U.S. Trade Representative Katherine Tai announced this afternoon that the Biden administration supports waiving IP protections for COVID-19 vaccines. “This is a global health crisis, and the extraordinary circumstances of the COVID-19 pandemic call for extraordinary measures,” Tai said in the statement. Get the full story on our sister site Pharmaceutical Processing World.
COVID-19
Pfizer to seek FDA approval for COVID-19 vaccine, will seek authorization for kids above 2
Pfizer CEO Albert Bourla said the company will soon seek full FDA approval and authorization for further age groups for its COVID-19 vaccine. Speaking during the company’s first-quarter earnings call yesterday, transcribed by The Motley Fool, Bourla outlined the regulatory pathways that the company is pursuing for the vaccine it developed with BioNTech, which is […]
FDA could soon authorize Pfizer COVID-19 vaccine for younger adolescents
The COVID-19 vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) appears to be on the cusp of winning regulatory authorization for use in adolescents between the ages of 12 and 15, according to several media reports. FDA has authorized the vaccine for people aged 16 and up. In March, Pfizer submitted clinical trial results to FDA, suggesting the efficacy of the […]
MedTech 100 roundup: Return to normal following recent spike
After back-to-back all-time best performances, the medtech industry had a slight regression over the course of the last week. MassDevice‘s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — had been continuously ticking up since the beginning of April, with its mark of 112.25 on April 16 representing an all-time […]
Pfizer and BioNTech seek EMA nod for younger adolescents
After announcing that its vaccine was 100% efficacious in a Phase 3 trial involving adolescents aged 12 to 15, Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) are seeking authorization from the European Medicines Agency (EMA) to distribute the vaccine to that age group. BioNTech’s CEO, Uğur Şahin, estimated that the vaccine would be available to early adolescents in 27 European countries […]
Side effects relatively rare for Pfizer-BioNTech vaccine, study says
A recent study found that only 13.5% of recipients of the COVID-19 vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) had systemic side effects after the first dose. That figure climbed to 22.0% after the second dose. Conversely, just over one-third (33.7%) of recipients of the first dose of vaccine from AstraZeneca (LON:AZN) had systemic side effects, according to the […]
Moderna pledges to manufacture up to 3B COVID-19 vaccine doses in 2022
Moderna (NSDQ:MRNA) announced today that it committed funds to increase its COVID-19 vaccine manufacturing capacity to up to 3 billion doses for 2022. Cambridge, Mass.-based Moderna’s new funding commitments would increase supply at its owned and partnered manufacturing facilities up to that 3 billion-dose capacity, depending upon the mix between the authorized Moderna COVID-19 vaccine at […]
Hologic earnings miss Wall Street expectations for Q2
Hologic (NSDQ:HOLX) posted second-quarter results today that trailed the consensus forecast, but the company forecasts a strong third quarter fueled by robust COVID-19 test revenue. The Marlborough, Mass.-based company posted profits of $1.09 billion, or $2.38 per share, on sales of $1.54 billion for the three months ended March 27, 2020. Sales growth in the […]
Boston Scientific, Stryker may get extension on Medicare payments
CMS has issued a proposal for the 2022 fiscal year that would potentially help big medtech companies like Boston Scientific and Stryker. Released yesterday, the proposal for the Medicare Hospital Inpatient Prospective Payment System (IPPS) and Long Term Care Hospital (LTCH) offers updated Medicare payment policies and rates for operating and capital-related costs of acute […]
Abbott sees a future for at-home diagnostics after COVID-19
Abbott CEO Robert B. Ford has suggested that at-home diagnostics could be here to stay even after the COVID-19 pandemic. Speaking on Abbott’s April 20 earnings call, transcribed by SeekingAlpha, Ford pointed out that the company’s diagnostics sales increased by 115% year-over-year from the first quarter of 2020, with a significant chunk of that made […]
U.S. to donate 60M doses of AstraZeneca’s COVID-19 vaccine
The Biden administration announced today that it will begin sharing its store of AstraZeneca’s COVID-19 vaccine following safety reviews. Once the vaccine clears federal safety reviews, 60 million doses of the vaccine are expected to be made available, according to a Tweet from senior White House advisor Andy Slavitt. “BREAKING: U.S. to release 60 million Astra Zeneca […]
