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FDA Grants Orphan Drug Designation to First-in-Class Treatment for Eosinophilic Esophagitis
The immune-resetting peptide, developed by Revolo Biotherapeutics, received positive results from its Phase IIb study.
FDA Give Guidance on Human Genome Editing in Gene Therapies
The final guidance provides recommendations for developing gene therapy products incorporating genome editing of human somatic cells.
IMU Biosciences Raises Millions in Series A Funding Round
IMU Biosciences has secured £11.5 million in its Series A financing round.
Sanofi to Aquire Inhibrx for $1.7 Billion
The acquisition adds a potential rare disease asset to Sanofi’s alpha-1 antitrypsin deficiency pipeline.
Winners of the 2024 Pharmapack Europe Awards are Announced
The 2024 Pharmapack Europe Award winners include companies involved in ground-breaking innovations in novel drug delivery solutions, reusable connected devices, and recyclable packaging.
Takeda’s Subcutaneous Immunoglobulin Receives FDA Approval for Maintenance Therapy of Rare Neuromuscular Disorder
Takeda has received FDA approval for HYQVIA, a subcutaneous immunoglobulin for the maintenance treatment of chronic inflammatory demyelinating polyneuropathy.
KBI Biopharma and Argonaut Manufacturing Services Team Up on Drug Substance and Drug Product Manufacturing Solutions
Under a new alliance, KBI Biopharma and Argonaut Manufacturing Services will combine their strengths to offer end-to-end biopharma development and CGMP manufacturing solutions.
Abzena Launches New Cell Line Development Platforms
Abzena has launched its AbZelect platforms, designed for improving cell line development.
EMA Looks Back at Medicines Approved in 2023
The agency recommended 77 drugs for marketing authorization in 2023, including 39 new APIs.
Novartis Acquires Calypso Biotech for up to $425 Million
The acquisition will give Novartis full rights to CALY-002, Calypso’s lead product candidate.
CDER Approved 55 Novel Drugs in 2023
FDA’s Center for Drug Evaluation and Research released its report on new drugs approved in 2023.
Charles River Launches Off-the-Shelf Rep/Cap Plasmids for AAV Vector Manufacturing
Charles River’s off-the-shelf rep/cap plasmids are intended to simplify gene therapy supply chains.
Bora Pharmaceuticals Fuels Global Expansion with Acquisition in US
The acquisition marks a pivotal expansion for the company into the US market.
EMA Starts Safety Review of CAR T-Cell Medicines
The agency is reviewing data on secondary malignancies related to T-cells for approved CAR T-cell medicines.
Merck to Acquire Harpoon Therapeutics in Deal Valued at $680 Million
Through the acquisition of Harpoon Therapeutics, Merck will gain an investigational delta-like ligand 3-targeting T-cell engager under development for cancer treatment.
AI Biotech Secures Funding to Speed Up Stem Cell Therapy Development
CellVoyant has raised £7.6 million in seed funding to speed up the development of novel cell therapies.
Precautionary Measures Recommended in Use of Valproate Medicines
The European Medicines Agency safety committee says there is a potential risk of neurodevelopment disorders in children born to men treated with valproate.
Boehringer Ingelheim Expands Facility in Greece for Production of New Therapeutics
Boehringer Ingelheim is investing €120 million (US$131 million) into its Koropi, Greece site to expand production for new therapeutics.
A Platform for mRNA Platforms
Regulators from around the world will gather to help shape the mRNA and RNA therapeutics landscape at an exceptional April 2024 Washington, D.C. convocation.
Pluri Launches New Cell Therapy CDMO Division
Pluri has launched PluriCDMO, a new contract development and manufacturing organization business that will offer cell therapy manufacturing services.
Cherwell Joins AnalytiChem Group
Cherwell Laboratories’ cleanroom microbiology solutions will join AnalytiChem’s group of seven companies across Europe, North America, and Australia.
GSK to Acquire Aiolos Bio, Expands Respiratory Portfolio
In a deal worth up to $1.4 billion, GSK aims to acquire Aiolos Bio and gain an expanded pipeline of biologic-based respiratory therapeutic candidates.
WuXi AppTec Expands Peptide and API Manufacturing
The expansion will boost solid-phase peptide synthesis total reactor volume to 32,000 L.
DoD Grants Additional Funds to MediWound for Advancement of Non-Surgical Treatment for Field Care Burns
MediWound has been granted an additional $6.7 million by the DoD to advance NexoBrid as a non-surgical field care solution for the US military.
Boehringer Ingelheim and Ribo Partner on RNA-based Liver Disease Therapeutics
Under the collaboration, Boehringer Ingelheim and Ribo will develop RNA-based therapeutics to treat NASH/MASH.
Roche to Acquire Point-of-Care Technology from LumiraDx in $350 Million Deal
Roche will acquire select parts of the LumiraDx group related to that company’s point-of-care technology, which integrates multiple tests on a single instrument.
AstraZeneca Poised to Acquire Cell Therapy Developer, Gracell, in Deal Valued at $1.2 Billion
AstraZeneca’s acquisition of Gracell includes a clinical-stage autologous cell therapy targeting hematologic malignancies and autoimmune diseases and a proprietary manufacturing platform.
QurAlis Opens European Headquarters in The Netherlands
The new Europe headquarters will be the hub for the company’s European operations, including production of product.
AstraZeneca to Acquire Icosavax in Deal Valued at Approximately $1.1 Billion
With the acquisition, AstraZeneca will gain a potential RSV and hMPV combination vaccine.
The Decline and Fall of the Clinician–Scientist
Clinician-Scientists are vital innovation spark plugs, accounting for 40% of Nobel awards in Physiology or Medicine, and two thirds of Big Pharma CSOs.
