Merck KGaA raises full-year forecast; Perlmutter's new gig tackles 'undruggable targets'

| 05 May 2021 | By Kari Oakes 

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)
  • 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.


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