Search Results for “FDA” – Page 152 – media

After selling Rubraca, Clovis Oncology unveils CRL for potential label expansion

Paul Schloesser Associate Editor Clovis Oncology is facing yet another setback with the FDA giving the battled company a complete response letter and rejecting a potential label expansion for its PARP inhibitor Rubraca. A new SEC filing Friday detailed how it received the CRL from the FDA on May 26, rejecting an sNDA for Rubraca as a first-line maintenance treatment for women with advanced ovarian cancer who are in complete or partial response to a first-line, platinum-based chemotherapy. FDA said that for the agency to reconsider the application, per the filing, Clovis would need to show results from an overall survival analysis that “do not demonstrate a potential OS detriment.” In the meantime, Clovis said that the FDA’s determination would impact the timing and achievability of milestone payments that Clovis is owed. The company sold rights to its PARP inhibitor to Swiss company pharma& Schweiz GmbH in an April deal ...
- Source: drugdu
- 206
- June 7, 2023
NICE recommends Bristol Myers’ heart drug Camzyos in UK

Paul Schloesser Associate Editor Bristol Myers Squibb’s heart drug Camzyos has been recommended by the National Institute for Health and Care Excellence as the medication inches closer to approval in the UK and Europe. In final draft guidance released Friday, NICE recommended mavacamten (branded as Camzyos) as an add-on to standard care for symptomatic obstructive hypertrophic cardiomyopathy. Obstructive HCM is a heart condition that occurs when part of the muscular wall in the heart becomes thicker, which can then reduce blood supply to the rest of the body. NICE recommended the drug for several reasons. While the standard care for the disease treats symptoms, the organization said Camzyos is the first to treat oHCM, as compared with beta blockers, certain calcium channel blockers or disopyramide. Some of those treatments have side effects and are not always effective, the organization said. “We’re therefore pleased to be able to recommend a treatment ...
- Source: drugdu
- 245
- June 6, 2023
After nabbing historic RSV shot approval, GSK looks to boost US vaccination rates

Rates of vaccination in the U.S. have dropped in recent years, with the COVID-19 pandemic hitting uptake. GSK, with a new vaccine to market, is looking to help turn this around.GSK is running a new “COiMMUNITY Initiative” that will add new funds, deeper data transparency and collaboration for all vaccine uptake across the country. On the money side, GSK said in a press release that it is “committing” up to $1 million in grant funding to support groups focused on adult immunization and health equity. On the data and collaboration side, GSK said it will continue to make adult vaccination claims data available through Vaccine Track platform, which publishes on a quarterly basis. The company also said it will “enhance the platform’s capabilities.” GSK is also looking to open the platform up to public and private stakeholders “to potentially integrate and host additional data and viewpoints on adult vaccination trends,” ...
- Source: drugdu
- 129
- June 6, 2023
Look out, GSK. Pfizer has its adult RSV vaccine approval and is raring to launch

About a month after GSK won the world’s first approval for a respiratory syncytial virus (RSV) vaccine, rival Pfizer has followed suit. Late Wednesday, the New York drugmaker said its Abrysvo won FDA approval to prevent against lower respiratory tract disease caused by RSV in adults 60 and older. Both companies are looking to launch their offerings ahead of the upcoming RSV season, which typically starts in the late fall. Before the launch, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) will meet later this month to discuss recommendations for the newly approved RSV shots. Pfizer expects to make the vaccine available in the third quarter, should ACIP members put their support behind the vaccine. The FDA approved Abrysvo based on data from a phase 3 trial called RENOIR, which enrolled about 37,000 participants. In the study, the vaccine achieved 66.7% protection against RSV-associated lower ...
- Source: drugdu
- 125
- June 5, 2023
Medicare details plan to cover Alzheimer’s treatments

Medicare Part B will cover treatments for Alzheimer’s disease that receive U.S. Food and Drug Administration approval, according to the federal agency that administers the program for seniors. Anyone who has Medicare Part B and meets “eligibility criteria” will be covered for new antibody treatments such as Leqembi once the FDA approves them, said Chiquita Brooks-LaSure, the administrator of the Centers for Medicare & Medicaid Services, on Thursday. Part B is an optional part of the Medicare program for seniors that typically covers the costs of drugs patients cannot administer themselves, such as infusions. The new policy will provide broader access to treatments, such as Leqembi, that slow cognitive decline. But patients will have to participate in so-called registries that collect real-world data on how the drugs work. Brooks-LaSure said the expanded coverage will go into effect on the same day the FDA approves an Alzheimer’s antibody treatment. The FDA ...
- Source: drugdu
- 115
- June 4, 2023
Lawmakers look to crack down on Big Pharma tax breaks

