In the quest to outsmart viral foes such as SARS-CoV-2, RSV and influenza, Codagenix, a clinical-stage biotech firm based in Farmingdale, New York, has engaged a unique arsenal: the intersection of synthetic biology and machine learning. Their weapon of choice is a blend of live-attenuated virus design and codon deoptimization technology. Their process involves introducing…

GSK (NYSE:GSK) has secured FDA approval for its respiratory syncytial virus (RSV) vaccine Arexvy, marking a significant milestone in the RSV vaccine landscape. RSV is common and usually results in mild infections, but can be dangerous in the immunocompromised as well as in younger and older populations. The GSK vaccine targets adults aged 60 and…

As the world continues to grapple with global health challenges, the role of science and biotech law has taken center stage in shaping public health policy and innovation. The FDORA and PREVENT Pandemics Acts are poised to help shape the landscape. In a recent interview, life sciences attorney Barbara Binzak Blumenfeld offers insights into significant…

The COVID-19 pandemic has had a profound impact on the best-selling pharmaceuticals, leading to shifts in the list with Pfizer and BioNTech’s Comirnaty surpassing AbbVie’s Humira for the No. 1 spot in 2021. That momentum continued in 2022, with Pfizer and BioNTech jointly raking in $59.1 billion in revenue from the sales of the COVID-19…

The FDA has granted InflaRx (Nasdaq:IFRX) emergency use authorization (EUA) for the monoclonal antibody Gohibic (vilobelimab) to treat critically-ill COVID-19 patients. The company’s shares were up yesterday almost 84% to $3.77. Today, its shares jumped an additional 62% to $6.10. The EUA represents a significant advance for the Jena, Germany–based company, which on March 31,…

Respiratory syncytial virus (RSV) remains a prominent global health concern. Each year, the virus is to blame for 2.1 million outpatient visits for children under 5 years old, according to CDC. Other vulnerable populations, including older adults and immunocompromised individuals, are also at risk. Nevertheless, RSV has long been a research focus. Scientists first identified RSV in 1956.…

Engineers at MIT designed a new way to trigger cells that could lead to targeted therapies for cancer and other diseases. Using an RNA sensor for the trigger, the researchers ensure that synthetic genes activate only in specific cells. They demonstrated that the sensor could accurately identify cells expressing a mutated version of the p53…

COVID-19 vaccine developers Pfizer (NYSE:PFE) and its partner BioNTech (Nasdaq:BNTX) have won emergency use authorization (EUA) for a single booster dose of their omicron BA.4/BA.5-adapted bivalent COVID-19 booster for kids between 6 months and 4 years of age. The booster can be administered at least two months after completing the primary vaccination series with three…

Emory University has partnered with Pfizer (NYSE:PFE) to create new drugs and therapies aimed at stopping serious disease from COVID-19. The Emory and Pfizer collaboration will take place in Emory University’s Schinazi Laboratory, led by scientist Raymond Schinazi, with the goal of producing novel antiviral compounds to combat COVID, according to The Atlanta Journal-Constitution. Although…

The current mRNA vaccines from Moderna (Nasdaq:MRNA) and Pfizer (NYSE:PFE)/BioNTech (Nasdaq:BNTX) stimulate the production of neutralizing antibodies that bind to the spike protein of SARS-CoV-2. But there is a novel mRNA vaccine that activates T cells to attack cells infected with the virus. Developed by researchers at MIT and other institutions, the new vaccine could…

The investigational antiviral ensitrelvir promises to accelerate recovery from mild to moderate COVID-19. Investigators concluded that patients who received the investigational drug recovered from COVID-19 symptoms about 24 hours earlier than those in the control group. Additionally, participants in the ensiltrelvir group tested negative for SARS-CoV-2 about 29 hours earlier. The drug, developed by Shionogi…

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…