Recon: Mexico authorizes AstraZeneca COVID vaccine; Woodcock returns to new role in Commissioner’s office
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
Drugmakers kick off 2021 with 500 US price hikes (Reuters) (STAT)
Inovio expects to begin late-stage COVID-19 vaccine study in second quarter (Reuters)
Most US COVID-19 vaccines go idle as New York, Florida move to penalize hospitals (Reuters)
Haven, ambitious health venture backed by Amazon, to shut down (STAT) (Reuters)
Many Health Plans Now Must Cover Full Cost of Expensive HIV Prevention Drugs (KHN)
Janet Woodcock bumped to Commissioner’s office, will remain involved in OWS (Politico)
HHS rebukes drug makers for curtailing discounts to hospitals that serve low-income populations (STAT)
In Focus: International
EU seeks up to 100 million more doses of Pfizer vaccine in new deal – sources (Reuters)
EMA says interval between Pfizer vaccine doses should be respected (Reuters)
China doubles down on COVID narrative as WHO investigation looms (Reuters)
Canada on track to have more than 1 million Pfizer and Moderna doses by end-January - PM Trudeau (Reuters)
Pfizer Has Offered South Africa Discounted Covid-19 Vaccines (Bloomberg)
India readies roll-out of COVID-19 vaccines for 300 million people (Reuters)
Mexico approves AstraZeneca COVID-19 vaccine, minister says (Reuters)
Israel authorises use of Moderna's COVID-19 vaccine (Reuters)
Coronavirus Pandemic
Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine (NEJM 1, 2, 3)
Dutch caught off guard by Pfizer approval, unable to start vaccinations until Weds says PM (Reuters)
Belgium to get half the Pfizer vaccine doses it ordered for January (Reuters)
Italy to invest in biotech ReiThera to support COVID-19 vaccine development (Reuters)
China's CNBG has supplied 3 million COVID-19 vaccine doses to UAE (Reuters)
Stemirna COVID-19 vaccine candidate obtains clinical trial approval in China (Reuters)
Brazil to requisition syringes for COVID-19 vaccination plan (Reuters)
FDA flags false negative risk of startup Curative's COVID-19 test (MedtechDive) (FDA)
Pharma & Biotech
Pfizer Introduces New Logo Playing Up Role in Drug Creation (WSJ)
Roche's tiragolumab receives U.S. breakthrough therapy designation (Reuters)
The biotech scorecard for the first quarter: 17 stock-moving events to watch (STAT)
Surprise! Brand-Name Drug Prices Fell (Again) in 2020 (Drug Channels)
Plenty Of Action On EU Accelerated Assessment Front (Pink Sheet)
Oral Contraceptives Tied to Lower Risk for Certain Cancers (NYTimes)
Triplet Therapeutics and three other startups got venture funding a year ago. Where are they now? (STAT)
Mace Rothenberg starts the year by stepping out of his top job in Pfizer R&D — as Stanford’s Aida Habtezion steps in (Endpoints)
WuXi Biologics Receives GMP Certification from Brazil (GEN)
Recall report: Nostrum expands recall of diabetes drug metformin after carcinogen concerns (Endpoints)
Regeneron's Schleifer, Yancopoulos set their company's ambitions sky high with $1.4B on the table in performance awards (Endpoints)
Edging toward a pivotal readout, Biogen picks a new discovery partner for ophthalmic gene therapy (Endpoints)
Can a new protein bring RNA drugs where they can't reach? J&J vet Sue Dillon's Ionis-partnered biotech gets $88M to prove yes (Endpoints)
Ikena bags $120M to advance growing pipeline of cancer drugs (Fierce)
Eli Lilly's transpacific bosom buddy Terns bags late-round funding to drive NASH hopefuls through the clinic (Endpoints) (Fierce)
Charles River Laboratories spends $83M to snap up Distributed Bio to boost antibody work (Fierce)
Fujifilm's CDMO carves foothold in Boston biotech hub with new HQ focused on viral vectors, gene therapies (Endpoints)
Shanghai Pharma maps out $1.18B industrial park in hometown biopharma hub (Fierce)
AbbVie bails on Sosei Heptares pact for novel neurology candidates in blow to discovery outfit's A-list Rolodex (Endpoints)
Millendo braces for deep cuts after its last clinical effort ends in defeat and a last search for a way to end things (Endpoints)
BioXcel scores another win with reformulated Pfizer sedative, this time in an Alzheimer's symptom (Endpoints)
News briefing: Marius submits NDA for oral hypogonadism therapy; Celltrion's billionaire founder steps down (Endpoints)
Risankizumab (SKYRIZI®) Phase 3 Results Demonstrate Improvements in Disease Activity Across Joint and Skin Symptoms Among Psoriatic Arthritis Patients (Press)
Medtech
Color raises $167M to scale up US testing and telehealth services (MedtechDive)
What’s On The European Commission’s Agenda For Medtechs In 2021 (MedtechInsight)
Asia Medtech Reg Discussions: COVID-19 Is A Golden Moment For Medtech And Governments To Learn How To Deal With Future Crises (MedtechInsight)
Becton Dickinson, ramping up syringe capacity, set to turn out 1B COVID-19 vaccine devices by year-end (Fierce)
Government, Regulatory & Legal
DOJ Backs AbbVie At 7th Circ. In 'Patent Thicket' Case (Law360)
DC Judge Calls Teva's Bid To Reclassify Drug Anticompetitive (Law360)
DOJ Attys Dish On Indivior Opioid Case As Sentencing Wraps (Law360)
Allergan Seeks Quick Appeal After Failing To Nix FCA Suit (Law360)
Zantac Generics MDL Labeling Claims Axed As Preempted (Law360)
Final Medicaid Best Price Changes Encourage Value Based Purchasing but Discourage Copay Assistance (FDA Law Blog)
Value-Based Contracting: CMS Final Rule Leaves ‘Multiple Best Price’ Questioned Unresolved (Pink Sheet)
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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