Search Results for “FDA” – Page 52 – media

FDA Approves First-Of-Its Kind Drug to Ease Menopause Symptoms

An Astellas Pharma drug that treats hot flashes and night sweats from menopause is now approved by the FDA, a regulatory decision that makes the therapy the first one that hits a particular central nervous system target to ease the symptoms of this change in life. The Friday approval of the drug, fezolinetant, covers the treatment of moderate-to-severe vasomotor symptoms caused by menopause. Tokyo-based Astellas will market the once-a-day pill under the brand name Veozah. In an email, the company said the new drug will carry a wholesale price of $550 for a 30-day supply. Astellas expects Veozah will become available within three weeks. Menopause brings a decline in the production of estrogen and progesterone. The resulting hormonal imbalance can affect the way the body regulates body temperature, leading to hot flashes, the sudden and intense feelings of warmth. While hormone therapy is standard treatment for such vasomotor symptoms, ...
- Source: drugdu
- 143
- May 16, 2023
FDA greenlights a new type of drug for menopausal hot flashes

By Brenda Goodman, CNN CNN — The US Food and Drug Administration on Friday approved a new type of drug to treat hot flashes and night sweats during menopause. Veozah, or fezolinetant, made by Astellas Pharma, is the first approved neurokinin 3 (NK3) agonist. It blocks receptors in the brain that play a role in the regulation of body temperature. It’s an alternative to traditional hormone replacement therapies to manage hot flashes, which are a common symptom of menopause that can be disruptive if they become severe. Women at higher risk of stroke, heart attacks or some kinds of cancer are sometimes advised against using hormone replacement therapies because they increase the risk of blood clots and cancers. “Hot flashes as a result of menopause can be a serious physical burden on women and impact their quality of life,” said Dr. Janet Maynard, director of the FDA’s Office of ...
- Source: drugdu
- 115
- May 16, 2023
After costly setback, Astellas’ menopause drug crosses FDA finish line

After Astellas’ shot at a speedy FDA approval for its menopause drug was derailed in February, the therapy has finally crossed the FDA finish line. The drug, branded as Veozah, won FDA approval to treat moderate to severe menopause-related vasomotor symptoms. It’s the first nonhormonal neurokinin 3 (NK3) receptor antagonist approved to treat the condition. It’s been a bit of a bumpy road to the green light. After shelling out 13.1 billion Japanese yen ($97 million) to secure a priority review voucher and speed up the regulatory timeline, the FDA extended its review just days before the drug’s prior regulatory decision date. Vasomotor symptoms, or hot flashes and night sweats, are the hallmark of menopause. Some 60% to 80% of women experience the symptoms during or after menopausal transition, Astellas said in its release. The drug’s nonhormonal aspect is key because some people with menopause can’t take hormone therapies, the ...
- Source: drugdu
- 106
- May 16, 2023
Chiesi, Protalix’s PRX-102 secure FDA nod to treat Fabry disease

Chiesi Global Rare Diseases and Protalix BioTherapeutics have received approval from the US Food and Drug Administration (FDA) for PRX-102 (pegunigalsidase alfa) to treat Fabry disease in adult patients. The latest move follows the receipt of marketing authorisation for PRX-102 from the European Commission (EC) for the same indication. The PEGylated enzyme replacement therapy (ERT), PRX-102 is a recombinant human α‑Galactosidase‑A enzyme expressed in plant-cell culture that is designed for providing a long half-life. The therapy was found to have an initial half-life of 78.9 ± 10.3 hours, in clinical trials. Chiesi Global Rare Diseases head Giacomo Chiesi said: “While much progress has been made in the treatment of Fabry disease, there is still a need for new treatment options. “We established Chiesi Global Rare Diseases to deliver innovative therapies and solutions for people affected by rare diseases. “With the FDA approval of PRX-102, we can now offer people ...
- Source: drugdu
- 139
- May 15, 2023
ImmunityBio gets manufacturing-related FDA snub on cancer drug, shares crash

ImmunityBio was hit with a complete response letter from the FDA for its bladder cancer prospect, sending the California-based company’s stock into a steep slide Thursday. The company’s stock fell more than 50% in overnight trading after it announced in a Securities and Exchange Commission filing Wednesday that it received a CRL from the agency on its application for its drug Anktiva in combination with a vaccine mainly used against tuberculosis, Bacillus Calmette-Guérin. The treatment is designed for patients with BCG-unresponsive, non-muscle invasive bladder cancer. Shares in the overnight session tumbled to $3.39 from Wednesday’s closing price of $6.22. “The deficiencies relate to the FDA’s pre-license inspection of the company’s third-party contract manufacturing organizations,” ImmunityBio said in the filing. “Satisfactory resolution of the observations noted at the pre-license inspection is required before the [application] may be approved.” ImmunityBio said it has requested a meeting with the FDA to address the agency’s concerns. The ...
- Source: https://seekingalpha.com/news/3969942-immunitybio-stock-crashes-after-fda-snub-cancer-therapy
- 118
- May 14, 2023
Perrigo’s OTC birth control pill aces FDA expert meeting

