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Celltrion launches Humira biosimilar in US

July 7, 2023
Medical Communications Chronic Diseases, Humira, Yuflyma, arthritis, celltrion

South Korean biopharmaceutical company Celltrion has announced that its US branch โ€“ Celltrion USA โ€“ has launched a Humira (adalimumab) …

Alzheimer's brain

FDA grants Alzheimerโ€™s disease drug Leqembi full approval

July 7, 2023
Medical 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 Immunotherapiesโ€™ UC drug gets DSMB positive recommendation

July 6, 2023
Research and Development EMA, Gastrointestinal tract, OSE Immunotherapeutics, ulcerative colitis

Frenchย biotech company OSE Immunotherapeutics has announced that its Ulcerative Colitis (UC) trialโ€™s Independent Drug Safety Monitoring Board (DSMB) has provided …

FDA grants Priority Review for Astellas Pharmaโ€™s BLA for cancer drug

July 6, 2023
Research 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, 2023
Research 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 …

Jacobio Pharma receives CDE approval for pancreatic cancer study in China

July 5, 2023
Medical Communications CDE, China, Jacobio Pharma, Oncology, Pancreatic cancer, clinical trial

Jacobio Pharma has announced that its novel KRAS G12C inhibitor glecirasibโ€™s pivotal study for pancreatic cancer has been approved by …

Roger Dmochowski appointed as Versamebโ€™s chief medical officer

July 5, 2023
Business Services Roger Dmochowski, Urology, Versameb, appointment, chief medical officer

Versameb AB has announced the appointment of Professor Roger Dmochowski as chief medical officer. Dmochowski is a renowned researcher and …

Cytovation appoints Olav Hellebรธ to board of directors

July 5, 2023
Business Services Cytovation, Olav Hellebรธ, Oncology, appointment, board of directors

Cytovation ASA, a clinical stage immune-oncology company with a focus on targeted tumour membrane immunotherapies, has announced that it has …

Amsterdam UMCโ€™s new drug doubles remission rates in patients with ulcerative colitis

July 4, 2023
Research and Development Amsterdam UMC, Gastrointestinal tract, mirikizumab, ulcerative colitis

A new drug, being investigated by Amsterdam UMC along with colleagues at various universities, has been shown to be effective …

Croda International acquires Solus Biotech

July 4, 2023
Business Services Croda International, Pharmacy, Solus Biotech, acquisition

Croda International has confirmed that it has successfully acquired Solus Biotech, following receipt of approval from the South Korean regulatory …

brainss

Sosei Heptares announces first subject dosed in phase 1 trial for schizophrenia therapy

July 3, 2023
Research and Development HTL'149, Neurology, Sosei Heptares, clinical trial, schizophrenia

Sosei Heptares has announced that it has dosed its first patient in its phase 1 trial evaluating HTL0048149 (HTLโ€™149), a …

lungs

AstraZeneca shares results from phase 3 trial of datopotamab deruxtecan for NSCLC

July 3, 2023
Medical Communications AstraZeneca, NSCLC, Oncology, clinical trial, datopotamab deruxtecan

AstraZeneca has announced results from its TROPION-Lung01 phase 3 trial for its TROP2-directed antibody drug conjugate, developed in collaboration with …

Josef Penninger appointed as new scientific director of Helmholtz Centre for Infection Research

July 3, 2023
Business Services Helmholtz Centre for Infection Research, Josef Penninger, appointment, scientific director

The Helmholtz Centre for Infection Research (HZI), Germany, has appointed Professor Josef Penninger as scientific director. Penninger has previously worked …

Kevin Hawkins appointed as Reactaโ€™s head of regulatory affairs

July 3, 2023
Business Services Kevin Hawkins, Reacta, appointment, head of regulatory affairs

Reacta Healthcare, an early-stage food allergy diagnostic company, has announced the appointment of Kevin Hawkins as head of regulatory affairs. …

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FDA approves BioMarinโ€™s Roctavian for adults with severe haemophilia A

June 30, 2023
Medical Communications BioMarin, FDA, Haematology, Roctavian, haemophilia

Global biotechnology company BioMarin Pharmaceuticals has announced that the US Food and Drug Administration (FDA) has approved Roctavian (valoctocogene roxaparvocec-rvox) …

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Eli Lilly to acquire Sigilon Therapeutics

June 30, 2023
Business Services Chronic Diseases, Eli Lilly, Sigilon, acquisition

Eli Lilly and Sigilon Therapeutics have announced a definitive agreement for Lillyโ€™s acquisition of Sigilon, a biopharmaceutical company focusing on …

diabetes

First cellular therapy for patients with type 1 diabetes approved by FDA

June 29, 2023
Medical Communications Diabetes, FDA, Lantidra, Type 1 diabetes, diabetes

The US Food and Drug Administration (FDA) has announced that it has approved Lantidra, the first allogeneic (donor) pancreatic islet …

Astellas establishes open innovation hub for tumour microenvironment research

June 29, 2023
Research and Development Astellas Pharma, Mitsui Fudosan, Oncology, open innovation hub, tumour microenvironment

Astellas Pharma and Mitsui Fudosan have announced that Astellas plans to establish a tumour microenvironment (TME) open innovation hub, intended …

Anavex Life Sciences and Partex NV Group announce AI-based strategic partnership to enhance patient experience

June 28, 2023
Research and Development AI, Anavex Life Sciences, Partex NV Group, Pharmacy, patient experience

US-based clinical-stage biopharmaceutical company Anavex Life Sciences and German digital pharma platform Partex NV Group have announced a strategic partnership …

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Microba commences phase 1 clinical trial for IBD drug

June 28, 2023
Medical Communications Biotherapeutic, Gastrointestinal tract, Microba, clinical trials, ibd

Australian precision microbiome company Microba has announced that the first participants in its phase 1 inflammatory bowel disease (IBD) clinical …

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