News

WHO provides a look at the world’s health as the agency turns 75.

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.

The agencies published a joint guidance document regarding quality development for breakthrough therapies and PRIME programs.

Under a collaboration, Daiichi Sankyo and Depixus will use Depixus’ MAGNA technology to accelerate drug discovery efforts of RNA-targeted therapeutics.

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 plan to co-develop and co-commercialize lead ADC candidate for cancer treatment in US.

The Multi-annual AI Workplan creates a strategy to maximize the benefits and manage the risks of artificial intelligence.

The guidance document discusses the impact of clinical pharmacology considerations on peptide drug development.

The US District Court for the District of Massachusetts entered a consent decree of permanent injunction against Pharmasol Corporation for distributing adulterated drugs.

RoslinCT will manufacture Vertex Pharmaceuticals’ CRISPR-based gene therapy, Casgevy, recently approved for treating sickle cell disease and β thalassemia.

The new advisory committee will provide the agency with technical and scientific advice and recommendations on potential treatments for genetic metabolic diseases.

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.

Regulators in the European Union have published the first version a list of critical medicines in the EU to avoid potential shortages.

The product is being voluntarily recalled because of powder leakage due to seal integrity issues.

The agency released two guidance documents on the interim policy on compounding using bulk drug substances for both outsourcing and non-outsourcing facilities.

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’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).

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’s new platform combines generative AI, machine learning, and computer-aided drug-design aimed at increasing the success rate of new drugs and therapies.

AstraZeneca will utilize Absci’s AI antibody drug creation platform to create an AI-designed antibody.

The medicines, levetiracetam and clobazam, may a cause life-threatening reaction to patients if not caught and treated quickly.

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.

Drug shortages across Europe are being exacerbated by increased demand, struggling supply chains, and manufacturer suspensions.

What does the 2024 VPAS mean for pharma?

Pharmaceuticals are entering a transition into a far more complex era of patient therapies, and patient segmentation.

Novo Nordisk will invest more than DKK 16 billion (US$2.3 billion) to expand its production facilities in Chartres, France.

Exagamglogene autotemcel seen as synechdoche.

TAU Systems plans to establish TAU Labs, a new next-generation, laser-driven plasma accelerator laboratory, in Carlsbad, Calif.

Under this multi-year collaboration, Genentech and NVIDIA will use AI to optimize and accelerate each company’s platforms to discover and develop innovative therapeutics.

Chris Spivey, editorial director for Pharmaceutical Technology, discusses messenger RNA (mRNA) advances with Guillaume Roelandts, Head of Products and Marketing, Quantoom Biosciences, at the 11th International mRNA Health Conference in Berlin, Germany.