Search Results for “FDA” – Page 39 – media

FDA sends warning to CVS, Walgreens and other companies over unapproved eye products

By Jamie Gumbrecht, CNN CNN — The FDA sent warnings letters to eight companies for marketing and manufacturing of unapproved eye products. Sarah Silbiger/Getty Images The US Food and Drug Administration on Monday sent warning letters to CVS, Walgreens and other companies over manufacturing and marketing of unapproved eye products the agency says could pose a risk to people who use them. The agency said the products are illegally marketed to treat conditions including conjunctivitis — pink eye — glaucoma and cataracts, and some of the warnings cited sterility issues with the products. The agency issued warning letters to CVS Health, Walgreens Boots Alliance Inc., Boiron Inc., DR Vitamin Solutions, Natural Ophthalmics Inc., OcluMed LLC, Similasan AG/Similasan USA and TRP Company Inc. Some companies have also been placed on import alert to stop products from entering the United States. “The FDA is particularly concerned that these illegally marketed, unapproved ophthalmic ...
- Source: drugdu
- 115
- September 18, 2023
Alnylam’s RNA interference drug wins favour of FDA AdCom

The US Food and Drug Administration (FDA) voted nine to three in favour of expanding the label of Alnylam Pharmaceuticals’ Onpattro (Patisiran) at a 13 September Advisory Committee (AdCom) meeting. A possible approval would allow the drug to be used to treat cardiomyopathy caused by a wild-type or hereditary transthyretin-mediated amyloidosis (ATTR/ ATTR-CM). At a Cardiovascular and Renal Drugs AdCom meeting, a panel reviewed results from the Phase III (NCT03997383) APOLLO-B trial. In the study, the drug showed favourable effects on functional capacity and quality of life. The drug also demonstrated a good safety profile through the 18 months of treatment with most adverse events being mild or moderate, as per May 2023 interim results. The AdCom discussed if the results from the APOLLO-B study were enough to prove a clinically meaningful benefit for the drug in the new indication. Dr Eric Peterson, a professor of internal medicine at the ...
- Source: drugdu
- 185
- September 16, 2023
FDA to start review of subcutaneous Entyvio for Crohn’s disease

The US Food and Drug Administration (FDA) has accepted Takeda’s biologics license application (BLA) for the company’s investigational subcutaneous administration of Entyvio (vedolizumab) for the treatment of Crohn’s disease. The BLA, which is for maintenance therapy of moderate to severe active forms of the disease after induction therapy with IV vedolizumab, will now be reviewed by the FDA alongside a separate BLA submitted by Takeda for the same formulation indicated for ulcerative colitis treatment. Dr Vijay Yajnik, vice president and head of US Medical for Gastroenterology at Takeda said in a statement: “With two applications for a subcutaneous option of Entyvio now under FDA review, we remain firm in our commitment to the inflammatory bowel disease community—adults with ulcerative colitis or Crohn’s disease—and the healthcare professionals actively managing their care.” Takeda submitted the most recent BLA with data from a Phase III clinical trial demonstrating that Entyvio led to a ...
- Source: drugdu
- 131
- September 15, 2023
TB deaths prompt FDA warning on reducing transmission risk

Dive Brief The Food and Drug Administration has issued advice on how to mitigate the risk of cell and tissue products transmitting tuberculosis. The recommendations follow a report from the Centers for Disease Control and Prevention that showed two recipients of bone matrix products died. In July, Aziyo Biologics, now rebranded as Elutia, recalled its viable bone matrix (VBM) products after two patients developed post-surgical infections. Elutia withdrew all of its VBM products and pivoted to drug-eluting biomatrices in response to its second link to tuberculosis since 2021. The FDA’s advice covers the role of the responsible person and donor screening. While the FDA has yet to authorize a donor screening test, it is “evaluating the risks and appropriate mitigation strategies including testing.” Dive Insight Elutia, then called Aziyo, found itself at the center of reports of tuberculosis cases in June 2021. At the time, the company voluntarily recalled a ...
- Source: drugdu
- 173
- September 15, 2023
Alnylam Wins Adcomm’s Support for Heart Disease Drug Despite FDA Concerns

By Hayley Shasteen Pictured: FDA headquarters, iStock, GrandbrothersT he FDA’s Cardiovascular and Renal Drugs Advisory Committee on Wednesday voted 9-3 in favor of Alnylam Pharmaceuticals’ patisiran on whether its benefits outweigh its risks for the treatment of adults with cardiomyopathy induced by transthyretin amyloidosis. In the company’s announcement on Wednesday, Alnylam CMO Pushkal Garg said the “positive outcome” of the adcomm meeting is “supported by the efficacy and safety data observed in the APOLLO-B Phase III study and is another step toward bringing patients with the cardiomyopathy of ATTR amyloidosis a novel treatment option that addresses the underlying cause of disease and has the potential to meaningfully benefit patients’ functional capacity and quality of life.” The decision came after the panel’s day-long meeting in which adcomm members discussed whether the treatment effects demonstrated by data from Alnylam’s Phase III APPOLLO-B clinical trial were clinically meaningful for patients with cardiomyopathy induced ...
- Source: drugdu
- 114
- September 15, 2023
In warning letters, FDA tells 8 companies to stop selling illicit eye drugs

