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January 6, 2021
by Michael Mezher

Recon: Germany says it won’t delay second COVID vaccine dose; Alexion buys Rhythm PRV for $100M

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Studies to see if Moderna COVID-19 vaccine doses can be halved may take two months (Reuters)
  • So why is Alexion paying $100M for a PRV as AstraZeneca lines up their $39B buyout? (Endpoints) (Fierce)
  • Walgreens Boots to Sell Pharmacy Wholesale Operation to AmerisourceBergen (WSJ)
  • Trump administration speeds up plan to deliver Covid shots in pharmacies (Politico)
  • CVS, Walgreens to administer COVID-19 vaccines at US nursing homes by Jan 25 (Reuters)
  • States struggle for control of chaotic vaccine rollout (Politico)
In Focus: International
  • How the EU filled its basket in COVID-19 shopping spree (Reuters)
  • Moderna COVID-19 vaccine gets the green light in Europe (Reuters)
  • Europe prepares for Moderna vaccine rollout as fears grow over virus variants (Reuters)
  • After EU approval, Britain's MHRA still assessing Moderna vaccine, says PM's spokesman (Reuters)
  • Germany says does not intend to delay second COVID-19 vaccine shot (Reuters)
  • Pizza-sized boxes and paying a premium: Israel's COVID-19 vaccine rollout (Reuters)
  • EU may soon approve new use of Pfizer vaccine boosting doses by 20% -source (Reuters)
  • AstraZeneca applies for emergency use for vaccine in Philippines (Reuters)
Coronavirus Pandemic
  • A second coronavirus vaccine developed in India is set to enter phase three clinical trial ‘very, very soon’ (CNBC)
  • China plays down WHO concern about delay in coronavirus team's trip (Reuters)
  • Australia brings forward COVID-19 vaccine roll-out to early March (Reuters)
  • Colombia regulator approves Pfizer-BioNTech vaccine for emergency use (Reuters)
  • Japan’s stagnant vaccine industry falls far behind in COVID-19 race (Asahi Shimbun)
  • Criticism mounts over India's 'abrupt' approval of COVAXIN (Reuters)
  • Ukrainian firm applies to make Russia's COVID-19 vaccine, sparking political dilemma (Reuters)
  • Russia says Bolivia has registered Sputnik V vaccine (Reuters)
  • EU should share vaccines with Balkan neighbours, 13 governments say (Reuters)
Pharma & Biotech
  • CRISPR cures progeria in mice, raising hope for one-time therapy for a disease that causes rapid aging (STAT) (Science)
  • US FDA Faces Succession Questions As Hahn’s Departure Nears (Pink Sheet)
  • 2020 FDA drug approvals (Nature)
  • 5 FDA approval decisions to watch in the 1st quarter (BioPharmaDive)
  • Is The Opioid REMS Too Big To Study? (Pink Sheet)
  • Growing Pains For US FDA Oversight Of Opioids: Starting Over On Assessment Of REMS (Pink Sheet)
  • UK Tests Faster Ethics Review Of Non COVID-19 Trials (Pink Sheet)
  • Takeda Closes Sales of 16 Non-Core Meds to Germany’s Cheplapharm (PharmaJapan)
  • Allergy Therapeutics launches biomarker study of peanut allergy vaccine candidate (PharmaTimes)
  • EU authorises intramuscular administration of Biogen’s Plegridy for MS (PharmaTimes)
  • Biogen pushes further into gene therapy for the eye with new deal (BioPharmaDive)
  • Genentech Launches $1B+ RNA Collaboration with Ribometrix (GEN)
  • AstraZeneca's Farxiga gets rough FDA review date for groundbreaking move into chronic kidney disease (Endpoints)
  • AbbVie eyes Humira matching move into psoriatic arthritis for immunology follow-up Skyrizi (Endpoints) (Fierce)
  • Opdivo's in small cell lung cancer no more as Bristol Myers pulls out after trial failure (Fierce)
  • Autolus buckles down, chopping 20% of staff and seeking partner for a lead CAR-T program (Endpoints)
  • Imara attempts to spin weak data into an 'encouraging' result — but investors aren't having it (Endpoints)
  • Roche isn’t done lining up new collaborations in the hot field of drugging RNA. Here’s one more (Endpoints)
  • News briefing: Dewpoint scores another Big Pharma deal, this time with Pfizer; Kite joins forces with Oxford BioTherapeutics (Endpoints)
  • With lessons learned from Vor, Siddhartha Mukherjee takes a different route to target solid tumors with startup Myeloid (Endpoints) (STAT)
  • Tim Lu’s quest to break new cell therapy ground with gene circuits gets Bayer’s backing in a big new financing round (Endpoints) (BioPharmaDive)
  • After an up-and-down year, Nektar watches development head Wei Lin walk away as it pursues pipeline rebound (Endpoints)
Medtech
  • Stryker acquires digital knee replacement developer OrthoSensor (Fierce)
  • FDA Finalizes Guidance On Role Of Mouse Embryos In ART Device Toxicity Testing (MedtechInsight)
  • Hologic's M&A march continues with $230M Biotheranostics deal (Fierce)
  • Lobbying For A One-Year Delay To The EU IVDR: Solution Or Forlorn Hope? (MedtechInsight)
Government, Regulatory & Legal
  • Copaxone Legal Fight May Finally Be Over As Court Finds The MS Treatment Is Not A Biologic (Pink Sheet)
  • Mylan Urges Fed. Circ. To Keep Hatch-Waxman Venue Limits (Law360)
  • CDER’s Coronavirus Aid, Relief, and Economic Security Act (CARES Act) Efforts (FDA)
  • Merck, Glenmark Fight Zetia Class Cert. At 4th Circ (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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