Drug pricing crackdowns aren’t the only way lawmakers are looking to reign in pharma’s business practices. With scrutiny of the industry intensifying on Capitol Hill, a Senate committee is now shining a spotlight on how Big Pharma is paying taxes, too. Earlier this month, Senate Finance Committee Chair Ron Wyden, D-Ore., released a memo revealing the latest findings of an ongoing investigation into how the industry has used a Trump-era law to reap massive decreases in tax rates. “Big Pharma gets us coming and going — they charge Americans sky-high prices and they pay absolute rock-bottom taxes,” Wyden said in a statement. According to Wyden, the industry has been leveraging a 2017 law that triggered a 40% reduction in the industry’s tax rate since it was enacted. All told, Wyden’s investigation found that in 2019 and 2020, the industry paid an effective tax rate of 11.6%, down from 19.6% on ...
- Source: drugdu
- 164
- June 3, 2023
Medicare holds firm on Alzheimer’s drug coverage policy

By Rachel Cohrs CMS Administrator Chiquita Brooks-LasureCHIP SOMODEVILLA/GETTY IMAGES WASHINGTON — Despite pressure from Congress and advocates, Medicare isn’t changing its coverage plan for new Alzheimer’s drugs anytime soon. Medicare on Thursday issued a statement reiterating its intent to require patient registries to collect data about how medications perform even after they gain full Food and Drug Administration approval. Eisai’s Leqembi could gain full approval within the next month, so time is running short for the agency to solidify details. Right now, Leqembi and Biogen’s Aduhelm only have accelerated approval from the FDA, and are subject to even more restrictive coverage limits that require patients to be enrolled in a clinical trial to receive the medications. If Leqembi wins full approval, those restrictions will relax slightly, but providers would still need to collect data about all patients who receive the drugs in a patient registry. Medicare had previously announced ...
- Source: drugdu
- 105
- June 3, 2023
77.4% ORR! Abbisko to present the updated clinical phase Ib data of Pimicotinib (ABSK021) at the 2023 ASCO Annual Meeting

SHANGHAI, May 28, 2023 /PRNewswire/ — Abbisko Therapeutics Co., Ltd. (“Abbisko Therapeutics” hereafter) today announced that the updated results of Phase Ib study of its CSF-1R inhibitor Pimicotinib (ABSK021) in treating patients with advanced tenosynovial giant cell tumor (“TGCT”), will be released at the 2023 American Society of Clinical Oncology (“ASCO”) annual meeting to be held in Chicago, USA from June 2 to June 6, 2023. The data demonstrates the excellent antitumor efficacy and the safety profile of Pimicotinib in the treatment of patients with advanced TGCT and will be presented with the title of “EFFICACY AND SAFETY PROFILE OF PIMICOTINIB (ABSK021) IN TENOSYNOVIAL GIANT CELL TUMOR (TGCT): PHASE 1B UPDATE” in a poster presentation with the poster Bd# of “493”. Among the data released by Abbisko, the most remarkable result is the objective response rate (ORR) of the 50 mg QD dose group of Pimicotinib (ABSK021), which reached 77.4% ...
- Source: drugdu
- 132
- May 31, 2023
EU regulators recommend yanking authorization for Novartis’ sickle cell med Adakveo after phase 3 miss

After Novartis’ sickle cell disease medicine Adakveo flopped in a phase 3 trial, European regulators promised to take a closer look at its prior approval. Now, the re-examination has come back with a recommendation to revoke authorization. The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) recommended snatching back Novartis’ approval after concluding that the med’s benefits did not outweigh the risks. The decision was based on the results of the phase 3 STAND trial, where the drug didn’t outperform placebo. Specifically, Adakveo (crizanlizumab) couldn’t reduce the number of painful crises leading to a healthcare visit. Adakveo-treated patients saw an average of 2.5 painful crises resulting in a healthcare visit over their first year of treatment, while patients in the placebo group had an average of 2.3. Another nail in the coffin was the average number of crises requiring a home healthcare visit or treatment, which ...
- Source: drugdu
- 162
- May 30, 2023
Merck’s Keytruda, Novartis’ Kisqali face their moment of truth in early-stage cancers

Two cancers studies are slated to grab significant attention at the upcoming American Society of Clinical Oncology 2023 annual meeting, and each could lead to a major label expansion for the companies involved. With KEYNOTE-671, Merck is looking to shake up how nonmetastatic non-small cell lung cancer (NSCLC) is treated by testing Keytruda both before and after surgery. For its part, Novartis will elaborate on the postsurgery data for Kisqali in early breast cancer from the NATALEE trial. When the company said the trial met its endpoint, investors sent the Big Pharma’s stock price up by 8% in a single day. Before the official data revelations on June 2 for NATALEE and June 3 for KEYNOTE-671, Fierce Pharma gathered expectations for the two studies from oncology leaders at Penn Medicine and MD Anderson Cancer Center plus market analysts at multiple firms. The NATALEE study could open a market that’s worth ...
- Source: drugdu
- 120
- May 30, 2023

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