Search Results for “Astellas” – Page 5 – media

CHMP recommends European authorisation for seven new drugs

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended seven new drugs for authorisation. The drugs include Pfizer’s Elrexfio for the treatment of multiple myeloma and Astellas Pharma’s Veozah for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause. Elrexfio (elranatamab) is a subcutaneously administered bispecific B-cell maturation antigen-directed CD3 T-cell engager. The US Food and Drug Administration (FDA) granted accelerated approval for Elrexfio in August for patients who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody. According to GlobalData, sales for Elrexfio are expected to reach $536m by 2029. One of its competitors in the market is Talvey (talquetamab-tgvs), marketed by Janssen, which was approved as a fifth-line treatment for relapsed/refractory multiple myeloma in August. Talvey is forecasted to generate $1.9bn in sales by 2029. Astellas Pharma’s Veozah ...
- Source: drugdu
- 111
- October 19, 2023
Merck’s Keytruda Poised for Bladder Cancer Expansion with New Phase III Data

By Tristan Manalac Pictured: Merck signage outside its office in California/iStock, hapabapa Merck on Thursday reported that its blockbuster PD-1 inhibitor Keytruda (pembrolizumab) met one of its dual primary endpoints in the Phase III AMBASSADOR trial in muscle-invasive urothelial carcinoma. Details of the study were limited but Merck said that at a pre-specified interim analysis review Keytruda treatment led to a statistically significant and clinically meaningful improvement in disease-free survival compared with simple observation. AMBASSADOR is ongoing and will continue to assess the effects of Keytruda on overall survival (OS), the study’s second primary endpoint. The promising initial data from AMBASSADOR point to the “potential of Keytruda to prevent recurrence” in patients who had undergone surgery, Marjorie Green, senior vice president and head of late-stage oncology, global clinical development at Merck Research Laboratories, said in a statement. AMBASSADOR, also known as KEYNOTE-123, is a randomized and open-label study enrolling approximately ...
- Source: drugdu
- 104
- October 9, 2023
Merck’s Keytruda Poised for Bladder Cancer Expansion with New Phase III Data

Merck on Thursday reported that its blockbuster PD-1 inhibitor Keytruda (pembrolizumab) met one of its dual primary endpoints in the Phase III AMBASSADOR trial in muscle-invasive urothelial carcinoma. Details of the study were limited but Merck said that at a pre-specified interim analysis review Keytruda treatment led to a statistically significant and clinically meaningful improvement in disease-free survival compared with simple observation. AMBASSADOR is ongoing and will continue to assess the effects of Keytruda on overall survival (OS), the study’s second primary endpoint. The promising initial data from AMBASSADOR point to the “potential of Keytruda to prevent recurrence” in patients who had undergone surgery, Marjorie Green, senior vice president and head of late-stage oncology, global clinical development at Merck Research Laboratories, said in a statement. AMBASSADOR, also known as KEYNOTE-123, is a randomized and open-label study enrolling approximately 740 patients with localized muscle-invasive or locally advanced urothelial carcinoma. Pembrolizumab was ...
- Source: drugdu
- 103
- October 8, 2023
Taysha Drops Gene Therapy Candidate as FDA Again Calls for Study Changes

By Connor Lynch Pictured: FDA sign in its headquarters/iStock, Grandbrothers Taysha Gene Therapies has decided to drop its lead experimental AAV-based gene therapy candidate after the FDA reiterated calls for the company to put the treatment through a randomized, double-blind placebo-controlled trial. The Dallas-based company announced on Tuesday that it would no longer be developing its TSHA-120 treatment for giant axonal neuropathy (GAN) based on the FDA’s Type C meeting feedback regarding the therapy’s potential pathway. “FDA continues to recommend a randomized, double-blind, placebo-controlled trial as the optimal path to demonstrate efficacy in TSHA-120,” the company said in a statement. Taysha noted in the announcement that the FDA “provided a potential path for a single-arm trial with an external control group matched with to-be treated patients by multiple prognostic factors and recommended longer term follow up to account for potential bias.” CEO Sean Nolan said in a statement that the ...
- Source: drugdu
- 188
- September 22, 2023
AstraZeneca Latest to Sue Biden Administration Over IRA’s Drug Price Negotiations

