Voyager Therapeutics shares data from preclinical programmes for Alzheimer’s treatment

February 21, 2024
Research and Development Alzheimer's, Neurology, Voyager Therapeutics, preclinical

Voyager Therapeutics has announced new data from is two preclinical programmes targeting pathological tau for the treatment of Alzheimer’s disease …

Pfizer’s Velsipity approved by EC for ulcerative colitis treatment

February 20, 2024
Medical Communications European Commission, Gastrointestinal tract, Pfizer, Velsipity, ulcerative colitis

Pfizer has announced that the European Commission (EC) has granted marketing authorisation for Velsipity (etrasimod) in the European Union (EU). …

argenx announces FDA acceptance of sBLA for Vyvgart Hytrulo for CIDP treatment

February 20, 2024
Medical Communications CIDP, FDA, Neurology, Vyvgart Hytrulo, argenx, sBLA

argenx has announced that the US Food and Drug Administration (FDA) has accepted a supplemental Biologics License Application (sBLA) for …

AstraZeneca’s Tagrisso approved by FDA for lung cancer treatment

February 19, 2024
Medical Communications AstraZeneca, Oncology, Tagrisso, lung cancer

AstraZeneca has announced that the US Food and Drug Administration (FDA) has approved Tagrisso for the treatment of adult patients …

Iovance’s Amtagvi gains FDA accelerated approval for melanoma treatment

February 19, 2024
Medical Communications Iovance, Oncology, accelerated approval, melanoma

Iovance Biotherapeutics has announced that the US Food and Drug Administration (FDA) has approved Amtagvi (lifileucel) suspension for intravenous infusion …

Astellas and Kelonia Therapeutics enter agreement for development of immuno-oncology therapeutics

February 16, 2024
Research and Development Astellas Pharma, Kelonia Therapeutics, Oncology, collaboration, immuno-oncology

Astellas Pharma and Kelonia Therapeutics have announced that Xyphos Biosciences (a wholly owned subsidiary of Astellas) and Kelonia have entered …

Freenome raises $254m funding for early cancer detection platform

February 16, 2024
Research and Development Diagnostics, Freenome, Oncology, cancer detection, funding

Freenome has announced that it has raised $254m from new and existing investors, intended to be used for the advancement …

Domainex opens new Biology Centre of Excellence in Cambridge, UK

February 14, 2024
Business Services Pharmacy, domainex, facility

Domainex has announced that it has opened a new Biology Centre of Excellence at the Unity Campus at Pampisford, Cambridge, …

FDA approves Ipsen’s Onivyde for pancreatic adenocarcinoma treatment

February 14, 2024
Medical Communications FDA, Oncology, Onivyde, ipsen, pancreatic adenocarcinoma

Ipsen has announced that the US Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) for …

EC approves Vertex’s Casgevy for sickle cell disease treatment

February 13, 2024
Medical Communications Casgevy, European Commission, Haematology, Vertex pharmaceuticals, sickle cell disease

Vertex Pharmaceuticals has announced that the European Commission (EC) has granted conditional marketing authorisation to Casgevy (exagamglogene autotemcel), a CRISPR/Cas9 …

DelSiTech and Tolmar announce global license and development agreement

February 13, 2024
Medical Communications DelSiTech, Pharmacy, Tolmar, collaboration

DelSiTech and Tolmar International have announced that they have entered into a global license and development agreement, following a previous …

J&J’s nipocalimab gains breakthrough therapy designation from FDA for HDFN treatment

February 12, 2024
Medical Communications Breakthrough Therapy Designation, FDA, HDFN, J&J, Reproductive health

Johnson & Johnson (J&J) has announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) …

GSK gains FDA Fast Track designation for chronic hepatitis B treatment

February 12, 2024
Medical Communications FDA, GSK, Hepatology, fast track designation, hepatitis B

GSK has announced that the US Food and Drug Administration (FDA) has granted Fast Track designation for bepirovirsen, an investigational …

BioNTech and Autolus announce CAR T-cell therapy collaboration

February 9, 2024
Research and Development Autolus, BioNTech, CAR T-cell, Oncology, collaboration

BioNTech and Autolus Therapeutics have announced that they have entered a strategic collaboration intended to further both companies’ autologous CAR …

Fresenius Medical Care gains FDA 501(k) clearance for haemodialysis system

February 9, 2024
Medical Communications 501(k), FDA, Fresenius Medical Care, Nephrology, dialysis

Fresenius Medical Care has announced that it has received US Food and Drug Administration (FDA) 501(k) clearance for its 5008X …

Regenxbio announces positive data from trial for MPS II treatment

February 8, 2024
Research and Development Hunter syndrome, MPS II, Neurology, Regenxbio, clinical trial

Regenxbio has announced topline results from the phase 1/2/3 CAMPSIITE trial of RGX-121 for the treatment of patients up to …

Tenax Therapeutics enrolls first patient in phase 3 trial for pulmonary hypertension treatment

February 8, 2024
Research and Development Cardiology, Tenax Therapeutics, clinical trial, pulmonary hypertension

Tenax Therapeutics has announced that it has enrolled the first patient in its phase 3 LEVEL study, which aims to …

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Jazz Pharmaceuticals enters agreement to acquire rights to KRAS inhibitor programme from Redx Pharma

February 7, 2024
Business Services Pharmacy, RedX Pharma, acquisition, jazz pharmaceuticals

Jazz Pharmaceuticals and Redx Pharma have announced that the companies have signed a definitive agreement under which Jazz will acquire …

Medidata and Sanofi Vaccines extend collaboration

February 7, 2024
Research and Development Immunology, Medidata, Sanofi Vaccines, eCOA

Medidata and Sanofi Vaccines have announced a collaboration utilising Medidata electronic clinical outcome assessment (eCOA) within vaccine trials, building on …

Novartis to acquire MorphoSys AG for €2.7bn

February 6, 2024
Business Services Novartis, Pharmacy, acquisition, morphosys

Novartis has announced that it has entered an agreement to acquire MorphoSys AG for €2.7bn, or €68 per share. The …

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