Search Results for “AstraZeneca” – Page 6 – media

Merck’s Keytruda nabs FDA nod in biliary tract cancer, catching up with AstraZeneca’s Imfinzi

After AstraZeneca’s Imfinzi last year claimed new territory in the biliary tract cancer space, Merck’s Keytruda has hit the scene with an FDA nod to match its rival. The approval in locally advanced unresectable or metastatic biliary tract cancer, combined with the chemotherapies gemcitabine and cisplatin, marks Keytruda’s sixth U.S. nod in gastrointestinal cancer, Merck said. The FDA based the approval on data from the company’s Phase 3 KEYNOTE-966 trial, which showed that the Keytruda-chemo combo extended patients’ survival time compared with chemotherapy alone. In the study, patients in the treatment arm lived a median 12.7 months, compared to 10.9 months for those on solo chemo. The Keytruda-chemo combo reduced the risk of death by 17% over solo chemotherapy, researchers found. In addition, Keytruda-treated patients experienced a longer median duration of response at 9.7 months, compared with 6.9 months for solo chemotherapy. Merck is “proud” to offer the new treatment ...
- Source: drugdu
- 100
- November 3, 2023
AstraZeneca studies highlight burden of COVID-19 for immunocompromised

Two AstraZeneca studies have highlighted the continued significant and disproportionate burdens of COVID-19 on immunocompromised (IC) individuals.Covering almost 30 million individuals, the INFORM and EPOCH real-world studies showed that IC individuals have a higher rate of severe outcomes from COVID-19 compared to the general population. Including around 12 million participants aged 12 years and older in England, the INFORM study aimed to assess clinical outcomes and utilisation of healthcare resources in relation to COVID-19.The EPOCH study conducted an extensive insurance claims database of around 17 million people, providing real-world data on COVID-19 risks and outcomes in IC and non-IC populations within the US.The data revealed that 22% of all COVID-19 hospitalisations consisted of IC individuals, along with 28% of ICU admissions and 25% of deaths in England. People who are IC have a weakened immune system and are more susceptible to illness with COVID-19 or could be sick for a ...
- Source: drugdu
- 190
- October 20, 2023
report

Antibodies and immunotherapies are all the rage in the lung cancer drug market, but older, small molecule drugs can still carve out a healthy niche-and AstraZeneca’s Tagrisso is set to be the leader in that market. That’s according to a new report out by analysts at GlobalData who see more than $7 billion in sales by 2029 for Tagrisso, a small molecule kinase inhibitor. It was first approved in 2015 for certain non-small cell lung cancer (NSCLC) patients with an EGFR mutation, later receiving a first-line green light in 2018 and an adjuvant approval in 2020. Tagrisso is AstraZeneca’s biggest-selling drug, making $5.44 billion in 2022, up 15% in 2021 and more than double its newer oncology drugs Imfinzi, an immunotherapy and PARP inhibitor Lynparza. “In the ever-evolving landscape of oncology, small-molecule drugs are carving a significant niche in lung cancer treatment,” said analysts at GlobalData. “Tagrisso is projected to ...
- Source: drugdu
- 185
- October 14, 2023
AstraZeneca’s Forxiga shows promise in paediatric type 2 diabetes trial

AstraZeneca (AZ) has shared positive results from a late-stage trial evaluating its oral SGLT2 inhibitor Forxiga (dapagliflozin) in children and adolescents with type 2 diabetes (T2D). T2D is the most common type of diabetes, accounting for over 90% of cases worldwide, and its prevalence in children and adolescents is increasing globally. The disease is characterised by pathophysiologic defects leading to elevated glucose levels, which over time contribute to further disease progression. “Despite the growing global burden of T2D among children and adolescents, the treatment options available are currently limited,” said Ruud Dobber, executive vice president, BioPharmaceuticals Business Unit, AZ. “It is well documented that some patients find injectable therapies challenging, making the need for effective oral treatment alternatives paramount,” he added. AZ’s phase 3 T2NOW, which is one of the largest paediatric T2D studies performed to date, assessed the efficacy and safety of Forxiga as an add-on treatment in children ...
- Source: drugdu
- 100
- October 13, 2023
AstraZeneca’s Forxiga meets primary endpoint for T2D

