June 15, 2023

European Commission approval for Pedmarqsi to reduce the risk of hearing loss in paediatric oncology patients – Fennec Pharma

Fennec Pharmaceuticals Inc.has announced Pedmarqsi– known as Pedmark in the U.S. – was granted marketing authorization by the European Commission. Pedmarqsi is the first and only approved therapy in the EU for the prevention of ototoxicity (hearing loss) induced by cisplatin chemotherapy in patients 1 month to less than 18 years of age with localised, non-metastatic, solid tumors. Further, Pedmarqsi […]

admin Health 0 2 min read
June 14, 2023

European Commission approval for Cosentyx as first and only IL-17A inhibitor for hidradenitis suppurativa – Novartis

Novartis announced that the European Commission (EC) has approved Cosentyx (secukinumab) for use in adults with active moderate to severe hidradenitis suppurativa (HS) and an inadequate response to conventional systemic HS therapy. “With only one currently approved treatment option, I see HS patients with a tremendous need for alternatives that reduce the disabling physical symptoms of HS, improve the emotional […]

admin Health 0 43 sec read
June 13, 2023

Andexxa phase IV trial stopped early after achieving pre-specified criteria on haemostatic efficacy versus usual care – AstraZenca

ANNEXA-I, a post-marketing Phase IV trial to assess the efficacy and safety of Andexxa (andexanet alfa) from AstraZeneca in patients on oral FXa-inhibitor treatment including apixaban and rivaroxaban experiencing an intracranial haemorrhage, will be stopped early. The decision is based on achieving pre-specified stopping criteria of superior haemostatic efficacy, the ability to limit the expansion of a potentially life-threatening bleed […]

admin Health 0 1 min read
June 12, 2023

Presentation of longer-term data for Tecvayli showing a duration of response of 22 months in patients with r/r multiple myeloma – Janssen

The Janssen Pharmaceutical Companies of Johnson & Johnson announced long-term data from the pivotal Phase 1/II MajesTEC-1 study showing the sustained efficacy and safety of Tecvayli (teclistamab-cqyv) in the treatment of patients with relapsed or refractory multiple myeloma (RRMM) who are triple-class exposed and previously received treatment with three or more prior lines of therapy. These results showed that nearly […]

admin Health 0 4 min read
June 11, 2023

EU approves Arexvy for respiratory syncytial virus – GSK

GSK announced that the European Commission has authorised Arexvy (respiratory syncytial virus vaccine, adjuvanted) for active immunisation for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in adults 60 years of age and older. This is the first time an RSV vaccine for older adults has been granted European Marketing Authorisation. The first launches […]

admin Health 0 47 sec read
June 10, 2023

Kisqali significantly reduced the risk of recurrence by 25% across a broad population of patients with early breast cancer; clinically meaningful benefit was consistent .across subgroups – Novartis

Novartis presents positive primary endpoint data from the pivotal Phase III NATALEE trial at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting . Data showed that Kisqali (ribociclib) plus endocrine therapy (ET), compared to ET alone, lowered the risk of cancer recurrence by 25.2% in patients with stage II and III hormone receptor-positive/human epidermal growth factor receptor 2-negative […]

admin Health 0 2 min read
June 9, 2023

Presentation of new Lumakras CODEBREAK 200 CNS data at ASCO 2023 meeting – Amgen

Amgen announced the presentation of new data from the CodeBreaK clinical trial program, the most comprehensive global development program in patients with KRAS G12C-mutated cancers, at the American Society of Clinical Oncology (ASCO) Annual Meeting taking place June 2-6 in Chicago. The research presented reinforces the efficacy of Lumakras/Lumykras (sotorasib) in advanced non-small cell lung cancer (NSCLC) and metastatic colorectal […]

admin Health 0 3 min read
June 8, 2023

EU approves Briumvi in adults with relapsing multiple sclerosis – TG Therapeutics

TG Therapeutics announced that the European Commission (EC) has granted approval of Briumvi (ublituximab xiiy) for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features. Briumvi was granted approval by the FDA on December 28, 2022, for the treatment of RMS in adults. Briumvi is the first and […]

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June 7, 2023

Keytruda + chemotherapy before surgery and continued as a single agent after surgery reduced the risk of event-free survival events by 42% versus pre-operative chemotherapy in resectable Stage II, IIIA or IIIB NSCLC – Merck Inc

Merck known as MSD outside of the United States and Canada, announced positive results from the pivotal Phase III KEYNOTE-671 trial evaluating Keytruda, Merck’s anti-PD-1 therapy, as a perioperative treatment regimen, which includes treatment before surgery (neoadjuvant) and after surgery (adjuvant), for patients with resectable stage II, IIIA or IIIB non-small cell lung cancer (NSCLC). After a median follow-up of […]

admin Health 0 2 min read
June 6, 2023

Presentation of Ingezza capsules data on tardive dyskinesia improvement regardless of baseline antipsychotic use at 2023 Psych Congress Elevate – Neurocrine Biosciences

Neurocrine Biosciences, Inc. presented findings from a meta-analysis of three long-term studies evaluating Ingrezza (valbenazine) capsules that demonstrated substantial and sustained improvements in tardive dyskinesia (TD) in adults with or without concomitant antipsychotic therapy. The data (Poster #4) were presented at 2023 Psych Congress Elevate in Las Vegas. The analysis of the three studies (KINECT 3, KINECT 4, and J-KINECT) […]

admin Health 0 4 min read

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