BioPharm International Editors

FDA sent a warning letter to LEC Custom Products for a variety of CGMP violations including use of inappropriate equipment and processes.

Orgenesis has completed its previously announced acquisition of Koligo Therapeutics with the additional acquisition of Tissue Genesis’ cell isolation technology, Icellator.

The company’s new closed cell therapy processing system enables scalable, cost-effective development and manufacturing of cell therapies.

OptiGel DR softgel capsules are formed by the combination of pectin, a naturally derived polysaccharide, and gelatin, which eliminates the need for a separate capsule coating step.

The company was selected because of its nucleic acid platform which, when combined with virotherapy, has the potential to treat liver cancer by using a lipid nanoparticle delivery system.

Rigaku is featuring its latest x-ray instrumentation at three virtual booths at the virtual 27th International Trade Fair for Laboratory Technology, Analysis, and Biotechnology conference.

FDA issued guidance for applicants that must report annually on the status of postmarketing studies and clinical trials under section 506B of the FD&C Act.

The facility will include a high-speed sterile line for live virus filling, a line for standard fill/finish, cleanroom capacity, labs, warehousing, and offices to support production.

The new VirusExpress lentiviral production platform increases dose yields and reduces process development time for cell and gene therapies.

The new facility at the company’s San Diego, CA, site will be for late phase and commercial CGMP manufacturing.

Recent data, from BIA and Clarivate, has revealed that investment in UK biotech continues to be strong.

The UK's MHRA has joined the Australia-Canada-Singapore-Switzerland (ACSS) Consortium of regulators.

The approval comes after a Phase III trial that showed Keytruda reduced the risk of disease progression or death by 35%.

Regeneron will distribute Inmazeb treatment doses over the course of six years to BARDA.

The judges chose Sheng from a shortlist of seven candidates and highlighted his work in the Taiwanese and global markets while guiding the company through “pivotal changes” that demonstrated his abilities as a “top CEO.”

Roche will use Dyno’s CapsidMap platform to develop next-generation adeno-associated virus vectors for gene therapies for central nervous system diseases and liver-directed therapies.

Virtual Touring allows companies to inspect and visit vendor and contract partner sites remotely during the COVID-19 pandemic.

The unexplained illness in a study participant is being reviewed and evaluated by an independent data safety monitoring board and internal clinical and safety physicians.

The company will supply its LIMS to the Walter Reed Army Institute of Research (WRAIR) to support vaccine production programs for COVID-19 at WRAIR’s pilot bioproduction facility.

The companies are entering into an agreement for the late-stage development and large-scale manufacturing of AZD7442, AstraZeneca’s investigational product for treatment and prevention of COVID-19.

The partnership aims to provide a platform of hiPSC-based assays, drug discovery technologies, high-throughput screening, and high-content screening.

Rentschler will handle the downstream processing to provide highly purified drug substance at its headquarters in Laupheim, Germany.

Independent research performed at the University of St. Andrews in the UK has reportedly demonstrated the effectiveness of Alfacyte in-vitro against SARS-CoV-2.

Under the contract, Pharm-Olam will offer routine and response clinical services for the development of medical countermeasures.

The study, entitled CV-NCOV-002, is being held in Peru and Panama and has enrolled 690 participants, including older adults ages 61 and above, and younger participants 18 to 60 years old.

Eudratec Fasteric is an oral drug delivery technology that offers enteric protection after rapid, homogeneous release for targeting the upper small intestine.

Through the acquisition, Bristol Myers Squibb will gain access to MyoKardia’s mavacamten, a cardiovascular drug for the treatment of obstructive hypertrophic cardiomyopathy, a chronic heart disease.

Optimus Holding has successfully completed the acquisition of OM Pharma.

Symbiosis has successfully completed a scheduled inspection by MHRA.

The technology is a novel, plasmid-free manufacturing system for robust and reproducible manufacture of AAV at scale.