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Intas on import alert as FDA flags data manipulation, management failures in warning letter

Drug manufacturer Intas Pharmaceuticals is no stranger to FDA scrutiny. Now, one of its plants has been placed on an import alert after a series of interactions with the agency. After a May inspection of Intas’ plant in Gujarat, India, the FDA published a warning letter that points a finger at management and labels products made at the site “adulterated” because of the company’s manufacturing deficiencies. Before this development, the FDA earlier this year slapped the site with a Form 483 filing outlining problems at the plant. Shortly after that, the company provided a response that proved to be “inadequate,” as the FDA described it. In the warning letter, the FDA blasted Intas for an “egregious pattern” of shortfalls that shows the company’s failure to carry out “basic responsibilities.” The agency tracked multiple instances of data manipulation going back to 2021. In these cases, visual inspectors manipulated particle and other ...
- Source: drugdu
- 105
- December 1, 2023
Eli Lilly advances small molecule drug portfolio with Prism Biolab partnership

Eli Lilly is building on its small drug molecule portfolio with a partnership with Prism Biolab to develop and commercialise small molecules that modulate targets picked by Lilly. As part of the agreement, Prism will receive upfront payments and up to $660m based on preclinical, clinical, and commercial development milestone payments, along with royalty payments. This alliance will utilise Prism’s PepMetics technology platform to discover oral protein-protein interaction (PPI) targets. Lilly has made several moves in the last couple of years to develop small-drug molecules. Earlier this month, the company was one of the investors in Alto Neuroscience’s $45m Series C financing round, which will support Alto’s clinical programme of four small-molecule CNS candidates to treat psychiatric disorders including depression and post-traumatic stress disorder. Alto is expecting positive topline data from Phase II studies investigating two of the molecules, ALTO-100 and ALTO-300, in H2 2024 and H1 2025, respectively. In ...
- Source: drugdu
- 103
- December 1, 2023
FDA opens investigation into secondary cancer risk with CAR-T therapies

The US Food and Drug Administration (FDA) has started an investigation to review the safety of chimeric antigen receptor (CAR)-T cell immunotherapies following reports of T cell malignancies in patients who received these immunotherapies. The therapies under investigation include six approved B cell maturation antigen (BCMA)- or CD19-directed CAR-T cell therapies. The investigation follows reports collected from clinical trials and post-marketing adverse event surveillance. The FDA had required companies to conduct 15-year long term follow-up observational safety studies to assess the long-term safety and the risk of secondary malignancies as part of the respective therapy’s approval. The risk of post-therapy malignancies applies to all FDA-approved BCMA- or CD19-directed CAR-T cell therapies, as per a 28 November press release. The agency added that although the therapy benefits “continue to outweigh their potential risks for their approved uses”, the FDA is evaluating the need for regulatory action regarding the risk of T-cell ...
- Source: drugdu
- 100
- December 1, 2023
MS Expands Cardio Partnership with Avidity in Potential $2.3B Deal

By Kate Goodwin Pictured: Bristol Myers Squibb building in Munich/iStock, Tati Campelo Bristol Myers Squibb is upping the ante in its partnership with Avidity Biosciences. The San Diego-based biopharma announced Tuesday an expansion of its previous collaboration with BMS, with the latter paying $100 million upfront and adding up to five cardiovascular targets. With potential cumulative payments of up to $2.3 billion plus low double-digit royalties, the partnership could be a lucrative one for the RNA biopharma. The deal expansion sent Avidity’s suffering stock soaring around 35% in premarket trading. A welcome reprieve to the 72% tumble it took earlier this year. Avidity will get a $60 million upfront cash payment in addition to BMS scooping up $40 million of its stock to deliver new cardiovascular treatments utilizing the former’s antibody oligonucleotide conjugates (AOCs). Avidity’s AOCs combine the targeting specificity of monoclonal antibodies with the precision of oligonucleotide therapies to ...
- Source: drugdu
- 106
- November 30, 2023
FDA Launches Probe of Malignancies Linked to CAR-T Therapies

By Tyler Patchen Pictured: Exterior of an FDA building/iStock, Grandbrothers The FDA announced Tuesday that it is investigating the “serious risk” of malignancies in patients who received treatment with BCMA- or CD19-directed autologous CAR-T cell immunotherapies. The regulator said it has determined that the risk of T-cell malignancies “is applicable to all currently approved BCMA-directed and CD19-directed genetically modified autologous CAR T cell immunotherapies” including Bristol Myers Squibb’s Abcema and Breyanzi, Johnson & Johnson’s Carvykti, Novartis’ Kymriah and Gilead’s Tecartus and Yescarta. “T-cell malignancies have occurred in patients treated with several products in the class,” according to the FDA, which said it received reports from clinical trials and postmarketing adverse event data. While the agency said that the overall benefits of these products continue to outweigh their potential risks, it “is investigating the identified risk of T cell malignancy with serious outcomes, including hospitalization and death, and is evaluating the ...
- Source: drugdu
- 116
- November 30, 2023
Season Health Expands Provider Network Through Strategic Asset Acquisition from Wellory

