Accurately targeted immunotherapies through reliable neoantigen recognition enable personalized medicine development.

Research into Cold Cancers Heating Up

Activation and expansion are essential for success in both autologous and allogeneic therapies.

Development of Gamma-Delta T-Cell Therapies

Continuous manufacturing and a quality-by-design development approach are a natural fit.

QbD for Small-Molecule Continuous Process Development

Topic

Articles

Martin A. Makary, confirmed by a bipartisan vote of the US Senate, has been sworn in as FDA’s new commissioner.

Martin A. Makary Becomes New FDA Commissioner

Patrick Lavery is an Editor for the MJH Life Sciences brands 

. Previously at MJH, he filled the same role for 

The company said the Stratyx 250 is the first bioreactor of its kind to offer biotech companies a combination of automation, remote process control, and flexibility.

Culture Biosciences Opens INTERPHEX 2025 with Launch of Cloud-Integrated Mobile Bioreactor

Mike Hennessy Jr. is the President and CEO of 

Over the course of the next five years, the bio/pharma industry is expected to see the patents of multiple blockbuster drugs expire, impacting some key industry players.

Facing the Latest Patent Cliff

Marks called out an ‘assault’ on truth and science in his resignation letter, which has sent the bio/pharmaceutical industry reeling.

FDA CBER Director Peter Marks Resigns

Feliza Mirasol is the science editor for 

In the latest of a series of warning letters to India-based API manufacturers, FDA issued a warning letter to Aspen for deviations in CGMP in the production of APIs.

FDA Issues Warning Letter to Aspen Biopharma Labs for API Manufacturing Deviations

The Biotechnology Innovation Organization’s new membership survey said that 90% of US biotech companies rely on imported components for at least half of their FDA-approved products.

BIO Survey: Tariffs May Reduce Access, Delay Innovation, Create Red Tape

With a completed €40 million (US$43 million) investment in Slovenia, Novartis has opened its first specialized viral vector production facility in Europe, following earlier significant investments in R&D that has led to the growth of Slovenia’s workforce.

Novartis’ Steady Investments in Slovenia Result in New Viral Vector Manufacturing Facility and a Growing Work Force

The contract will support R&D of high-quality APIs for substance use disorders and mental health conditions, starting with synthesis and scale-up of psilocybin, which is derived from mushrooms.

Benuvia Awarded NIH Contract for GMP Synthesis of Psilocybin, Other Drug Substances

Under the agreement, AstraZeneca will use Alteogen’s proprietary hyaluronidase platform technology to develop and commercialize subcutaneous formulations of multiple oncology assets in its portfolio.

AstraZeneca and Alteogen Sign License Agreement for Developing Subcutaneous Formulations of Oncology Assets

With financing led by Blue Owl Capital, Latigo will use the funds to further develop non-opioid pain treatments as well as develop other candidates in its pipeline.

Drug Development

Research into Cold Cancers Heating Up

Development of Gamma-Delta T-Cell Therapies

QbD for Small-Molecule Continuous Process Development