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Recon: Drugmakers tell Congress vaccine supply to increase in March; Pfizer accused of playing hardball in Latin American vaccine negotiations

Posted 23 February 2021 | By Michael Mezher 

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.

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