The jury has spoken, giving a unanimous “yes” to push Perrigo’s birth control tablet Opill over the counter. Wednesday, experts from a joint FDA meeting of outside experts voted 17 to 0 in favor of Opill’s over-the-counter approval pivot. If approved later this year by the FDA, Opill would become the first OTC daily hormonal birth control pill cleared in the U.S. The unanimous vote came despite a number of big questions from the FDA about the potential for Opill’s responsible over-the-counter use in the real world. The FDA does not have to follow the advice of its advisory committees when making an approval vote, though it often does. Panelists had one main question to consider. Namely: Was there “adequate information to conclude that consumers will be likely to use [Opill] properly, such that the benefits of making this available for nonprescription use … exceed the risks.” Overall, panelists concluded ...
- Source: drugdu
- 122
- May 12, 2023
GSK’s RSV vaccine approved by FDA for older adults

GSK’s respiratory syncytial virus (RSV) vaccine has been approved in the US for the prevention of RSV-caused lower respiratory tract disease (LRTD) in adults aged 60 years and older. The US Food and Drug Administration’s (FDA) decision makes Arexvy the first RSV vaccine for older adults to be approved anywhere in the world. RSV is a common contagious virus characterised by several mild, cold-like symptoms. Although most people can recover within a week or two, older adults are at a high risk for severe disease. This is partly due to age-related decline in immunity. RSV can also exacerbate other conditions, including chronic obstructive pulmonary disease, asthma and chronic heart failure. Overall, RSV infections in older adults account for over 170,000 hospitalisations and approximately 14,000 deaths each year in the US. The company’s application was supported by positive results from its phase 3 AReSVi-006 trial, in which the vaccine showed ...
- Source: drugdu
- 140
- May 12, 2023
FDA completes inspection of Nexus’ manufacturing facility in US

The Food and Drug Administration (FDA) has successfully inspected Nexus Pharmaceuticals’ pharmaceutical manufacturing facility located in Pleasant Prairie, Wisconsin, US. The inspection will allow the company to commence commercial operations at the three-storey, 84,000ft² manufacturing facility. Nexus Pharmaceuticals stated that the regulatory approval process validates facilities’ compliance with stringent quality and safety standards. Equipped with advanced isolator technology, the Pleasant Prairie facility adheres to the highest current good manufacturing practice (CGMP) standards. It is designed to manufacture a broad range of injectable medications and will provide hospitals and clinicians access to affordable, safe, and critical-need medicines. Nexus Pharmaceuticals President and CEO Usman Ahmed said: “We are thrilled to receive the EIR for our Pleasant Prairie facility. “This is a major milestone for our company and reflects our commitments to reshoring sterile pharmaceutical manufacturing to the US. “We are proud of our team’s hard work and focus on achieving a ...
- Source: drugdu
- 119
- May 10, 2023
Manufacturing operations for Eli Lilly, Rentschler reprimanded by FDA

After FDA inspectors visited Eli Lilly and Rentschler Biopharma production sites in October 2022 and early 2023, respectively, the U.S.’ drug regulator is making concerns about the facilities public. In Form 483 filings posted this week, the FDA flagged Lilly’s site in Indianapolis for three manufacturing-related shortfalls and Rentschler’s Baden-Wurttemberg, Germany, site for five deficiencies. At Lilly’s site, the regulator said the company’s aseptic technique for an undisclosed drug’s filling operation was “deficient.” Specifically, operators “handled unprotected sterile components” in a way that “may introduce contaminants onto sterile surfaces” in certain areas, the FDA said. Aside from that observation, the FDA flagged “processing areas” for two filling lines as substandard. Again, the FDA flagged sanitization procedures as not meeting its standards. Inspectors visited Lilly’s Indianapolis site from Oct. 17-21, 2022. In parallel to the Indianapolis site inspection and filing, the FDA in April rejected Eli Lilly’s ulcerative colitis prospect mirikizumab over manufacturing-related shortfalls. It isn’t immediately clear whether the ...
- Source: drugdu
- 180
- May 8, 2023
After FDA rejection, Gilead’s Hepcludex looks set for full EU nod

Six months after Gilead got a smackdown in the United States for its drug to treat hepatitis delta virus (HDV), bulevirtide has scored a regulatory win in Europe. The Committee for Medicinal Products for Human Use (CHMP) has given bulevirtide a thumbs up for patients with HDV and compensated liver disease. If the European Commission signs off on the entry inhibitor, it will become the only authorized treatment for HDV in Europe. Known commercially as Hepcludex, the drug received conditional approval in Europe three years ago. Since then, a phase 3 trial has demonstrated the effectiveness and safety of the treatment. Gilead hoped the results of the MYR301 study—which were released in June of last year and showed significant viral declines after 48 weeks of treatment—would pave the way for approval in the U.S. But the FDA sent Gilead a complete response letter (CRL) citing manufacturing and delivery concerns. The regulator did not ask Gilead to conduct another ...
- Source: drugdu
- 385
- May 8, 2023

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