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Recon: Pfizer to boost US vaccine deliveries as EU secures more doses; Tango to go public in $353M SPAC deal

Posted 14 April 2021 | By Michael Mezher 

Recon: Pfizer to boost US vaccine deliveries as EU secures more doses; Tango to go public in $353M SPAC deal

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • CDC to weigh rare clot risk with J&J's COVID-19 vaccine as use paused (Reuters) (NYTimes)
  • Biden officials bracing for possibility of weekslong disruption to J&J vaccine supply (Politico)
  • FDA to scrutinize vaccine design behind COVID-19 shots linked to blood clots (Reuters)
  • Pfizer to deliver 10% more doses to US by end of May- CEO (Reuters)
  • Moderna says protection from its COVID-19 vaccine still strong six months on (Reuters)
  • Justice Department backs extending ban on fentanyl copycats (Reuters)
  • Overdose Deaths Have Surged During the Pandemic, CDC Data Shows (NYTimes)
  • Federal prosecutors launch Alnylam marketing probe, demanding Onpattro documents (Fierce)
  • Tango Therapeutics to go public in $353 million SPAC deal (STAT) (BioPharmaDive)
  • White House Expands List of Potential FDA Commissioners (WSJ) (Law360)
  • A US appeals court upholds the FTC view of controversial pay-to-delay settlements (STAT) (Endpoints)
In Focus: International
  • EU to raise COVID vaccine supplies from Pfizer in second quarter to 250 million doses (Reuters)
  • In world first, Denmark ditches AstraZeneca's COVID-19 shot (Reuters)
  • EU Commission to end AstraZeneca and J&J vaccine contracts at expiry – paper (Reuters)
  • CanSinoBIO says no serious blood clots from its vaccine (Reuters)
  • AstraZeneca's drug Tagrisso gets China nod for early lung cancer (Reuters)
  • UK trial on switching COVID-19 vaccines adds Moderna and Novavax shots (Reuters)
  • Brazil justice gives health regulator 30 days to decide on Sputnik vaccine (Reuters)
Coronavirus Pandemic
  • France says to administer J&J COVID-19 vaccine as planned (Reuters)
  • Sweden pauses plans for J&J COVID-19 vaccinations, awaits review (Reuters)
  • Stalled Pfizer deal clouds Israel's hopes of swift herd immunity (Reuters)
  • Canada reports first case of rare blood clotting after AstraZeneca COVID shot: ministry (Reuters)
  • Armenia to receive 1 million doses of Russia's Sputnik V shot: TASS (Reuters)
  • South Africa suspends J&J vaccine rollout after U.S. pause (Reuters)
  • South Africa says downpayments to J&J, Pfizer not refundable (Reuters)
  • OHT-7’s Q1 2021 Report Card on EUA Reviews (FDA Law Blog)
  • TGA grants provisional determination to Glaxo SmithKline Australia Pty Ltd for COVID-19 monoclonal antibody treatment – SOTROVIMAB (TGA)
  • Lucira gets FDA nod for OTC molecular COVID-19 test (MedtechDive)
Pharma & Biotech
  • Lilly, Arch join Deerfield in backing new gene therapy biotech Jaguar (BioPharmaDive)
  • Eli Lilly seeds a well-connected China neuro startup with drugs aiming at where Biogen, Voyager missed (Endpoints)
  • FDA grants accelerated approval to sacituzumab govitecan for advanced urothelial cancer (FDA)
  • Novavax CFO Greg Covino to step down (Reuters)
  • Former head of FDA’s medical and scientific affairs on Covid: ‘FDA has never been tested like this’ (Endpoints)
  • PhRMA chief talks strategy — and he’s surprisingly optimistic about drug pricing reform (STAT)
  • Can Biosimilars Compete With ‘Unbranded Biologics’ In The US Market? (Pink Sheet)
  • Gross-to-Net Bubble Update: Net Prices Drop (Again) at Six Top Drugmakers (Drug Channels)
  • Lilly Closes Dermira’s Menlo Park Facility, Cutting 163 Jobs in the Process (BioSpace)
  • After being goaded to sell the company, Alexion's CEO set some ambitious new goals for investors. Then Pascal Soriot came calling (Endpoints)
  • Forxiga accepted for use within NHS Scotland for chronic heart failure (Pharmafile)
  • NICE publishes new guidance on chronic pain management (PharmaTimes)
  • Pfizer, Myovant begin dosing in relugolix contraceptive study (PharmaTimes)
  • Meet Benchling, the latest unicorn seeking to revolutionize the way scientists do work with the help of the cloud (Endpoints)
  • Amylyx to move forward with ALS program in Europe, but FDA wants another look; Humacyte adds $50M in debt financing (Endpoints)
  • Launched by MIT grads, a small startup gets $20M to back a robotics revolution in cell therapy manufacturing (Endpoints)
  • Nearly a year after Audentes' gene therapy deaths, the trial continues. What happened remains a mystery (Endpoints)
  • Anti-aging biotech upstart plucks a drug from Amgen's discard pile, pivoting from heart failure to muscle conditions (Endpoints)
  • Mid-sized medtechs hit hardest by pandemic, though sector seen resilient: poll (MedtechDive) (Emergo)
  • Roche, Biocorp begin French rollout of add-on device connecting insulin pens to smartphone apps (Fierce)
  • Medtronic launches 7-day diabetes infusion tubing set in Europe (Fierce)
  • AstraZeneca, Sanguina to develop app for bloodless blood testing (Fierce)
  • TFDA releases details about transition to new Taiwanese medical device regulations (Emergo)
  • TGA presentation: The regulation of medical device software, February 2021 (TGA)
Government, Regulatory & Legal
  • 4th Circ. Revives Antitrust Suit Over Actelion's Drug Tracleer (Law360)
  • Federal Court Halts Implementation of 340B Dispute Resolution Rule (Harvard Bill of Health)
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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