During the COVID-19 pandemic, many patients experienced a loss of taste and smell during and after being infected with SARS-CoV-2. A retrospective study by researchers at Massachusetts Eye and Ear, a member of the Mass General Brigham healthcare system, investigated the loss of olfactory and gustatory senses and estimated that about a quarter of Americans who had COVID-19 reported only partial or no recovery of taste or smell. The results are published in The Laryngoscope. “We wanted to quantify the national impact of smell disorders resulting from COVID,” said Neil Bhattacharyya, MD, FACS, Professor of Otolaryngology at Mass Eye and Ear. “With this data we can understand, in big numbers, how many people lost their sense of smell or taste due to COVID infection and how many people never fully recovered those senses.” The retrospective study utilizes data from the 2021 National Health Interview Survey (NHIS), a branch of the ...
Two years after the initial COVID-19 vaccine push swept across the globe, Pfizer’s COVID-19 vaccine partner BioNTech is heading to court in its home country of Germany to defend itself against allegations that its shot caused injuries. This lawsuit comes from a German healthcare worker who seeks at least 150,000 euros ($161,500) in damages for alleged bodily harm, plus compensation for unspecified material damage, Reuters reports. The woman claims she suffered from upper-body pain, swollen extremities, fatigue and a sleeping disorder as a result of taking the Comirnaty vaccine. The plaintiff’s attorneys at the firm Rogert & Ulbrich will challenge the vaccine’s positive risk-benefit profile as assessed by European Union regulators and vaccine assessment agencies, according to the news service. Under German drug laws, drugmakers are only liable for side-effect damages if “medical science” can prove their meds have an incorrect label or cause disproportionate harm relative to their benefits, ...
Another biosimilar product copying Johnson & Johnson’s top-selling drug Stelara may enter the U.S. market without a patent infringement challenge by early 2025 thanks to a new settlement.J&J has signed an agreement granting Alvotech and Teva a license for their proposed Stelara biosimilar, AVT04, in the U.S. The settlement allows the biosimilar makers to launch their version no later than Feb. 21, 2025, the companies said Monday. The new Stelara biosim deal follows another one J&J recently inked with Amgen, which gives the latter a license to launch its copycat no later than Jan. 1, 2025. Like Amgen, Alvotech and Teva haven’t gotten the FDA’s blessing for AVT04. The pair in January said the FDA had accepted its application with a decision targeted for the second half of this year. A verdict for Amgen’s version is expected by the end of the third quarter. Settling those biosimilar entry dates is ...
Novartis has entered into an agreement to acquire Chinook Therapeutics for approximately $3.5bn, marking a notable expansion to the Swiss drugmaker’s renal pipeline. The deal grants Novartis access to the US biopharma’s two late-stage candidates in development for Immunoglobulin A Nephropathy (IgAN), a rare and progressive kidney disease that mostly affects young adults. IgAN, which Novartis says currently lacks targeted treatment options, affects up to 21 people per million per year in the US, with a higher rate among Asian populations. The most advanced of the two assets is atrasentan, an oral endothelin A receptor antagonist that Chinook bought from AbbVie at the beginning of 2020. The candidate is currently in phase 3 development for IgAN, with a readout from the study expected in the fourth quarter of this year. The second candidate, zigakibart (BION-1301), is a subcutaneously administered anti-APRIL monoclonal antibody that is expected to enter phase 3 development ...
U.S. Food and Drug Administration staff on Monday said updated Covid boosters should target XBB omicron subvariants for the upcoming fall and winter vaccination campaign. The U.S. should use a monovalent vaccine targeting either XBB.1.5, XBB.1.16, or XBB.2.3, collectively the dominant strains nationwide, the staff said in a briefing document. The FDA staff made the conclusion ahead of a meeting on Thursday, when a panel of external advisors to the agency will recommend a strain for new Covid shots to target later this year. There is no set date for when the vaccination campaign will begin. Vaccine manufacturers will be expected to update their shots once that strain is selected. Pfizer, Moderna and Novavax are already developing versions of their respective vaccines targeting XBB.1.5 and other circulating variants. The upcoming strain selection will be crucial to those companies’ abilities to compete in the fall, when the U.S. is expected to ...
A team of researchers at NYU Abu Dhabi, led by Associate Professor of Biology Youssef Idaghdour and working in collaboration with clinicians at several Abu Dhabi hospitals, investigated the association between microRNAs, a class of small RNA molecules that regulate genes, and COVID-19 severity among 259 unvaccinated COVID-19 patients living in Abu Dhabi. The team identified microRNAs that are associated with a weakened immune response and admission to ICU. During this process, they created the first genomic picture of the architecture of blood microRNAs in unvaccinated COVID-19 patients from the Middle East, North Africa, and South Asia regions whose populations are consistently underrepresented in genomics research. The researchers identified changes in microRNAs at the early stages of infection that are associated with specific blood traits and immune cell death, allowing the virus to evade the immune system and proliferate. The results of the system’s genetics study demonstrate that a patient’s ...
Consuming turmeric – the oriental spice often used in cooking – accelerates post-match recovery in professional footballers, a study has shown. Researchers at Nottingham Trent University found that drinking a 60 ml turmeric drink twice-a-day allowed players to return to their pre-game fitness faster than those who did not. Playing football causes muscle damage in players and an inflammatory response – and their rapid recovery is crucial to optimising their next performance and reducing injury risk. The active ingredient in turmeric is curcumin – known to have anti-inflammatory properties – and previous studies have found that curcumin supplementation can reduce soreness following muscle-damaging exercise. This process appears to be aided by a reduction in pro-inflammatory proteins in the blood, known as cytokines, which increase in response to a stress, such as intense exercise. The Nottingham researchers are the first to demonstrate that a curcumin-containing supplement can reduce pro-inflammatory cytokine concentrations ...
Long COVID and myalgic encephalomyelitis/chronic fatigue syndrome are debilitating conditions with similar symptoms. Neither condition has diagnostic tests or treatments approved by the Food and Drug Administration (FDA) and each cost the United States billions of dollars each year in direct medical expenses and lost productivity. Doctors and researchers have wondered what are the underlying biological abnormalities that may cause symptoms, and whether these abnormalities are similar in the two illnesses. A review article authored by senior investigators at Brigham and Women’s Hospital and Harvard Medical School, and the Mailman School of Public Health and Vagelos College of Physicians and Surgeons of Columbia University, addresses these questions. In it, the authors review 559 scientific publications. The authors compared the symptoms of both conditions, noting their great similarity, and then showed that very similar underlying biological abnormalities have been found in both conditions, abnormalities involving the brain, immune system, heart, lungs, ...
With two cell therapies approved and three more in its pipeline, Bristol Myers Squibb is working to beef up its manufacturing capabilities for the complex, personalized, one-and-done medicines.On Thursday, BMS took a positive step in that direction as the FDA gave the go-ahead for the company to begin commercial cell therapy manufacturing at its sprawling facility in Devens, Mass. The cell therapy portion of the Devens site includes 244,000 square feet and has been under construction since 2021. It becomes BMS’ third commercial CAR-T manufacturing facility in the U.S. and adds more than 500 new cell therapy jobs. It is the second significant expansion of the Devens complex, which sits on 89 acres of land and covers 700,000 square feet and has been operational for more than a decade. BMS’ cell therapies, Abecma and Breyanzi—both for blood cancers—were approved a month apart in early 2021. Abecma pulled in sales of ...
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