FDA approves AstraZeneca’s drug to prevent RSV in babies and young children
July 18, 2023Research and Development AstraZeneca, FDA, Immunology, RSV, Vaccine, paediatrics
The US Food and Drug Administration (FDA) has announced that it has approved Beyfortus (nirsevimab-alip) for the prevention of respiratory …
Inizio Engage launches Patient Access Services – an integrated suite of patient support services to enhance access and adherence for specialty therapies
July 18, 2023Business Services Inizio Engage, Patient Access Services, Pharmacy, patient support
Fort Washington, US — Inizio Engage is pleased to announce the launch of Patient Access Services. This custom-built, integrated suite of patient support services …
Alnylam shares positive results from phase 1 trial
July 17, 2023Research and Development ALN-APP, Alnylam, Alzheimer's disease, Cerebral Amyloid Angiopathy, Neurology, clinical trial
Alnylam Pharmaceuticals has announced positive interim results for the ongoing single ascending dose section of its phase 1 study of …
Eli Lilly to acquire Versanis Bio for $1.9bn
July 17, 2023Sales and Marketing Cardiology, Eli Lilly, Versanis Bio, acquisition, cardiometabolic diseases
Eli Lilly and Versanis Bio have announced a definitive agreement for Lilly to acquire Versanis, a private clinical-stage biopharmaceutical company …
FDA approves first OTC daily oral contraceptive pill
July 14, 2023Medical Communications Contraception, FDA, OTC, Opill, contraceptive pill
The US Food and Drug Administration (FDA) has announced that it has approved the Opill (norgestrel) tablet for nonprescription use …
EMA accepts Astellas’ MAA for Zolbetuximab
July 14, 2023Medical Communications Astellas, Cancer, EMA, Oncology, zolbetuximab
Astellas Pharma has announced that the European Medicines Agency (EMA) has accepted the company’s marketing authorisation application (MAA) for regulatory …
Recursion and NVIDIA partner for AI-enabled drug discovery developments
July 13, 2023Research and Development AI, Pharmacy, Recursion, drug discovery
Clinical stage biotech company Recursion has announced a $50m investment by NVIDIA, intended to accelerate the development of its AI …
Genentech shares results from phase 3 trial for MS treatment
July 13, 2023Research and Development Genentech, MS, Neurology, Ocrevus, clinical trial
Genentech has announced positive results from its phase 3 OCARINA II trial which assessed Ocrevus (ocrelizumab) as a twice-a-year, ten-minute …
CellCentric announces $25m investment from Pfizer
July 12, 2023Business Services Cancer, CellCentric, Oncology, Pfizer, collaboration, investment
UK-based biotechnology company CellCentric has announced a strategic investment from Pfizer including $25m to finance further development of inobrodib, its …
ADC Therapeutics puts clinical trial enrollment on hold following patient deaths
July 12, 2023Medical Communications ADC Therapeutics, DLBCL, Oncology, clinical trial
ADC Therapeutics has announced a voluntary pause in the enrollment of patients for its phase 2 LOTIS-9 clinical trial which …
Virtual Inspections: Embracing the Digital Change
July 12, 2023Manufacturing and Production ACG, Pharmacy, digital, manufacturing, virtual inspections
Virtual inspections must become a part of companies’ repertoires if they aim to maintain quality standards in their organisations. Digital …
Innate Pharma doses first patient in relapsed/refractory multiple myeloma trial
July 11, 2023Research and Development Innate Pharma, Oncology, Sanofi, clinical trial, multiple myeloma
Innate Pharma has announced that the first patient has been dosed in its Sanofi-sponsored phase 1/2 clinical trial, which aims …
Astellas and 4D Molecular Therapeutics enter license agreement for rare ophthalmic targets
July 11, 2023Research and Development 4D Molecular Therapeutics, AAV vectors, Astellas Pharma, Opthalmology, ophthalmology
Astellas Pharma and 4D Molecular Therapeutics (4DMT) have announced a license agreement under which Astellas has the right to use …
MHRA authorises GSK’s RSV vaccine for older adults
July 10, 2023Medical Communications Arexvy, GSK, Infections and infestations, MHRA, RSV
GSK has announced that the Medicines and Healthcare products Regulatory Agency (MHRA) has authorised its Arexvy respiratory syncytial virus (RSV) …
Nanobiotix announces license agreement with Janssen for development and commercialisation of new cancer treatment
July 10, 2023Sales and Marketing Cancer, Janssen, License Agreement, Oncology, nanobiotix
Nanobiotix has announced a global licensing, co-development and commercialisation agreement with Janssen Pharmaceutica NV, one of the Janssen Pharmaceutical Companies …
Celltrion launches Humira biosimilar in US
July 7, 2023Medical Communications Chronic Diseases, Humira, Yuflyma, arthritis, celltrion
South Korean biopharmaceutical company Celltrion has announced that its US branch – Celltrion USA – has launched a Humira (adalimumab) …
FDA grants Alzheimer’s disease drug Leqembi full approval
July 7, 2023Medical Communications Alzheimer's disease, Biogen, Eisai, FDA, Neurology
Japanese pharmaceutical company Eisai and US-based biotechnology company Biogen have announced that the US Food and Drug Administration (FDA) has …
OSE Immunotherapies’ UC drug gets DSMB positive recommendation
July 6, 2023Research and Development EMA, Gastrointestinal tract, OSE Immunotherapeutics, ulcerative colitis
French biotech company OSE Immunotherapeutics has announced that its Ulcerative Colitis (UC) trial’s Independent Drug Safety Monitoring Board (DSMB) has provided …
FDA grants Priority Review for Astellas Pharma’s BLA for cancer drug
July 6, 2023Research and Development Astellas Pharma, Biologics License Application, FDA, GEJ, Oncology
Japanese pharmaceutical company Astellas Pharma has announced that the US Food and Drug Administration (FDA) has granted Priority Review for …
Skyline Therapeutics receives FDA clearance of IND for candidate for neovascular age-related macular degeneration
July 5, 2023Research and Development FDA, IND, Opthalmology, Skyline Therapeutics, neovascular age-related macular degeneration
Skyline Therapeutics has announced that the US Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application …
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