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.
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