Interest in mRNA therapy has exploded in recent years following the development of mRNA-based COVID-19 vaccines, but can the platform live up to the initial hype that surrounded it? More companies have announced clinical trial data from mRNA trials for conditions ranging from cardiovascular disease to cancer. mRNA, or messenger RNA, is a type of…

Vir Biotechnology (Nasdaq: VIR) has amended its research collaboration with GSK to reflect its ongoing efforts to develop next-generation COVID-19 therapies. The former company said it would continue developing COVID-19 therapies alone or in cooperation with other partners. Vir and GSK will continue collaborating to ensure ongoing access to the monoclonal antibody sotrovimab, where it…

In 2021, Takeda (TYO:4502) announced that it would manufacture 150 million doses of COVID-19 vaccine from NovaVax (Nasdaq:NVAX). But the company has disclosed that the Japanese government has canceled the remaining order for the Nuvaxovid vaccine. The Japanese government acquired 8.24 million vaccine doses but said it would cancel the remaining order for the remaining…

A Swiss study found that the monovalent Moderna (Nasdaq:MRNA) COVID-19 booster vaccine may be linked to a higher risk of a type of hives known technically as chronic spontaneous urticaria (CSU). In a cohort of the study based in the Swiss canton of Vaud, 90% of people who received the mRNA-based Moderna COVID-19 booster and developed…

New York City–based Pfizer (NYSE:PFE) announced that its full-year 2022 revenues were $100.3 billion, a record for the company. Pfizer has more than doubled its revenue compared to 2020 when it generated $42.9 billion in sales. In 2021, its revenue hit $81.3 billion. But the company will likely have trouble sustaining that momentum, considering its revenues,…

The biopharma CureVac (Nasdaq:CVAC) and its partner GSK (NYSE:GSK) have announced positive extended preliminary data from two Phase 1 mRNA vaccine trials, one involving COVID-19 and another seasonal flu. The company says the positive data support the next stage of clinical testing for modified mRNA COVID-19 and flu vaccines in 2023. CureVac, which struggled to…

The FDA has withdrawn the emergency use authorization (EUA) for AstraZeneca’s Evusheld (tixagevimab with cilgavimab) as a COVID-19 pre-exposure prophylaxis owing to the emergence of new variants. Evusheld has been found to be ineffective against several omicron subvariants, including BQ.1, BQ.1.1, BF.7, BF.11, BA.5.2.6, BA.4.6, BA.2.75.2, XBB, and XBB.1.5.1. The XBB.1.5 subvariant is becoming more…

mRNA vaccine company Moderna (Nasdaq:MRNA) plans on submitting for regulatory approval for its investigational RSV mRNA-1345 vaccine after it met primary efficacy endpoints in the Phase 3 ConquerRSV study (NCT05127434). The RSV data are “a clear positive for MRNA” and represent a good omen for upcoming mRNA Phase 3 influenza data, noted UBS in a…

The mRNA technology company Moderna (Nasdaq:MRNA) said it is planning to charge between $110 to $130 for COVID-19 vaccine doses in the U.S. once private market sales begin. Pfizer (NYSE:PFE) had previously announced that it was targeting the same range for COVID-19 vaccine doses. Moderna CEO Stéphane Bancel said the company is now in discussions with hospitals, pharmacies…

Vaccine developer Novavax (Nasdaq:NVAX) has begun a Phase 2 study of its COVID-19-influenza combination (CIC) shot as well as an influenza-only vaccine candidate. Rivals Moderna (Nasdaq:MRNA) and Pfizer (NYSE:PFE)/BioNTech (Nasdaq:BNTX) have made similar moves. Moderna has a slew of flu vaccine candidates in its pipeline, including MRNA-1010, which is the subject of a Phase 3…

The mRNA vaccine company BioNTech (Nasdaq:BNTX) has begun a Phase 1 study of BNT165b1, a multi-antigen malaria vaccine candidate that belongs to its BNT165 malaria program.  Researchers at Oxford University are farther along with their R21/Matrix-M vaccine. A recently completed Phase 3 trial focused on R21. It could win licensure in 2023.  In a Phase…

Roche (SIX:RO,ROG; OTCQX:RHHBY) announced that it received FDA approval for the intravenous (IV) monoclonal antibody Actemra (tocilizumab) for hospitalized patients with severe COVID-19. The indication covers hospitalized adults receiving systemic corticosteroids who need supplemental oxygen, noninvasive or invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO). Tocilizumab targets the interleukin-6 receptor. It first won FDA approval…

