News

The Vault Quality Suite will help Adare simplify its quality operations across its sites in the United States, France, and Italy.

It is intended to identify the most prevalent and immunogenic targets in solid tumors by uniquely combining high-diversity target libraries with active machine learning.

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.

The agency revised a regulation to enable pharmacies to dispense mifepristone directly to individuals with a prescription.

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.

Bio/pharma has evolved and adapted to a variety of challenges in 2022, but what might be on the cards for the industry in 2023?

Cautiously setting aside pandemic practices, pharma workers appear ready for flux, change, evolution, and expanding molecular diversity.

As the therapeutic landscape grows more complex, so too must the analytical techniques for cleaning validation to ensure the utmost cleanliness is achieved.

In light of increasingly stringent sustainability requirements, bio/pharma companies need to make sure they formulate effective ESG strategies.

CMOs are hoping to grow outsourcing to significantly higher levels in many different areas, with a focus on analytical testing, toxicity testing, and fill/finish operations.

Coverage of COVID-19 vaccines was surprisingly displaced by this year’s astounding oncology and iconoclastic gene therapy “cures.”

TreeFrog Therapeutics is leaping ahead in cell therapies through resources such as new technologies and investor partnerships.

The latest report from Clarivate has been published, highlighting 15 potential blockbusters to watch out for in 2023, the majority of which are personalized medicines.

Does the new regulatory framework have the potential to incentivise R&D investment in rare diseases?

Cell and gene therapies is unequivocally viewed as the biggest opportunity in the bio/pharma space.

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.