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FDA finalizes breakthrough device changes to target health inequities

Dive Brief The Food and Drug Administration has finalized changes to its breakthrough devices guidance, adopting revisions that could accelerate development of products that address health inequities. Eleven months ago, the FDA proposed updating its breakthrough guidance to clarify that devices that improve accessibility, and thereby tackle health inequities, can qualify for the program. The proposals received broadly positive feedback, including from industry trade group AdvaMed, leading the FDA to finalize the changes with only minor revisions and schedule a webinar to discuss its new policy. Dive Insight The FDA designed the breakthrough program to support development of devices that could better treat or diagnose life-threatening or irreversibly debilitating diseases or conditions. Originally, the guidance lacked a specific reference to accessibility as a way that devices can improve care. In October, the FDA proposed updating the guidance to explain that it considers the “totality of information regarding the proposed device, ...
- Source: drugdu
- 212
- September 20, 2023
Meridian Bioscience announces FDA clearance for innovative Curian® Shiga Toxin Assay

Meridian Bioscience, Inc., a leading global provider of diagnostic testing solutions and life science raw materials, announced today that the United States Food and Drug Administration (FDA) had granted clearance for the company’s new Curian® Shiga Toxin assay. This assay joins Curian HpSA® and Curian Campy as Meridian expands its Curian diagnostic platform to maintain leadership in the gastrointestinal disease testing market. Foodborne illness is a severe global public health problem that causes 48 million people to get sick yearly and 128,000 hospitalizations from common bacterial agents like Campylobacter and E. coli.1 Meridian is expanding its foodborne immunofluorescent testing capabilities beyond Campylobacter by adding Shiga toxin to the Curian platform. Speedy diagnosis is essential with patients suspected of having a Shiga toxin-producing E. coli infection because the use of antibiotics for treatment can increase Shiga toxin release, leading to hemolytic uremic syndrome (HUS), a potentially life-threatening complication. The Curian Shiga ...
- Source: drugdu
- 241
- September 20, 2023
FDA Approves GSK’s Momelotinib for Myelofibrosis Patients with Anemia

By Tristan Manalac Pictured: GSK building in Poland/iStock, Wirestock The FDA on Friday approved GSK’s oral drug momelotinib, now to be marketed under the brand name Ojjaara, for the treatment of myelofibrosis in adults with anemia. Myelofibrosis patients often develop anemia, which forces them to discontinue treatment and raise the need for transfusions. Ojjaara’s approval will help address this “significant medical need in the community” and lead to better outcomes in these patients, Nina Mojas, GSK senior vice president for oncology global product strategy, said in a statement. With Friday’s approval, Ojjaara becomes the first authorized treatment for both newly diagnosed and previously treated myelofibrosis patients with anemia that also targets the key symptoms of the condition, according to the company’s press release. The approval comes after a three-month delay in June 2023, which the FDA said was to give it more time to review additional data supporting the application. ...
- Source: drugdu
- 222
- September 20, 2023
Anthos Stops Mid-Stage Atrial Fibrillation Trial Due to ‘Unprecedented’ Efficacy

By Tristan Manalac Pictured: Illustration of a blood clot in a blood vessel/iStock, libre de droit Anthos Therapeutics is ending the Phase II AZALEA-TIMI 71 study ahead of schedule after its investigational monoclonal antibody abelacimab demonstrated an “overwhelming reduction” in bleeding compared to Bayer and Johnson & Johnson’s Xarelto (rivaroxaban), the company announced Monday. Patients treated with abelacimab saw a sharp reduction in the composite endpoint of major and clinically relevant non-major bleeding events compared with counterparts given rivaroxaban, the current standard-of-care oral anticoagulant. The Massachusetts-based biopharma did not provide specific data in Monday’s announcement but said that the Data Monitoring Committee stopped the study early following these data. Anthos will share the full results and analysis of the trial in an upcoming medical meeting. Due to the “overwhelming reduction in bleeding” reported in AZALEA-TIMI 71, abelacimab may represent a “paradigm shift” in atrial fibrillation care particularly in the prevention ...
- Source: drugdu
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- September 20, 2023
FDA revises biosimilar guidelines for clearer drug labelling

The US Food and Drug Administration (FDA) released a draft guidance giving drug manufacturers recommendations for biosimilar and interchangeable biosimilar products, detailing tips for drafting label prescription information, on 15 September. In the “Labeling for Biosimilar and Interchangeable Biosimilar Products” document, the agency said that “the biosimilar or interchangeable biosimilar label should only be used in labelling text that is specific to the biosimilar or interchangeable biosimilar product or refers solely to it.” The FDA defines an interchangeable biosimilar as a “biosimilar that meets additional requirements and may be substituted for the reference product at the pharmacy, depending on state pharmacy laws.” The agency guided drug manufacturers to only include the drug product’s proprietary name in the following sections: indications and usage, dosage and administration, dosage forms and strengths, description and how supplied/storage and handling. The FDA also recommended its use in recommendations for preventing, monitoring, managing, or mitigating risks. ...
- Source: drugdu
- 108
- September 20, 2023
FDA approves Pfizer/BioNTech and Moderna’s adapted COVID-19 vaccines