In October, Pfizer (NYSE:PFE) signaled its plans to raise its COVID-19 vaccine price to roughly $110 to $130 per dose. The new price would go effect after the U.S. government’s purchase program for the vaccine expires, said Angela Lukin, Pfizer’s global primary care and U.S. president. Senator Warren and Senator-elect Welch asked Pfizer CEO Albert…

The pandemic has complicated the treatment of cold agglutinin disease (CAD), a rare autoimmune hemolytic anemia accounting for roughly 20% of all autoimmune hemolytic anemia. CAD affects older adults primarily. The anti-CD20 therapies commonly used off-label to treat the disease also increase the risk of serious COVID-19 infections and interfere with the immune response to COVID-19…

Pfizer (NYSE: PFE) and its COVID-19 vaccine partner BioNTech (Nasdaq: BNTX) today announced they’ve submitted a EUA application with the FDA for an omicron COVID-19 booster for children under 5. The companies are seeking authorization for their omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine as the third 3-µg dose in the three-dose primary series for children 6…

Pfizer (NYSE:PFE) and vaccine firm Valneva (Nasdaq:VALN; Euronext Paris:VLA) have released six-month antibody persistence data for children and adults receiving their Lyme disease vaccine candidate.  In the Phase 2 VLA15-221 study, individuals received either three doses of the vaccine (at months 0, 2 and 6) or two doses (at months 0 and 6).  The study…

Antimicrobial resistance (AMR) is a growing global threat that, without intervention, could lead to as many as 10 million deaths annually by 2050.1 Unfortunately, the development of new antibiotics that could combat this risk is a significantly underinvested area, with few new treatments in the pipeline, and other therapy areas currently offering more attractive opportunities for…

Pfizer (NYSE:PFE) and BioNTech (Nasdaq:BNTX) have announced that their omicron BA.4/BA.5-adapted bivalent booster fared well against novel omicron variants in neutralizing antibody detection tests. The company published the results from the bivalent booster tests against the BA.4.6, BA.2.75.2, BQ.1.1 and XBB.1 subvariants on the preprint server BioRxiv. One month after administering a fourth vaccine dose, the…

Pfizer (NYSE:PFE) and BioNTech (Nasdaq:BNTX) have begun a Phase 1 study to investigate the next-generation BNT162b4 COVID-19 vaccine candidate that could potentially result in a stronger and more durable immune response. Known as BNT162b4, the vaccine candidate has a T cell antigen mRNA encoding for SARS-CoV-2 non-spike proteins that are conserved across various variants. The…

The European Commission has approved the VidPrevtyn Beta COVID-19 vaccine as a booster for individuals who are at least 18. The vaccine is the first next-gen protein-based adjuvanted COVID-19 booster to win European approval. Sanofi (Nasdaq:SNY) developed the vaccine based on the beta variant using GSK’s (NYSE:GSK) pandemic adjuvant. After announcing the news, Sanofi shares…

The antiviral nirmatrelvir in Paxlovid reduced the likelihood of people experiencing long-term symptoms after a COVID-19 infection, according to a recent preprint. Individuals who took Paxlovid within five days after infection were 26% less likely to have symptoms of long COVID 90 days after infection.  The drug was associated with a reduced risk of long-COVID symptoms,…

On the heels of winning an EU nod for its RSV vaccine marketing authorization application, GSK (LSE/NYSE:GSK) has announced that FDA has accepted a Biologics License Application for its RSV vaccine candidate for older adults. The agency also granted priority review to the vaccine, which will clip four months off the vaccine candidate’s biologics license application (BLA)…

Although not available in the U.S., AstraZeneca’s (LON:AZN) Vaxzevria COVID-19 vaccine has won full marketing authorization in the European Union. European authorities initially granted conditional marketing authorization to the vaccine for individuals at least 18 years old in early 2021. However, in April, the European Medicines Agency (EMA) noted that the vaccine had a possible link to…

Pfizer (NYSE:PFE) today announced positive topline data from a Phase 3 clinical trial for its bivalent respiratory syncytial virus (RSV) prefusion vaccine candidate. The MATISSE (Maternal Immunization Study for Safety and Efficacy) study investigates Pfizer’s RSVpreF vaccine candidate. It observed the vaccine when administered to pregnant participants to help protect their infants from RSV disease…

GSK (LSE/NYSE:GSK) has won validation of the marketing authorization application from the European Medicines Agency (EMA) for its respiratory syncytial virus (RSV) vaccine candidate. GSK is pursuing authorization to use the vaccine annually in older adults. European regulators will likely announce a final regulatory decision in the third quarter of 2023. The vaccine candidate would…