Recon: GSK Looks to Cut 900+ Jobs in Belgium; Biogen Wins Tecfidera Dispute Against Mylan

• Bristol-Myers earnings rise due to Celgene contribution (Reuters) (Press)
• Regeneron likely to make coronavirus treatments available in few months (Reuters)
• Biogen shares soar 32% on MS drug patent win over Mylan (Reuters) (STAT)
• Gilead loses its challenge to a pair of U.S. patents for an HIV prevention pill (STAT) (Endpoints)
• AbbVie's Rinvoq scores Humira-matching trial win in psoriatic arthritis (Fierce) (Press)
• Beam Therapeutics IPO Raises $180M After Nearly Doubling Shares Offered (Xconomy)

• GSK’s vaccines group — including R&D — faces heavy job cuts in latest restructuring (Endpoints) (Fierce)
• China’s Drug Patent Grab Makes Coronavirus Scary for Pharma (Bloomberg)
• US clashes with China over Taiwan's place at the WHO table (Reuters)
• WHO convening experts on drugs, vaccines to set coronavirus research agenda (Reuters)
• Cancer gene map heralds new era of personalised treatment (Financial Times) (Nature)
• Sanofi vows 2020 profit growth amid strategy overhaul (Financial Times) (Press)
• French drugmaker Sanofi working on coronavirus initiative (Reuters)
• Sanofi's phase 2 MS data spark broad push into late-stage trials (Fierce) (Press)
• Roche posts data on SMA rival to drugs from Biogen, Novartis (Fierce) (Endpoints) (Press)
• Novartis faces criticism over Zolgensma ‘health lottery’ (PMLive)
• Women of defective French breast implants may claim damages only in France: EU court adviser (Reuters)

• Everyone’s a Critic: FDA Under Fire for High Drug Approval Numbers (FDA Law Blog)
• We need better regulation of stem cell therapies, especially rogue clinics (STAT)
• The Value of One: What Can We Learn from Case Studies? (Undark)
• Bristol’s doomsday scenario: could Opdivo start shrinking next year? (Vantage)
• ICER Will Assess Real World Evidence On Accelerated Approvals After Two Years (Pink Sheet-$)
• Jeffrey Bluestone steps down as Parker Institute president to develop cell therapies for autoimmune diseases (STAT)
• Ian Read adds a new post to his growing roster of post-Pfizer positions — and this one pays well (Endpoints)
• MD Anderson emerges with strong evidence for natural killer cell therapy, and Takeda looks like a winner (Endpoints)
• After Cancer Took His Mother, James Allison Taught Our Immune Systems How to Fight It (Time)
• Years later, raw clinical trial data tells us the extent of Avandia’s heart risks (STAT)
• Open science, publishing, and public research support: Could Trump have it right? (STAT)
• European rare disease biotech Azafaros grabs $28M early funding round (Fierce)
• Improved access to opioid addiction treatment bypasses some communities (Reuters)
• Immune therapy tweak offers new hope to blood cancer patients (NBC)
• Coherus biosciences SEC Form 8-K (SEC)
• Coda Bio Acquires Drug Candidates to Pair With Engineered Receptors (Xconomy)
• Racial differences seen in acne treatment for US patients (Reuters)
• HIV Antiretroviral Therapy Costs in the United States, 2012-2018 (JAMA)
• Biosimilars Update: Bio-Thera Solutions BAT1706 (bevacizumab) and Pfizer RUXIENCE (rituximab) (Big Molecule Watch)
• For Novartis' Generic Advair, Another 18 Months Was Too Far Into The Unknown (Pink Sheet-$)
• Adverse Events For Generic Of GSK's Advair Diskus On US FDA’s Radar (Pink Sheet-$)
• Zydus Cadila Explores Orphan Drug Indication For NASH Candidate (Scrip-$)
• Biocon hit with FDA 483 after inspection of API facility (InPharmaTechnologist)

