Search Results for “AstraZeneca” – Page 15 – media

Contentious Medicare price negotiations underway as US drug prices rise

The US’ HHS has sent the first offers to participating drug companies eligible for negotiation under the Medicare price negotiation programme as required by the Inflation Reduction Act (IRA). The Centers for Medicare and Medicaid Services is managing these talks, with a 30-day window given to involved drug companies to indicate acceptance of the suggested prices or present an alternative offer. Once both Medicare and the drug company agree on a price, the revised prices will become effective within Medicare in 2026.The IRA allows Medicare to directly negotiate to reduce prescription prices for certain drugs and requires certain companies to pay rebates back to Medicare if the drug prices exceed the rate of inflation. The first ten drugs selected to be negotiated in the programme include those marketed by pharma giants AstraZeneca and Merck & Co’s anti-diabetic drugs, Farxiga (dapagliflozin), and Januvia (sitagliptin), respectively. In the announcement accompanying the offers, CMS administrator Chiquita ...
- Source: drugdu
- 91
- February 7, 2024
Drug shortages challenge type 2 diabetes patients in the UK

Drug shortages are continuing to persist in the UK affecting patients with different conditions, including those with type-2 diabetes who are on GLP-1 receptor agonists (GLP-1 RAs). Earlier this month, NHS England issued a National Patient Safety Alert regarding the shortage of GLP-1Ras. This was following a similar one issued in July 2023, which stated and that supplies were unlikely to stabilise sufficiently to meet market demand until at least mid-2024. In response to the January alert, the Diabetes UK issued a statement saying such shortages were being seen globally due to an increase in off-label use of semaglutide for weight loss. The alert issued actions to be taken by healthcare workers, such as only prescribing GLP-1 RAs for their licensed indications, and prescribing Rybelsus, another form of the GLP1RA semaglutide, for new treatment initiations and for those patients who can be switched from AstraZeneca’s Byetta (exenatide) and Novo Nordisk’s ...
- Source: drugdu
- 93
- January 30, 2024
Gilead Drug Fails Pivotal Lung Cancer Study, But Still Might Have Path Forward

Gilead Sciences said even though Trodelvy missed the main goal of its Phase 3 test in non-small cell lung cancer, the drug’s preliminary results show numerical improvement in patients whose disease did not respond to prior treatment with immunotherapy. The company plans to discuss with regulators a possible path forward in these patients. By FRANK VINLUAN Sales for Gilead Sciences cancer drug Trodelvy are growing, but the company is counting on additional approvals to boost the product to blockbuster status and justify the premium price it paid to acquire the therapy. The drug’s failure in a pivotal lung cancer study is a setback to that strategy. Treatment with Trodelvy, an antibody drug conjugate (ADC), fell short of a Phase 3 study’s main goal of showing statistically significant improvement in overall survival in patients with advanced cases of non-small cell lung cancer (NSCLC), Gilead announced Monday. Nevertheless, the company pointed to numerical ...
- Source: https://medcitynews.com/author/fvinluan/
- 195
- January 24, 2024
Merck’s Keytruda again bags industry-first cervical cancer nod—with limitation

After crowning Keytruda as the first immunotherapy for advanced cervical cancer back in 2021, the FDA has awarded the drug another industry-first designation in an earlier stage of the tumor type. But again, the achievement was not perfect for Merck. Thanks to a new FDA nod, Merck’s Keytruda is the first PD-1 drug to be approved in combination with chemoradiotherapy to treat patients with stage 3 to 4a cervical cancer, the New Jersey pharma giant said Friday. This marks Keytruda’s 39th indication in the U.S. The approval, however, was narrower than expected. It came on the back of results from the Keynote-A18 trial, which showed a tumor progression benefit for the Keytruda-chemoradiation regimen in a broader patient population with earlier-stage cervical cancer. Keynote-A18 tested the Keytruda combo in patients whose cancer was as early as stage 1b2. Among the entire trial population, adding Keytruda to chemoradiotherapy slashed the risk of ...
- Source: drugdu
- 91
- January 21, 2024
Across 25 industries, pharma staffers most satisfied with compensation

2023 was riddled with labor strikes across industries as workers lobbied for higher pay amid economic headwinds that shook up the global economy. As for the biopharma industry, employees are more content with their income compared with workers in other fields, a new report suggests. USA Today recently analyzed more than 3 million reviews on the employee review service Glassdoor, focusing on 500 large companies in 25 industries and seeking to identify the industries with the highest number of pay-related complaints. Employees in the pharma and biotechnology sector reported the fewest number of pay complaints, according to the report. On the flip side, the healthcare field took the second-highest position for pay frustration, second only to education. Some drugmakers in particular rose above their peers and others in terms of pay. Novartis, GSK, AstraZeneca and Genentech made the list of the top-10 companies overall where employees are most satisfied with ...
- Source: drugdu
- 95
- January 21, 2024
Cell Therapy Startup With Stanford Roots Unveils $75M to Seek Inflammation Cures

