In recent months, the biotech and biopharma industries have been struggling with layoffs and dropping stocks. However, some companies are still experiencing success. Sanofi, AstraZeneca, Avillion and Diadem recently announced positive clinical results, providing positive news for patients with multiple myeloma, asthma and Alzheimer’s disease.
AstraZeneca’s Alexion received a supplemental New Drug Application approval for Ultomiris (ravulizumab-cwvz) from the U.S. Food and Drug Administration to treat adults with generalized myasthenia gravis (gMG).
The FDA issued new guidance, titled “Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Subgroups in Clinical Trials,” that calls for companies to submit a Race and Ethnicity Diversity Plan to include more underrepresented minority populations in the United States.
A fourth dose of the COVID-19 vaccine from Pfizer and BioNTech provided significant added protection against severe disease, hospitalization and death for at least a month in older individuals, according to a study from Israel conducted when the Omicron variant was dominant. Additionally, new findings suggest patients with COVID-19 may have an increased risk of rare vision-threatening blood clots in the eye for months afterward.
An experimental vaccine developed by GeoVax Labs Inc. succeeded in promoting development of antibodies that target two different sites on the virus in a small pilot study and was advanced to mid-stage clinical trials, researchers reported.
COVID-19 patients who receive one of the few antibody treatments that works against the Omicron variant must be carefully monitored because after the drug is infused, the virus may mutate and become resistant to it, researchers warned after seeing such cases with Delta variant patients.
The latest results from Sanofi and AstraZeneca’s Phase III trial for nirsevimab demonstrate the vaccine’s ability to protect all infants from the respiratory syncytial virus (RSV) with a single dose.
Early in the COVID-19 pandemic, there was a lot of talk about the “new normal,” with most people wanting to get back to the “old normal.” Two-plus years into the pandemic, it’s obvious that COVID-19 is not going away, prompting discussion about what this “new normal” will actually look like.
A therapy mix including Bayer’s Nubeqa drug was shown to significantly prolong the lives of men suffering from metastatic prostate cancer in a clinical study, prompting the company to boost sales estimates for the product.
The immune response to COVID-19 helps protect against reinfection, but that protection is weaker against Omicron than it was against earlier variants of the coronavirus, according to new data. In other news, protection provided by booster shots of the mRNA vaccines from Moderna Inc. or Pfizer Inc. and partner BioNTech SE starts waning quickly, according to data published in Feb. 11th’s Morbidity and Mortality Weekly Report from the U.S. Centers for Disease Control and Prevention (CDC).
Jane Qiu, a freelance science writer based in Beijing, published an overview of her efforts to investigate the lab-leak theory for the origin of COVID-19. In another update, the FDA’s Vaccines and Related Biological Products Advisory Committee is scheduled to meet on February 15 to discuss an amended Emergency Use Authorization for the Pfizer-BioNTech COVID-19 vaccine for children 6 months through 4 years of age.