Search Results for “FDA” – Page 28 – media

Merck’s 21-Valent Pneumococcal Conjugate Vaccine Granted FDA Priority Review

Pharmaceutical Executive Editorial Staff Merck’s Biologics License Application for V116, a novel 21-valent pneumococcal conjugate vaccine has been given a Prescription Drug User Fee Act (PDUFA) date of June 17, 2024. The FDA has granted priority review to Merck’s Biologics License Application (BLA) for V116, a novel 21-valent pneumococcal conjugate vaccine developed as a single dose for the prevention of invasive pneumococcal disease and pneumococcal pneumonia in adults. The BLA has been given a Prescription Drug User Fee Act (PDUFA) date of June 17, 2024. “Invasive pneumococcal disease poses a greater risk to older adults or those with weakened immune systems, in part due to disease-causing serotypes not covered by currently licensed pneumococcal conjugate vaccines,” Eliav Barr, MD, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories, said in a press release. “If approved, V116 would be the first pneumococcal conjugate vaccine specifically designed ...
- Source: drugdu
- 133
- December 25, 2023
FDA Grants Priority Review to Genentech’s sBLA for Xolair to Treat Food Allergies

Pharmaceutical Executive Editorial Staff If approved by the FDA, Xolair would be the first drug indicated to lower allergic reactions to multiple foods after an accidental exposure, including peanut, milk, and egg allergies. The FDA has granted Priority Review to Genentech’s supplemental Biologics License Application (sBLA) for Xolair (omalizumab) for the treatment of allergic reactions, such as anaphylaxis, that may result from an accidental exposure to one or more foods in patients aged 1 year and older with a food allergy. If the FDA approves the application, Xolair would be the first drug indicated to lower allergic reactions to multiple foods after an accidental exposure. Roche said it expects the FDA to decide on the approval in the first quarter of 2024. “Despite the significant and growing health burden from food allergies, treatment advances have been limited,” said Levi Garraway, MD, PhD, Genentech’s chief medical officer and head of Global ...
- Source: drugdu
- 103
- December 22, 2023
Calliditas wins over FDA for full approval, broader label on kidney disease drug Tarpeyo

Two years after securing an accelerated approval for its primary immunoglobulin A nephropathy (IgAN) therapy Tarpeyo (budesonide), Calliditas Therapeutics has scored a full FDA endorsement for the oral, delayed-release drug. Tarpeyo becomes the first treatment fully approved in the United States specifically for the chronic autoimmune kidney condition, also known as Berger’s disease. While some graduations from accelerated to full approval are ceremonial, this endorsement carries extra weight as it expands the label for Tarpeyo, allowing it to be accessed by all patients with IgAN. Perviously, the FDA limited the med’s use to those at risk for rapid disease progression. The expansion was facilitated by a confirmatory trial, which was the first phase 3 IgAN study to show significant improvement in estimated glomerular filtration rate (eGFR), which is the most reliable measure of kidney function. The results showed that Tarpeyo can reduce the time to kidney failure by 30%, potentially ...
- Source: drugdu
- 222
- December 22, 2023
FDA drafts guidance outlining real-world evidence for medical device submissions

Dive Brief The Food and Drug Administration posted a draft guidance on Monday clarifying how it evaluates real-world data in its decisions to clear or approve medical devices. The draft is an update to a final guidance in 2017 and includes more detail on how the agency assesses the relevance and reliability of real-world data, study design elements and recommendations on documentation for FDA review. An omnibus spending bill passed at the end of 2022 required the FDA to issue a draft guidance on the use of real-world data in premarket submissions. Two years after the public health emergency ended, the law also requires the FDA to specify how many requests for clearance or approval it has received and how many of those applications were approved or denied when real-world evidence was submitted. Dive Insight The 21st Century Cures Act, signed into law in 2016, created a framework for the ...
- Source: drugdu
- 117
- December 21, 2023
Chiesi Rare Skin Disease Drug Acquired in Billion Dollar Deal Wins FDA Approval

Chiesi Group’s Filsuvez is the second drug to win FDA approval for epidermolysis bullosa and the first for junctional EB, a more severe form of the rare skin disease. The birch tree bark-derived drug is from Chiesi’s $1.25 billion Amryt Pharma acquisition. By FRANK VINLUAN The rare inherited disorder epidermolysis bullosa, or EB, leads to skin so fragile that it tears like tissue paper. The resulting wounds and blisters are slow to heal and prone to infection. On Tuesday, the FDA approved a Chiesi Group drug developed to promote faster wound healing in EB patients. Privately held Chiesi will market its new drug as Filsuvez, the same brand name for the product in Europe, where it won its first regulatory approval last year. The FDA decision for this topical gel covers the treatment of patients age six months and older. EB stems from a mutation to the gene that codes ...
- Source: drugdu
- 101
- December 21, 2023
After missing out on FDA voucher, bluebird quickly raises funds to support gene therapy launches

