Regulatory Focus™ > News Articles > 2021 > 3 > Recon: Pfizer, BioNTech raise 2021 vaccine output to 2.5B doses; FDA rejects Keytruda in early breas

Posted 30 March 2021 | By Michael Mezher 

Recon: Pfizer, BioNTech raise 2021 vaccine output to 2.5B doses; FDA rejects Keytruda in early breast cancer

2703 Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • The operation formerly known as Warp Speed: Biden leans heavily on the flagship Trump-era initiative (STAT)
  • Pfizer raise 2021 vaccine output goal to 2.5B doses (Reuters) (Endpoints) (FT)
  • Johnson & Johnson vaccine partner Emergent still lacks FDA's manufacturing green light (Fierce)
  • Biden urged to keep patent protections for Covid vaccines (FT)
  • FDA snubs Keytruda in early breast cancer after harsh review as Merck looks to next data analysis (Fierce) (Endpoints)
  • House Democrats target HHS 'sunset' rule with Congressional Review Act (The Hill)
In Focus: International
  • Canada pauses AstraZeneca COVID-19 vaccine use for those under 55, wants new risk analysis (Reuters)
  • Germany to recommend AstraZeneca shot only for over 60s: media (Reuters)
  • Biggest share of Indian-made vaccines for poor country programme stays in India (Reuters)
  • India extends shelf life of AstraZeneca vaccine - document, source (Reuters)
  • Asian countries seek vaccine supplies after India export curbs hit COVAX (Reuters)
  • Austria in talks to buy a million doses of Russia's Sputnik V vaccine (Reuters)
  • Novavax COVID-19 vaccine could be approved by UK in April, Evening Standard says (Reuters)
  • Amarin's heart drug Vazkepa gets European Commission approval (Reuters)
  • Novartis says Kesimpta gets EU approval in multiple sclerosis (Reuters) (Press)
  • Roche, Novartis approvals in Europe signal more head-to-head competition (Reuters) (Press)
  • Canadian company pursues compulsory license to distribute Covid-19 vaccine to low-income countries (STAT)
  • BioNTech owners in talks to invest in German cancer labs group: sources (Reuters)
Coronavirus Pandemic
  • CureVac taps Swiss contract drugmaker Celonic for COVID-19 vaccine production (Reuters)
  • Brazil regulator says Bharat Biotech vaccine does not meet factory standards (Reuters)
  • U.S., China positive on pandemic treaty idea: WHO's Tedros (Reuters)
  • Humanigen says its drug keeps Covid patients off ventilators. But are some data missing? (STAT)
  • Mali approves Russia's Sputnik V vaccine - Russian sovereign wealth fund (Reuters)
  • Pakistan to import Chinese Cansino COVID vaccine in bulk to package 3 million doses locally: minister (Reuters)
Pharma & Biotech
  • Novartis and Genentech push for clarity from FDA on how disease progression models can be used for regulatory decisions (Endpoints)
  • A CRISPR 2.0 pioneer, expecting credit on its own invention, is ruffled by a competitor (STAT)
  • Oxford Nanopore picks London for latest tech IPO (FT)
  • Takeda taps BridGene to pursue hard-to-drug neurodegenerative disease targets (Fierce)
  • Wave culls leading Huntington's meds as shares go under after rival Roche hit by similar fate (Fierce) (Endpoints)
  • After Pfizer cancer deal, Pyxis Oncology nabs a hefty $152M series B (Fierce)
  • EU recommendations for 2021-2022 seasonal flu vaccine composition (EMA)
  • Armed with Pfizer's ADC platform, Pyxis scores $152M round to shoot for the clinic while taking its time on I/O programs (Endpoints)
  • The IBD market is set to soar to $32B. AbbVie could be the big winner, but there's meat left on the bone — top analyst (Endpoints)
  • Going head-to-head with Merck on I/O, Genentech vets raise fresh round and enter clinic (Endpoints)
  • Inctye’s Pemazyre authorised in the EU for bile duct cancer (PharmaTimes)
  • Flagship startup Omega takes lead 'epigenomic controller' candidate closer to the clinic with new $126M round (Endpoints)
  • After tackling Covid-19 with AstraZeneca, Oxford's Jenner Institute is hard at work on a different kind of vaccine (Endpoints)
  • Forma sees data 'supporting' sickle cell therapy dosing levels; LianBio teams with Tarsus for eye irritation in China (Endpoints)
  • U.S. FDA Accepts AbbVie's New Drug Application for Atogepant for the Preventive Treatment of Migraine (Press)
  • Novartis dives even deeper into radioligands, notching licensing deal with iTheranostics for multiple compounds (Endpoints) (Press)
  • Japan Gives Up on Setting New Generic Target by March as Manufacturing Scandals Weigh (PharmaJapan)
  • MHLW Panel Approves List of “Stable Supply Medicines”; Pricing to Become Topic of Discussions (PharmaJapan)
  • FDA panel to probe Endologix, broader stent graft safety in Q4 (MedtechDive)
  • Boston Scientific pads case for radioactive microspheres with liver cancer survival win (Fierce)
  • Full results of EndeavorRx adjunct trial show longer benefits with or without stimulant therapy (mobihealthnews)
  • NMPA publishes revised Chinese medical device regulations (Emergo)
  • Merck sets up $240M Alydia Health buyout to beef up its future Organon women's health spinout (Fierce)
  • EU approval for new AI technology that can predict heart attacks (PharmaTimes)
Government, Regulatory & Legal
  • Pfizer, BioNTech Call IP Suit A 'Burden' On Vaccine Effort (Law360)
  • Arthrex Cleared Of Infringing TriMed Patent After Bench Trial (Law360)
  • Opioid MDL's Tribal Bellwether Dodges Early Drug Co. Attacks (Law360)
  • A Mixed R&R From The Abilify MDL (Drug & Device Law)
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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