News

The agency issued two final and two draft guidance documents to help identify and trace drug products in the supply chain.

AGC Biologics has partnered with BioNTech to further supply plasmid DNA starting material from its Heidelberg, Germany, facility for the Pfizer-BioNTech COVID-19 vaccine.

FDA has granted fast track designation to a GLP-1/glucagon dual agonist in development by Boehringer Ingelheim and Zealand Pharma for the treatment of NASH.

FDA approved Ryplazim (plasminogen, human-tmvh) for the treatment of plasminogen deficiency type 1.

FDA has granted Janssen breakthrough therapy designation for teclistamab, an investigational bispecific antibody under development for treating relapsed or refractory multiple myeloma.

FDA has granted accelerated approval to Biogen for Aduhelm (aducanumab), a new mAb treatment for Alzheimer’ disease.

The Biden administration supports a notable increase in funding for public health and research as a lead priority for the coming year.

The Module Type Package standard is now supported in Emerson’s DCS and PLCs.

MedPharm’s new facility for process development and small-scale manufacturing is in North Carolina, near its existing R&D center.

Hovione has re-joined iBET to increase its R&D programs in novel and high potential pharmaceutical technologies and to combine expertise for industrial innovation in new therapeutic fields.

Through the acquisition, Aceto can now offer its customers support throughout the drug development process and access to North American manufacturing for APIs and advanced intermediates.

The added capabilities include clinical-scale sachet and blister packaging for clinical trial pharmaceuticals and a relationship with a European Union Qualified Person for its CTS offerings.

Aptamer Group and PinotBio have formed a strategic collaboration aimed at the development of new drug conjugates for targeted drug delivery.

Eight companies representing the pharmaceutical supply chain have joined a newly founded non-profit membership association, Alliance to Zero, aimed at facilitating the transition of the pharma sector to comply with net-zero emissions.

The Optima Group is expanding production capacities in Germany to meet with high demand for packaging and filling solutions.

The acquisition of Advanz Pharma by Nordic Capital has now completed, in a deal worth $846 million.

Samsung Biologics and KAHR Medical have signed a strategic development and manufacturing agreement for a cancer immunotherapy drug candidate.

Celltrion Healthcare has revealed positive one-year results from a Phase III trial comparing biosimilar adalimumab, Yuflyma, with the reference adalimumab in patients with rheumatoid arthritis.

As recent COVID-19 vaccine facility citations make clear, failure to meet cleaning and sanitization requirements puts patients, facilities, and operators at risk.

GoSilico’s software for digital twins of downstream biopharmaceutical processes will be integrated into Cytiva.

Currently, PNI offers a Genetic Medicine Toolkit, including its GenVoy LNP delivery platform and NanoAssemblr microfluidic-based nanoparticle manufacturing platform, for the development of genetic medicines.

Through the acquisition, Avantor will have access to RIM’s Changzhou, China, facility, making it Avantor’s first single-use production plant in the AMEA region.

The companies are expanding their collaboration to extend the drug substance manufacturing of Moderna’s COVID-19 vaccine with the addition of a new manufacturing line at Lonza’s Geleen, Netherlands, site.

Moderna has initiated a rolling submission process with FDA for a biologics license application for its mRNA COVID-19 vaccine for individuals 18 years of age and older.

GSK’s position is raising concerns as it continues working towards its separation of businesses.

Bio/pharmaceutical manufacturers have made a good first step toward global vaccination through pledging doses at no- to low-profit rates.

Technology advances foster new therapies.

The acquisition gives PerkinElmer access to Nexcelom Bioscience’s complementary cell counting and analysis capabilities and enhances its QA/QC capabilities.

PPD has opened its new multipurpose clinical research laboratory in Suzhou, China, which offers bioanalytical, biomarker, and vaccine sciences services for China and the global market.

Expected to be completed by 2022, the new addition is part of the Samsung Biologics’ long-term strategy to become a fully integrated global biopharmaceutical company.