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vaccines

Pfizer highlights COVID-19 and flu vaccine strategy in Q2 earnings call

July 29, 2021 By Brian Buntz

With vaccines generating a significant portion of Pfizer’s (NYSE:PFE) revenue in the first six months of 2021, the company shed light on its vaccine plans in its most recent quarterly earnings call. While the company recently won FDA approval for its potential blockbuster pneumococcal 20-valent vaccine, its mRNA vaccine strategy understandably took center stage during […]

Filed Under: Business/Financial News, Featured, MassDevice Earnings Roundup, Pharmaceutical, Wall Street Beat Tagged With: BioNTech, coronavirus, COVID-19, COVID-19 vaccine, Pfizer, vaccines

Pandemic Emergency Manufacturing Act would supplement DPA

February 4, 2021 By Nancy Crotti

A rewritten pandemic manufacturing bill was introduced to both houses of Congress yesterday to enable the federal government to manufacture or contract with existing manufacturers to make products to fight COVID-19. The bill, introduced by Sen. Elizabeth Warren (D-Mass.) and Rep. Jan Schakowsky (D-Ill.), builds off the COVID-19 Emergency Manufacturing Act, introduced in 2020 to […]

Filed Under: Business/Financial News, Contract Manufacturing, Diagnostics, Featured, Pharmaceutical, Regulatory/Compliance Tagged With: coronavirus, COVID-19, Defense Production Act, Donald Trump, Joe Biden, personal protective equipment, vaccines

Canada signs off on Pfizer-BioNTech COVID-19 vaccine

December 9, 2020 By Brian Buntz

Canada’s health regulator has authorized the COVID-19 vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX).  Pfizer submitted documentation related to the BNT162b2 vaccine to Canadian regulators on Oct. 9, 2020.   “Canadians can feel confident that the review process was rigorous and that we have strong monitoring systems in place,” Health Canada explained in a statement. The agency also stressed […]

Filed Under: Business/Financial News, Featured, Regulatory/Compliance Tagged With: BioNTech, coronavirus, COVID-19, Health Canada, Pfizer, vaccines

Who would — and wouldn’t — line up for COVID-19 vaccines?

November 24, 2020 By Nancy Crotti

Once enough people receive effective vaccines against the novel coronavirus, experts say, the end of the pandemic may be in sight. But a new poll of older adults — one of the highest-priority groups for vaccination — suggests an uphill climb lies ahead to reach that goal. In all, 58% of adults aged 50 to […]

Filed Under: Drug-Device Combinations, Featured, Pharmaceutical, Research & Development Tagged With: AARP, BioNTech, coronavirus, COVID-19, Moderna, Pfizer, U.S. Centers for Disease Control and Prevention, UBS, University of Michigan, vaccines

7 things to know about COVID-19 vaccines

November 10, 2020 By Brian Buntz

Enthusiasm surrounding COVID-19 vaccines is on the upswing after Pfizer announced preliminary data suggesting its vaccine could be 90% effective at preventing COVID-19 infections. The Bay Area Council hosted a webinar yesterday to provide more information about coronavirus vaccines. Here are seven considerations to keep in mind now that the prospect of a widely deployed COVID-19 […]

Filed Under: Biotech, Clinical Trials Tagged With: Clinical Trials, coronavirus, COVID-19, Pfizer, vaccines

5 things you need to know about FDA and COVID-19 vaccines

October 23, 2020 By Brian Buntz

There was no clear bombshell in the first meeting of an FDA advisory committee dedicated to COVID-19 vaccines. There were, however, several conclusions.  Known as the Vaccines and Related Biological Products Advisory Committee (VRBAC), the meeting yesterday provided an overview of the steps medical and government authorities are taking to approve COVID-19 vaccines.  Go to […]

Filed Under: Featured, Food & Drug Administration (FDA), Pharmaceutical, Regulatory/Compliance Tagged With: coronavirus, COVID-19, FDA, vaccines

Sanofi to launch COVID-19 vaccine trial in Q4

October 15, 2020 By Sean Whooley

Sanofi (NYSE:SNY) and Translate Bio (NSDQ:TBIO) announced today that a Phase 1/2 clinical trial for its COVID-19 vaccine candidate is set for the fourth quarter of 2020. Preclinical results for MRT5500, the COVID-19 vaccine candidate under development by the two companies, demonstrated a favorable immune response profile against SARS-CoV-2, the virus causing coronavirus, which supports the selection […]

Filed Under: Clinical Trials, Featured, Pharmaceutical Tagged With: coronavirus, COVID-19, Sanofi, Translate Bio, vaccines

J&J exec denies pressure to rush COVID-19 vaccine

October 8, 2020 By Nancy Crotti

Johnson & Johnson’s (NYSE:JNJ) chief scientific officer said today that the first doses of his company’s COVID-19 vaccine could be available for frontline healthcare workers in January or February, but added the company isn’t rushing it. If granted an emergency use authorization by the FDA, that’s the earliest Dr. Paul Stoffels said the single-dose vaccine developed […]

Filed Under: Clinical Trials, Distribution, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Pharmaceutical, Regulatory/Compliance Tagged With: coronavirus, COVID-19, FDA, Janssen Pharmaceuticals, Johnson & Johnson, vaccines

FDA defies Trump on vaccine approval timeline

October 6, 2020 By Nancy Crotti

The FDA today told COVID-19 vaccine developers that it needs two months’ worth of safety data before it will consider emergency approvals. The agency’s move cast further doubt on a vaccine against SARS-COV-2 being ready by election day, November 3 — a notion mentioned repeatedly by President Trump in attempts to pressure the agency to […]

Filed Under: Clinical Trials, Featured, Food & Drug Administration (FDA), Regulatory/Compliance Tagged With: coronavirus, COVID-19, Donald Trump, FDA, vaccines

U.S. should have enough COVID-19 vaccine by Q3 2021, CDC head tells Senate panel

September 16, 2020 By Nancy Crotti

CDC director Dr. Robert Redfield told a Senate panel today that the federal government should have enough coronavirus vaccine for Americans to resume “regular life” by the third quarter of 2021, according to a report by CNBC. Redfield said vaccinations could begin November or December of 2020 and that it could take 6 to 9 months to […]

Filed Under: Distribution, Drug-Device Combinations, Featured Tagged With: coronavirus, COVID-19, U.S. Centers for Disease Control and Prevention, U.S. Senate, vaccines

Moderna touts preclinical study results for COVID-19 vaccine candidate

July 28, 2020 By Sean Whooley

Moderna (NSDQ:MRNA) announced today that the preclinical study of its COVID-19 vaccine candidate observed immune response and protection against the virus in non-human primates. Cambridge, Mass.-based Moderna’s study, published in The New England Journal of Medicine, showed that a two-dose vaccination schedule of the mRNA-1273 vaccine candidate led to a “robust immune response and protection” against SARS-CoV-2 infection […]

Filed Under: Business/Financial News, Clinical Trials, Featured, Research & Development Tagged With: coronavirus, COVID-19, Moderna, vaccines

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