Search Results for “Pfizer” – Page 29 – media

US announces first ten drugs up for Medicare price negotiation

Medicare will soon be able to negotiate the prescription drug prices for the first time, under US President Joe Biden’s Inflation Reduction Act (IRA), which was enacted last year. Earlier today, the US Department of Health and Human Services (HHS) released a list of ten drugs that will be up for price negotiations. Aimed at driving down healthcare costs and increasing patient power, the IRA allows the Centers for Medicare and Medicaid Services (CMS), the US Government’s national insurance programme, to provide drugs at reduced prices. The price negotiation process will consider elements like the drug’s clinical benefit, the unmet clinical need, and the costs associated with the drug’s production. The negotiations with manufacturing companies will occur in 2023 and 2024, with any price changes rolling in by 2026. Blockbuster drugs are aplenty on the list. Bristol-Myers Squibb (BMS) and Pfizer’s co-developed drug Eliquis (apixaban) and Amgen’s Enbrel (etanercept) are ...
- Source: drugdu
- 103
- August 31, 2023
FTC pulls back on legal challenge to Amgen’s $28B bid for Horizon

By objecting to Amgen’s deal for Horizon, the FTC put to the test new ideas about how drugmaker mergers can harm consumers. Typically, regulators have maintained that overlaps between competing products can give combining companies a more powerful market position, and have sought divestments as a resolution. However, in this case, the FTC argued that Amgen could use rebates and discounts on established drugs like Enbrel to secure favorable insurance coverage for Horizon drugs like Tepezza and Krystexxa. The FTC claimed Amgen has a history of using such “cross-market bundling” practices. The Horizon acquisition was one of the first major opportunities for the FTC to apply the new framework for reviewing pharmaceutical mergers, which agency leadership laid out early in the Biden administration. A pre-trial settlement could reveal the evidence regulators have compiled to support their case, and indicate whether they believe they can prevail in court. In a statement ...
- Source: drugdu
- 115
- August 30, 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
BridgeBio Builds ATTR-CM Case for Acoramidis with Promising Phase III Data

By Tristan Manalac Pictured: Ultrasound machine used to obtain images of the heart/iStock, sudok1 Detailed results from the Phase III ATTRibute-CM study showed that BridgeBio Pharma’s acoramidis met its primary endpoint, inducing significant improvements in patients with transthyretin amyloid cardiomyopathy (ATTR-CM), the company announced Sunday. ATTRibute-CM is a randomized and double-blinded study with over 630 patients enrolled. Its primary endpoint is a combination of all-cause mortality, frequency of cardiovascular-related hospitalizations and changes from baseline in NT-proBNP levels and six-minute walk distance (6MWD) performance. Acoramidis achieved a “highly statistically significant result” compared with placebo, BridgeBio wrote in its announcement, touting a Win Ratio of 1.8 with a p-value less than 0.0001. This effect was consistent across NYHA functional classes and between wild-type and variant transthyretin amyloid cardiomyopathy (ATTR-CM) patient subgroups. BridgeBio presented the findings at the 2023 Congress of the European Society of Cardiology, held in Amsterdam over the weekend. The ...
- Source: drugdu
- 108
- August 30, 2023
Moderna says new Covid vaccine was effective against Eris variant in early trial

Moderna’s new Covid vaccine generated a robust immune response against the now-dominant Eris variant and another rapidly spreading strain of the virus in an early clinical trial, the biotech company said Thursday. The updated shot is designed to target omicron subvariant XBB.1.5, but the results suggest that the jab may still be effective against newer variants of the virus that are gaining ground nationwide. That includes Eris and another variant nicknamed Fornax, both of which are also descendants of the omicron virus variant. Moderna’s vaccine and new shots from Pfizer and Novavax are slated to roll out within weeks, pending potential approvals from the U.S. Food and Drug Administration. Meanwhile, Covid-related hospitalizations fueled by Eris and other variants continue to accelerate but remain below the summer peak that strained hospitals this time last year. Eris, also known as EG.5, accounted for 17.3% of all cases as of earlier this month, ...
- Source: drugdu
- 108
- August 20, 2023
MSF, trying to secure supplies of ViiV’s Apretude, calls out new clauses in purchasing contract