AstraZeneca has announced positive results from the T2NOW Phase III trial for paediatric patients treated with forxiga (dapagliflozin) for the treatment of type 2 diabetes (T2D). Forxiga is an oral sodium-glucose co-transporter-2 (SGLT2) inhibitor that lowers blood glucose levels. The drug is approved in 122 countries to improve glycaemic control in T2D patients in conjunction with diet and exercise. In the EU, paediatric patients above the age of 10 can be administered the drug after positive results from the T2GO study. Forxiga has not yet been approved for paediatric patients in the US. The T2NOW trial results showed a significant reduction in A1C, an average blood sugar marker in patients taking forxiga and metformin, insulin, or both, compared with patients receiving the placebo. Safety results in 10–17-year-olds are consistent with adult patients who take the drug. Forxiga is not the only SGLT2 inhibitor on the market. Invokana (canagliflozin) by J&J ...
- Source: drugdu
- 235
- October 7, 2023
AstraZeneca Signs AI-Powered Drug Discovery Pact with Verge

By Tristan Manalac AstraZeneca, through its rare disease division Alexion, has entered into a multi-target agreement with Verge Genomics to discover and develop drugs against novel targets in rare neurodegenerative and neuromuscular diseases, the companies announced Friday. Under the agreement, Alexion will make a $42 million payment in upfront fees, as well as equity and near-term investments. Counting milestones, the four-year collaboration can yield up to $840 million for Verge, plus potential royalties down the line. Alongside the drug discovery pact, AstraZeneca will also take an equity position in Verge. In return, Alexion will gain access to the California biotech’s proprietary full-stack CONVERGE platform, which applies machine learning to human tissue data in order to identify novel disease targets that have a high probability of yielding clinical success. Friday’s partnership will apply the AI-driven approach to several yet-undisclosed rare neurodegenerative and neuromuscular conditions. Alexion will have the option to select ...
- Source: drugdu
- 194
- September 12, 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
- 107
- August 30, 2023
Chasing AstraZeneca and Pfizer, Johnson & Johnson snags FDA nod for prostate cancer combo Akeega

Following FDA approvals for fellow PAPR inhibitors made by AstraZeneca/Merck and Pfizer, Johnson & Johnson has got its own combo approval in prostate cancer. The tablet treatment, known commercially as Akeega, combines J&J’s androgen-directed Zytiga (abiraterone acetate) and the PARP inhibitor niraparib, which is sold by GSK as Zejula in other indications. The FDA has signed off on its use along with the corticosteroid prednisone, but only in a subset of mCRPC patients—those with BRCA mutations. Akeega will compete with AstraZeneca and Merck’s Lynparza as well as Pfizer’s Talzenna in the indication. Eleven weeks ago, the FDA gave Lynparza the same narrow label for those with the BRCA-positive tumors. Talzenna’s approval covers a broader population, including other mutations in the homologous recombination deficiency family. Under a 2016 deal with Zejula’s developer Tesaro, J&J carved out rights to the drug in prostate cancer. GSK then bought out Tesaro in 2019. The ...
- Source: drugdu
- 118
- August 16, 2023
Eco-minded AstraZeneca doubles down on renewable energy push in Sweden

AstraZeneca is often at the forefront when it comes to sustainability efforts among pharma companies. Now, the British drugmaker is doubling down on its clean energy commitments in Sweden. AstraZeneca and Stratkraft—Europe’s largest renewable energy producer—have entered into an agreement on wind power deliveries that will increase the supply of renewable electricity in Sweden based on the commissioning of new wind farms, the companies said Wednesday. Under the deal, AZ will purchase 200 gigawatt-hours per year for 10 years, the partners explained. That amount corresponds to roughly 80% of the company’s total electricity needs at its research facility in Gothenburg and its manufacturing plant in Södertälje. The wind farms for this project will be located in Strömstad and Årjäng, in the same region as AZ’s research and manufacturing facilities. Across its Swedish operations, AstraZeneca is also working to cut back on its electricity consumption. One way it’s meeting this goal ...
- Source: drugdu
- 113
- August 11, 2023
AstraZeneca/Sanofi’s RSV antibody receives FDA approval for use in infants

AstraZeneca and Sanofi’s Beyfortus (nirsevimab) has been approved in the US for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) in newborns and infants born during or entering their first RSV season, the companies announced. The US Food and Drug Administration’s (FDA) decision makes the long-acting antibody the first preventive option approved to protect a broad infant population, including those born healthy at term, preterm, or with specific health conditions that make them vulnerable to severe RSV disease. The approval, which also applies to children aged up to 24 months who remain vulnerable to severe RSV disease through their second RSV season, was based on results from the Beyfortus clinical development programme spanning three pivotal late-stage clinical trials and follows a unanimous vote by the Antimicrobial Drugs Advisory Committee on the favourable benefit-risk profile of the drug. Across all clinical endpoints, a single dose of Beyfortus ...
- Source: drugdu
- 121
- July 22, 2023

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