PharmaFocus Today – Page 337 – media

Freiburg researchers gain new insights into metabolic processes in the kidney

Researchers at the Faculty of Medicine at the University of Freiburg have gained significant new insights into metabolic processes in the kidney. The scientists from the Institute of Genetic Epidemiology at the Medical Center – University of Freiburg measured tiny molecules, so-called metabolites, which occur in blood and urine and reflect our metabolism, in samples from more than 5,000 study participants. They compared these with the genome of the test persons and were able to identify 1,299 genetic changes that are associated with metabolites and contribute to their production, degradation or transport. The findings provide a better understanding of processes throughout the body and particularly in the kidney, which produces urine from blood plasma. These discoveries, which appeared June 5, 2023, in the journal Nature Genetics, could lead to a better understanding of diseases and new approaches to their treatment. For example, a new class of therapies for treating diabetes, ...
- Source: drugdu
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- June 7, 2023
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
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- June 7, 2023
Johnson & Johnson’s Balversa tops chemotherapy in bladder cancer trial

Johnson & Johnson’s Balversa can keep some metastatic bladder cancer patients alive longer than chemotherapy, according to a study of 266 who have fibroblast growth factor receptor (FGFR) gene mutations and had already received checkpoint inhibitors.In the phase 3 THOR trial, Balversa cut the risk of death by 36% to accomplish its primary objective. It helped extend lives by an average of 12.1 months versus a 7.8-month average for patients on chemotherapy. The interim results were from cohort 1 of the confirmatory study and were presented Monday at the American Society of Clinical Oncology’s (ASCO’s) annual meeting in Chicago. “The use of Balversa in this setting supports recommendations for FGFR testing in all patients with metastatic urothelial cancer,” Yohann Loriot, M.D., Ph.D., of the University of Paris-Saclay in France and the principal study investigator, said in a release. Balversa was approved on an accelerated basis in 2019, becoming the first ...
- Source: drugdu
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- June 7, 2023
AstraZeneca shares positive phase 3 results for Tagrisso in lung cancer

AstraZeneca (AZ) has shared positive results from a late-stage study evaluating Tagrisso (osimertinib) as an additional treatment for certain lung cancer patients. The phase 3 ADAURA trial enrolled 682 patients with early-stage epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) who had undergone surgery to remove their primary tumour. Patients were treated with Tagrisso 80mg once-daily oral tablets or placebo for three years or until disease recurrence. The results, which were presented at the American Society of Clinical Oncology annual meeting, showed that the drug reduced the risk of death by 51% compared to placebo in both the primary analysis population (patients with stages 2 to 3a EGFRm NSCLC) and in the overall trial population (stages 1b to 3a). In the primary analysis population, an estimated 85% of Tagrisso-treated patients were alive at five years compared to 73% in the placebo cohort. In the overall trial population, around 88% of ...
- Source: drugdu
- 206
- June 7, 2023
Moderna and Merck cancer vaccine used with Keytruda reduces risk of deadly skin cancer spreading

Moderna and Merck’s experimental cancer vaccine, used in combination with Merck’s Keytruda, reduced the risk of the most deadly form of skin cancer spreading to other parts of the body in a clinical trial, according to the midstage trial results published Monday. Moderna and Merck’s cancer vaccine reduced the risk of melanoma spreading to other parts of the body or death by 65% in patients with stage 3 or 4 of the disease compared with patients who received Merck’s immunotherapy treatment alone, the trial has found. Moderna and Merck will present the data at the American Society of Clinical Oncology’s annual conference in Chicago at 5 p.m. ET. The clinical trial has enrolled 157 patients who have had their cancer surgically removed. Patients in the treatment group receive 1 milligram injections of the vaccine every three weeks for nine total doses and 200 mg intravenous infusions of Keytruda every three ...
- Source: drugdu
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- 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
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- June 7, 2023
FDA OKs Injectafer for Iron Deficiency Anemia in Heart Failure

