PharmaFocus Today – Page 294 – media

Phathom passes acid tests, capturing 2 FDA approvals for Voquezna after impurity setback

In a span of three days, Phathom Pharmaceuticals has scored two green lights from the FDA for its first-in-class heartburn drug Voquezna (vonoprazan). The first came Monday when the regulator signed off on Phathom’s reformulation of Voquezna to treat Helicobacter pylori infection. The second came Wednesday when the FDA blessed Voquezna for gastroesophageal reflux disease erosive esophagitis (erosive GERD) and associated heartburn. Two approvals for the same compound in a week is unusual. The FDA originally endorsed Voquezna for H. pylori in May of last year, but then it put Phathom’s launch plans on hold when trace levels of a cancer-causing agent were discovered in commercial batches of the treatment. That initial approval was later revoked. During the impurity-related holdup, the FDA also iced Phathom’s application for approval for erosive GERD. In April, after receiving complete response letters for both applications, Phathom said that it had shown the FDA stability ...
- Source: drugdu
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- November 4, 2023
Sarepta enjoys early sales ramp for DMD gene therapy, maintains confidence in label expansion

The third quarter marked a momentous one for Sarepta Therapeutics, bringing the long-anticipated launch of its Duchenne muscular dystrophy (DMD) gene therapy Elevidys. After traveling a tumultuous road to the June approval, Sarepta reaped $69.1 million from Elevidys’ first quarter on the market. The number was more than enough to beat analysts’ expectations of between $20 million and $24 million. Sarepta stayed mum on exactly how many patients have received an infusion and instead provided revenue as a marker for uptake, CEO Doug Ingram said on Sarepta’s third-quarter earnings call. The drug is priced at $3.2 million per infusion. Also on the call, Sarepta reiterated its confidence that its phase 3 EMBARK study can potentially support a label expansion for Elevidys despite missing its primary endpoint. The company’s discussions with FDA leadership have shown that the agency is open to the idea of a label expansion “if supported by review ...
- Source: drugdu
- 172
- November 4, 2023
FDA warning letter accuses Wavi of selling unapproved neurological device

Dive Brief The Food and Drug Administration has sent a warning letter to Wavi, accusing the company of selling an unauthorized device to help diagnose patients with potential neurological conditions. Wavi markets its headset, plus associated devices and software, as providing a baseline scan for patients who have a traumatic event, an injury or are worried about their brain as they age. The FDA, which sent inspectors to Wavi’s facility in Denver in March, views the technology as a medical device and sent a warning letter because the product lacks premarket approval. Dive Insight In the letter, the FDA states that Wavi promotes and distributes Wavi Desktop, a product that collects, analyzes and interprets electroencephalograph data, event-related potentials and heart rate variability data. The instruction manual “contains evidence that the device is intended to aid in the evaluation of autonomic nervous system function, head injury, depression, attention-deficit/hyperactivity disorder, anxiety, and ...
- Source: drugdu
- 268
- November 3, 2023
$13M NIH grant funds research to rejuvenate immune system in older adults

University of Arizona Health Sciences researchers received a $13.1 million grant from the National Institute on Aging to continue studies aimed at rejuvenating the immune system of older people in order to improve health throughout the lifespan. Older adults are disproportionally affected by infection, cancer and certain types of autoimmune disease. This is influenced by the fact that as a person ages, their body produces fewer T cells and gets less proficient at maintaining them. T cells are a type of white blood cell essential to the immune system and defense against infection. Janko Nikolich, MD, PhD, principal investigator, professor and head of the Department of Immunobiology at the University of Arizona College of Medicine – Tucson, said, “It is clear how much our immune system declines with age when you look at all the previous epidemics and pandemics that have hit us, including COVID-19. Older adults die at a ...
- Source: drugdu
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- November 3, 2023
More Than 60 Groups Ask Senate Leadership To Pass Legislation To Lower Drug Prices

In a letter to Senate leadership, several organizations asked for the passing of legislation that would reform the patent system and improve competition in the prescription drug space. By MARISSA PLESCIA More than 60 organizations sent a letter Wednesday to Senate Majority Leader Chuck Schumer (D-New York) and Senate Minority Leader Mitch McConnell (R-Kentucky). The letter calls for the passing of legislation that the organizations say would lower drug prices through patent reform and increased competition. The organizations include Patients for Affordable Drugs Now, a nonprofit fighting to lower prescription drug prices, and AARP, a nonprofit focused on Americans aged 50 and older. They call for the Senate leadership to advance the following bills: • S. 142, which would tamp down on pay-for-delay deals. This refers to when brand name drug makers pay potential generic and biosimilar competitors to prevent them from bringing their product to market. • S. 150, ...
- Source: drugdu
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- November 3, 2023
FDA Grants Fast Track Designation to Sellas Life Sciences’ SLS009 for Lymphoma