As GSK’s ViiV Healthcare looks to widen the reach of its HIV franchise, Médecins Sans Frontières (MSF) has been working to secure access to the company’s long-acting HIV prevention drug, Apretude, for more than a year. Now, the organization is airing grievances about the negotiation process with an open letter to ViiV’s executive team. MSF is calling on the company to take out what it says are problematic new amendments to the proposed purchase agreement. Since last June, MSF has been stuck in contract negotiations with ViiV for Apretude, according the letter from Sidney Wong, executive co-director of MSF’s access campaign, and Philip Aruna, team leader for MSF’s southern Africa region. The sides almost reached a deal in December, but ViiV subsequently changed the terms because of supply limitations, Wong and Aruna wrote. Thanks to last-minute edits that deviate from standard MSF purchase agreements, the new contract more closely resembles ...
- Source: drugdu
- 135
- August 19, 2023
GSK stays a step ahead in RSV vaccine battle as Arexvy becomes available at US pharmacies

As companies have flocked to compete in the new respiratory syncytial virus (RSV) vaccine market, GSK has had the best timing. In May, the U.K. company was first to secure FDA approval for its shot Arexvy for adults 60 and older, beating out rivals from Pfizer and Moderna. And now—well in advance of the fall and winter RSV season—Arexvy is available in major U.S. retail pharmacies, GSK said Thursday. Under the Inflation Reduction Act, Medicare Part D patients will pay no out-of-pocket expenses for the shot, GSK said. Additionally, under the Affordable Care Act, patients with commercial insurance may be covered when Arexvy is administered in-network, GSK said. In June, the Advisory Committee on Immunization Practices (ACIP) recommended that people 60 and older decide in consultation with their healthcare provider whether to receive the RSV vaccine. As people age, their immune systems can become compromised, making them more vulnerable to ...
- Source: drugdu
- 173
- August 19, 2023
Seagen Touts Phase III Data for Breast Cancer Combo Therapy

By Connor Lynch Pictured: Cancer patient in bed looking out window/iStock, Ridofranz Biotech Seagen announced promising Phase III results Wednesday for its tyrosine kinase inhibitor Tukysa (tucatinib), in combination with Genentech’s antibody-drug conjugate Kadcyla (ado-trastuzumab emtansine), which met its primary endpoint of progression-free survival in HER-2 breast cancer patients. The HER2CLIMB-02 trial was investigating the efficacy of Tukysa in combination with Genentech’s Kadcyla to treat locally advanced or metastatic HER-2 breast cancer that had received previous treatment with taxane and trastuzumab. While the trial met the primary endpoint of PFS, the study’s data on its secondary endpoint of overall survival “were not yet mature,” Seagen Chief Medical Officer Roger Dansey said in a statement. The combination arm of the trial also resulted in more discontinuation “due to adverse events,” but also noted that “no new safety signals emerged for the combination.” Serious adverse reactions occurred in the study in 26% ...
- Source: drugdu
- 204
- August 18, 2023
Arcturus JV scored $115M in Japanese grants to boost mRNA manufacturing

Right after Daiichi Sankyo picked up Japan’s first mRNA vaccine approval, a potential rival has revealed substantial financial backing from the Japanese government. The Japanese government awarded two grants totaling $115 million to Arcalis to support the production of mRNA vaccines and therapeutics. Arcalis is an mRNA-focused CDMO joint venture by Arcturus Therapeutics and Japanese drug discovery service provider Axcelead. The money was granted in December 2021 and October 2022 to support the construction of Arcalis’ vaccine factory in the Japanese city of Minamisoma and to support the manufacturing of mRNA drug substance and final drug product, respectively, an Arcturus spokesperson told Fierce Pharma. Arcalis completed construction of the drug substance part of the plant at the end of July. The facility occupies an area of 1,933 square meters (nearly half an acre) and boasts total floor space of 7,252 square meters (more than 78,000 square feet). The company plans ...
- Source: drugdu
- 231
- August 16, 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

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