Recon: Alzheimer’s drugmakers undeterred on accelerated approval despite Aduhelm coverage decision; Japan cancels a third of its AstraZeneca vaccine order
Recon: Alzheimer’s drugmakers undeterred on accelerated approval despite Aduhelm coverage decision; Japan cancels a third of its AstraZeneca vaccine order
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
FDA's Califf on accelerated approval: 'In God, we trust, everyone else must bring good evidence' (Fierce)
‘Precedents are important’: Aduhelm coverage restrictions could shape the future of accelerated approval (STAT)
Alzheimer's drugmakers seek accelerated FDA review despite U.S. coverage decision (Reuters)
Pfizer taps David Denton from Lowe's as CFO (Reuters)
Walgreens trial over its part in Florida opioid crisis set to begin (Reuters)
Biotechs take a beating in first round of #AACR22 as weak data cripple share prices (Endpoints)
In Focus: International
Moderna recalls thousands of COVID vaccine doses in Europe (Reuters)
Drugmakers pledge speedier European market launches to avert stricter regulation (Reuters)
India's COVID-19 vaccine prices cut as booster program is extended (Reuters)
Taiwan orders Pfizer's COVID-19 pill as infections rise (Reuters)
Japan cancels a third of contracted AstraZeneca vaccine purchase (Reuters)
WHO says it is analysing two new Omicron COVID sub-variants (Reuters)
Demand for Covid vaccines falls amid waning appetite for booster shots (FT)
Germany agrees deal with CureVac, GSK for mRNA vaccines until 2029 (Reuters)
Vaccine group Gavi secures $4.8 billion in funding pledges for COVAX (Reuters)
Incomplete data likely masks a rise in U.S. Covid cases as focus on infection counts fades (NBC)
There’s an uptick in U.S. vaccinations, and older Americans are the reason (NBC)
Pharma & Biotech
AACR: Bristol Myers details Opdivo's presurgery lung cancer win, with an early sign of survival benefit (Fierce)
AACR22: Amgen reveals new long-term data for Lumakras, looking to keep pressing market advantage over Mirati (Endpoints)
AACR22: Affimed's NK cell therapy produces more patient responses — and more durability questions (Endpoints)
An mRNA vaccine boost may help CAR T-therapy treat solid cancers (STAT)
Flagship-backed microbiome company Kaleido Biosciences shuts down (Endpoints)
Scoop: AbbVie drops IBS drug Viberzi in Canada, 'devastating' patients (Endpoints)
Exclusive: Flagship snags another CEO-partner, on a personal mission, to lead its tRNA boat (Endpoints)
Medtech
Fitbit tails Apple Watch with FDA-cleared algorithm to passively check for afib (Fierce) (TechCrunch)
FDA official: Draft cybersecurity guidance has 'teeth' (MedtechDive)
Pfizer to drop $74M for COVID cough-screening smartphone app developer (Fierce)
Government, Regulatory & Legal
Seagen scores $41.8M in Enhertu patent case against Daiichi Sankyo (Fierce) (Law360)
Vanda Sues US FDA For Documents Backing Complete Response For Hetlioz Jet Lag Indication (Pink Sheet)
When Congress Seeks Cos.' Nonpublic Info From Regulators (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.
Adam Fisher, the staff director of the Office of Pharmaceutical Quality in the Center for Drug Evaluation and Research (CDER) at the US Food and Drug Administration (FDA), reported that the agency has approved 17 pharmaceuticals that utilize continuous manufacturing in their production.
The European Medicines Agency (EMA), in partnership with the European Commission (EC) and the Heads of Medicines Agencies (HMA), has published the first quarterly report on the state of clinical trials conducted in the EU and the European Economic Area (EEA). The report is intended to shed light on the progress being made to attract more clinical trials to the region and increase access to new treatments as part of the targets set by the EU in 2025.
An official from the US Food and Drug Administration (FDA) on Monday presented three case studies demonstrating how sponsors effectively utilized real-world evidence (RWE) and real-world data (RWD) to secure approval for their products.