Pharmaceutical Technology Editors

This self-emulsifying system improves the miscibility and dispersibility of formulations in aqueous environments and may improve API solubility.

Epinephrine is a critical medication used during life-threatening conditions that can affect any age and any person.

A REMS document is a part of a REMS required by FDA and establishes the goals and requirements of the REMS.

The definitive agreement will give AstraZeneca global rights to CinCor’s portfolio of cardiorenal disease treatments.

Chiesi will acquire Amryt Pharma, a commercial-stage biopharmaceutical company, in a deal worth up to $1.47 billion.

The company was awarded the Terra Carta Seal in recognition of its commitment to creating a sustainable future.

Ipsen’s $952 million acquisition of Albireo is designed to bolster the company's rare disease portfolio.

Sartorius and RoosterBio will work together to address purification challenges and establish scalable downstream manufacturing processes for exosome-based therapies.

Getinge is launching Livit Flex, a bioprocess control system designed to help pharmaceutical and biotech products get to market faster.

The collaboration will see Moderna and CytomX work together to develop mRNA-based conditionally activated therapeutics.

Eisai’s Alzheimer’s treatment, Leqembi (lecanemab-irmb), received approval from FDA via the Accelerated Approval pathway.

Astrea Bioseparations has acquired Delta Precision, a manufacturer of chromatography columns for biomanufacturing.

Avantor and Catalent have entered into a multi-year supply and services agreement.

Agilent’s acquisition of Avida grants them access to high-performance enrichment workflows that enable NGS approaches for studying cancer.

Merck, known as MSD outside of the United States and Canada, will pay Kelun-Biotech up to $9l3 billion for seven early-stage oncology treatments.

The ROSS Model HSM-405SC-25 Inline High Shear Mixer with SLIM Technology is a flexible mixing solution.

Particle Measuring Systems’ MiniCapt Pro Remote Microbial Air Sampler is designed for effective remote microbial monitoring for cleanroom professionals.

Celegance’s Dossplorer can import product registration dossiers and ready regulatory submissions for electronic common technical documents compliance.

Bio-Rad Laboratories’ Pioneer Antibody Discovery Platform is an antibody discovery service specifically designed to develop best-in-class biologic candidates.

Additionally, 89 human medicines have been recommended for approval by the EMA, and the organization also analyzed a new vaccine against dengue and two diabetes treatments that address important public health issues outside the EU.

In addition, the Clinical Trials Regulation is set to become a single-entry point for sponsors and regulators in January 2023 for the submission and assessment of all new clinical trials.

In terms of extensions, the committee recommended Adcirca, Dupixent, Edistride, Enhertu, Fintepla, Forxiga, Hemlibra, Imfinzi (including two new indications), Kerendia, Spikevax and Triumeq.

The complaint states the company introduced adulterated drugs into interstate commerce that were manufactured, processed, packed, or held under conditions that defy current good manufacturing practice (CGMP) requirements.

Bylvay has minimal systemic exposure and acts locally in the small intestine as a potent, once-daily, non-systemic ileal bile acid transport inhibitor (IBATi).

The MAA is supported by data from the pivotal Phase III GEMSTONE-302 trial that evaluated treatment with sugemalimab in combination with chemotherapy in patients with metastatic NSCLC.

FDA has announced that bebtelovimab is not currently authorized for emergency use in any region of the US.

Sosei Heptares and Eli Lilly have entered a multi-target collaboration and license agreement in diabetes and metabolic diseases.

The launch of Discovery Life Sciences’ new Proteomic Services Division offers a single source for large-scale population studies, biobank characterization, and multi-omic biomarker analysis.

GSK and Wave Life Sciences have entered into a collaboration to drive drug discovery and development for novel genetic targets.

AbCellera and Rallybio are teaming up to discover, develop, and commercialize novel antibody-based therapeutics for rare diseases.