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Pardes Biosciences Looks For Alternatives After Failed COVID-19 Study
Monday, April 3, 2023 - 12:39pm | 271Pardes Biosciences Inc (NASDAQ: PRDS) reported topline results from its Phase 2 clinical trial evaluating pomotrelvir (previously PBI-0451) for mild-to-moderate COVID-19 in vaccinated adults without risk factors for developing severe disease. Pomotrelvir did not meet the...
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Why YS Biopharma Stock Is Plunging Today
Monday, March 27, 2023 - 1:06pm | 269YS Biopharma (NASDAQ: YS) stock is falling Monday after the company announced PIKA recombinant COVID-19 vaccine. YS Biopharma announced interim Phase 2 safety and immunogenicity data for its PIKA recombinant COVID-19 Vaccine. The interim data were from the Phase 2 part of the...
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Additional COVID-19 Booster Shots? Officials Anticipate FDA Authorization Within Few Weeks
Tuesday, March 21, 2023 - 2:43pm | 380The U.S. Food and Drug Administration is reportedly moving toward authorizing a second round of omicron-targeted COVID-19 booster shots for the elderly and other people at high risk. FDA officials could decide within a few weeks and could change their mind, Wall Street Journal reported ...
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Where Did COVID-19 Really Originate? Biden Signs Bill To Declassify Origins Information
Tuesday, March 21, 2023 - 9:17am | 367President Joe Biden signed legislation requiring the Office of the Director of National Intelligence to declassify information on any possible links between a lab in China and the origins of the Covid-19 pandemic. The House and the Senate unanimously passed the legislation earlier this...
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FDA Approves Pfizer/BioNTech's Bivalent COVID-19 Vaccine For Youngest Kids
Wednesday, March 15, 2023 - 8:21am | 392The FDA has expanded the emergency use authorization (EUA) of Pfizer Inc (NYSE: PFE) / BioNTech SE's (NASDAQ: BNTX) bivalent COVID-19 vaccine as a single booster dose in children under five years of age. The amended authorization is for children six months through...
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FDA Addresses 'Misinformation' Concerning Delayed Approval Of Lucira Health's COVID-19 & Flu Home Test
Friday, March 10, 2023 - 12:51pm | 454The FDA provided additional information about the agency's interactions and decisions regarding the emergency use authorization (EUA) of Lucira Health Inc's (OTC: LHDXQ) COVID-19 & Flu Home test. The statement comes due to concerns about the agency's length...
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FDA's Regulatory Delay is The Reason For Novavax, Lucira Health's Failure: WSJ Report
Tuesday, March 7, 2023 - 2:29pm | 609Failures of Covid vaccine maker Novavax Inc (NASDAQ: NVAX) and diagnostic start-up Lucira Health Inc (NASDAQ: LHDX) show that companies often succeed or fail, owing to the whims of the government. Last week, while reporting Q4 earnings, Novavax raised doubts about its...
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How Much Did US Government Spend On mRNA Vaccine Technology Before And During The Pandemic? The Number Can Be Surprising
Friday, March 3, 2023 - 12:22pm | 378The U.S. government invested at least $31.9 billion to develop, produce, and purchase mRNA COVID-19 vaccines, including sizeable investments in the three decades before the pandemic through March 2022, according to a new BMJ study. That includes at least $337 million was invested pre-...
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Why Veru Stock Is Crashing Today?
Friday, March 3, 2023 - 10:27am | 398The FDA declined to grant Veru Inc's (NASDAQ: VERU) request for Emergency Use Authorization (EUA) for sabizabulin to treat hospitalized adult patients with moderate to severe COVID-19 who are at high risk for Acute Respiratory Distress Syndrome (ARDS). Separately, the FDA also...
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European Commission Keeps Mum On Talks Regarding Pfizer COVID-19 Vaccine Contract: Report
Thursday, March 2, 2023 - 3:03pm | 460European Commission President Ursula von der Leyen remains silent on her dealings with Pfizer Inc (NYSE: PFE) regarding the EU's COVID-19 vaccine contract is hurting public trust. "We need to hear what went on, otherwise it's going to drag on," Reuters quoted ...
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Valneva Shares Updated Data From Now Shelved COVID-19 Vaccine Development Program
Thursday, March 2, 2023 - 12:15pm | 396As previously announced, Valneva SE (NASDAQ: VALN) said it would not invest in further COVID-19 vaccine development, VLA2001, without a new partnership. However, it is completing the remaining clinical studies and submissions. Last week, the Committee for Medicinal Products for...
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Oragenics Looks To Boost Potency Of Its Nasal COVID-19 Vaccine With New Licensing Pact
Wednesday, March 1, 2023 - 12:47pm | 326Oragenics Inc (NYSE: OGEN) entered into an exclusive global license agreement with Inspirevax Inc for its novel intranasal mucosal adjuvant, BDX301, to develop NT-CoV2-1, Oragenics' lead intranasal COVID-19 vaccine candidate. Under the exclusive licensing agreement,...
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Biophytis Seeks Early Access Authorization For Its COVID-19 Treatment In France
Monday, February 27, 2023 - 12:44pm | 319Biophytis SA (NASDAQ: BPTS) has begun the early access application process in France for Sarconeos (BIO101) for the treatment of severe COVID-19. A pre-submission meeting with the French National Authority for Health (HAS) is scheduled for March. The application for early access...
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Pfizer/BioNTech Seek Expanded Approval For Its Updated COVID-19 Shot As Primary Series Vaccination
Friday, February 24, 2023 - 11:03am | 369Pfizer Inc (NYSE: PFE) and BioNTech SE (NASDAQ: BNTX) have submitted an FDA supplemental marketing application for approval of omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine as a primary series and booster dose(s) for 12 years and older. In January, the FDA's...
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European Authority Recommends Against Approval For Merck-Ridgeback Biotherapeutics' COVID-19 Pill
Friday, February 24, 2023 - 10:06am | 289Merck & Co Inc (NYSE: MRK) and Ridgeback Biotherapeutics announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) had recommended the refusal of the marketing authorization for Lagevrio (molnupiravir) for COVID-19...