Search Results for “FDA” – Page 156 – media

Novavax surges after biotech company unveils job cuts, positive vaccine data

Novavax’s stock jumped around 30% on Tuesday after the biotech company unveiled promising new vaccine data and a broad cost-cutting push that includes major layoffs. The announcements are a sign of hope for investors after last quarter, when the company raised doubts about its ability to stay in business and decided not to provide full-year guidance. Novavax’s stock closed Tuesday at $9.52. The company’s share price is down more than 7% so far this year, giving it a market value of nearly $821 million. Novavax is now betting on its cost controls and new vaccines to help it stay afloat, forecasting 2023 sales of $1.4 billion to $1.6 billion, according to its first-quarter earnings report. The Gaithersburg, Maryland-based company said its combination vaccine targeting Covid and the flu produced a strong immune response against the viruses and was well tolerated in a phase two trial. Novavax shared similar trial results ...
- Source: drugdu
- 137
- May 11, 2023
Novel Rutgers COVID vaccine may provide long-lasting protection

Animal studies indicate that a new COVID-19 vaccine developed at Rutgers may provide more durable protection against SARS-CoV-2 and its emerging variants than existing vaccines. “We need a better vaccine, one that provides years of robust protection with fewer booster shots against a variety of SARS-CoV-2 strains. Our data suggest this vaccine candidate might be able to do that,” said Stephen Anderson, associate professor of Molecular Biology and Biochemistry in SAS, resident member of the Rutgers Center for Advanced Biotechnology and Medicine and senior author of the paper in Vaccines. Existing COVID vaccines often provide some protection against serious disease and death. However, these vaccines typically elicit temporary bursts of protective antibodies that rapidly wane, even after booster doses, leaving most individuals vulnerable to potentially dangerous repeat infections. This new vaccine, dubbed MT-001, might provide longer-lasting protection against many COVID-19 varieties. “Thankfully, the current vaccines saved many lives, but they’re ...
- Source: drugdu
- 137
- May 10, 2023
AI helps create better, simpler hepatitis and COVID-19 tests

Going beyond pregnancy and COVID-19, the world could someday soon come to rely on at-home tests for many diseases thanks in part to AI-fueled improvements. University of Florida scientists have used artificial intelligence tools to simplify a test that works for both hepatitis C and SARS-CoV-2, the virus that causes COVID-19. The simplified test happens in one small test tube in just a few minutes. With further refinement, it could come to doctor’s offices soon and, one day, even home tests that are as easy as a pregnancy test. “We are trying to build a home-based test that is as reliable as a lab-based test,” said Piyush Jain, a UF professor of chemical engineering who led the latest research. “We are trying to make the test simple, eliminate the need for expensive equipment and provide results in just 10 to 20 minutes.” To accomplish those goals, Jain’s group is innovating ...
- Source: drugdu
- 112
- May 10, 2023
Treatment for uterine fibroids without surgery

A newer, more effective treatment for uterine fibroids is available that doesn’t require surgery. That’s good news for the estimated 26 million women in the U.S. who have fibroids—including the millions of Black women who are disproportionately affected by these benign tumors. Black women in the U.S. are up to three times more likely to develop fibroids than white women. Dr. Elizabeth Stewart, a Mayo Clinic gynecologist and researcher, recently published a review on these approved fibroid medications. They are called oral gonadotropin-releasing hormone (GnRH) antagonist combinations. “There are two new FDA-approved drugs for the medical treatment of uterine fibroids,” says Dr. Stewart. Dr. Stewart says the drugs are effective in treating heavy menstrual bleeding, relieving pain and reducing the need for a hysterectomy. “Because many women are pushed in the direction of surgical therapy, and we know there are big limitations to surgical therapies, this is a great treatment option for many ...
- Source: drugdu
- 121
- May 9, 2023
Eli Lilly’s Alzheimer’s drug shown to significantly slow disease progression in phase 3 trial

Eli Lilly’s experimental Alzheimer’s drug, donanemab, has been shown to significantly slow cognitive and functional decline in patients with early-stage disease. The phase 3 TRAILBLAZER-ALZ 2 study met its primary endpoint, with the drug slowing the progression of the disease by 35% compared to placebo in 1,182 patients with early symptomatic Alzheimer’s disease and intermediate levels of tau protein. All secondary endpoints of cognitive and functional decline were also met and showed highly statistically significant clinical benefits, the company said. Results from the trial demonstrated that 47% of patients who received donanemab showed no disease progression a year after starting treatment, compared with 29% on placebo. Additionally, 52% of patients completed their course of treatment by one year, and 72% completed by 18 months as a result of achieving amyloid plaque clearance. Patients receiving donanemab also experienced a 39% lower risk of progressing to the next stage of disease, and ...
- Source: drugdu
- 140
- May 7, 2023
US drug regulator approves world’s first RSV vaccine