Food-as-medicine platform Season Health has closed on its strategic asset acquisition from Wellory, which offers a network of registered dietitians, the companies announced Tuesday. Austin, Texas-based Season Health offers personalized food recipes, pre-made meals, grocery support, one-on-one meetings with a dietitian and nutrition education. It serves payers and employers. New York City-based Wellory works with payers and connects patients to dietitians for one-on-one virtual nutrition sessions. This network of dietitians provides care for 25 different specialties in 15 languages across all 50 states. “Food-as-medicine, as far as I can tell, is still excitingly emerging,” said Josh Hix, CEO and co-founder of Season Health, in an interview. “There’s not yet one definition [of food-as-medicine], and in our opinion, it needs to include dietitian services. We see patients all the time where they have, for example, uncontrolled diabetes or poorly controlled diabetes. No one’s ever told this person that it’s large volumes ...
- Source: drugdu
- 94
- November 30, 2023
Medtronic to chase Boston Scientific, Abbott in left atrial appendage closure market

Dive Brief Medtronic said Monday it is launching a device in the U.S. designed to close the left atrial appendage (LAA) of the heart in patients undergoing cardiac surgery. The treatment is intended for patients who have atrial fibrillation (AFib), an arrhythmia that can lead to stroke. The introduction of the implantable LAA clip, called Penditure, marks Medtronic’s entry into the fast-growing market for left atrial appendage closure devices, led by Boston Scientific’s Watchman franchise. Medtronic said it acquired the LAA exclusion system in August from Miami-based medical device incubator Syntheon, in a move to expand its cardiac surgery portfolio. Terms of the transaction were not disclosed. Dive Insight Medtronic’s device is the newest challenger to Boston Scientific’s Watchman in a growing market that includes Abbott’s Amplatzer Amulet treatment, which gained approval from the Food and Drug Administration in 2021, and AtriCure, whose AtriClip device was the first LAA exclusion ...
- Source: drugdu
- 176
- November 30, 2023
Citing Ongoing Drug Shortages, Biden Administration Invokes Defense Production Act

Don Tracy, Associate Editor Law aims to mitigate ongoing global drug shortages. US President Joe Biden has announced approximately 30 new actions aimed at strengthening supply chains critical to national interests. According to the White House, these actions aim to help Americans get necessary products when they need them. Furthermore, the president has invoked the Defense Production Act, enabling investment in domestic manufacturing of essential medicines, medical countermeasures, and critical inputs that have been deemed as essential to the national defense.1 “And today, we’re coming together to ask a simple question: What’s next?What can we do? What must we do to keep making progress to keep our supply chain stable and secure in the long term, to keep preserving that breathing room—that little bit of breathing room for American families for the season to come, no matter what challenges we face,” Biden said during a speech delivered yesterday.2 Earlier this ...
- Source: drugdu
- 120
- November 30, 2023
Season Health Expands Provider Network Through Strategic Asset Acquisition from Wellory

By acquiring clinical assets from Wellory, Season Health will be able to greatly expand its provider network. The company will also gain national contracts with Aetna and Cigna. By MARISSA PLESCIA Food-as-medicine platform Season Health has closed on its strategic asset acquisition from Wellory, which offers a network of registered dietitians, the companies announced Tuesday. Austin, Texas-based Season Health offers personalized food recipes, pre-made meals, grocery support, one-on-one meetings with a dietitian and nutrition education. It serves payers and employers. New York City-based Wellory works with payers and connects patients to dietitians for one-on-one virtual nutrition sessions. This network of dietitians provides care for 25 different specialties in 15 languages across all 50 states. “Food-as-medicine, as far as I can tell, is still excitingly emerging,” said Josh Hix, CEO and co-founder of Season Health, in an interview. “There’s not yet one definition [of food-as-medicine], and in our opinion, it needs ...
- Source: drugdu
- 197
- November 30, 2023
AstraZeneca’s rare disease unit receives NICE recommendation for Wolman disease therapy in infants

AstraZeneca’s rare disease unit has received a recommendation from the National Institute for Health and Care Excellence (NICE) for the use of its enzyme replacement therapy in infants with Wolman disease. Alexion’s Kanuma (sebelipase alfa), which has been specifically recommended for use in patients who are aged two years or younger when administration begins, will now become the first treatment available on the NHS for the rapidly-progressive rare genetic disease. Occurring in around one in 350,000 births, Wolman disease causes a build-up of fat in cells in the liver, heart, blood vessels and digestive system. Symptoms in infants include enlarged liver and spleen, poor weight gain, low muscle tone, jaundice, vomiting, diarrhoea, developmental delay and anaemia. Until now, standard care for the disease has been palliative and limited to managing symptoms, with patients normally not surviving past the age of one without treatment. Administered as weekly intravenous infusions which can ...
- Source: drugdu
- 100
- November 30, 2023

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