The updated vaccines more closely target current circulating variants The US Food and Drug Administration (FDA) has granted approval for Pfizer/BioNTech and Moderna’s updated COVID-19 vaccines, to tackle currently circulating variants. As previously recommended by the FDA, both vaccines have been adapted to closely target the XBB.1.5. Omicron variant by including a monovalent component. Both companies’ mRNA vaccines are approved for use in individuals aged 12 years and older and authorised for emergency use in those aged six months to 11 years. The FDA has said that it is “confident in the safety and effectiveness” of the two updated vaccines and that its risk assessment demonstrated that the benefits of both vaccines for individuals aged six months and older outweighed the risks. “The public can be assured that these updated vaccines have met the agency’s rigorous scientific standards for safety, effectiveness, and manufacturing quality,” said Peter Marks, director of the ...
- Source: drugdu
- 148
- September 20, 2023
Pfizer’s Vydura recommended by NICE for acute migraines

The treatment is the first oral GPCR receptor antagonist class recommended for NHS use The National Institute for Health and Care Excellence (NICE) has recommended Pfizer’s Vydura (rimegepant) as a cost-effective option for the treatment of acute migraines in adults. The recommendation marks Vydura as the first drug in the oral GPCR receptor antagonist class to be recommended for routine NHS use as treatment for the condition. Published in NICE’s draft guidance, Vydura is recommended for adults who have previously tried at least two triptant-based therapies that were ineffective, not tolerated, or contraindicated. It is also recommended after prior use of nonsteroidal anti-inflammatory drugs, such as ibruprofen and aspirin, and paracetamol didn’t work well enough. Triptants are a group of medicines used to treat a migraine or headache. The recommendation was based on clinical trial evidence, which showed that Vydura is more likely to reduce pain in patients within 2 ...
- Source: drugdu
- 132
- September 20, 2023
As Lonza CEO departs, Catalent scoops up rival CDMO’s bioscience business head to lead biologics

Mere hours after it surfaced that Lonza’s CEO, Pierre-Alain Ruffieux, will step down, the Swiss CDMO has lost another major executive. And this time, the exec is jumping ship to U.S. contract manufacturing rival Catalent. Monday, Catalent named Lonza’s David McErlane group president of its biologics segment. McErlane, who most recently served as Lonza’s senior vice president and head of the bioscience business, will take up his post at Catalent on Sept. 25, a source familiar with the matter told Fierce Pharma. McErlane’s hiring represents one of the first major strategic grabs since Catalent caved in to activist investor Elliott Management last August. The New Jersey CDMO is now working to rejuvenate its business after a difficult stretch of manufacturing snares, executive turnover and dwindling revenues. Before joining Catalent, McErlane led a Lonza department that provides specialty raw materials and technology solutions for cell and gene therapies, injectable drugs, vaccines ...
- Source: drugdu
- 100
- September 20, 2023
FDA Approves GSK Myelofibrosis Med That Has Edge Over Others in Drug Class

Myelofibrosis can already be treated with several drugs from a class of medicines that address a pathway driving this type of blood cancer. A drug from GSK is now the latest entrant into the class, but with an additional component that specifically treats the anemia complication affecting myelofibrosis patients. FDA approval of GSK’s momelotinib covers the treatment of adult myelofibrosis patients regardless of whether or not they have been previously treated with another drug for the cancer. The regulatory decision announced late Friday marks the payoff for the pharmaceutical giant’s bet on a molecule it acquired in a $1.9 billion deal. The GSK drug, known in development as momelotinib, will be marketed under the brand name Ojjaara. In myelofibrosis, inflammation and scar tissue (fibrosis) impair the bone marrow’s ability to normally produce red blood cells. The disease leads to anemia, which must be treated with regular blood transfusions. Other complications ...
- Source: drugdu
- 181
- September 19, 2023
CMS Is Getting More Serious About Penalizing Hospitals For Price Transparency Noncompliance

The Centers for Medicare & Medicaid Services (CMS) has fined two hospitals in September for alleged violations of its price transparency rule. This marks the third month in a row that the agency has issued fines against hospitals for price transparency noncompliance, following a yearslong period of light enforcement. The two fines issued on September 5 were the thirteenth and fourteenth penalties CMS has imposed on hospitals for price transparency violations. Saint Elizabeths Hospital in Washington, D.C. was fined $677,440, and Holy Cross Hospital in Silver Spring, Maryland was fined $325,710. CMS’ rule aims to make hospitals’ pricing data more accessible to patients so they can compare costs and make more informed decisions about the healthcare services they choose. The law requires all hospitals to post their gross charges, payer-specific negotiated charges, de-identified minimum negotiated charges, de-identified maximum negotiated charges and cash prices on their websites in a machine-readable file. ...
- Source: drugdu
- 105
- September 19, 2023

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