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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.
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.
RoslinCT to Manufacture CRISPR-Based Gene Therapy Casgevy
RoslinCT will manufacture Vertex Pharmaceuticals’ CRISPR-based gene therapy, Casgevy, recently approved for treating sickle cell disease and β thalassemia.
FDA Announces Advisory Committee for Genetic Metabolic Disease Treatments
The new advisory committee will provide the agency with technical and scientific advice and recommendations on potential treatments for genetic metabolic diseases.
Sanofi to Terminate Rare Disease Drug Licensing Agreement with Maze Therapeutics in Wake of FTC’s Challenge
Sanofi has issued a statement expressing its disappointment with FTC’s decision to block an exclusive licensing agreement with Maze Therapeutics for a rare disease drug candidate.
List of Critical Medicines Published in EU
Regulators in the European Union have published the first version a list of critical medicines in the EU to avoid potential shortages.
InvaGen Pharmaceuticals Recalls Vigabatrin for Oral Solution, USP 500 mg
The product is being voluntarily recalled because of powder leakage due to seal integrity issues.
FDA Releases Compounding Guidance
The agency released two guidance documents on the interim policy on compounding using bulk drug substances for both outsourcing and non-outsourcing facilities.
A Look at New Airlift Technology in Single-Use Bioreactors Systems
Pharmaceutical Technology Europe® spoke with Fiona Bellot, sales director, Cellexus BioreactorSystems, at the inaugural Start-Up Market on the show floor at CPHI Barcelona 2023.
AbbVie to Acquire ImmunoGen in Deal Valued at $10.1 Billion
AbbVie’s proposed acquisition of ImmunoGen is expected to accelerate AbbVie's entry into the commercial market for ovarian cancer and includes ImmunoGen’s flagship cancer therapy, ELAHERE (mirvetuximab soravtansine-gynx).
AbbVie Collaborates with BigHat Biosciences on Next-Gen Therapeutic Antibodies
This collaboration will combine BigHat Biosciences’ AI/ML-guided Milliner platform with AbbVie's expertise in oncology and neuroscience to develop next-generation antibodies.
MilliporeSigma Launches AI Solution for Integrating Drug Discovery and Molecule Synthesis
MilliporeSigma’s new platform combines generative AI, machine learning, and computer-aided drug-design aimed at increasing the success rate of new drugs and therapies.
Absci and AstraZeneca Collaborate on AI-Driven Oncology Candidate
AstraZeneca will utilize Absci’s AI antibody drug creation platform to create an AI-designed antibody.
FDA Warns of Rare but Serious Drug Reaction to Antiseizure Medicines
The medicines, levetiracetam and clobazam, may a cause life-threatening reaction to patients if not caught and treated quickly.
Novartis Voluntarily Recalls Two Lots of Sandimmune Oral Solution, 100 mg/mL
Novartis has issued a nationwide voluntary recall of two lots of Sandimmune Oral Solution (cyclosporine oral solution, USP), 100 mg/mL because of crystallization issues.
