The Pfizer-BioNTech vaccine booster had been previously limited in the U.S. to individuals at least 12 years old, but now children as young as 5 are eligible, thanks to an expanded emergency use authorization related to the vaccine. The agency agreed to expand the vaccine’s use in children to “provide continued protection against COVID-19,” said…

RQ Biotechnology (London) emerged from stealth mode today, saying that AstraZeneca will pay it up to $157 million plus royalties for its existing mAbs against SARS-CoV-2. “Our vision is to build on our successful debut with neutralizing antibody therapy for SARS-CoV-2 and develop innovative medicines to address current and evolving unmet needs in other viral…

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…

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…

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 (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 (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…

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.…

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…

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.…

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…

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 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…

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 (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 (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.…

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…

Moderna’s mRNA Access program (Nasdaq: MRNA) enables researchers to use its mRNA technology platform for research projects related to emerging and neglected infectious diseases. “It takes a community of scientists and disease experts to develop novel vaccines to tackle our greatest public health threats,” said Hamilton Bennett, Moderna’s senior director, vaccine access and partnerships. “mRNA Access was…

French vaccine company Valneva SE (Nasdaq:VALN; Euronext Paris:VLA) has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has sent the company a “small set” of questions related to its VLA2001 COVID-19 vaccine candidate. The firm announced on February 25 that CHMP had sent the company a…

The Pfizer-BioNTech COVID-19 vaccine lowered the incidence of omicron-based SARS-CoV-2 infection by 31% in children aged 5 to 15 in a recent study. The vaccine was more effective in children between the ages of 12 and 15, lowering the risk of omicron infection by 59%, according to the study from CDC and Abt Associates. Participants…

Researchers from the NIH’s National Institute of Allergy and Infectious Diseases (NIAID) are conducting a clinical trial on allergic reactions to mRNA-based COVID-19 vaccines. The single-site trial will enroll up to 100 people between 16 and 69 years old who had an allergic reaction to a first dose of COVID-19 mRNA vaccines. NIAID seeks participants…

The pharma industry has ramped up its ability to innovate in the past couple of years. Many firms in the sector have retooled operations, rethought clinical trials and accelerated the ability to commercialize new drugs. Clarivate’s Top 100 Global Innovators 2022 report, however, cited only two pharma companies. Clarivate also projects that the level of innovation…

GlaxoSmith Kline (NYSE:GSK) and Sanofi (NYSE:SNY) recently announced their intent to seek regulatory authorization for an adjuvanted recombinant protein-based COVID-19 vaccine. Now, GSK and its partner Medicago have received approval from Health Canada for another COVID-19 vaccine, which combines the former’s adjuvant technology with the latter’s plant-derived vaccine.  Known as Covifenz, the vaccine makes use of plant-based virus-like…

Moderna (NSDQ:MRNA) shares are on the rise on fourth-quarter results that came in ahead of the consensus forecast. MRNA shares were up 11.7% at $161.51 per share in midday trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — was up 1.1%. The Cambridge, Massachusetts-based company posted…

In the U.S., Moderna (NASDAQ:MRNA) and Pfizer (NYSE:PFE) continue to dominate the COVID-19 landscape while demand for Johnson & Johnson’s (NYSE:JNJ) vaccine remains limited. Now, Sanofi (NASDAQ:SNY) and GSK (NYSE:GSK) are preparing to get into the game by preparing their regulatory submissions for their COVID-19 vaccine. The companies are currently communicating with the FDA and…