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Regulatory Focus™ > News Articles > 2021 > 6 > Recon: Lawmakers to investigate Biogen Alzheimer’s drug; Idorsia to trial self-injection heart attac

Recon: Lawmakers to investigate Biogen Alzheimer’s drug; Idorsia to trial self-injection heart attack drug

Posted 28 June 2021 | By Michael Mezher 

Recon: Lawmakers to investigate Biogen Alzheimer’s drug; Idorsia to trial self-injection heart attack drug

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Lawmakers to investigate approval, pricing of Biogen Alzheimer's drug (Reuters) (STAT) (Endpoints)
  • Costly New Alzheimer’s Drug Could Force Medicare to Restrict Access (WSJ)
  • New Alzheimer's drug may be a catastrophe in the making (Axios) (NBC)
  • Calls rise for FDA to fully approve COVID-19 vaccines (The Hill)
  • Pfizer and Moderna Vaccines Likely to Produce Lasting Immunity, Study Finds (NYTimes)
  • Johnson & Johnson to Pay New York $230 Million to Settle Opioid Case (NYTimes) (FT) (STAT)
  • In a first for genome editing, Intellia Therapeutics reports positive early data on in vivo CRISPR therapy (STAT) (FT)
  • Booster may be needed for J&J shot as Delta variant spreads, some experts already taking them (Reuters)
  • Lilly's COVID antibody combo halted nationwide, dealing huge blow to blockbuster program (Fierce)
  • Novartis says it overpaid Roche's Genentech nearly $210 million in a licensing deal—and it wants its money back (Fierce) (Law360)
In Focus: International
  • Mixing Pfizer and AstraZeneca vaccines provides strong protection, according to a preliminary study (NYTimes) (Reuters)
  • Roche's neuromyelitis optica drug Enspryng wins EU approval (Reuters)
  • Idorsia to trial self-injection drug for heart attack victims (Reuters)
  • Indonesia recommends Sinovac vaccine for children aged 12-17 (Reuters)
  • Saudi Arabia to inoculate those aged 12 to 18 with Pfizer vaccine – ministry (Reuters)
  • AstraZeneca's diabetes drug study shows benefit in adolescents (Reuters)
  • GlaxoSmithKline Taps Goldman and Citi for Consumer Spinoff (Bloomberg)
  • In an about-face, Health Canada allows a controversial rare disease drug back on the market (STAT)
Coronavirus Pandemic
  • The hunt for a coronavirus super shot (FT)
  • ‘A tough slog’: White House struggles to increase vaccination rates as Delta variant surges (NYTimes)
  • Last foreign scientist to work at Wuhan lab: 'What people are saying is just not how it is' (The Hill)
  • S.Korean consortium to produce Russia's Sputnik Light vaccine (Reuters)
  • AstraZeneca kick-starts new COVID variant-busting vaccine test (Fierce)
  • Germany expects faster Moderna COVID-19 vaccine deliveries (Reuters)
  • Dr. Reddy's Laboratories announces commercial launch of COVID-19 drug 2-DG (Economic Times)
  • AstraZeneca on track to meet Southeast Asia vaccine orders (Reuters)
  • TGA grants third provisional approval to COVID-19 vaccine: Janssen (TGA)
Pharma & Biotech
  • Gilead matches Bristol Myers in showing benefit to earlier CAR-T treatment (BioPharmaDive)
  • Sanofi sells portfolio of regional consumer brands to Stada (Reuters)(Fierce)
  • Erasing cancer, reviving oncolytic virus, treating a rare neuromuscular condition: Here's what you need to know about the 5 new biotechs filing for IPOs (Endpoints)
  • Biopharma M&A set for a strong H2 despite political noise—and Biogen and Gilead look like buyers: analysts (Fierce)
  • Gilead's Kite earns second-line win for CAR-T Yescarta, setting up a battle over earlier blood cancer patients (Endpoints)
  • After years of failure, ViaCyte shows off first proof-of-concept for diabetes stem cell transplants (Endpoints)
  • Exelixis posts mixed results for Cabometyx combo in early liver cancer patients, casting doubt on pivotal readout (Endpoints)
  • J&J chooses an advocate of the “golden age” of vaccines at the Gates Foundation to lead the pipeline into the future (Endpoints)
  • Orphazyme plans to lay off most of its staff following a string of failures for lead 'pipeline-in-a-product' (Endpoints)
  • AstraZeneca names Galbraith as Baselga successor in cancer R&D (Fierce)
  • Polyphor flops a phase 3, jeopardizing its future as shares more than halved (Fierce)
  • AstraZeneca, Sanofi post RSV data ahead of 2022 approval filings (Fierce)
  • Novo Nordisk reveals positive results at ADA 2021 for higher-dose Ozempic in type 2 diabetes (PMLive)
  • Lilly showcases tirzepatide type 2 diabetes data at ADA 2021 (PMLive)
  • MSD Chief Wants Japan to Eliminate Disincentives Tied to Re-Pricing Rules as Keytruda Faces Repeated Cuts (PharmaJapan)
  • Japan Issues Guidelines on Drug Delivery by Drones; Operation Plan, Quality Assurance Required (PharmaJapan)
  • Novo’s Smart Insulin Pens Get Japan Approval, Launch in H1 2022 (PharmaJapan)
Medtech
  • Avid Medical Recalls Medical Convenience Kits for Risk of Fungal Contamination (FDA)
  • ADA: Insulet's automated Omnipod drops HbA1c in preschoolers with Type 1 diabetes (Fierce)
  • Stroke device maker RapidPulse spins out of Syntheon incubator (Fierce)
  • CMR Surgical amasses giant £425M funding round to take its surgery robot global (Fierce)
  • EU clarifies Eudamed rules for legacy and custom-made devices (MedtechDive)
  • FDA Recommends Broader Use Of Single-Use Bronchoscopes (MedtechInsight)
  • USFDA issues two observations after inspection of Granules India's Chantilly facility in US (Economic Times)
Government, Regulatory & Legal
  • New Alliance Urges Countries To Ratify Treaty On African Medicines Agency (Pink Sheet)
  • Mylan Nabs Partial Win On EpiPen Claims, Still Faces Trial (Law360)
  • Pharma Co. Sues Insurer For Coverage In Opioid Suits (Law360)
  • 3 Pharmacies Cut From NY Opioid Trial, CVS Reaches Deal (Law360)
Regulatory Recon is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe.
 
A story's inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.

 

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