Search Results for “FDA” – Page 47 – media

Blue Water Biotech shores up portfolio with purchase of six FDA-approved treatments

Blue Water Biotech has expanded its commercial portfolio with the purchase agreement of six assets from WraSer. The agreement includes an $8.5m cash payment and the offering of one million restricted shares. Blue Water’s deal includes treatments across cardiology, otic infections, and pain management indications and will see Zontivity (vorapaxar), Trezix (acetaminophen-caffeine-dihydrocodeine), Nalfon (fenoprofen calcium), Conjupri (levamlodipine), Otovel (ciprofloxacin and fluocinolone acetonide) and Cetraxal (ciprofloxacin) all exchange hands to Blue Water’s ownership. All six treatments are US Food and Drug Administration (FDA) approved. At market open, shares in Blue Water surged 90% higher than the previous day’s (13 June) market close. The company has a market cap of $20m. Blue Water’s major purchasing agreement comes at a time when pharma mergers and acquisitions are beginning to pick up after a slow start to 2023. Included in the agreement are the patents related to Zontivity – a medication for patients with ...
- Source: drugdu
- 101
- June 17, 2023
After Albireo buyout, Ipsen’s Bylvay picks up new FDA-approved use

After Ipsen made a splash at this year’s J.P. Morgan Healthcare Conference by scooping up liver disease specialist Albireo Pharma, the centerpiece of the buyout, Bylvay, has won a coveted label expansion.First approved by the FDA to treat cholestatic pruritus from progressive familial intrahepatic cholestasis, Bylvay has now won an FDA approval in another liver disease. Specifically, the drug can now treat cholestatic pruritus due to Alagille syndrome in patients 12 months of age and older. Cholestatic pruritus is the intense itching that afflicts patients with the diseases. A once-daily ileal bile acid transport inhibitor (IBATi), Bylvay will challenge Mirum Pharmaceuticals’ Livmarli in this disease. Livmarli won an FDA approval in Allagile syndrome back in 2021 and generated $29 million during the first quarter of 2023. Analysts with Evercore ISI have previously put a $1 billion peak sales target on Mirum’s rival drug. Bylvay’s new approval is based on results ...
- Source: drugdu
- 109
- June 15, 2023
Updated Covid vaccines need to target XBB omicron variants this fall, FDA staff says

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 ...
- Source: drugdu
- 96
- June 14, 2023
Bristol Myers’ cell therapy manufacturing site in Massachusetts is good to go, FDA says

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 ...
- Source: drugdu
- 106
- June 13, 2023
Eisai, Biogen’s Alzheimer’s disease drug Leqembi passes muster at FDA adcomm

After a daylong discussion among experts on an FDA advisory committee, Eisai and Biogen’s Leqembi is heading into the final stretch of its regulatory review on strong footing.During a Friday meeting, members of the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee took a careful look at the data behind the partners’ Alzheimer’s disease drug. Ultimately, the group voted 6 to 0 that the drug’s Clarity AD study verify its clinical benefit. In the discussion portion of the meeting, advisory committee members described the trial results as “robust,” “meaningful,” “consistent” and “significant.” Now, it’s up to the FDA to decide whether to follow the advisory committee’s guidance. The agency is expected to decide on the application by July 5. Before the Friday discussion, the FDA released its own briefing document that appeared to outline agency support for a full approval. During the meeting, the FDA’s acting director of the ...
- Source: drugdu
- 109
- June 13, 2023
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
- 160
- 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
- 99
- 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
- 116
- 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
- 124
- 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
- 176
- June 9, 2023

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