Merck KGaA raises full-year forecast; Perlmutter's new gig tackles 'undruggable targets'
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
Lilly hit by staff accusations, FDA scrutiny at COVID drug factories ( Reuters )
Pharma showers Menendez with rare, off-cycle burst of campaign cash as Democrats eye drug pricing reforms (STAT )
Rising wholesale drug prices really do matter to half of all commercially insured Americans (STAT )
Facing fresh pricing threats in D.C., pharma spent a record $92M peddling influence during the first quarte (Fierce )
White House will make unordered vaccine supply available to other states (WaPo )
White House set to send vaccines abroad (Politico )
U.S. cases, vaccinations continue to drop as White House sets new inoculation goal (CNBC )
Connecticut becomes the first state with half of all adults fully vaccinated amid slowing pace of U.S. inoculations (CNBC )
CDC projects a surge in U.S. Covid cases through May due to variants before vaccinations drive a ‘sharp decline’ ( CNBC )
In Focus: International
UK Spinraza Data Review Shows Benefits Of NICE Flexibility (Pink Sheet )
Younger people filling up COVID-19 intensive care wards in Americas, PAHO says ( Reuters )
India is suffering immensely under the weight of Covid. Now its failures are threatening much of the world (Reuters )
New Scottish Agency Would Ensure Supply Of Cost-Effective Drugs (Pink Sheet )
India approves Roche/Regeneron antibody cocktail to treat COVID-19 (Reuters )
Explainer: COVID-19 vaccine patents dominate global trade talks (Reuters )
WHO to open a global pandemic ‘intelligence’ hub in Germany (CNBC )
Coronavirus Pandemic
Canada authorizes Pfizer COVID-19 vaccine for children aged 12 to 15 ( Reuters )
Adagio offers first peek at Covid-19 antibody data, with preventative numbers that may rival mRNA vaccines (Endpoints )
Canada's Alberta confirms first death linked to AstraZeneca vaccine (Reuters )
BioNTech on course to produce three billion doses of Pfizer-partnered COVID-19 vaccine in 2021 (PMLive )
WHO experts voice "very low confidence" in some Sinopharm COVID-19 vaccine data (Reuters )
Nasal spray shown to be effective in reducing COVID-19 transmission (EPR )
CureVac says well on track to request vaccine approval as planned (Reuters ) (NYT )
Experts Weigh In On Mixing And Matching COVID-19 Vaccines (NPR )
Pharma & Biotech
The long wait for Cel-Sci to finally admit its cancer drug doesn’t work (STAT )
ChemoCentryx's stock sinks as FDA flags issues with pivotal data (Fierce ) (BioCentury )
Elizabeth Holmes back in court for first time in 15 months, putting Silicon Valley culture under scrutiny (CNBC )
The editor of digital health’s newest journal wants to democratize medicine with data (STAT )
Roger Perlmutter, former Merck R&D head, becomes CEO of super-microscopy startup (STAT ) (Endpoints )
Ex-Novartis CEO Joe Jimenez and a lead Kite player take up new posts at an off-the-shelf rival (Endpoints )
FDA approves 100th monoclonal antibody product (Nature Reviews Drug Discovery )
Affinia Therapeutics raises $110 million for gene therapy treatments (STAT )
Day One pivots to an IPO for more funding to back its work in pediatric cancer (Endpoints )
The weird science of the placebo effect keeps getting more interesting (Vox )
New variant-hardy AbCellera-Lilly mAb shows utility of viral genomics surveillance (BioCentury )
Athenex shares soar with buyout of natural killer T cell player (Endpoints )
Pfizer's Hospira recalls hospital anesthetics, flags 'moderate to high severity' safety risks (Fierce )
Startup sets out to tackle the gene therapy manufacturing crisis (Endpoints )
Esker, a new biotech startup, launches with plans to make targeted immune drugs (BioPharma Dive )
AbbVie's Humira regains top pharma TV spender spot, while sibling brands Rinvoq and Skyrizi tag along (Fierce )
Pfizer ups COVID-19 vaccine revenue estimates (BioPharma Reporter )
Merck KGaA raises forecast for full year 2021 (Pharmaletter )
Medtech
Microneedles are promising devices for painless drug delivery with minimal side effects (EurekAlert )
Inside Vida Health’s $110M Series D & Big Push into Digital Mental Health (The Health Care Blog )
AI, digital health feature in latest batch of FDA breakthrough device designations (MedTech Dive )
Operating Rooms Go Under the Knife (NYT )
BD Taps Contract Packager for COVID-19 Test Kits (MD+DI )
Zimmer sees Q1 sales growth after CEO warned of down quarter (MedTech Dive )
A Digitalization Tipping Point for the Medical Manufacturing Supply Chain (MD+DI )
Siemens Healthineers Sees Revenue Soar From COVID-19 Test Demand (MD+DI )
Government & Regulatory
My Conversation with Daniel Carpenter, on regulation and also the FDA (Marginal Revolution )
Remote Regulatory Assessments (FDAatty )
The new EU AI regulation proposal, medical devices and IVDs (Medicaldeviceslegal )
USDA now only partially inspects some lab animal facilities, internal documents reveal (Science )
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.