By Nadia Bey Pictured: AstraZeneca’s San Francisco office/iStock, hapabapa AstraZeneca has joined a growing list of drugmakers suing the Biden administration over a provision in the Inflation Reduction Act that allows the federal government to negotiate Medicare drug prices, the company announced Friday. The British drugmaker is the latest pharma company to file a legal complaint. Boehringer Ingelheim filed a lawsuit Aug. 18, arguing that Medicare price negotiations under the IRA violate the company’s constitutional rights to due process, protection against excessive fines and free speech. Other companies—including Merck, Bristol Myers Squibb, Johnson & Johnson and Astellas—that have sued the U.S. government over the IRA have focused on constitutional arguments. Similarly, the lobbying group Pharmaceutical Research and Manufacturers of America filed a suit challenging the constitutionality of the law. However, AstraZeneca has taken a different approach in its legal complaint filed Aug. 25 in the U.S. District Court for the ...
- Source: drugdu
- 108
- August 30, 2023
FDA Approves J&J’s Akeega for BRCA-Positive Prostate Cancer

By Tristan Manalac Pictured: Janssen headquarters in California/iStock, Sundry Photography The FDA on Friday signed off on Janssen Pharmaceutical’s niraparib and abiraterone acetate tablets, now to be marketed as Akeega, for the treatment of metastatic castration-resistant prostate cancer in patients carrying the BRCA mutation. According to Janssen’s announcement, Akeega is the first dual-action tablet that combines the activity of a PARP inhibitor with abiraterone acetate, an androgen biosynthesis inhibitor sold by the company under the brand name Zytiga. Janssen is a subsidiary of Johnson & Johnson. The approval covers a combination regimen of Akeega with prednisone and is based on data from the Phase III MAGNITUDE study, a randomized, double-blinded and placebo-controlled trial with 765 participants. Compared with Zytiga plus prednisone, the Akeega-based regimen significantly improved radiographic progression-free survival by 47% in BRCA-positive patients. Akeega also led to a trend toward better overall survival, though this effect fell short of ...
- Source: drugdu
- 187
- August 16, 2023
FibroGen CEO Conterno, Who Scrapped Post-Lilly Plans Over Roxadustat Hype, Resigns After Launch Setbacks

Hopes around FibroGen’s anemia drug roxadustat were high in early 2020 when Enrique Conterno arrived as the company’s new CEO. He’d just come off a 27-year-run at Eli Lilly and was, according to an analyst interview at the time, “most impressed” by the commercial opportunity for roxadustat.But the last few years have not been kind to FibroGen and AstraZeneca’s drug, with an FDA rejection, commercial disappointments and a clinical trial flop considerably blunting the oral anemia med’s trajectory. It’s against that backdrop—plus a major layoff round—that Conterno, who’s been chief at FibroGen since January 2020, is now hitting the exit. Conterno has resigned from the FibroGen CEO post for “personal reasons,” the company said Tuesday. As FibroGen looks for a permanent successor, the company’s chief commercial officer Thane Wettig will don the mantle of interim chief executive officer. To support Wettig, Conterno plans to stick around as a special advisor to ...
- Source: drugdu
- 251
- July 27, 2023
Johnson & Johnson Becomes 4th Drugmaker to File Suit Against IRA’s Drug Price Negotiations

Johnson & Johnson has hopped on the litigation bandwagon, becoming the fourth large drugmaker to sue the U.S. government over drug price negotiations in the Inflation Reduction Act (IRA).In U.S. District Court in New Jersey, J&J claimed (PDF) that price negotiations by Medicare would violate the First and Fifth Amendments of the U.S. Constitution. Merck, Bristol Myers Squibb and Astellas have made the same argument in separate lawsuits. Last week in federal court in Washington, D.C., Merck applied more pressure, filing for a decision in its case without a trial. The U.S. Chamber of Commerce and industry association PhRMA have also filed suits with similar claims. “The government is forcing (J&J) to provide its innovative, patented medicines on pricing terms that by law must be significantly below market prices,” J&J said in a release. “This would upend the current self-sustaining cycle of pharmaceutical innovation that provides patients with access ...
- Source: drugdu
- 279
- July 20, 2023
Bayer needs ‘midsize acquisition’ to reach $10B oncology sales goal, exec says

Bayer recently laid out its ambition to achieve $10 billion in sales from its oncology business by 2030 and become a top 10 cancer drug player. To get there, the company is looking outside for a “midsize acquisition,” Bayer’s oncology chief Christine Roth said.Right now, Bayer’s Nubeqa leads the charge in the company’s oncology department, with its sales projected to peak at more than 3 billion euros. In addition, the company’s acquisitions of Vividion Therapeutics, BlueRock Therapeutics and Noria Therapeutics in recent years have bolstered its research capabilities. “We’ve done a lot of activity to fill our early pipeline,” Roth said in an interview with Fierce Pharma on the sidelines of the American Society of Clinical Oncology’s 2023 annual meeting. “But if we want to achieve that top 10 spot in the next four to six years, it’s going to take the right midsize acquisition to get there.” Roth agreed ...
- Source: drugdu
- 116
- June 15, 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

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