By Max Matza BBC News The US Food and Drug Administration has approved a vaccine against respiratory syncytial virus (RSV) – an illness that kills thousands of Americans each year. The vaccine still needs approval from the US Centers for Disease Control and Prevention before it can be rolled out to the public. Officials say the vaccine, named Arexvy by the manufacturer GSK, is a major breakthrough that will save many lives. It could be available to people over 60 within months, officials say. “Today’s approval of the first RSV vaccine is an important public health achievement to prevent a disease which can be life-threatening,” said Dr Peter Marks, who leads the Center for Biologics Evaluation and Research at the Food and Drug Administration (FDA). RSV is a respiratory illness that typically results in cold-like symptoms for adults, but can be dangerous for young children, the elderly, and those with ...
- Source: drugdu
- 128
- May 7, 2023
Pfizer Acquires COVID-Flu Test Developer Lucira Health for USD 36.4 Million

By LabMedica International staff writers Pfizer Inc. (New York, NY, USA) has acquired Lucira Health, Inc. (Emeryville, CA, USA) for USD 36.4 million in a bankruptcy auction. Lucira filed for bankruptcy in February 2023, just two days before receiving FDA Emergency Use Authorization (EUA) for the first over-the-counter (OTC) at-home diagnostic test capable of differentiating and detecting influenza A and B. The COVID-19 & Flu Home Test is a single-use at-home test kit that delivers results from self-collected nasal swab samples in about 30 minutes. Lucira had previously received the first FDA EUA for an at-home rapid self-test, the Lucira COVID-19 All-in-One Test Kit, in November 2020, and the company announced in April 2021 that it had secured OTC EUA for its Lucira Check It test kit for SARS-CoV-2. The company’s tests use a handheld battery-powered real-time testing instrument with nasal swab samples and loop-mediated isothermal amplification to provide ...
- Source: drugdu
- 122
- May 5, 2023
Johnson & Johnson’s PARP combo nabs first global nod but faces tough fight against AZ, Merck’s Lynparza

Johnson & Johnson’s idea to carve out the prostate cancer indication from GSK’s PARP inhibitor Zejula has yielded its first global approval. Following a recommendation from the European Medicines Agency, the European Commission has officially approved J&J’s Akeega in metastatic castration-resistant prostate cancer (mCRPC), J&J said Friday. The drug is a fixed-dose combo of Zejula and J&J’s androgen-directed Zytiga, and it’s used alongside a corticosteroid. Under a 2016 deal with Zejula’s developer Tesaro, J&J specifically carved out rights to the drug in prostate cancer. GSK then bought out Tesaro in 2019. Not all patients can get Akeega under the drug’s European label. To be eligible, a patient’s tumor must test positive for BRCA1/2 mutations, which account for 10% to 15% of all cases, J&J said. Akeega’s label in Europe is narrower than that of rival PARP inhibitor Lynparza from AstraZeneca and Merck. The European Commission in December cleared Lynparza and Zytiga for mCRPC ...
- Source: drugdu
- 127
- May 3, 2023
Moderna says it expects up to $15 billion in sales of Covid, RSV, flu vaccines in 2027

Moderna on Tuesday said it expects to see between $8 billion and $15 billion in sales from its Covid, RSV, flu and other respiratory vaccines in 2027. The biotech company said it sees a corresponding operating profit in the range of $4 billion to $9 billion. Those respiratory product estimates are supported by additional research investments of $6 billion to $8 billion “over the next few years,” Moderna added. The announcement came ahead of Moderna’s Vaccine Day on Tuesday. At the annual event, the company presented updates on its vaccine portfolio to investors and analysts eager to see how the company will navigate its post-pandemic boom. Moderna said earlier this year it expects $5 billion in mRNA Covid vaccine sales in 2023, a steep drop from the $18 billion the shot raked in last year. The Cambridge, Massachusetts-based company’s Covid vaccine remains its only commercially available product. ...
- Source: drugdu
- 123
- May 2, 2023
Moderna says it expects up to $15 billion in sales of Covid, RSV, flu vaccines in 2027

Moderna on Tuesday said it expects to see between $8 billion and $15 billion in sales from its Covid, RSV, flu and other respiratory vaccines in 2027. The biotech company said it sees a corresponding operating profit in the range of $4 billion to $9 billion. Those respiratory product estimates are supported by additional research investments of $6 billion to $8 billion “over the next few years,” Moderna added. The announcement came ahead of Moderna’s Vaccine Day on Tuesday. At the annual event, the company presented updates on its vaccine portfolio to investors and analysts eager to see how the company will navigate its post-pandemic boom. Moderna said earlier this year it expects $5 billion in mRNA Covid vaccine sales in 2023, a steep drop from the $18 billion the shot raked in last year. The Cambridge, Massachusetts-based company’s Covid vaccine remains its only commercially ...
- Source: drugdu
- 143
- April 30, 2023

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