Eight companies are finding themselves in hot water for allegedly churning out illicit eye drugs, the FDA said Tuesday. The drugs are unapproved and illegally marketed, the FDA said, which is especially risky considering that medications administered through the eye bypass some of the body’s natural defenses. The illegal therapies are purportedly used to treat diseases such as pink eye, cataracts, glaucoma and more, according to the agency’s release. The companies in the warning letter sweep are: Boiron, CVS Health, DR Vitamin Solutions, Natural Ophthalmics, OcluMed, Similasan, TRP Company and Walgreens Boots Alliance. Consumers using the illicit products should talk to a doctor, according to the FDA. The companies, for their part, must respond within 15 days of receiving the FDA’s warning letters. CVS appears to be responding quickly. Reuters reports the company said it has stopped the sale of its Pink Eye Relief Eye Drops and that customers who ...
- Source: drugdu
- 105
- September 14, 2023
FDA Questions Efficacy of Alnylam’s Drug in ATTR-CM Ahead of Adcomm Meeting

By Connor Lynch Pictured: FDA Sign in front of building with blue sky background/Adobe Stock, Grandbrothers Alnylam Pharmaceuticals’ push for patisiran to be expanded to a much larger pool of patients for the treatment of the cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis has hit a significant hurdle. In a briefing document released ahead of the Sept. 13 meeting of the FDA’s Cardiovascular and Renal Drugs Advisory Committee, the agency called into question the efficacy of the drug in treating that pool of patients. The company has been seeking approval for its drug patisiran, sold under the brand name Onpattro, to be used to treat patients with cardiomyopathy induced by transthyretin amyloidosis (ATTR-CM). The disease typically affects the hearts and tendons of elderly people, causing an accumulation of proteins which can lead to severe cardiomyopathy. The APOLLO-B study was looking at one key primary efficacy endpoint and one key secondary ...
- Source: drugdu
- 131
- September 14, 2023
Moderna, Pfizer-BioNTech’s Updated COVID-19 Vaccines Approved by FDA

By Hayley Shasteen Pictured: Syringe drawing up vaccine/iStock, Diy13 The FDA approved two updated COVID-19 booster shots from Pfizer-BioNTech and Moderna Monday afternoon, just in time for the fall vaccination season. The reformulated mRNA vaccines are specifically tailored to provide protection against circulating Omicron-related variants, including subvariant XBB.1.5, which the FDA had recommended vaccines be updated to cover in June 2023. The CDC is anticipated to release its recommendation guidance on the boosters Tuesday. A positive endorsement by the agency could see boosters available at pharmacies and doctors’ offices by the end of the week, The New York Times reported. CDC Director Mandy Cohen is expected to recommend the updated vaccines and sign off on their use, having previously made remarks favoring an updated booster. The approval for both boosters covers individuals ages 12 years and up, with Emergency Use Authorization granted for individuals ages six months to 11 years. ...
- Source: drugdu
- 233
- September 13, 2023
Pfizer, Moderna score FDA nods for next round of seasonal COVID-19 vaccines

Out with the old and in with the new: Monday, the U.S. FDA approved retooled mRNA shots against COVID-19 from Pfizer-BioNTech and Moderna, simultaneously bidding adieu to the companies’ bivalent shots in the U.S.The FDA has approved Pfizer-BioNTech and Moderna’s separate vaccine formulations that are more closely targeted to current variants of the disease, the agency said in a release. Specifically, each company’s shot is approved for people ages 12 and up and emergency authorized for patients 6 months old to 11 years old. The vaccines have been updated to include a monovalent component aimed at omicron variant XBB.1.5, according to the companies and the FDA. Meanwhile, Novavax’s revised shot is still pending regulatory approval. Moderna noted the COVID is “on the rise again” and warned of a “’tripledemic’” of COVID, flu and respiratory syncytial virus this winter and fall. Vaccines should remain “top of mind,” the company said. Following ...
- Source: drugdu
- 109
- September 13, 2023
FDA fast tracks Mendus’s acute myeloid leukaemia vaccine vividencel

The US Food and Drug Administration (FDA) has granted fast track designation to Mendus’s cancer vaccine vividencel for the treatment of acute myeloid leukaemia (AML). The FDA’s decision was based on results from the Phase II ADVANCE II trial (NCT03697707), which investigated the vaccine’s use as a maintenance monotherapy in patients with AML in complete remission. Fast track designations enable earlier interactions with the FDA for the pursuit of accelerated approval. The status also opens chances of rolling reviews. In June, the Swedish company, which was previously known as Immunicum, presented comprehensive immunomonitoring data at the European Hematology Association’s 2023 hybrid congress. According to Mendus, the vaccine led to increased levels of activated, cancer-killing T cells and reduced levels of immune-suppressive T cells in the majority of the patients in the Phase II ADVANCE II study. Prior to this, the company published data on the drug’s effects on measurable residual ...
- Source: drugdu
- 167
- September 12, 2023

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