Search Results for “FDA” – Page 47 – media

Intercept winds down NASH programme after FDA pulls plug on Ocaliva

Following a negative Advisory Committee (AdCom) decision, the US Food and Drug Administration (FDA) has rejected Intercept’s Ocaliva (obeticholic acid) for the treatment of pre-cirrhotic fibrosis due to nonalcoholic steatohepatitis (NASH) in a complete response letter (CRL) to the company. In a 23 June conference call, the company announced that it would begin the process of shutting down the REGENERATE trial (NCT02548351), with an aim to complete this process by the end of 2023. Intercept will continue to collect study data until the trial is fully terminated. Furthermore, the biotech has already begun “winding down” its NASH-related investment into research and development, commercial, medical affairs and administrative function. The company will also cut down its workforce by a third to minimise operating expenses, beginning in the coming weeks with plans to complete this by the end of 2023. Intercept will pivot its focus to Ocaliva’s use for primary biliary cholangitis ...
- Source: drugdu
- 105
- June 25, 2023
FDA approves Duchenne gene therapy with hefty $3.2m price tag

Children with a confirmed mutation of the DMD gene – responsible for causing Duchenne muscular dystrophy (DMD) – are closer to receiving the first gene therapy for the disease after the US Food and Drug Administration (FDA) approved Sarepta’s highly anticipated Elevidys (delandistrogene moxeparvovec-rokl). On a conference call following the approval, Sarepta CEO Douglas Ingram said the company has set the wholesale acquisition cost of Elevidys at $3.2m. After a narrow US Food and Drug Administration Advisory Committee (AdCom) panel vote and a delay to the Prescription Drug User Fee Act (PDUFA) date, Sarepta’s therapy crossed the approval finish line. The decision, which came through the accelerated approval pathway, is for children ages four to five with a confirmed mutation in the DMD gene. As per Sarepta, Elevidys’ price is below the cost-effectiveness range, which is estimated to be between $5m and $13m. Sarepta’s adeno-associated virus (AAV) mediated therapy delivers ...
- Source: drugdu
- 101
- June 25, 2023
Calliditas files sNDA to US FDA for TARPEYO to treat primary IgAN

Calliditas Therapeutics has submitted a supplemental new drug application (sNDA) to the US Food and Drug Administration (FDA) for complete approval of TARPEYO (budesonide). The TARPEYO delayed-release capsule is a corticosteroid indicated for reducing proteinuria to treat primary immunoglobulin A nephropathy (IgAN) in adult patients at risk of quick disease progression, generally having a urine protein-to-creatinine ratio greater than or equal to 1.5g/g. The therapy received accelerated approval based on showing a reduction in proteinuria. The submission of sNDA to the regulator was based on the findings obtained from the Phase III NefIgArd clinical trial. The multicentre, randomised, double-blind trial was designed to evaluate the safety and efficacy of TARPEYO 16 mg compared with placebo against a background of optimised RASi (renin–angiotensin system inhibitor) therapy in primary IgA adult patients. TARPEYO showed a highly statistically significant benefit in estimated glomerular filtration rate (eGFR) over a two-year period of treatment. The ...
- Source: drugdu
- 122
- June 23, 2023
SFDA approves Amarin’s VASCEPA to reduce CV risk in Saudi Arabia

The Saudi Food and Drug Authority (SFDA) has granted approval to Amarin’s VASCEPA (icosapent ethyl) capsules for reducing cardiovascular (CV) risk. VASCEPA is indicated as an adjunct to statin therapy for use in adult patients with elevated levels of triglycerides (TG). This means levels greater than or equal to 150 mg/dL. It has also been approved for use in patients at increased risk of CV events caused by at least one other CV disease risk factor and established CV disease, or who have diabetes mellitus. The therapy is the first and only medicine to receive approval from the regulator to reduce CV risk beyond cholesterol-lowering therapy in patients on high-risk statin treatment and who have increased TG levels. Amarin stated that the country’s National Heart Center (NHC) and the Saudi National Diabetes Center (SNDC) have mentioned icosapent ethyl (IPE) as an adjunct to statin therapy for CV risk reduction in ...
- Source: drugdu
- 129
- June 23, 2023
FDA Puts Mersana’s Ovarian Cancer Trials on Partial Clinical Hold

By Tristan Manalac www.biospace.com Pictured: FDA Building/courtesy of Grandbrothers/Adobe Stock The FDA has placed Mersana Therapeutics’ UP-NEXT and UPGRADE-A trials on partial clinical hold, the company announced Thursday. Both studies evaluate Mersana’s investigational antibody-drug conjugate upifitamab rilsodotin in platinum-sensitive ovarian cancer. The regulatory pause was triggered by an aggregate safety report containing information from around 560 patients who had received upifitamab rilsodotin (UpRi). Mersana’s data showed a higher rate of serious bleeding events, though most of these episodes were low-grade. Still, five cases of serious bleeding were fatal. The exact causes of bleeding are still unknown and are currently being investigated. Mersana’s stocks fell 60% in pre-market trading Thursday in response to the news. The FDA has yet to provide Mersana with a formal written communication regarding the partial clinical hold. However, the company expects the regulator to request a more comprehensive evaluation of UpRi’s safety data. Mersana is working ...
- Source: drugdu
- 104
- June 17, 2023
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
- 106
- 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
- 115
- 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
- 102
- 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
- 110
- 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
- 111
- June 13, 2023

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