Search Results for “FDA” – Page 48 – media

Sanofi, AstraZeneca’s RSV antibody for infants easily clears FDA adcomm, likely setting up approval

Seeking to launch their respiratory syncytial virus (RSV) prevention antibody for infants later this year, Sanofi and AstraZeneca have cleared one more regulatory hurdle.Thursday, experts on the FDA’s Antimicrobial Drugs Advisory Committee voted 21 to 0 that nirsevimab boasts a favorable benefit-risk profile to protect against RSV-associated lower respiratory disease in infants born during or entering their first RSV season. On a separate question of whether the drug has a favorable benefit-risk profile in children up to 24 months of age who remain vulnerable through their second RSV season, the vote was 19 to 2 in favor of the drug. “Most babies hospitalized with RSV are born at term and healthy, which is why interventions specifically designed to protect all infants are likely to result in the greatest impact,” Sanofi’s executive vice president of vaccines, Thomas Triomphe, said in a Thursday statement. “We are encouraged by the Advisory Committee’s positive ...
- Source: drugdu
- 166
- June 10, 2023
FDA Indicates Potential Full Approval for Eisai & Biogen’s Leqembi Ahead of Adcomm

By Rosemary Scott Pictured: Three side-by-side scans of a human brain/iStock, semnic The FDA released briefing documents Wednesday that signal it is likely to grant Eisai and Biogen’s Leqembi (lecanemab) full approval to treat Alzheimer’s disease on its decision date in July. The documents come just two days before an advisory committee is scheduled to vote on whether to recommend the drug’s approval. The FDA has asked the six members of the advisory committee to answer the following question: Do the results of a pivotal trial dubbed Study 301 (CLARITY AD) verify the clinical benefit of lecanemab for the treatment of AD? But it appears the agency may have already decided for itself. Both the briefing documents and the committee’s decision will be based on the Study 301results. In the documents, the FDA stated that the data from the trial showed “consistently favorable results for the primary and secondary endpoints,” ...
- Source: drugdu
- 104
- June 10, 2023
FDA advisers endorse antibody to protect against RSV in infants and some young toddlers

By Jamie Gumbrecht, CNN CNN — Advisers to the US Food and Drug Administration voted Thursday to endorse a monoclonal antibody designed to protect infants and some young toddlers from RSV. Members of the agency’s Antimicrobial Drugs Advisory Committee voted 21-0 that the benefit-risk profile of nirsevimab was favorable in infants and 19-2 that it was favorable in children up to 24 months who are vulnerable to severe respiratory syncytial virus. Next, the FDA will consider the advice of the advisers and decide whether to approve the treatment. The monoclonal antibody, nirsevimab, was developed by AstraZeneca and Sanofi. It’s designed to be given to infants in a single shot at birth or just before the start of a baby’s first RSV season, or as a larger dose in a second RSV season in children who are highly vulnerable. If approved, it will be the first single-dose preventative treatment for all ...
- Source: drugdu
- 120
- June 10, 2023
Philips faces new recall of Evo respirators, tagged Class I by FDA

Dive Brief As many as 57,000 Evo ventilators are facing a voluntary recall by Philips over problems with the machines’ air flow sensor. The U.S. Food and Drug Administration has labeled the recall Class I, warning that filters must be changed regularly to prevent debris accumulating on sensors and impeding air flow. The recall is the second for the Evo ventilator in recent months, and follows the recall of more than 5 million CPAP, BiPAP and other breathing assistance devices made by Philips. Dive Insight Philips’ Respironics unit has faced multiple recalls since it first flagged problems with soundproofing foam used in several of its sleep apnea devices and ventilators in 2021. The Evo ventilator used in hospital and professional care settings is facing its second Class I recall in recent months. The Dutch device maker issued the recall on May 1, instructing users to change filters more frequently to ...
- Source: drugdu
- 127
- June 9, 2023
FDA document outlines apparent agency support for full approval of Biogen, Eisai’s Leqembi

As Alzheimer’s disease partners Eisai and Biogen lay the groundwork for a wider launch of Leqembi, their efforts center on winning a full FDA approval. Wednesday, that vision came into better focus as the FDA released a document showing how the agency views the drug.In advance of a highly anticipated FDA advisory committee set for Friday, the agency released a briefing document that appears to support a full FDA approval for Leqembi. On efficacy, the agency said the drug’s treatment effect in its pivotal trial, called Study 301, is “supported by the consistently favorable results for the primary and secondary endpoints across the prespecified subgroups of interest.” In the study, investigators tested Leqembi against placebo in patients with mild cognitive impairment due to Alzheimer’s or mild Alzheimer’s dementia. The study measured the drug’s efficacy on an endpoint called the Clinical Dementia Rating-Sum of Boxes at 18 months of treatment. On ...
- Source: drugdu
- 181
- June 9, 2023
Abiomed heart pump recall labeled Class I by FDA, no deaths reported