• Bayer’s Eylea proves efficacy, safety in ALTAIR study (PharmaTimes)
• Blueprint Medicines Announces PDUFA Date Extension for New Drug Application of Avapritinib for the Treatment of Adults with Fourth-Line Gastrointestinal Stromal Tumor (Press)
• ReAlta Life Sciences Announces FDA Orphan Drug Designation for PIC1 for the Treatment of Hypoxic-Ischemic Encephalopathy (Press)
• Revance Announces U.S. FDA Acceptance of Biologics License Application (BLA) for DAXI to Treat Glabellar (Frown) Lines (Press)
• Kleo Pharmaceuticals Receives IND Authorization to Proceed from FDA for its Multiple Myeloma Therapeutic (Press)
• Lineage Provides Positive Update on Phase I/IIa Clinical Study of OpRegen® for the Treatment of Dry Age-Related Macular Degeneration (Press)
• Preliminary Data from NIH/NIAID-sponsored Phase 2 Clinical Trial of BiondVax's M-001 Universal Influenza Vaccine Candidate Validates Results of Previous Clinical Trials (Press)
• Kodiak Sciences Announces Upcoming Presentation of Additional KSI-301 Phase 1b Clinical Study Data at Angiogenesis, Exudation, and Degeneration 2020 Meeting (Press)

• Qiagen, still independent, limps back from 2019 (MedtechDive)
• BD plummets on Q1 results as it cuts 2020 outlook (MassDevice)
• Cardinal Health stocks up 11% in Street-beating Q2 results (MassDevice)
• Abiomed beats on earnings, misses on revenue in Q3 results (MassDevice)
• Boston Scientific expects up to $40M hit in Q1 from coronavirus (MedtechDive)
• Hackers Can Wreak Havoc on Medical Devices, But Manufacturers Can Fight Back (Bloomberg)
• Medical device innovation – what it takes to go the distance (MedCity)
• CardioFocus seeks PMA supplement to launch HeartLight X3 endoscopic ablation system (MassDevice)
• Aria CV Receives FDA Breakthrough Designation for Its Medical Device for Treating Pulmonary Arterial Hypertension (Press)
• Atlantic Therapeutics Announces FDA Clearance for Over-the-Counter Use of INNOVO® (Press)
• In2Bones Receives FDA 510(k) Clearance for Quantum™ Total Ankle (Press)

• Biosimilar Appellate Update: Genentech v. Immunex, Genentech v. Amgen, Janssen v. Celltrion (Big Molecule Watch)
• Trump’s prepared speech included a guarantee to protect preexisting conditions. He didn’t say it. (Washington Post)
• Juul bulks up its science staff as FDA vaping deadline nears (LA Times)
• Juul and other e-cig makers to Congress: FDA, not you, should regulate us (STAT)
• US government proposes higher payments to Medicare insurers in 2021 (Reuters)
• Gilead's IPR Bid Over 2 Gov't HIV-Prevention Patents Fails (Law360-$)
• ITC To Review Patent Dispute Between Biotech Firms (Law360-$)
• Illumina Beats Claims Its Attys Deceived PTAB, Fed. Circ. (Law360-$)
• CVC Submits Motion No. 2 in Opposition to Broad's Substantive Motion No. 2 to Substitute the Count (Patent Docs)

• FDA Advisory Committee Calendar
• Health Canada and FDA Joint Public Consultation on International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use – 3 April 2020

• New video launched: How does EMA support SMEs? (EMA)
• ABPI response to proposed UK-‘Rest of the World’ FTA negotiation approaches (ABPI)
• London Cancer Hub receives major investment (PharmaTimes)
• Draft motion for a resolution - Strategic approach to pharmaceuticals in the environment (Europarl)
• Company led drug alert – Iohexol solution for injection (350mg/ml and 300 mgI/ml) (MHRA)

• Interim decisions and invitation for further comment on substances referred to the November 2019 ACMS/ACCS meetings (TGA)

• Experts offer first US nCoV clinical guidance (CIDRAP)
• WHO chief says 80% of China virus cases are in Hubei province (Reuters)
• Qiagen expects coronavirus test to be ready this month: CEO (Reuters)
• Drugmakers see long road ahead in coronavirus vaccine race (Reuters)
• WHO probes Singapore meet linked to spread of virus (Reuters)
• China's virus-hit Hubei short of medical workers (Reuters)
• Scientists Link China Coronavirus to Intersection of Humans and Wildlife (WSJ)
• Coronavirus case confirmed in Wisconsin, the 12th case in the US (NBC)