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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
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- 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
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- 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
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FDA investigates ‘serious risk’ of secondary cancer following CAR-T treatment

In a blow to CAR-T therapies, the FDA is investigating a “serious risk” of patients developing new cancers after treatment with these highly efficacious oncology drugs. The FDA unveiled the probe Tuesday. The agency said it has received reports of T-cell malignancies, including CAR-positive lymphoma, among patients who received BCMA- or CD19-directed CAR-T cell immunotherapies. Some patients involved have had to be hospitalized or died, according to the agency. The cases stem from clinical trials and postmarketing adverse event surveillance, the FDA said. The FDA has determined that the potential risk is applicable to all currently approved CAR-T therapies, as T-cell malignancies have occurred after patients received several different products. The FDA is now weighing potential regulatory action—even as the potential risk of developing secondary cancer is already included as a class warning on the labels of the CAR-T therapies. Currently marketed CD19 CAR-Ts include Yescarta and Tecartus from Gilead ...
- Source: drugdu
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Bayer’s stock drops to new 18-year low after asundexian trial termination

Bayer’s stock price has plummeted to its lowest since 2005 after a clinical trial investigating the anti-coagulant drug asundexian was stopped early due to lack of efficacy. The Phase III OCEANIC-AF trial (NCT05643573) aimed to determine asundexian’s use as a treatment for people living with atrial fibrillation in a bid to prevent strokes or systemic embolisms. The Independent Data Monitoring Committee (IDMC) found that asundexian was inferior in terms of efficacy when compared to the control arm of the trial. The OCEAN-AF trial was a part of the overall OCEAN Phase III programme. However, the committee recommended continuing another Phase III OCEANIC-STROKE trial (NCT05686070) examining the use of the drug in stroke patients. Following the announcement on 19 November 2023, the German pharmaceutical firm’s stock value dropped from €41.45 ($45.38) per share down to €30.77 ($33.68), as of 28 November. It is the lowest price in 18 years. The last ...
- Source: drugdu
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- November 30, 2023
Acelyrin claims errors by CRO Fortrea led to late-stage trial downfall

Immunology biotech Acelyrin has determined that its CRO partner Fortrea is responsible for the late-stage failure of its immunotherapeutic drug candidate for moderate to severe hidradenitis suppurativa (HS). The company says a programming blunder by a vendor recruited by the CRO resulted in two erroneously treated patient arms going undetected through the testing processes. Los Angeles-based Acelyrin was aiming to make waves in a fiercely competitive psoriasis market with a breakout $540m IPO in May and a steady stream of clinical data and patient enrolment updates on its izokibep clinical program. But in September, when the Phase IIb/III study (NCT05355805) failed to meet its endpoint of achieving a 75% reduction in total abscesses and inflammatory nodules, the company’s stock more than halved overnight and has not yet recovered to the levels seen before 11 September. While a press release issued by Acelyrin outlining the error did not identify Fortrea as ...
- Source: drugdu
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- November 30, 2023
FDA withdraws from Global Harmonization Working Party

Dive Brief The U.S. Food and Drug Administration decided to withdraw from the Global Harmonization Working Party (GHWP), one of multiple groups working to align international standards for medical devices. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, raised concerns about “divergent harmonization efforts” in a Monday letter to Jinghe Xu, chair of the GHWP and deputy commissioner of China’s National Medical Products Administration. Shuren’s concerns included efforts that do not align with the FDA’s priorities or international best practices and the lack of collaboration with the International Medical Device Regulators Forum (IMDRF), another international standards group. Dive Insight The FDA joined the GHWP in December 2021 with the goal of serving as a bridge between the organization and the IMDRF. At the time, the FDA didn’t realize how divergent the two organizations had become, Shuren wrote. “I would like to see GHWP and IMDRF collaborating ...
- Source: drugdu
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- November 29, 2023
Biodegradable patch holds promise of correcting congenital heart defects in infants

Using laboratory engineered tissue, scientists at the University of Colorado Anschutz Medical Campus have created a full thickness, biodegradable patch that holds the promise of correcting congenital heart defects in infants, limiting invasive surgeries and outlasting current patches. The findings were published this week in the journal Materials Today. Jeffrey Jacot, PhD, study’s senior author, associate professor of bioengineering, University of Colorado School of Medicine, said, “The ultimate goal is to make lab-grown heart tissue from a patient’s own cells that can be used to restructure the heart to correct for heart defects.” About 10,000 babies are born with a complex congenital heart defect every year in this country, requiring surgery in the first year of life. Some of these operations require the implantation of a full-thickness heart patch. But the current materials used in the patch are non-living and non-degradable. They don’t grow with the patient and often fail ...
- Source: drugdu
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- November 29, 2023
Henry Schein reports more disruption as cyberattackers take credit

BY JIM HAMMERAND Henry Schein (Nasdaq: HSIC)+ said today that it is working to bring its ecommerce platform back up after more problems related to its cyberattack. The medical device manufacturer and distributor said last week that its ecommerce platform and other applications were unavailable and that “the threat actor from the previously disclosed cyber incident has claimed responsibility.” Today, the company said its ecommerce platform is back online in the U.S. and was expected to be restored in Canada and Europe “shortly.” Henry Schein said it continued to take orders via alternate methods previously communicated to customers, and continued shipping products. Earlier this month, the company warned customers and suppliers that their sensitive information may have been exposed in the cyberattack. Henry Schein first disclosed the cyber security incident in October. A ransomware gang known as BlackCat/ALPHV later said they encrypted the company’s systems and stole 35 TB of ...
- Source: drugdu
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- November 29, 2023
Phase 3 Clinical Trial for Dupixent Reports Significant Reduced COPD Exacerbations

Don Tracy, Associate Editor Trial results expected to accelerate the potential of Dupixent to become the first FDA-approved treatment for chronic obstructive pulmonary disease. Regeneron Pharmaceuticals and Sanofi have announced that a Phase 3 trial evaluating Dupixent (dupilumab) in the treatment of chronic obstructive pulmonary disease (COPD) showed the drug reduced exacerbations by 34%, reportedly confirming positive results from its earlier Phase 3 BOREAS trial. According to a Regeneron press release, the NOTUS trial also confirmed that treatment led to rapid and significant improvements in lung function by 12 weeks and were sustained at 52 weeks. Back in May, the companies also announced the success of the aforementioned BOREAS trial for investigational use of Dupixent in adults currently on maximal standard-of-care inhaled therapy (triple therapy) with COPD and evidence of type 2 inflammation. Earlier this year, the drug was granted FDA Breakthrough Therapy designation as an add-on maintenance treatment in ...
- Source: drugdu
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- November 29, 2023

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