The FDA said Monday that Abiomed, the heart device maker bought by Johnson & Johnson last year for $16.6 billion, is recalling some sets of the Impella 5.5 heart pump with the SmartAssist function after receiving complaints that purge fluid has leaked from the purge sidearm of the pump. The FDA has identified the action as a Class I recall, the most serious kind, meaning that continued use may cause serious injuries or death, unless corrective measures are taken. The Impella 5.5 with SmartAssist System is used for up to 14 days to support the pumping chambers of the heart when there is ongoing cardiogenic shock that occurs less than 48 hours after a severe heart attack, open-heart surgery, or when the heart is not functioning well due to a condition called cardiomyopathy, the FDA said in a statement. The FDA warned that if a purge leak occurs, “the system ...
- Source: drugdu
- 151
- June 7, 2023
FDA OKs Injectafer for Iron Deficiency Anemia in Heart Failure

Megan Brooks The US Food and Drug Administration (FDA) has expanded the indication for ferric carboxymaltose injection (Injectafer, Daiichi Sankyo/American Regent) to include treatment of iron deficiency in adults with New York Heart Association (NYHA) class II/III heart failure (HF). “This new indication for Injectafer marks the first and only FDA approval of an intravenous iron replacement therapy for adult patients with heart failure,” Ravi Tayi, MD, MPH, chief medical officer at American Regent, said in a news release. Ferric carboxymaltose injection is also indicated for the treatment of iron deficiency anemia in adults and children as young as 1 year of age who have either intolerance or an unsatisfactory response to oral iron, and in adult patients who have nondialysis dependent chronic kidney disease. The new indication in HF was supported by data from the CONFIRM-HF randomized controlled trial that evaluated the efficacy and safety of ferric carboxymaltose injection ...
- Source: drugdu
- 137
- June 7, 2023
Dana-Farber research supports FDA approval of new therapy for metastatic breast cancer

Sacituzumab govitecan, a novel antibody drug-conjugate therapy was granted accelerated approval on February 3, 2023 by the U.S. Food and Drug Administration (FDA) for the treatment of metastatic HR+, HER2- breast cancer. The FDA action was based on the results of TROPICS-02, a study in which Dana-Farber Cancer Institute’s Sara Tolaney, MD, MPH, helped lead and which was presented at the European Society of Medical Oncology annual meeting in September 2022 as well as the American Society of Clinical Oncology meeting in June 2022. Researchers reported that the sacituzumab govitecan produced a statistically significant improvement in overall survival rates compared to chemotherapy. The overall survival rate for patients taking part in the global phase 3 study was 14.4 months for those who received sacituzumab govitecan and 11.2 for those given chemotherapy. The sacituzumab arm of the study also showed superior response rates as well as prolonged median progression free survival ...
- Source: drugdu
- 152
- June 6, 2023
FDA allows temporary import of unapproved Chinese cancer drug to ease U.S. shortage

The U.S. Food and Drug Administration has authorized the temporary importation of an unapproved chemotherapy drug from China in effort to ease an acute shortage of cancer drugs in the United States, according to an update posted to the agency’s website Friday. Qilu Pharmaceutical, which makes and markets cisplatin injections in China, received FDA permission to export the drug to the U.S. market weeks ago, a document shows. A letter dated May 24 from Qilu’s deputy general manager notified health care professionals of the approval. Qilu is coordinating with a Toronto-based company, Apotex, to distribute 50-milligram cisplatin vials in the U.S. Health care providers can begin ordering the drug Tuesday through their wholesalers. Cisplatin is a generic drug that has been available for decades in the U.S. and is distributed by several approved manufacturers. Those manufacturers have been unable to keep up with demand. Qilu’s version of cisplatin is not ...
- Source: drugdu
- 133
- June 6, 2023
Coherus, Junshi eye FDA finish line after agency finally conducts plant inspection

It’s been a long road for PD-1 partners Coherus BioSciences and Junshi Biosciences since their FDA rejection for cancer drug toripalimab more than a year ago, but the companies appear to be nearing the regulatory finish line in the U.S.Wednesday, Coherus said in a Securities and Exchange Commission filing that the U.S. FDA “successfully completed the required pre-licensing inspection” of Junshi’s manufacturing site in China. The FDA made three observations about plant deficiencies, but Coherus believes those are “readily addressable.” The partners plan to submit their response to the FDA in the coming weeks. Coherus says it’s planning to launch toripalimab in the U.S. after a potential FDA approval. The inspection comes after multiple regulatory delays. In May 2022, the FDA rejected the drug and requested a quality process change. At the time, the companies noted that a resubmission would take about six months because plant inspections had been delayed ...
- Source: drugdu
- 135
- June 5, 2023

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