Search Results for “EC” – Page 103 – media

Abiomed heart pump recall labeled Class I by FDA, no deaths reported

The FDA said Monday that Abiomed, the heart device maker bought by Johnson & Johnson last year for $16.6 billion, is recalling some sets of the Impella 5.5 heart pump with the SmartAssist function after receiving complaints that purge fluid has leaked from the purge sidearm of the pump. The FDA has identified the action as a Class I recall, the most serious kind, meaning that continued use may cause serious injuries or death, unless corrective measures are taken. The Impella 5.5 with SmartAssist System is used for up to 14 days to support the pumping chambers of the heart when there is ongoing cardiogenic shock that occurs less than 48 hours after a severe heart attack, open-heart surgery, or when the heart is not functioning well due to a condition called cardiomyopathy, the FDA said in a statement. The FDA warned that if a purge leak occurs, “the system ...
- Source: drugdu
- 147
- 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
- 199
- 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
- 133
- 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
- 161
- 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
- 121
- 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
- 240
- June 6, 2023
Pfizer’s antibiotic combination shows promise in treating multi-drug resistant infections

Pfizer has announced positive phase 3 results supporting the safety and efficacy of its investigational antibiotic combination, aztreonam-avibactam (ATM-AVI), in treating serious infections caused by multi-drug resistant, gram-negative bacteria. Declared by the World Health Organization as one of the top ten threats to global health, antimicrobial resistance occurs when bacteria, viruses, fungi and parasites change and adapt to antibiotics over time. As a result, infections become harder to treat and the risk of disease spread, severe illness and death increases. Pfizer’s late-stage programme included a study which compared ATM-AVI and metronidazole with two older antibiotics – meropenem and colistin – for the treatment of complicated intra-abdominal infections, hospital-acquired pneumonia and ventilator-associated pneumonia. For patients with complicated intra-abdominal infections, the cure rate was 76.4% in the ATM-AVI plus metronidazole treatment group, versus 74% in the meropenem and colistin cohort. Additionally, for patients with hospital-acquired pneumonia and ventilator‐associated pneumonia, the cure rate ...
- Source: drugdu
- 115
- June 6, 2023
Coherus, Junshi eye FDA finish line after agency finally conducts plant inspection

It’s been a long road for PD-1 partners Coherus BioSciences and Junshi Biosciences since their FDA rejection for cancer drug toripalimab more than a year ago, but the companies appear to be nearing the regulatory finish line in the U.S.Wednesday, Coherus said in a Securities and Exchange Commission filing that the U.S. FDA “successfully completed the required pre-licensing inspection” of Junshi’s manufacturing site in China. The FDA made three observations about plant deficiencies, but Coherus believes those are “readily addressable.” The partners plan to submit their response to the FDA in the coming weeks. Coherus says it’s planning to launch toripalimab in the U.S. after a potential FDA approval. The inspection comes after multiple regulatory delays. In May 2022, the FDA rejected the drug and requested a quality process change. At the time, the companies noted that a resubmission would take about six months because plant inspections had been delayed ...
- Source: drugdu
- 131
- June 5, 2023
Novel technology helps analyze tumor growth in another dimension

Tumors are composed of rapidly multiplying cancer cells. Understanding which biochemical processes fuel their relentless growth can provide hints at therapeutic targets. Researchers from Washington University in St. Louis have developed a technology to study tumor growth in another dimension -; literally. The scientists established a new method to watch what nutrients are used at which rates spatially throughout a tissue. By using this multidimensional imaging approach, they identified pathways whose activities are uniquely elevated in brain cancer, offering clues for potential treatment strategies. The study was published May 19 in Nature Communications. Gary Patti, Michael and Tana Powell Professor of Chemistry in Washington University in St. Louis, said, “We figured out how to infer the rate of biochemical reactions directly from discrete regions of tissue.” Patti, who is also a research member of the Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine, is senior author ...
- Source: drugdu
- 165
- June 4, 2023
Former Novartis execs cleared of Greek bribery charges after yearslong investigation

After a yearslong investigation involving politicians and medical professionals alike, Novartis is looking to close the books on its Greek bribery imbroglio. The probe into allegations that the company paid kickbacks between 2006 to 2015 has culminated in Greece’s Council of Misdemeanor Courts clearing four former Novartis executives and a former politician of bribery charges, Greece’s Kathimerini reports. Former Novartis Greece Vice President Konstantinos Frouzis, alongside three other Novartis execs and former Health Ministry adviser Nikos Maniadakis, couldn’t be charged of bribing nonpolitical individuals due to the expiration of the statute of limitations, according to the publication. Ten other politicians were investigated, but no evidence was found to prove passive bribery, according to Kathimerini. Meanwhile, 15 doctors who allegedly received financial benefits for prescribing Novartis drugs have been charged for passive bribery and money laundering, according to the publication. Novartis did not immediately reply to Fierce Pharma’s request for comment. ...
- Source: drugdu
- 126
- June 4, 2023

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