Megan Brooks The US Food and Drug Administration (FDA) has expanded the indication for ferric carboxymaltose injection (Injectafer, Daiichi Sankyo/American Regent) to include treatment of iron deficiency in adults with New York Heart Association (NYHA) class II/III heart failure (HF). “This new indication for Injectafer marks the first and only FDA approval of an intravenous iron replacement therapy for adult patients with heart failure,” Ravi Tayi, MD, MPH, chief medical officer at American Regent, said in a news release. Ferric carboxymaltose injection is also indicated for the treatment of iron deficiency anemia in adults and children as young as 1 year of age who have either intolerance or an unsatisfactory response to oral iron, and in adult patients who have nondialysis dependent chronic kidney disease. The new indication in HF was supported by data from the CONFIRM-HF randomized controlled trial that evaluated the efficacy and safety of ferric carboxymaltose injection ...
- Source: drugdu
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- June 7, 2023
Study shows efficacy and safety of novel FolRα-targeting antibody drug conjugate in recurrent epithelial ovarian cancer

Updated dose expansion data of the phase I STRO-002-GM1 study have been presented today by Ana Oaknin, Principal Investigator of the Vall d’Hebron Institute of Oncology’s (VHIO) Gynecological Malignancies Group, on the ground at the 2023 Annual Meeting of the American Society of Clinical Oncology (ASCO), 2-6 June in Chicago, USA. This global study was designed to evaluate the efficacy and safety of the novel FolRα-targeting antibody drug conjugate (ADC) luveltamab tazevibulin (STRO-002 – luvelta) in patients with recurrent epithelial ovarian cancer with identified expression levels of folate receptor alpha (FolRα) higher than 25%. This ADC induces cytotoxic and immunologic cell death, and using site-specific conjugation technology and is designed to target a broad range of FolRα-expressing ovarian tumors. “Folate receptor alpha is a folate-binding protein overexpressed on ovarian and several other epithelial malignancies. Its overexpression in solid tumors promotes cancer cell proliferation and persists in metastatic or recurrent disease ...
- Source: drugdu
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- June 6, 2023
Combination therapy successfully treats Pasteurella multocida-related invasive infections

Announcing a new article publication for Zoonoses journal. Pasteurella multocida, a Gram-negative, penicillin-sensitive coccobacillus that is frequently a member of the normal respiratory microbiota of different animals, remains a clinically important pathogen with the ability to cause severe disease. Few case reports have involved P. multocida infections without animal bites. Moreover, few reports have identified P. multocida as the causative agent of septic shock, which usually occurs in patients with cirrhosis and/or immunocompromised patients. To our knowledge, a human submandibular salivary gland abscess caused by P. multocida has not been reported. Pasteurella spp. are resistant to benzylpenicillin, and human isolates of beta-lactamase-producing resistant strains of P. multocida resistant have also been documented. The noteworthy findings of the current study were as follows: (i) the combination of ceftriaxone and ciprofloxacin successfully treated two patients infected with P. multocida; (ii) the first reported case of a septicemic patient with no history of ...
- Source: drugdu
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- June 6, 2023
NICE recommends Bristol Myers’ heart drug Camzyos in UK

Paul Schloesser Associate Editor Bristol Myers Squibb’s heart drug Camzyos has been recommended by the National Institute for Health and Care Excellence as the medication inches closer to approval in the UK and Europe. In final draft guidance released Friday, NICE recommended mavacamten (branded as Camzyos) as an add-on to standard care for symptomatic obstructive hypertrophic cardiomyopathy. Obstructive HCM is a heart condition that occurs when part of the muscular wall in the heart becomes thicker, which can then reduce blood supply to the rest of the body. NICE recommended the drug for several reasons. While the standard care for the disease treats symptoms, the organization said Camzyos is the first to treat oHCM, as compared with beta blockers, certain calcium channel blockers or disopyramide. Some of those treatments have side effects and are not always effective, the organization said. “We’re therefore pleased to be able to recommend a treatment ...
- Source: drugdu
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- June 6, 2023

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