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FDA approves UCB’s inflammatory disease drug Bimzelx for plaque psoriasis

The US Food and Drug Administration (FDA) has approved UCB’s inflammatory disease drug to treat moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.The decision makes Bimzelx (bimekizumab-bkzx) the first and only approved psoriasis treatment designed to selectively inhibit IL-17A and IL-17F, two key cytokines driving inflammatory processes. More than 7.5 million adults in the US are affected by some form of psoriasis, a chronic inflammatory condition caused by dysfunction of the immune system, which results in skin cells reproducing at a faster rate than normal.Up to 90% of patients with psoriasis have plaque psoriasis, characterised by dry, raised, red skin lesions (plaques) covered with silvery scales. The plaques may be itchy or painful and can occur anywhere on the body, including the scalp, elbows, knees and lower back. As well as its physical manifestations, psychological impact has been increasingly recognised as a significant part of ...
- Source: drugdu
- 139
- October 20, 2023
Mirum’s plans to expand Livmarli’s market get hit as FDA pushes approval date

The US Food and Drug Administration (FDA) has announced an extended review of the Supplemental New Drug Application (sNDA) for Mirum Pharmaceutical’s Livmarli (maralixibat) to treat patients with cholestatic pruritus in progressive familial intrahepatic cholestasis (PFIC). The company announced that the FDA extended the prescription drug user fee act (PDUFA) date to allow time for a full review of a submission provided in response to an FDA information request, which is deemed to be a major amendment. The date has been pushed from 13 December to 13 March, 2024. The news was announced after markets closed on 17 October. Earlier today, Mirum’s stock opened more than 4% lower than the previous day. Mirum submitted the sNDA in February of this year based on the Phase III MARCH trial. The study was the largest randomised trial conducted for patients with PFIC. A statistically significant difference in efficacy was reported between the ...
- Source: drugdu
- 159
- October 20, 2023
After launch limitations, Johnson & Johnson exec touts manufacturing progress on CAR-T drug Carvykti

As Johnson & Johnson and Legend Biotech have sought to grow the reach of their multiple myeloma CAR-T drug Carvykti since winning FDA approval last year, they’ve occasionally run into manufacturing pitfalls. Now, with an eye on a big market expansion, J&J is laying out the state of its cell therapy production writ large. Over the past several months, J&J has been “progressively adding more and more capacity” to churn out Carvykti, John Reed, M.D., Ph.D., executive vice president of pharmaceuticals R&D, said on a Tuesday conference call. Aside from the company’s original launch site in New Jersey, Reed said J&J is close to having an additional Carvykti manufacturing site “up and rolling” in Belgium. The company also plans to boost output by leveraging excess capacity from Novartis under a relatively new partnership. Reed described the lentivirus portion of Carvykti as a “rate-limiting” component of the therapy. Lentiviral vectors are pricey delivery components used to ...
- Source: drugdu
- 112
- October 20, 2023
Ardelyx Nabs FDA Approval for First Phosphate Absorption Blocker in CKD

Pictured: Test-tube containing a blood sample for measuring serum phosphorus levels/iStock, Md Saiful Islam Khan The FDA on Tuesday gave the greenlight to Ardelyx’s tenapanor, now to be marketed under the brand name Xphozah, indicated to reduce serum phosphorus levels in patients with chronic kidney disease. Tuesday’s approval covers chronic kidney disease (CKD) patients on dialysis who had previously shown an inadequate response to phosphate binders, or who are otherwise intolerant to such therapies. Xphozah’s label bears no boxed warning but carries a precaution against severe diarrhea, the most common observed adverse event during the drug’s development. Ardelyx CEO Mike Raab called Tuesday’s approval an “important milestone” for dialysis patients, their families and the larger nephrology care community. Xphozah “represents a new mechanism and new option for patients who, despite treatment with phosphate binders, continue to have elevated phosphorus.” Xphozah is taken as 30-mg oral tablets twice-daily, before the morning and evening meals. Its ...
- Source: drugdu
- 111
- October 20, 2023
Ultimovacs Rebounds on New Universal Cancer Vaccine Data for Mesothelioma

Pictured: Artistic rendering of doctor diagnosing lungs on screen/iStock, greenbutterfly Despite missing the primary endpoint mark in June 2023, Ultimovacs hasn’t given up on trying to prove its universal cancer vaccine has a benefit for deadly mesothelioma. The Norwegian biotech reported new data Tuesday, proving strong clinical responses with extended overall survival in a follow up analysis. When combined with Bristol Myers Squibb’s Opdivo and Yervoy as a second-line treatment to platinum chemotherapy, Ultimovacs’ UV1 reduced risk of death by 27% for patients with malignant pleural mesothelioma, a cancer in the lining of the lungs. Caused by asbestos fibers that have embedded in the pleura, eventually leading to mesothelioma tumors, this cancer is aggressive and often incurable. The five-year survival rate for localized pleural mesothelioma, the most treatable type, is 24%. Median overall survival for patients receiving the vaccine combined with the checkpoint inhibitors was 15.4 months, compared to 11.1 months on the immunotherapy treatments alone. ...
- Source: drugdu
- 107
- October 20, 2023
Surgery to straighten a crooked septum more effective than nasal sprays, trial suggests

