Susan Haigney

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.

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

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

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

Biologics have specific quality considerations that make fast tracking these drugs more difficult.

The 3M Harvest RC Chromatographic Clarifier, BT500 is the latest addition to the company’s chromatographic clarifier portfolio.

How can sustainability and zero-carbon initiatives be achieved?

Aitia will access Charles River’s Logica drug solution platform to develop therapeutic programs for neurodegenerative disease and oncology.

Recommended medicines include treatments for generalized myasthenia gravis, glioma, neovascular age-related macular degeneration, and more.

Electronic product information for selected human medicines that have been harmonized across the European Union have been published for the first time.

The document includes recommendations for the reporting and implementation of changes to container closure system components.

The EC is calling for interested parties for their safety and orphan drug committees.

According to USP, the products will advance quality and reduce risk in the development and manufacture of biologics and vaccines.

The new centralized hub will provide advanced testing of nucleic acids, which is expected to simplify mRNA substance testing.

The guidance describes the agency’s procedures for performing remote interactive evaluations at drug manufacturing and bioresearch monitoring facilities.

Bettersize US showcases their BeNano Series, Bettersizer 2600, and BetterPyc 380 instruments at the AAPS 2023 PharmSci 360 event.

The winners of the 2023 CPHI Pharma Awards were announced on October 25 at the CPHI Barcelona event.

The agency’s solidarity mechanism allows Member States to support each other when there is a shortage of a critical medicines.

The final guidance document was issued to assist bio/pharma companies in the clinical development and licensure of COVID-19 vaccines.

The agency recommended conditional marketing authorization for Elrexfio (elranatamab) as a monotherapy for adult patients with relapsed and refractory multiple myeloma.

The recommended medicines include treatments for Duchenne muscular dystrophy, relapsed or refractory multiple myeloma, hyperargininemia, invasive candidiasis, menopause symptoms, and diagnostic medicines for characterizing lesions.

The new Digital Health Advisory Committee will advise the agency on issues related to technologies such as AI, virtual reality, and machine learning.

The program will improve access to adeno-associated virus gene therapy vectors.

The commission’s membership will help facilitate reach and impact for standards harmonization.

With the acquisition, Sharp plans on offering fully integrated small-to-medium scale sterile injectable services.

The companies plan on targeting the production of abundant, low-cost messenger RNA from C1-cells.

The agency’s work with EUnetHTA 21 helped it to prepare the EU for implementation of the regulation.

The draft guidance document discusses the development of labeling for proposed biosimilars and interchangeable biosimilars for submission under section 351(k) of the Public Health Service Act.

The agency is reviewing the medicines after receiving reports of self-injury and suicidal thoughts in patients using the type 2 diabetes treatments.