Search Results for “AstraZeneca” – Page 22 – media

AZ notches postmarket win for bleeding reversal agent Andexxa, plans to seek full approval

After a postmarketing study of AstraZeneca’s bleeding reversal agent Andexxa met its primary endpoint earlier than planned, AZ is ending the study at the recommendation of a data monitoring board.In the study, investigators tested Andexxa versus standard care in more than 450 patients with intracranial bleeding who have received blood thinners called factor Xa inhibitors. Those who received the AstraZeneca drug experienced superior hemostatic efficacy compared with the control arm, AZ said in a Monday release. Hemostatic efficacy is a measure of the body’s ability to stop the flow of life-threatening brain bleeds. “We are proud to offer the first and only approved treatment to specifically reverse FXa inhibitor activity and help achieve haemostasis, providing an effective and reliable treatment when immediate care is required,” AZ’s executive vice president of biopharmaceuticals R&D, Mene Pangalos, Ph.D., said in a statement. Now, the company will look to convert Andexxa’s speedy approvals in ...
- Source: drugdu
- 119
- June 7, 2023
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
- 205
- June 7, 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
AZ, Merck’s Lynparza wins FDA nod in prostate cancer subgroup following advisory committee vote

After a panel of independent experts endorsed a narrow approval for AstraZeneca and Merck’s Lynparza in metastatic castration-resistant prostate cancer (mCRPC), the FDA has followed suit.Lynparza can now be used in combination with Johnson & Johnson’s Zytiga and a corticosteroid to treat patients with mCRPC whose tumors have BRCA mutations. The approval limits Lynparza’s use in the mCRPC population to about 10% of patients. The FDA’s decision comes after agency staffers and a committee of outside experts argued that the drug only showed a favorable risk-benefit in that population. Results from the phase 3 PROpel trial showed that the combo cut the risk of disease progression or death by 34% compared with solo Zytiga in newly diagnosed mCRPC patients regardless of mutation status. However, the FDA noted a “significant design flaw” with the trial in its briefing documents ahead of the meeting. Specifically, the FDA argued that the study didn’t ...
- Source: drugdu
- 144
- June 3, 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
- 119
- May 30, 2023
With Novartis circling, Lilly touts Verzenio’s ability to help cancer patients make memories in TV ad

Eli Lilly is throwing more money behind breast cancer drug Verzenio as it prepares to fend off a challenge from Novartis. Having seen growth hit 100% late last year, the Big Pharma has released a TV spot to push the message that Verzenio can help patients make new memories every day. Ads for Verzenio are a frequent sight on TV screens, with the estimated $111.8 million that Lilly spent on spots last year landing the drug in the 10 top most promoted products. Lilly has continued the promotional push in 2023. The “School Play” Verzenio spot was the second most seen pharma TV ad at the 65th Annual Grammy Awards early this year, and Lilly rolled out a fresh video earlier this month. The latest ad opens with a gray-haired Black woman sitting on a sofa looking at a photo album. As the camera zooms in and flips to an over-the-shoulder shot, a voice-over by the woman says ...
- Source: drugdu
- 126
- May 27, 2023
Crick Institute announces new molecular glue discovery to treat different diseases

A combined investment of £11.2m that includes a prosperity partnership grant from the Engineering and Physical Sciences Research Council (EPSRC) and funds from AstraZeneca (AZ) has enabled researchers at the Francis Crick Institute, Imperial College London and AZ to discover new ‘molecular glues’ to treat multiple diseases. Widely used as protein degraders, molecular glues bring together proteins that would not usually interrelate. The glues manage the modification and degradation of disease-causing target proteins by redirecting them to the cell’s natural waste disposal system. By facilitating the interaction between target protein and a cellular enzyme, the target protein is deactivated or broken down by additional proteins that are recruited by the enzyme. Group leader at the Crick Institute, Ed Tate, said: “Challenges arise when we can’t find a small molecule with the ability to interact with certain proteins. “If we can redirect these harmful proteins towards the cell’s own waste disposal ...
- Source: drugdu
- 113
- May 25, 2023
Despite rough quarter, Bayer’s duo of Nubeqa and Kerendia continue to excel

As Bayer presented its first-quarter earnings, much of the focus centered on the company’s struggling agricultural sector, which has been hindered by the poor performance of its glyphosate-based weedkillers. Somewhat under the radar is Bayer’s pharma business, which could use a boost as well. On the company’s list of best-selling medicines, seven of the top 10 posted a sales decline from the first quarter of last year. That list doesn’t include the aging eye treatment Eylea, which was up 2% on the quarter. Still, the drug posted a sequential (PDF) sales decline of 4% from the fourth quarter of last year. It all adds up to lots of pressure to perform for Bayer’s most promising new treatments—prostate cancer drug Nubeqa and kidney disease therapy Kerendia. Bayer’s small dose of good news on Thursday is that both are progressing nicely. The company has projected the drugs will generate 3 billion euros ($3.2 billion) each at peak. During the ...
- Source: https://www.fiercepharma.com/pharma/rough-quarter-bayers-duo-nubeqa-kerendia-continue-excel
- 124
- May 14, 2023
Johnson & Johnson’s PARP combo nabs first global nod but faces tough fight against AZ, Merck’s Lynparza

Johnson & Johnson’s idea to carve out the prostate cancer indication from GSK’s PARP inhibitor Zejula has yielded its first global approval. Following a recommendation from the European Medicines Agency, the European Commission has officially approved J&J’s Akeega in metastatic castration-resistant prostate cancer (mCRPC), J&J said Friday. The drug is a fixed-dose combo of Zejula and J&J’s androgen-directed Zytiga, and it’s used alongside a corticosteroid. Under a 2016 deal with Zejula’s developer Tesaro, J&J specifically carved out rights to the drug in prostate cancer. GSK then bought out Tesaro in 2019. Not all patients can get Akeega under the drug’s European label. To be eligible, a patient’s tumor must test positive for BRCA1/2 mutations, which account for 10% to 15% of all cases, J&J said. Akeega’s label in Europe is narrower than that of rival PARP inhibitor Lynparza from AstraZeneca and Merck. The European Commission in December cleared Lynparza and Zytiga for mCRPC ...
- Source: drugdu
- 126
- May 3, 2023
Sanofi, Regeneron unveil ‘blow-out’ smoker’s lung drug data

March 23 (Reuters) – Sanofi’s (SASY.PA) asthma drug Dupixent met all targets in a trial to treat “smoker’s lung”, potentially adding billions to the French drugmaker’s growth prospects, but also underscoring a heavy reliance on its bestseller. In a late stage trial Dupixent, jointly developed with Regeneron (REGN.O), led to a 30% reduction in moderate or severe acute exacerbations of chronic obstructive pulmonary disease (COPD), a potentially deadly disease marked by progressive lung function decline. Shares in Sanofi and Regeneron surged after they said in a joint statement on Thursday a Phase III trial involving 939 current or former smokers also showed improvements in lung function, quality of life and respiratory symptoms. The French group’s stock was up 5.2% at 1205 GMT, reaching a seven-month high and far outperforming the STOXX Europe 600 Health Care index (.SXDP), which was little changed. Regeneron jumped 8.6% in U.S. ...
- Source: drugdu
- 179
- April 28, 2023

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