Surgery to straighten a crooked septum (the thin wall of bone and cartilage dividing the space between the two nostrils) is more effective than nasal sprays, and should be offered to adults with at least moderate symptoms such as breathing disruption, suggests a UK trial published by The BMJ today.A crooked (deviated) septum often means that one nasal passage is narrower than the other, making it feel blocked, which can affect breathing, sleep or exercising. Surgery to correct this (septoplasty) is a common operation. In 2019-20, 16,700 septoplasties were carried out in England, but there’s a lack of high quality evidence evaluating septoplasty and therefore no clear guidelines for its use.To address this, a team of UK researchers designed the Nasal Airways Obstruction Study (NAIROS) to provide definitive evidence and recommendations for use of septoplasty. Their aim was to inform guidance on which patients may benefit from this treatment, and ...
- Source: drugdu
- 145
- October 20, 2023
Amazon Starts Delivering Medications via Drone

Amazon Pharmacy is working to speed up prescription medication delivery in College Station, Texas, through its free drone delivery service, the company announced Wednesday. With drones, Amazon said prescriptions can be delivered within 60 minutes. Customers in College Station can sign up for the drone delivery service by scheduling a free yard consultation, in which a local yard survey specialist will come to customers’ homes and examine their yards. If the specialist determines that the yard is suitable, then Amazon will provide a marker where the drone can deliver packages. Then when eligible customers order their medications, they can select drone delivery at checkout. The service is available for more than 500 medications that treat common conditions, such as flu, asthma and pneumonia. These medications include Levofloxacin, Bactrim, Atorvastatin and Levothyroxine. For many of these conditions, swift access to treatment is vital, but that doesn’t always happen, said Dr. Vin ...
- Source: drugdu
- 176
- October 20, 2023
Annual Family Premiums for Employer Coverage Increase 7%

Annual family premiums for employer-sponsored coverage rose 7% on average to $23,968 in 2023, a new KFF survey shows. This comes after nearly no premium increase last year. Of that family premium total, workers are contributing $6,575 annually (a $500 increase from last year), while employers are covering the rest. And further increases are expected to come, with 23% of employers saying they will increase employees’ contributions in the next couple of years. The KFF Employer Health Benefits Survey included responses from more than 2,100 small and large employers. It was fielded between January and July of 2023. The report comes at a time when about 153 million Americans rely on employer-sponsored insurance. Employees of firms with fewer than 200 workers contribute significantly more toward family premiums than those at larger firms: $8,334 versus $5,889 on average, according to KFF. About a quarter of employees at small firms pay at ...
- Source: drugdu
- 100
- October 20, 2023
Actym Therapeutics Extends Series A Financing with Additional $25.5M Closing

In a company press release, Actym Therapeutics announced that it has extended its Series A financing round with an additional close of $25.5 million, bringing the total Series A amount raised to $59.5 million. Co-led by Boehringer Ingelheim Venture Fund and Illumina Ventures, with GKCC LLC as a new investor, the new capital is expected to enable ACTM-838 into first-in-human oncology trial. “We have advanced the STACT platform and defined a value-building clinical pathway that will allow us to translate our deep understanding of the tumor microenvironment into a novel approach to an effective and safe cancer treatment,” said Christopher Thanos, PhD, CEO, co-founder, Actym Therapeutics. “We value the continued commitment from our current investors and welcome GKCC LLC into the syndicate. Through their combined support, we aim to bring innovative therapies to patients across multiple solid tumor indications.” Image Credit: Adobe Stock Images/Carlos Montes Published on: October 19, 2023
- Source: drugdu
- 106
- October 20, 2023
Thermo Fisher Adds Proteomics to Its Portfolio Through $3.1B Olink Acquisition

Drug discovery increasingly requires sophisticated analysis of proteins, and Thermo Fisher Scientific is building up its capabilities to support such research with the $3.1 billion acquisition of Olink, a company whose technologies and services are used in laboratories around the world. According to deal terms announced Tuesday, Thermo Fisher, based in Waltham, Massachusetts, will pay $26 cash for each American depositary share of Olink. That price represents a premium of about 74% to the Uppsala, Sweden-based company’s closing stock price on Monday. When Olink made its Nasdaq debut in 2021, it priced shares at $20 apiece. Olink is a player in the field of proteomics, the analysis of proteins. But the company does not discover or develop new drugs. Rather, it provides tools and services for the scientists who do that research at biopharmaceutical companies and universities. The company sells kits that drug researchers can use to analyze proteins in ...
- Source: drugdu
- 231
- October 19, 2023

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