Medical Communications

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ViiV Healthcare gains positive CHMP opinion for cabotegravir for HIV prevention

July 24, 2023 Medical Communications CHMP, EMA, HIV, HIV/AIDS, ViiV Healthcare, cabotegravir

GSK has announced that ViiV Healthcare has received a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal …

WHO releases Medical Product Alert for contaminated cough syrup

July 20, 2023 Medical Communications Pharmacy, WHO, cough syrups, medical product alert, world health organization

The World Health Organization (WHO) has shared a Medical Product Alert for an additional contaminated cough syrup medicine identified in …

Santhera closes exclusive license agreement with Catalyst Pharmaceuticals for Vamorolone

July 19, 2023 Medical Communications License Agreement, Musculo-skeletal disorder, Vamorolone, catalyst, santhera

Santhera Pharmaceuticals has announced the closing of its exclusive North American license agreement for vamorolone with Catalyst Pharmaceuticals. The agreement …

FDA approves first OTC daily oral contraceptive pill

July 14, 2023 Medical 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 …
Chemotherapy

EMA accepts Astellas’ MAA for Zolbetuximab

July 14, 2023 Medical 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 …

ADC Therapeutics puts clinical trial enrollment on hold following patient deaths

July 12, 2023 Medical 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 …
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MHRA authorises GSK’s RSV vaccine for older adults

July 10, 2023 Medical 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) …
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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 – Celltrion USA – has launched a Humira (adalimumab) …
Alzheimer's brain

FDA grants Alzheimer’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 …

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 glecirasib’s pivotal study for pancreatic cancer has been approved by …
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 …
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FDA approves BioMarin’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) …
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 …
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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 …

Astellas Pharma shares positive results from phase 3b trial of Fezolinetant for menopause symptoms

June 28, 2023 Medical Communications Astellas Pharma, Pharmacy, clinical trial, fezolinetant, menopause

Astellas Pharma has announced positive topline results from the phase 3b DAYLIGHT clinical trial for fezolinetant, its investigational oral, nonhormonal …
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