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Recon: Drugmakers tell Congress vaccine supply to increase in March; Pfizer accused of playing hardball in Latin American vaccine negotiations
Recon: Drugmakers tell Congress vaccine supply to increase in March; Pfizer accused of playing hardball in Latin American vaccine negotiations
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
J&J ready to ship nearly 4 million doses of COVID-19 vaccine in US (Reuters ) (Politico )
Pfizer to ship 13M COVID-19 vaccine doses per week to US by mid-March, says executive (Reuters )
FDA to allow Pfizer-BioNTech vaccine to be stored at standard freezer temps (Reuters ) (NYTimes )
Moderna says FDA gave positive feedback on request to increase Covid vaccine supply in each vial (CNBC )
AstraZeneca expects US COVID-19 vaccine authorization in April (Reuters )
White House working to fix federal COVID vaccine tracking system, says official (Reuters )
Future Vaccines Depend on Test Subjects in Short Supply: Monkeys (NYTimes )
Pharmacists say 'pooling' Covid vaccines could save thousands of doses (NBC )
House panel advances Biden's $1.9T COVID-19 aid bill (The Hill )
California inspectors find ‘deficiencies’ at virus test lab (AP )
Stephen Hahn makes first post-FDA move, joining board of under-the-radar UPenn spinout (Endpoints )
In Focus: International
‘Held to ransom’: Pfizer plays hardball in Covid-19 vaccine negotiations with Latin American countries (STAT )
EU drug watchdog to weigh in on extended use for remdesivir by summer (Reuters ) (EMA )
European Commission President supports donating vaccines to health care workers in Africa (Reuters )
Pfizer's COVID-19 vaccine gets nod in South Korea from first of three expert panels (Reuters )
China's Clover raises $230 million, plans vaccines for COVID-19 variants (Reuters )
India sends first vaccine doses to Africa under WHO's COVAX programme (Reuters )
New pledges boost COVAX, but critics say more is needed to ensure global vaccine access (STAT )
Guinea starts Ebola vaccine campaign as cases emerge (Reuters )
How vaccine laggard CureVac hopes to come out on top (FT )
Genomic sequencing head calls for ‘Bio Force’ to detect virus threats (FT )
Manufacturers of COVID-19 vaccines typically start delivering in under six months after tech transfer (KEI )
Coronavirus Pandemic
Rheumatoid Arthritis Drug Shows Promise in Fighting Covid-19 (WSJ )
Public stakeholder meeting: approval, safety monitoring and impact of COVID-19 vaccines in the EU (EMA )
UNICEF sends syringes to Maldives, Ivory Coast, for COVAX vaccine rollout (Reuters )
South Africa says J&J, Pfizer, Moderna vaccines those for 'immediate use' (Reuters )
World Bank threatens to cut Lebanon's vaccine aid over line-jumping (Reuters )
French researchers trial more accurate fast COVID-19 test (Reuters )
BD to develop smartphone-powered home COVID-19 test with Scanwell Health (Fierce )
NeuroRx chief lines up Hail Mary for once-rejected Covid-19 drug (Endpoints )
Pharma & Biotech
PDUFA VII Could Expand US Real-Time Review Beyond Oncology (Pink Sheet )
Access to heart drugs improves in middle-income countries, but still lags compared to wealthy nations (STAT )
Biopharma's success rate in bringing drugs to market has long been abysmal. Can new tools help rewrite that troubled past? (Endpoints )
‘Following the Amazon playbook’: As digital pharmacy grows more crowded, startups scramble to stand out (STAT )
Catalent uncorks play in plasmid DNA with buyout of Belgian neighbor Delphi, Maryland expansion launch (Endpoints )
Bristol Myers scales up cell therapy production with liso-cel nod in hand and another approval maybe on the way (Endpoints )
Beam turns its soaring valuation into new assets, buying out an under-the-radar spinout and their gene delivery tech (Endpoints )
Regeneron wins FDA OK in lung cancer for immunotherapy rival to Merck's Keytruda (BioPharmaDive )
Novartis may lay off 170 in India due to COVID (Times of India )
Seagen's breast cancer drug TUKYSA gets UK approval (Pharmafile )
Otonomy’s Otividex Fails Again In Phase III Meniere’s Study (Scrip )
Dynavax's hepatitis B vaccine gets EU approval (Pharmafile )
Jim Mullen won a $20M option package when he switched from chairman to the CEO job at Editas — and it's all tied to performance (Endpoints )
Intercept shakeup continues as CMO, former NASH chief resigns. Is the NASH biotech abandoning its flagship disease? (Endpoints )
UK sees a 20% growth in the number of advanced therapy trials, report finds (PharmaTimes )
USFDA rules against Sun Pharma Advanced Research Co's appeal regarding cancer drug application (Economic Times )
Indian pharmaceutical firms go local for APIs, seeking to end reliance on China (Economic Times )
Merck KGaA offloads clinical-phase cancer drugs to Day One (Fierce )
Intercept loses chief medical officer months after CEO stepped down (Fierce )
Medtech
Hillrom patient lift tied to 2 deaths, designated as Class I recall (MedtechDive )
Chosen wisely: Grail, Quest team up on cancer blood test (Fierce )
Toronto-based researchers measuring whether Apple Watch can spot early signs of worsening heart failure (mobihealthnews )
Brainlab Receives FDA Clearance For Imaging Robot, Alignment Module For Spine (MedtechInsight )
Government, Regulatory & Legal
Becerra to highlight family's health struggles at confirmation hearing (Politico )
NY AG Opioid Trial Gets March Start After COVID-19 Delays (Law360 )
Allergan Patents Spared From PTAB Review In Settlement (Law360 )
Walmart Says DOJ's 'Sensationalist' Opioid Suit Rings Hollow (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.