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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) …

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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 …

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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 …

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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 …

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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 …

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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 …

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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 …

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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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Vertex announces positive results from trial for cystic fibrosis combination treatment

February 6, 2024
Research and Development Chronic Diseases, Vertex pharmaceuticals, clinical trial, combination treatment, cystic fibrosis

Vertex Pharmaceuticals has announced positive results from its once-daily vanzacaftor/tezacaftor/deutivacaftor programme, the company’s phase 3 programme for the treatment of …

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Zuellig Pharma acquires Cialis and Alimta from Eli Lilly in certain ASEAN markets

February 5, 2024
Business Services Cialis, Eli Lilly, Pharmacy, Zuellig Pharma, acquisition

Zuellig Pharma has announced that it has completed the acquisition of two brands Cialis (Tadalafil) and Alita (Pemetrexed) from Eli …

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Regeneron’s linvoseltamab gains EMA filing acceptance for R/R MM treatment

February 5, 2024
Medical Communications EMA, Oncology, Regeneron, linvoseltamab, multiple myeloma

Regeneron Pharmaceuticals has announced that the European Medicines Agency (EMA) has accepted for review its Marketing Authorisation Application (MAA) for …

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Vivet Therapeutics gains €4.9m for gene therapy development

February 2, 2024
Research and Development CTX, Neurology, Vivet Therapeutics, funding, gene therapy

Vivet Therapeutics has announced that it has received €4.9m financing from the French Government for the advanced development of a …

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AstraZeneca shares results from phase 3 trial of acoramidis in adults with ATTR-CM

February 2, 2024
Research and Development ATTR-CM, AstraZeneca, Cardiology, acoramidis, clinical trial

AstraZeneca has announced positive high-level results from the phase 3 trial of acoramidis in adults with transthyretin-mediated amyloid cardiomyopathy (ATTR-CM) …

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NICE recommends SC treatment of AbbVie’s Tepkinly for patients with DLBCL

February 1, 2024
Medical Communications AbbVie, DLBCL, NICE, Oncology, lymphoma

AbbVie has announced that the National Institute for Health and Care Excellence (NICE) has recommended Tepkinly (epcoritamab) as a treatment …

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FDA grants ODD to Revolo Biotherapeutics’ eosinophilic esophagitis treatment

February 1, 2024
Medical Communications FDA, ODD, Pharmacy, Revolo Biotherapeutics, eosinophilic esophagitis

Revolo Biotherapeutics has announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to ‘1104, …

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MHRA approves GSK’s Omjjara in Great Britain for splenomegaly treatment

January 31, 2024
Medical Communications GSK, MHRA, Omjjara, Oncology, myelofibrosis, splenomegaly

GSK has announced that the Medicines and Healthcare products Regulatory Agency (MHRA) has granted Marketing Authorisation to Omjjara (momelotinib) in …

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Regeneron forms Regeneron Cell Medicines with acquisition of 2seventy bio

January 31, 2024
Business Services 2seventy bio, Pharmacy, Regeneron, Regeneron Cell Medicines, acquisition

Regeneron Pharmaceuticals has announced the formation of Regeneron Cell Medicines based on an agreement with 2seventy bio to acquire the …

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FDA clears IND for Gracell Biotechnologies’ phase 1 clinical trial for multiple myeloma treatment

January 30, 2024
Research and Development FDA, Gracell Biotechnologies, Oncology, clinical trial, multiple myeloma

Gracell Biotechnologies has announced that the US Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application, …

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Oxford Biomedica acquires ABL Europe for €15m

January 30, 2024
Business Services ABL Europe, Oxford BioMedica, Pharmacy, acquisition

Oxford Biomedica has announced that it has completed the acquisition of ABL Europe from Institut Mérieux. This follows announcements on …

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