Search Results for “FDA” – Page 52 – media

FDA advisors recommend Pfizer’s RSV vaccine for infants but raise safety concerns

The U.S. Food and Drug Administration’s independent panel of advisors Thursday recommended full approval of Pfizer’s vaccine that protects infants from respiratory syncytial virus, but raised safety concerns over premature births that may be tied to the shot. The committee unanimously said the vaccine efficacy data was sufficient. Ten of the advisors said the safety data on Pfizer’s shot was adequate, while four said it was not. “If the vaccine actually lives up to the data we’ve seen today, I can guarantee many infants and their parents will breathe easier in the coming years,” said Dr. Jay Portnoy, medical director at the Children’s Mercy Hospital in Kansas City, after voting in favor of the safety and efficacy of the shot. Dr. Paul Offit, a vaccine expert at the Children’s Hospital of Philadelphia, said he doesn’t believe there is enough data that indicates the safety of the vaccine is “reassuring.” “If ...
- Source: drugdu
- 115
- May 20, 2023
Intercept’s latest NASH bid in jeopardy after FDA questions drug’s efficacy, safety

An industry-first FDA approval for a nonalcoholic steatohepatitis (NASH) therapy may still be a ways off.After reviewing Intercept Pharmaceuticals’ latest application for obeticholic acid (OCA), the agency appears all but ready to reject the drug in NASH-related pre-cirrhotic liver fibrosis, according to a briefing document released ahead of an expert panel meeting set for Friday. Citing a long list of safety risks and the practical hurdle for patients to undergo a liver biopsy—coupled with “modest” efficacy—the FDA said it “cannot justify OCA use in NASH subjects with stage 2 or 3 fibrosis.” The FDA’s negative review could once again thwart Intercept’s bid to win the first NASH approval in the U.S. If members of the FDA’s Gastrointestinal Drugs Advisory Committee side with the FDA and the agency follows through with its own staff’s analysis, it would mark the second rejection for OCA in NASH. Intercept’s stock price was down more ...
- Source: drugdu
- 145
- May 19, 2023
Allergan’s new skin-smoothing product gets FDA nod—with novel delivery mechanism

AbbVie’s aesthetics unit is growing its product catalog once again with a new FDA approval.The product, called Skinvive, nabbed an FDA nod this week and falls within Allergan’s Juvederm dermal filler collection. Skinvive works by injecting hyaluronic acid (HA), plus a small amount of lidocaine, into facial skin to increase hydration while smoothing. The delivery mechanism is the first of its kind and “flows easily into the skin,” creating a “lasting glow,” Allergan said in a recent release. Skinvive got the green light for use in adults over the age of 21 with all Fitzpatrick skin types I-VI covered, a skin classification scale that ranges from light to dark. Its effects last six months and the procedure requires little to no downtime, according to the company. The approval was supported by a pivotal clinical study in which 58% of patients saw their skin improve by more than one point on ...
- Source: drugdu
- 120
- May 19, 2023
`FDA advisory committee backs Sarepta’s Duchenne muscular dystrophy gene therapy

A US Food and Drug Administration’s (FDA) panel of experts has recommended Sarepta Therapeutics’ Duchenne muscular dystrophy (DMD) investigational gene therapy for accelerated approval. The Cellular, Tissue and Gene Therapies advisory committee voted eight to six in support of SRP-9001 (delandistrogene moxeparvovec) as a treatment for ambulatory DMD patients with a confirmed mutation in the DMD gene. DMD is a rare and inherited X-chromosome-linked disease that results in the lack of dystrophin protein, which is required to strengthen and protect muscles. Over time, this causes progressive loss of muscle strength, with most patients requiring full-time use of a wheelchair by their early teens. Eventually, increasing difficulty in breathing due to respiratory muscle dysfunction requires ventilation support, and cardiac dysfunction can lead to heart failure. The disease almost exclusively affects males, occurring in approximately one in every 3,500-5,000 newborn males worldwide. SRP-9001 is designed to address the underlying cause of DMD ...
- Source: drugdu
- 111
- May 18, 2023
Pfizer’s maternal RSV vaccine effective at preventing severe infections in newborns, FDA says, but flags potential risk of preterm birth

By Brenda Goodman, CNN CNN — Pfizer’s vaccine to protect newborns from respiratory syncytial virus, or RSV, by vaccinating their moms late in pregnancy cuts the risk that infants will need to see a doctor or be admitted to the hospital with a moderate to severe infection before 6 months of age, according to a new analysis by government regulators. Many parents have been eagerly anticipating this news, particularly after last year’s long and severe RSV season. RSV is a major cause of hospitalization in infants and the elderly each year, and it typically hits hardest during the winter months. Scientists have been working on an effective RSV for young children for roughly 60 years, so there’s plenty of excitement around the prospect of having a candidate get so close to the finish line. But the news isn’t all rosy. Safety data published in an agency analysis Tuesday also showed ...
- Source: drugdu
- 134
- May 18, 2023
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
- 150
- 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
- 120
- 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
- 111
- 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
- 142
- 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
- 121
- May 14, 2023

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