All
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.
Replay Signs Exclusive Licensing Agreements with NIH and Miltenyi Biotec for Cell Therapy Development and Manufacturing
Through Syena, its oncology-focused product company, Replay will develop and manufacture T-cell receptor and natural killer cell therapies with the NIH and Miltenyi Biotec.
Körber and Franz Ziel Tighten Ties
Is increasing molecular diversity pushing manufacturing ecosystem consolidation toward turnkey solutions?
Tome brings $213 Million to the Programmable Genome Editing Party
Tome Bioscience is facilitating the transition in biology from the editing phase to the cut-and-paste phase.
European Medicines Regulatory Network on Track to Meet Goals
The midterm report of the European Medicines Agencies Network Strategy finds that the network has strengthened and is on track to achieve its objectives.
Ultragenyx Picks Andelyn Biosciences to Manufacture Novel Gene Therapy for Sanfilippo Syndrome
Andelyn Biosciences has been selected by Ultragenyx to manufacture UX111, that company’s gene therapy for treating Sanfilippo Syndrome.
A Record Year for Disease Elimination
WHO provides a look at the world’s health as the agency turns 75.
FDA Publishes Guidance on Real-Word Data
The final guidance document provides recommendations for designing a new registry or using an existing registry to support decisions regarding safety and effectiveness of a drug.
EMA and FDA Answer Questions About Breakthrough Therapies
The agencies published a joint guidance document regarding quality development for breakthrough therapies and PRIME programs.
Daiichi Sankyo Partners with Depixus to Accelerate RNA-Targeted Drug Discovery
Under a collaboration, Daiichi Sankyo and Depixus will use Depixus’ MAGNA technology to accelerate drug discovery efforts of RNA-targeted therapeutics.
NightHawk Biosciences Shifts into a Pure-Play Large-Molecule CDMO
Following the divestiture of its Elusys subsidiary and other non-core assets, NightHawk Biosciences will transform into a pure-play large-molecule CDMO.
Bristol Myers Squibb and SystImmune Enter Global ADC Collaboration Worth Potentially up to $8.4 Billion
Bristol Myers Squibb and SystImmune plan to co-develop and co-commercialize lead ADC candidate for cancer treatment in US.
EMA Publishes Guide for Use of AI in Medicine Regulation
The Multi-annual AI Workplan creates a strategy to maximize the benefits and manage the risks of artificial intelligence.
FDA Issues Guidance on Clinical Pharmacology for Peptide Drugs
The guidance document discusses the impact of clinical pharmacology considerations on peptide drug development.
Consent Decree Entered Against Pharmasol
The US District Court for the District of Massachusetts entered a consent decree of permanent injunction against Pharmasol Corporation for distributing adulterated drugs.
