The Biden-Harris administration has announced that the NIH has licensed COVID-19 research technologies and vaccine candidates to the Medicines Patent Pool (MPP). Working with the WHO’s COVID-19 Technology Access Pool (C-TAP), the NIH will provide licenses to enable manufacturers to use the technologies to develop COVID-19 vaccines, treatments and diagnostics. In total, NIH is providing…
FDA approves Olumiant for treating some hospitalized COVID-19 patients
The JAK inhibitor Olumiant (baricitinib) from Incyte (Nasdaq:INCY) and Lilly (NYSE:LLY) has scored FDA approval to treat hospitalized COVID-19 patients who need help breathing. In particular, the new indication covers adult patients needing supplemental oxygen, non-invasive or invasive mechanical ventilation or extracorporeal membrane oxygenation. Olumiant first won FDA approval in 2018 for treating moderately-to-severely active…
How Karius aims to transform the diagnosis of infections with a non-invasive liquid biopsy
The startup Karius aims to help establish a world where infectious disease is no longer a major threat to human health. “It’s an audacious vision,” said Dr. Brad Perkins, chief medical officer at Karius. “But I think it’s commensurate with the platform we’ve developed and continue to evolve.” The Redwood City, California-based company has developed…
FDA and Pfizer differ in interpreting Paxlovid treatment recommendations
Pfizer CEO Dr. Albert Bourla recently said that patients who relapse after completing a course of the COVID-19 antiviral Paxlovid (nirmatrelvir and ritonavir) could continue taking the drug. “Paxlovid does what it has to do: it reduces the viral load,” Bourla told Bloomberg. “Then your body is supposed to do the job.” “While the…
Pfizer ticks up on Street-beating Q1, lessens full-year guidance
Pfizer (NYSE:PFE) shares rose today on first-quarter financial results that came in ahead of the consensus forecast. The New York-based pharmaceutical company posted profits of $7.9 billion, or $1.37 per share, on sales of $25.7 billion for the three months ended April 3, 2022, for a 61.2% bottom-line gain on sales growth of 76.8%. Adjusted…
SK Bioscience and GSK seek regulatory nod for COVID-19 vaccine in South Korea
SK Bioscience (KRX:302440) and GSK (NYSE:GSK) have filed a biologics license application with the Korean Ministry of Food and Drug Safety for their SKYCovione, a recombinant protein-based COVID-19 vaccine candidate. The self-assembled nanoparticle vaccine candidate is adjuvanted with GSK’s pandemic adjuvant. SKYCovione fared well in a Phase 3 study involving more than 4,000 adults in…
First Wave BioPharma stock tanks after announcing COVID-19 therapy trial data
The clinical-stage company First Wave BioPharma (Nasdaq:FWBI) saw its share price fall by more than 40% to $0.37 in after-hours trading today after releasing new clinical trial data. To save money, the company will initiate austerity measures, cutting headcount by about 20% and closing clinical operations site in Hayward, California and a facility in Langlade, France.…
Moderna seeks authorization for COVID-19 vaccine in children as young as 6 months old
While a portion of the public is now eligible to receive a second booster dose of COVID-19 vaccine, the FDA has not yet authorized a vaccine for children aged 6 months to 5 years old. Moderna (Nasdaq:MRNA) is vying to be the first. The company announced today that it is filing a request for emergency…
Gilead notches remdesivir indication to treat young children
FDA has announced that it has signed off on the use of COVID-19 therapy Veklury (remdesivir) from Gilead Sciences (Nasdaq:GILD) to include children at least 28 days old who weigh at least 3 kg (roughly 7 lb) and test positive results for COVID-19. The indication is limited to children who are either hospitalized or have…
CureVac and GSK announce positive preclinical data for next-gen bivalent mRNA vaccine candidate
Tübingen, Germany–based CureVac N.V. (Nasdaq:CVAC) and its partner GSK (NYSE:GSK) have announced positive preclinical data about their second-generation COVID-19 vaccine candidate that combines mRNAs for the beta and delta variants. The companies conducted the preclinical research in conjunction with the Friedrich-Loeffler-Institut, Germany. The research pitted the bivalent candidate against monovalent COVID-19 vaccine candidates. The bivalent…
AstraZeneca’s Evusheld offered strong protection against COVID-19 in Phase 3 study
In the Phase 3 Provent trial, Evusheld (AZD442) cut the risk of developing symptomatic COVID-19 by 77% in the primary analysis focused on patients at high risk for severe COVID-19. The monoclonal antibody cocktail, including tixagevimab and cilgavimab cut the risk by 83% in the six-month follow-up analysis compared to placebo. The drug is currently authorized…
Takeda wins approval to distribute Novavax’s COVID-19 vaccine in Japan
Takeda (NYSE:TAK) has announced that it has won manufacturing and marketing approval from the Japan Ministry of Health, Labour and Welfare (MHLW) for Nuvaxovid, a novel COVID-19 vaccine. Nuvaxovid (NVX-CoV2373) was initially developed by Novavax (Nasdaq:NVAX). The approval covers the use of the vaccine as both a primary and booster immunization in adults at least…
Moderna says bivalent COVID-19 boosters could offer more robust protection against variants