Startup TrX1 develops cell therapies that function like a particular type of regulatory T cell, or Treg, whose role includes dampening inflammation and inducing long-term tolerance. Based on research from Stanford, TrX1’s lead program is a potential therapy for preventing graft-versus-host disease. By FRANK VINLUAN Post a comment / Jan 17, 2024 at 6:04 PM When immune cells go awry and spark inflammation, a different type of immune cell stands ready to counteract that effect and return the immune system to a state of balance. Therapies based on such cells are part of an emerging area of research for the treatment of a wide range of autoimmune diseases. The work of Tr1X focuses on a particular type of these cells and the startup has emerged from stealth with $75 million and a lead program on track for the clinic later this year. The cells that tamp down excessive immune responses ...
- Source: drugdu
- 112
- January 19, 2024
J&J, AZ/Daiichi Sankyo cancer therapies lead Clarivate’s annual rundown of notable new meds

Two cancer therapies have topped Clarivate Analytics’ Drugs to Watch in 2024, an annual report that identifies potential blockbusters and other medicines that could “transform treatment paradigms.” Clarivate predicts Johnson & Johnson’s combination treatment Akeega and Daiichi Sankyo and AstraZeneca’s datopotamab deruxtecan will generate $2.7 billion in sales each in 2029. On the list of 15 transformative medicines, these are the only ones expected to exceed $2 billion in sales by 2029. Clarivate’s report, which is in its 12th year, highlights drugs that have recently been approved or are expected to be approved in 2024. Its sales estimates cover the G7 countries—U.S., U.K., Japan, France, Italy, Germany and Canada. J&J was the only company with more than one drug on the list. Clarivate also spotlighted J&J’s Talvey, a first-in-class bispecific antibody to treat multiple myeloma. The analysts forecast Talvey’s sales will reach $850 million in 2029. The only other cancer ...
- Source: drugdu
- 152
- January 19, 2024
US agency nixes Seagen patent, handing Daiichi Sankyo a win in long-running Enhertu entanglement

After years of patent litigation between cancer drug developers Daiichi Sankyo and Seagen, the U.S. Patent and Trademark Office (U.S. PTO) has handed Daiichi the latest win in the saga. For years, the companies have clashed over Seagen’s so-called “‘039 patent,” which covers certain peptides conjugated to an antibody through various linkers. After a 2008 antibody-drug conjugate (ADC) partnership between the drugmakers ended in 2015, Daiichi Sankyo entered into a lucrative agreement with AstraZeneca to work on what became the cancer blockbuster Enhertu. Seagen staked a claim on the AZ contract in a 2020 lawsuit, arguing that the technology used for the med was created under its previous Daiichi ADC partnership. In 2022, a Texas jury found that Daiichi Sankyo stepped on Seagen’s patent willfully, awarding the latter company $41.8 million in royalties. The now Pfizer-owned company took its case a step further by asking for royalties from future U.S. ...
- Source: drugdu
- 146
- January 19, 2024
Manufacturing Issues Block Astellas From a First-in-Class Cancer Drug Approval

Astellas Pharma’s zolbetuximab was on track to become the first gastric cancer drug that targets claudin 18.1, a protein found on cancerous stomach cells. Others with clinical-stage programs addressing this this target include AstraZeneca and Bristol Myers Squibb. By FRANK VINLUAN Astellas Pharma’s path to winning the first drug approval for a particular promising gastrointestinal cancer target has hit a detour. The FDA turned down the drugmaker’s application, citing manufacturing issues for the therapy, zolbetuximab. Astellas announced the FDA action earlier this week. The company did not go into detail about the problems spotted by the regulator, but described them as “unresolved deficiencies following its pre-license inspection of a third-party manufacturing facility for zolbetuximab.” Astellas added that the agency did not raise any concerns about the safety or efficacy of the drug, nor is it asking for additional clinical data. Zolbetuximab was developed as a treatment for patients with locally ...
- Source: drugdu
- 224
- January 16, 2024
J&J Joins the Cancer ADC Dealmaking Spree With $2B Ambrx Acquisition

Johnson & Johnson’s acquisition of antibody drug conjugate developer Ambrx Biopharma comes as Novartis and Merck also unveiled M&A deals on the first day of the J.P. Morgan Healthcare conference. In a report, the investment bank said big pharmas are looking for deals involving de-risked assets. By FRANK VINLUAN Big pharmaceutical companies splashed out big bucks in 2023 to acquire or license antibody drug conjugates, or ADCs. The trend is continuing into the new year with Johnson & Johnson reaching a $2 billion deal to acquire clinical-stage Ambrx Biopharma. According to deal terms announced Monday, J&J will pay $28 cash for each Ambrx share, which is a 105% premium to the biotech’s closing stock price on Friday. In other biopharma deal announcements, Merck is paying $680 million to acquire Harpoon Therapeutics, a developer of targeted cancer therapies, and Novartis is buying autoimmune disease drug developer Calypso Biotech for $250 ...
- Source: drugdu
- 136
- January 10, 2024

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