Despite bluebird bio winning a recent FDA nod for its much-anticipated sickle cell disease gene therapy Lyfgenia, the regulatory triumph left something to be desired for the company because the agency didn’t grant a lucrative priority review voucher (PRV). That came as a surprise to bluebird, which had previously inked a deal to sell a potential PRV to Novartis for $103 million. Now, bluebird is hurrying to raise millions of dollars—through two separate avenues—to fund the launch of its new sickle cell disease gene therapy and others. In one fundraising approach, bluebird said it reached an agreement to hand over future gene therapy revenues to Alterna Capital Solutions in exchange for up-front funding. The deal covers a maximum credit of $100 million for bluebird, the company said in an SEC filing (PDF). Additionally, bluebird is working with Goldman Sachs and J.P. Morgan Securities to sell $150 million in new shares. ...
- Source: drugdu
- 97
- December 21, 2023
Glaukos wins FDA approval for drug-releasing eye implant to treat glaucoma

Dive Brief Glaukos Corporation received Food and Drug Administration approval for a drug-releasing implant that is designed to reduce intraocular pressure in patients with ocular hypertension or open-angle glaucoma. The implant was approved for single administration per eye. The device continuously delivers a formulation of travoprost, an established treatment for high pressure in the eye, to provide patients with an alternative to eye drops and remove the risk that noncompliance with the treatment regimen will affect outcomes. Glaukos failed to secure approval for repeat dosing but plans to work with the FDA to change the label. The wholesale acquisition cost (WAC) is $13,950 per dose, or implant, well above analysts’ expectations. William Blair analysts estimated the price would fall in a range of from $3,000 to $4,000 per implant, while BTIG analysts said they modeled a price of $5,000. Dive Insight Glaukos expects to generate up to $310 million in ...
- Source: drugdu
- 93
- December 19, 2023
FDA Approves Padcev/Keytruda Combo for Locally Advanced, Metastatic Urothelial Cancer

Pharmaceutical Executive Editorial Staff In clinical trials, Padcev (enfortumab vedotin-ejfv) plus Keytruda (pembrolizumab) produced a statistically significant improvement in survival compared to platinum-based chemotherapy alone in patients with locally advanced or metastatic urothelial cancer. Image credit: Olivier Le Moal | stock.adobe.com The FDA has approved Padcev (enfortumab vedotin-ejfv; Astellas Pharma and Seagen [now owned by Pfizer]) plus Keytruda (pembrolizumab; Merck) for patients with locally advanced or metastatic urothelial cancer (la/mUC).1 The FDA previously granted the application with priority review and breakthrough designation. The efficacy of the combination was evaluated in the open-label, randomized EV-302/KN-A39 (NCT04223856) trial, which enrolled 886 patients with la/mUC who received no prior systemic therapy for advanced disease. Patients were randomly assigned 1:1 to receive either Padcev with Keytruda or platinum-based chemotherapy consisting of gemcitabine with either cisplatin or carboplatin. The trial’s major efficacy outcomes were overall survival (OS) and progression-free survival (PFS) as assessed by blinded ...
- Source: drugdu
- 97
- December 19, 2023
With new FDA approval, Merck’s Welireg takes another step toward blockbuster goal

Since Merck secured approval for kidney cancer pill and blockbuster hopeful Welireg (belzutifan) in August of 2021, sales have grown slowly but surely. With a second FDA nod on Thursday for a much larger patient population, the company can anticipate a more pronounced upswing in revenue from the hypoxia-inducible factor-2 alpha (HIF-2a) inhibitor. The U.S. regulator has given a thumbs up for Welireg to treat relapsed or refractory renal cell carcinoma (RCC) for adult patients who have not responded to a PD-1 or PD-L1 inhibitor and who have also been treated with a vascular endothelial growth factor tyrosine kinase inhibitor (VEGF-TK1). Welireg becomes the first drug in its class for patients with advanced RCC and the first novel-class treatment in the indication since 2015, Merck noted. The nod comes on top of its original approval to treat the rare von Hippel-Lindau disease, a hereditary condition that causes tumor growth in ...
- Source: drugdu
- 92
- December 19, 2023
Arcutis’ Zoryve bags 2nd FDA nod, this time as a foam to treat ‘the great neglected disease in dermatology’

About a year after Arcutis Biotherapeutics unveiled positive data on roflumilast foam at the European Academy of Dermatology and Venereology congress 2022, the company has clinched a second FDA OK. Late Friday, Arcutis’ roflumilast—now approved in both cream and foam form under the brand name Zoryve—passed muster with U.S. regulators to treat seborrheic dermatitis in patients ages 9 and older. Arcutis has previously estimated there are more than 10 million people in the U.S. with seborrheic dermatitis, which causes red patches on the skin covered with large, flaking scales and a persistent itch. The disease most often affects parts of the body with oil-producing glands, such as the scalp, face, upper chest and back. Back in July 2022, roflumilast’s cream formulation won the company’s first approval in plaque psoriasis. In both its forms, roflumilast targets phosphodiesterase-4 (PDE4), an intracellular enzyme that boosts production of pro-inflammatory mediators and decreases production of ...
- Source: drugdu
- 88
- December 19, 2023

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