Recon: Eli Lilly, Rigel in $960 autoimmune tie-up; New WTO chief calls to end COVID export restrictions
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
Researchers urge delaying Pfizer vaccine's second dose as first highly effective (Reuters) (NEJM)
Eli Lilly in deal with Rigel to develop autoimmune therapy for up to $960 million (Reuters)
Johnson & Johnson has only a few million COVID-19 vaccine doses in stock as likely launch nears (Reuters) (CNBC)
CDC Announces $200 Million ‘Down Payment’ to Track Virus Variants (NYTimes)
Biden admin will spend $1.6B to expand Covid-19 testing and sequencing (Politico)
Clinical Trials Are Moving Out of the Lab and Into People’s Homes (NYTimes)
Botox Rival Stays on US Market After Court Order; Evolus Rises (Bloomberg)
States still can’t import drugs from Canada. Now, many are seeking to import Canadian prices (STAT)
US will pay WHO more than $200 million in membership fees withheld by Trump (CNBC)
US administers 56.3 million doses of COVID-19 vaccines (Reuters)
Biden picks Brooks-LaSure to run Medicare, Medicaid agency (Politico) (STAT)
In Focus: International
AstraZeneca vaccine faces resistance in Europe after health workers suffer side-effects (Reuters)
EU Health Security Committee agrees on a common list of COVID-19 rapid antigen tests (EC)
BioNTech/Pfizer vaccine is less potent against South African variant (FT) (STAT)
WTO Chief Calls on Nations to End Covid Export Restrictions (Bloomberg)
Countries to get confirmation soon on COVAX vaccines, but should expect small initial shipments: PAHO (Reuters)
India's Bharat Biotech pursues COVID-19 vaccine approval in over 40 countries (Reuters)
Coronavirus Vaccine Nears Final Tests in Cuba. Tourists May Be Inoculated. (NYTimes)
Emmanuel Macron urges Europe to send vaccines to Africa now (FT)
WHO deploys team to battle Ebola outbreaks (The Hill)
More than 11,000 Ebola vaccines expected in Guinea this weekend (Reuters)
Fujifilm's Avigan shows no significant benefit on COVID-19 mortality: study (Reuters)
Coronavirus Pandemic
New York's Mount Sinai Ends Blood-Plasma Treatment for Hospitalized Covid-19 Patients (WSJ)
Sinovac vaccine works on UK, South African variants - Brazil institute (Reuters)
Saudi Arabia approves AstraZeneca's COVID vaccine, state TV reports (Reuters)
Hong Kong approves China's Sinovac vaccine, rollout from February 26 (Reuters)
Brazil’s coronavirus vaccine rollout beset by supply problems (FT)
DHS seizes over 11 million counterfeit 3M N95 masks, more raids to come (CNBC)
South Korea to double syringe supplies for COVID-19 vaccine campaign (Reuters)
Inspectors force AstraZeneca's Mexico vaccine partner to overhaul its factory, holding up shot production (Fierce)
FDA could reject AstraZeneca’s COVID vaccine on efficacy and manufacturing shortfalls: analyst (Fierce)
COVID Therapeutics Progress (Or Lack Thereof) May Be Political Vulnerability For US FDA (Pink Sheet)
Pakistan to receive 2.8 million doses of AstraZeneca vaccine under COVAX scheme on March 2 (Reuters)
Everlywell’s home COVID-19 testing kit goes direct-to-consumer (Fierce)
Efanesoctocog alfa granted FDA Fast Track Designation for treatment of hemophilia A (Press)
Pharma & Biotech
Covid crushed in-person pharma sales. Tech is pitching itself as a solution (STAT)
The Covid effect has triggered some radical changes to the top 50 biopharma list, bringing a whole new group of players into the big league (Endpoints)
Pharma’s ambitious new antibiotic venture hires a CEO to fix a ‘broken’ pipeline (STAT)
5 years later, CAR-T pioneer Kymriah offers jaw-dropping evidence of durable remissions — even as it still proves a tough sell (Endpoints)
Royalty Pharma gets more competition as a private equity firm launches $725M royalty-buying fund (Endpoints)
Immunic's lead drug fails to impress in 2 separate trials — and it's blaming some of its woes on the pandemic (Endpoints)
EU approves Tukysa combo for advanced HER2-positive breast cancer (PharmaTimes)
Charles River jumps into cell and gene therapy manufacturing with $875M Cognate buy (Fierce)
Zyntgelo Advocates Accuse UK HTA Body Of Failing To 'Understand Patients' Lived Experience’ (Pink Sheet)
SpyBiotech cashes in on Serum Institute deal, netting $32.5M round for its 'superglue' VLP vaccine tech (Endpoints)
A step behind its major exosome challenger, Evox scores $95M round for final leg of race to the clinic (Endpoints)
Eduardo Bravo returns to bring European biotech in on the SPAC splurge (Endpoints)
Houston's Avance Biosciences announces another expansion, this time focused on cell-based assays (Endpoints)
Advent Life Sciences launches two funds totaling $215M, and teams with Harrington Discovery Institute to translate research (Endpoints)
Century Therapeutics boosts iPSC manufacturing space in New Jersey as part of company wide expansion (Endpoints)
VC style returns on 'unsexy' public health bets? Gates-backed Adjuvant Capital gathers $300M to mend a 'failure of imagination' (Endpoints)
A month after multi-billion dollar Novartis deal, BeiGene follows up with 'reverse' deal (Endpoints)
EMA Clarifies GCP Inspector Authority Over Accessing Patient Records (Pink Sheet)
Dermavant shows deepening effects of tapinarof on psoriasis ahead of FDA filing (Fierce)
FDA Refuse-To-File Decisions Are Rare, But CMC And Ignoring Agency Advice Are Often Triggers (Pink Sheet)
Chugai Re-Files Patent Suit over Edirol, Now Focuses on Crystalline Form (PharmaJapan)
Medtech
FDA approves 3D-printed ankle implant for humanitarian use (MedtechDive)
EU Must Up Pressure To Secure Swiss Device MRA Or Transitional Arrangements (MedtechInsight)
Zimmer Biomet taps former Medtronic exec to lead new spine, dental spinoff (Fierce)
Exact Sciences-Guardant rivalry in colorectal testing market heats up (MedtechDive)
Smith & Nephew Q4 knee sales plummet, exceeding drops reported by Stryker and Zimmer Biomet (MedtechDive)
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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