Biopharma sees strong Q2 2023 market cap growth
Johnson & Johnson have been shifted from the top position in the market capitalisation ranking for the first time, due to Eli Lilly having the largest growth during Q2 2023, research shows.
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CHMP to review MAA for geographic atrophy treatment
Iveric Bio's marketing authorisation application (MAA) for avacincaptad pegol (ACP) to treat a leading cause of blindness has been accepted for review by the European Medicines Agency.
Immunotherapy combo could overcome melanoma anti-PD-1 resistance
A “practice-changing” immunotherapy drug combination demonstrated inhibition of two main immune checkpoints in a trial assessing efficacy in metastatic melanoma.
CDMO to manufacture SARS-CoV-2 intranasal vaccine
In a collaboration between the Institutes of Health (NIH) and CDMO Exothera, an intranasal vaccine for SARS-CoV-2 will be manufactured for use in a clinical Phase I/II trial in Africa and the US.
AbbVie gains EU migraine treatment approval
The first once-per-day oral CGRP receptor antagonist gepant treatment has been approved in the EU as a preventative treatment for both chronic and episodic migraines.
Sandoz to file for approval of aflibercept biosimilar
Sandoz intends to seek regulatory approval for its aflibercept biosimilar in the US and EU in the coming months.
UK approval for Pompe Disease therapy
16 August 2023 | By
The MHRA has granted marketing authorisation for a two-component therapy for adults with late-onset Pompe Disease, a rare disorder.
CPHI to return to Milan in 2024
CPHI, the global pharmaceutical exhibition will take place in Milan, Italy from 8-10 October 2024.
Buccal drug delivery market to reach $7.1b by 2030
Growth of the buccal drug delivery market is driven by the high bioavailability of buccal formulations as well as the ageing population, smoking addiction and increased R&D.
Lilly completes biopharma acquisitions
Lilly expands its portfolio of treatments for cardiometabolic diseases with acquisition of Versanis Bio and Sigilon Therapeutics.
FDA approval for Janssen’s prostate cancer treatment
The US FDA approval of Akeega (niraparib and abiraterone acetate) is based on positive results from the Phase III MAGNITUDE study.
European Commission revokes marketing authorisation for Novartis’ crizanlizumab
Novartis will remove its sickle cell medicine crizanlizumab from the EU/EEA market following a European Commission decision.
CDMO expands CGT manufacturing site in Italy
The expansion of the CGT manufacturing site in Milan, Italy, will support viral vector development and manufacturing for late-stage clinical and commercial projects.
Multiple myeloma bispecific antibody granted accelerated approval
Accelerated US approval of a first-in-class bispecific antibody (BsAb) therapy offers a new option for a difficult-to-treat blood cancer.
FDA warning letters highlight CAPA concerns
Several FDA warning letters distributed to pharmaceutical manufacturers in 2023 have warned of numerous corrective and preventive action (CAPA) compliance concerns.
