US FDA expands Jemperli (dostarlimab-gxly) plus chemotherapy approval to all adult patients with primary advanced or recurrent endometrial cancer as the first and only immuno-oncology-based treatment to show an overall survival benefit
August 5, 2024Research and Development GSK, Oncology, Reproductive health, endometrial cancer
PHILADELPHIA–GSK plc today announced the US Food and Drug Administration (FDA) has approved Jemperli (dostarlimab-gxly) in combination with carboplatin and paclitaxel (chemotherapy) …
Johnson & Johnson’s MedTech announce orthopaedics receives 501K clearance from FDA for spinal robotics and navigation platform
August 5, 2024Research and Development 501k clearance, Johnson & Johnson MedTech, Orthopaedics, orthopaedics, robotics, spinal, surgery
Today, the Orthopaedics branch of Johnson & Johnson MedTech, DePuy Synthes, has announced that their surgical robotics system VELYS active …
Abbvie acquires Cerevel Therapeutics
August 2, 2024Mergers and Acquisitions AbbVie, Cerevel Therapeutics, Drug-Resistant Epilepsy, Neurology, Parkinson's disease, major depressive disorder, mergers & acquisitions, neurology, neuroscience, schizophrenia
Abbvie has announced the acquisition of Cerevel Therapeutics, strengthening its neuroscience pipeline. Cerevel has multiple programmes across neurological and psychiatric …
Adaptimmune receives US FDA Accelerated Approval for engineered cell therapy for a solid tumour
August 2, 2024Medical Communications Adaptimmune, Oncology, accelerated approval, engineered cell therapy, oncology, synovial sarcoma
Adaptimmune Therapeutics has announced today that the US Food and Drug Administration (FDA) has given accelerated approval for TECELRA (afamitresgene …
Novo Holdings Invests in Oxford Nanopore TechnologiesÂ
August 1, 2024Research and Development Microbiology, Novo Holdings, Oxford Nanopore Technologies, biopharmacuticals, biotech, data, drug therapies, investment
leading life science investor Novo Holdings, announced a £50m investment in Oxford Nanopore Technologies. Oxford Nanopore Technologies is a leading …
Inizio Engage and Nye Health form a strategic alliance to enhance patient support and outcomesÂ
August 1, 2024Research and Development Contraception, Inizio Engage, NHS, Nye Health, alliance, data, patient data, patient experience, support
 Nye Health’s digital platform will be coupled with the patient support experience available at Inizio Engage. The integrated approach will …
INDEPENDENT PARSORTIX STUDY HIGHLIGHTS BENEFITS OF COMBINED DNA ANALYSIS IN MELANOMA
August 1, 2024Medical Communications, Research and Development Angle, Internal Medicine, Oncology, Parsortix, melanoma
Multi-analyte approach has potential to guide personalised cancer care CTC mutation profiles associated with more aggressive disease ANGLE plc. a …
Eisai presents latest findings for lecanemab at Alzheimer’s Association International Conference (AAIC)
July 31, 2024Research and Development Alzheimers, Conference results, Eisai, Neurology
Clarity AD open-label extension (OLE) data show: three years of continuous lecanemab treatment reduced clinical decline by -0.95 vs expected …
Drug discovery and development partnership announced between Apollo Therapeutics and Oxford University
July 31, 2024Clinical Research, Medical Communications, Research and Development Apollo Therapeutics, Internal Medicine, Microbiology, drug development, drug discovery, research
Portfolio therapeutics company Apollo Therapeutics has announced earlier this week that it will provide capital and expertise to Oxford University’s …
FDA release statement exercising caution around dosing errors associated with compounded injectable semaglutide products
July 31, 2024Media Relations, Medical Communications, Pharmacovigilance, US Healthcare & Trade Press FDA, Gastrointestinal tract, compunded injectable, dosage, hospitalisation, pharmaceutical, warning
This week, the US Food and Drug Administration (FDA) and have issued warnings regarding dosing errors associated with compounded injectable …
AstraZeneca’s AMPLIFY trial interim analysis demonstrates positive results for Calquence plus venetoclax
July 30, 2024Research and Development AstraZeneca, Haematology, chronic lymphocytic leukaemia, haematology, trial analysis
AstraZeneca has announced positive high-level results from an interim analysis for its AMPLIFY phase 3 trial, combining AstraZeneca’s Calquence (acalabrutinib) …
Boehringer Ingelheim acquires Nerio Therapeutics, strengthening immune-oncology profile
July 30, 2024Mergers and Acquisitions Boehringer Ingelheim, Nerio Therapeutics, Oncology, immuno-oncology, oncology
Biopharmaceutical company Boehringer Ingelheim has announced the acquisition of drug discovery and development company Nerio Therapeutics for up to $1.3bn, …
Pierre Fabre Laboratories receives CHMP positive opinion for BRAFTOVI  in combination with MEKTOVI  for the treatment of adult patients with advanced non-small cell lung cancer  NSCLC) with a BRAFV600E mutation
July 29, 2024Clinical Trial Services BRAF mutation, CHMP, EMA, Oncology, Pierre Fabre Laboratories, colorectal cancer, european studies, non-small cell lung cancer
Pierre Fabre Laboratories has announced a positive opinion from the European Medical Association’s (EMA) Committee for Medicinal Products Human use …
CHMP gives positive opinion for Merck’s KEYTRUDA for unresectable or metastatic urothelial carcinoma
July 29, 2024Research and Development ADC, CHMP, Merck, Oncology, Urology, keytruda, metastatic urothelial carcinoma, unresectable urothelial carcinoma
Merck (known as MSD outside of the US and Canada) has announced that its anti-PD-1 therapy, in combination with Padcev …
Calliditas Therapeutics announces positive phase 2b data in Primary Biliary Cholangitis trial
July 26, 2024Research and Development Calliditas, Hepatology, clinical trials, elevated liver stiffness, primary biliary cholangitis
 Calliditas Therapeutics AB today announced that the phase 2b TRANSFORM trial met its primary endpoint. The trial showed statistically significant …
AC Immune’s pTau-targeting immunotherapy awarded Fast Track designation by FDA
July 26, 2024Research and Development AC Immune, Alzheimer's disease, Neurology, clinical trials, fast track designation, immunotherapy, tau protein
Clinical-stage biopharmaceutical company AC Immune announced that the US Food and Drug Administration (FDA) has granted its Alzheimer’s disease (AD) …
BioAtla gains FDA Fast Track Designation for ozuriftamab vedotin
July 25, 2024Medical Communications BioAtla, FDA, Oncology, fast track designation, ozuriftamab vedotin
BioAtla has announced that the US Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to ozuriftamab vedotin, …
Eisai and EcoNaviSta enter dementia collaboration
July 25, 2024Business Services EcoNaviSta, Eisai, Neurology, collaboration, dementia
Eisai and EcoNaviSta have announced that they have entered into a business alliance agreement, initiating their collaboration intended to build …
Agilent to acquire BIOVECTRA for $925m
July 24, 2024Business Services Agilent, CMDO, Pharmacy, acquisition
Agilent Technologies has announced that it has signed a definitive agreement to acquire BIOVECTRA, a leading specialised contract development and …
J&J seeks FDA approval of Spravato as monotherapy for treatment-resistant depression
July 24, 2024Medical Communications J&J, Johnson & Johnson, Neurology, Spravato, treatment-resistant depression
Johnson & Johnson (J&J) has announced that it has submitted a supplemental New Drug Application (sNDA) to the US Food …
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