Don Tracy, Associate Editor SLS009 is a novel CDK9 inhibitor under investigation for the treatment of relapsed/refractory peripheral T-cell lymphomas. Sellas Life Sciences announced that the FDA has granted Fast Track Designation to SLS009, its novel and highly selective CDK9 inhibitor, for the treatment of relapsed/refractory (r/r) peripheral T-cell lymphomas (PTCL). The designation intends to facilitate the development and review of drugs to treat serious conditions and fill an unmet medical need.1 “The FDA’s decision to grant SLS009 Fast Track designation signifies an important milestone towards developing a safe and effective treatment for PTCL, a group of aggressive and rare non-Hodgkin lymphomas, and underscores the urgent need for innovative therapies such as SLS009 that can significantly improve the outcome of PTCL patients,” said Angelos Stergiou, MD, ScD hc, president, CEO, Sellas, in a company press release. “SLS009 has demonstrated very promising clinical responses in PTCL patients in the recently completed ...
- Source: drugdu
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- November 3, 2023
Amgen scores FDA approval for Stelara biosimilar

Amgen’s interchangeable biosimilar version of Johnson & Johnson’s (J&J) Stelara, dubbed Wezlana (ustekinumab-auub), has received an US Food and Drug Administration (FDA) approval. The interchangeable biosimilar was approved for use in multiple inflammatory diseases, including for adults with moderate-to-severe plaque psoriasis who are candidates for phototherapy or systemic therapy, active psoriatic arthritis, moderate to severe active Crohn’s disease and moderate to severe active ulcerative colitis. The agency approved Wezlana after a comprehensive review of scientific evidence, which showed that Wezlana was highly similar to ustekinumab and there were no clinically meaningful differences between the products in regard to safety, purity, and potency. Stelara was first approved by the FDA for the treatment of adult patients with moderate to severe plaque psoriasis in September 2009. The FDA later approved the IL-12/IL-23 inhibitor’s use in moderate to severe Crohn’s disease in November 2016, and later for active psoriatic arthritis and ulcerative colitis. ...
- Source: drugdu
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- November 3, 2023
Novavax’s XBB.1.5-adapted COVID-19 vaccine receives EC approval

Novavax has announced that its updated COVID-19 vaccine, Nuvaxovid XBB.1.5, has been approved by the European Commission (EC) for active immunisation in individuals aged 12 and older. The decision follows a positive opinion for approval by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP). Developed to target the Omicron XBB sublineage, the updated vaccine prepares the body’s defences against COVID-19 and contains a version of the spike protein of the Omicron XBB.1.5 subvariant, as well as Matrix-M adjuvant to strengthen immune response. The approval was based on non-clinical data which showed that the vaccine induced functional immune responses against the COVID-19 variants XBB.1.5, XBB.1.16 and XBB.2.3. Additionally, the updated vaccine induced neutralising antibody responses to newly emerging subvariants of the SARS-CoV-2 virus, BA.2.86, EG.5.1, FL.1.5.1 and XBB.1.16.6, as well as strong CD4+ polyfunctional cellular (T-cell) responses against EG.5.1 and XBB.1.16.6. Based on previous recommendations by ...
- Source: drugdu
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- November 3, 2023
BioMarin’s longtime CEO Jean-Jacques Bienaimé hands the reins to Genentech’s Alexander Hardy

After 18 years at the helm, BioMarin’s CEO Jean-Jacques Bienaimé is hanging up the gloves. But he won’t be leaving the company without capable hands. Genentech CEO Alexander Hardy is leaving his current post—effective immediately—and will replace Bienaimé upon the BioMarin chief’s retirement on December 1. The transition comes after a “multi-year succession planning process” and a comprehensive search by BioMarin’s board, the company’s lead independent director Richard A. Meir said in a Wednesday statement. The Genentech CEO fit the bill as a candidate with “experience driving commercial growth and operational excellence,” Meier, who will now become chair of BioMarin’s board of directors, added. When Bienaimé took over BioMarin in 2005, the company was collecting some $26 million annually from its one marketed product, enzyme replacement therapy Naglazyme. Now, thanks to dwarfism med Voxzogo and hemophilia A gene therapy Roctavian, BioMarin recently turned a corner into profitability after many years ...
- Source: drugdu
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- November 3, 2023
Merck’s Keytruda nabs FDA nod in biliary tract cancer, catching up with AstraZeneca’s Imfinzi

After AstraZeneca’s Imfinzi last year claimed new territory in the biliary tract cancer space, Merck’s Keytruda has hit the scene with an FDA nod to match its rival. The approval in locally advanced unresectable or metastatic biliary tract cancer, combined with the chemotherapies gemcitabine and cisplatin, marks Keytruda’s sixth U.S. nod in gastrointestinal cancer, Merck said. The FDA based the approval on data from the company’s Phase 3 KEYNOTE-966 trial, which showed that the Keytruda-chemo combo extended patients’ survival time compared with chemotherapy alone. In the study, patients in the treatment arm lived a median 12.7 months, compared to 10.9 months for those on solo chemo. The Keytruda-chemo combo reduced the risk of death by 17% over solo chemotherapy, researchers found. In addition, Keytruda-treated patients experienced a longer median duration of response at 9.7 months, compared with 6.9 months for solo chemotherapy. Merck is “proud” to offer the new treatment ...
- Source: drugdu
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- November 3, 2023

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