2 PREVENT Study Results of Avexitide in Post-Bariatric Hypoglycemia at Endocrine Society Meeting (ENDO) 2019 (Press)
• Atossa Genetics Announces Institutional Review Board Approval of Oral Endoxifen as Post-Mastectomy Treatment for a U.S. Breast Cancer Patient (Press)

• FDA approves new device for treating patients with chronic heart failure (CNBC)
• Agency Information Collection Activities; Proposed Collection; Comment Request; Clinical Laboratory Improvement Amendments Waiver Applications (FDA)
• CardioFocus wins CE Mark for HeartLight X3 endoscopic ablation system (MassDevice)
• FDA clears shorter protocol for Nexstim’s NBT TMS depression treatment (MassDevice)
• Masimo wins FDA 510(k) for Rad-67 pulse co-oximeter (MassDevice)
• Medtronic responds to usability concerns for its MiniMed 670G insulin pump (MassDevice)
• FDA clears Genetesis’ CardioFlux biomagnetic cardiac imager (MassDevice)
• FDA Clears Zimmer Biomet's Rosa One Spine System (MDDI)
• Vela Diagnostics Announces FDA Submission of its Next Generation Sequencing (NGS) HIV Genotyping and Drug Resistance Mutation (DRM) Assay (Press)
• InControl Medical Wins FDA Clearance for Attain: The First Over-the-Counter, At-Home Device for the Treatment of Urinary and/or Fecal Incontinence in Women (Press)
• Elekta wins Health Canada approval for Elekta Unity MR radiation therapy system (MassDevice)

• Guest Post: When Is A Deadline Really The Deadline? – Class Certification, Motions to Reconsider, and Appeals Under Federal Rule 23(f) (Drug & Device Law)

• FDA Advisory Committee Calendar
• 2019 Seminar on "Quality Assurance of Sterile Medicinal Products - PIC/S GMP Guide Annex 1"  - 13-15 November 2019

• EU Project Seeks More Help To Improve Effectiveness Of Flu Vaccines (Pink Sheet-$)
• Medicines: reclassify your product (MHRA)
• Bank on this: EURIPID's pharmaceutical data makes healthcare planning easier and improves access to medicines (EC)

• Revcovi, Japan’s first Drug for ADA deficiency, approved (PharmaLetter-$)
• Oral JAK Inhibitor Smyraf® Tablets Approved in Japan for the Treatment of Rheumatoid Arthritis (including prevention of structural joint damage) in Patients Who Have an Inadequate Response to Conventional Therapies (Press)
• Breaking the cycle: Paediatric DR-TB detection, care and treatment in Tajikistan (MSF)

• CDSCO expert panel approves Sanofi proposal to conduct phase-III trial of rapid-acting insulin in Indian patients (PharmaBiz)