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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.
Moderating Innovation to Equipoise Risk
As innovation accelerates, pharmaceutical regulators continue their path of maintaining proportion, balance, and restraint.
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.
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.
Clarivate Highlights 13 Potential Drugs to Watch in Latest Report
Clarivate's Drugs to Watch report highlights 13 potential blockbuster drugs and gamechangers set to launch in 2024.
PharmaKure Gets Nod from MHRA to Trial Drug Targeting Amyloid Deposits
MHRA has granted a Clinical Trial Authorization to PharmaKure for its oral combined drug for the treatment of mild cognitive impairment.
Relative Bioavailability Trial of Nanotechnology-Enhanced Enzalutamide is Underway
Nanoform has completed the First Subject First Visit in a trial evaluating the relative bioavailability of its nanotechnology-enhanced enzalutamide.
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.
Leiters Health Recalls Vancomycin IV Bags, Phenylephrine IV Bags, and Fentanyl IV Bags
The potential for superpotent drug initiated the voluntary recall.
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.
Bridging Gaps and Investing in Change
European bio/pharma companies have no choice but to invest and adapt to the evolving industry needs.
Frontrunners in Molecular Glues
Novel molecular glues are transforming targeted protein degradation.
Bringing Collaboration to the Horizon Once More
UK scientists are once again able to participate in the Horizon European research programme thanks to a deal struck in 2023.
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.
Finalizing the European Health Data Space
The EHDS aims to increase access to health data, but how will it impact pharma?
Unlucky for Some
Clarivate has released its 2024 Drugs to Watch report, highlighting 13 therapies with great potential.
Reimbursement Precipitating Shortages
GSI shortages result from how hospitals buy GSI drugs, and the underinvestment in manufacturing operations that follow.
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.