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)
- 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)
- 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)
- 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)
- 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)
- 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)
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