Moderna (Nasdaq:MRNA) announced that its first bivalent booster vaccine candidate, mRNA-1273.211, offered superior protection against SARS-CoV-2 variants of concern compared with its first-gen mRNA-1273 vaccine. A 50-µg booster of the mRNA-1273.211 vaccine offered protection against the beta, delta and omicron variants for six months and appeared to provide similar tolerability to the FDA-approved mRNA-1273 vaccine.…
UK regulators approve Valneva’s COVID-19 vaccine
A COVID-19 vaccine from the French vaccine company Valneva SE (Nasdaq:VALN; Euronext Paris:VLA) has become the sixth to win regulatory approval in the United Kingdom. Valneva also anticipated that it would receive the regulatory nod from the European Medicines Agency (EMA) for its COVID-19 vaccine in April. Officials at the Medicines and Healthcare products Regulatory Agency (MHRA)…
Pfizer-BioNTech COVID-19 vaccine booster spurs strong immune response in kids 5–11
Pfizer (NYSE:PFE) and BioNTech SE (Nasdaq:BNTX) have shared positive data from a Phase 2/3 clinical study testing a third 10-µg dose of the Pfizer-BioNTech COVID-19 vaccine in healthy children aged 5 through 11. The most recent data show that a booster dose of the BNT162b2 vaccine led to increased neutralizing titers for the omicron variant…
Q-VANT Biosciences signs master agreement with the Kansas State University College of Veterinary Medicine
Quillaja saponin-based adjuvant specialist Q-VANT Biosciences announced that Kansas University College of Veterinary Medicine will test its adjuvants in several of its veterinary vaccines. The project’s first focus will test Q-VANT’s sustainable saponin-based adjuvants against other adjuvants using K-State’s subunit classic swine fever (CSF) vaccine. The Kansas University researchers will also validate the safety and…
Veru’s COVID-19 drug candidate cuts deaths by 55% in hospitalized patients in study
The oncology biopharma Veru Inc. (Nasdaq:VERU) revealed positive efficacy and safety data from an interim analysis of a Phase 3 trial testing oral sabizabulin 9 mg against placebo. The trial enrolled 210 hospitalized COVID-19 patients with an elevated risk of acute respiratory distress syndrome (ARDS). The interim analysis focused on data collected from 150 of…
Pfizer to Acquire ReViral and Its Respiratory Syncytial Virus Therapeutic Candidates
Pfizer (NYSE:PFE) announced today that it entered into an agreement to acquire biopharmaceutical company ReViral. ReViral discovers, develops and commercializes novel antiviral therapeutics designed to target respiratory syncytial virus (RSV). “At Pfizer, we have a strong heritage in, and commitment to, fighting infectious diseases, most recently evidenced by our delivery of the first authorized vaccine…
FDA further limits use of GSK’s and Vir’s SARS-CoV-2 antibody sotrovimab
As the omicron BA.2 subvariant has spread, FDA has announced that it will further constrain the use of the investigational monoclonal antibody sotrovimab. The agency announced that it would limit the use of the antibody in some U.S. regions last week. GlaxoSmithKline plc (LSE/NYSE:GSK) and Vir Biotechnology (Nasdaq:VIR) were initially confident that the antibody could…
BioNTech 2021 revenue surges 39x year over year
The mRNA vaccine pioneer (Nasdaq:BNTX) announced fourth-quarter revenue of €5.5 billion and €19.0 billion in revenue for 2021. Sales of the BNT162b2 COVID-19 vaccine, developed jointly with Pfizer, fueled the revenue growth. Net revenues of the vaccine between Pfizer and BioNTech surpassed $59 billion. In 2020, BioNTech’s revenues were €482.3 million. “Looking back, 2021 was…
CureVac launches Phase 1 study for next-gen mRNA COVID-19 vaccine
CureVac N.V. (Nasdaq:CVAC) and its partner GSK (NYSE:GSK) have launched a Phase 1 dose-escalation study to test the performance of CV2CoV, a COVID-19 vaccine candidate based on CureVac’s second-generation mRNA backbone. In late morning trading, CureVac’s stock ticked up 0.10% to $19.22. CVAC shares were trading above $100 before announcing in mid-June 2021 that the…
FDA amends EUA for SARS-CoV-2 antibody sotrovimab
GlaxoSmithKline plc (LSE/NYSE:GSK) and Vir Biotechnology (Nasdaq:VIR) have announced that FDA has concluded that the investigational monoclonal antibody sotrovimab is unlikely to be effective against the omicron BA.2 subvariant, which will soon dominate the U.S. FDA has amended the Emergency Use Authorization (EUA) Fact Sheet for sotrovimab and its website to exclude the antibody in…
Icosavax stock tanks after announcing disappointing interim SARS-CoV-2 Phase 1/2 results
Icosavax (Nasdaq:ICVX) saw its stock skid 65.5% to $4.26 in mid-day trading after announcing interim results from an ongoing Phase 1/2 trial of IVX-411, a virus-like particle vaccine candidate against SARS-CoV-2. After going public last July, the company’s stock hit a peak of $39.73 on September 3. Initial data from IVX-411 was comparable or below…
Moderna shares R&D updates at third annual vaccines day
Moderna (Nasdaq:MRNA) recently announced that an investigational version of its COVID-19 vaccine for potential use in children 6 months to 6 years met its primary endpoint in a Phase 2/3 study. Two doses of the vaccine were 43.7% effective at preventing infection during the omicron wave in children aged 6 months to 2 years old.…
Moderna seeks FDA blessing for second COVID-19 vaccine booster
Pfizer (NYSE:PFE) and BioNTech (Nasdaq:BNTX) recently asked FDA to allow individuals 65 and older to receive a second booster of their BNT162b2 COVID-19 vaccine. Now, Moderna (Nasdaq:MRNA) is filing for FDA authorization to permit a fourth dose of its Spikevax (mRNA-1273) COVID-19 vaccine for adults 18 and older. In its submission, Moderna included data gathered…