Industry News

The formation of the new gene therapy company stems from the progress and success of Nationwide Children’s Hospital’s clinical manufacturing and gene therapy work.

FDA has granted fast track designation for Novavax’s NanoFlu, a recombinant quadrivalent flu vaccine, for use by adults age 65 years and older.

Horizon Discovery Group and Mammoth Biosciences have signed a collaboration and license agreement aimed at the development of the next generation of engineered Chinese hamster ovary (CHO) cell lines to improve biotherapeutics production.

The Cell and Gene Therapy Catapult (CGT Catapult) has revealed that the United Kingdom is a favorable environment for cell and gene therapy clinical trials.

ProBioGen and Lava Therapeutics have closed the cell line development and manufacturing agreement for Lava’s novel bispecific antibody lead candidate.

Top of CDER’s to-do list for 2020 is tracking adverse events more effectively and combating the opioid crisis.

Can a commitment to limit prices to ensure patient access to important new medicines regain public trust and confidence in the biopharmaceutical industry?

The trial will test experimental stem-cell treatments against biologic therapies for severe forms of relapsing multiple sclerosis.

The company has various projects and launches scheduled for 2020 as part of its anniversary celebration.

Tim Howard will assume the role of acting ISPE CEO and president after John Bournas steps down from the positions.

The numbers of new molecular entities approved in 2019 are close to or exceed FDA’s performance in most previous years.

The agency sent a warning letter to Henan Kangdi Medical Devices Co. Ltd after an inspection found CGMP violations that included a variety of failures of the company’s quality unit.

Boehringer Ingelheim Biopharmaceuticals China is the first company to apply the adopted Marketing Authorization Holder system within the revised Chinese Drug Administration Law through its partnership with BeiGene for its monoclonal antibody, tislelizumab.

FDA sent a warning letter to GPT Pharmaceuticals Pvt. Ltd. after inspectors found CGMP violations that included equipment that was not properly maintained.

The new scientific advisory board will oversee innovation projects, identify and develop key new technologies, and be responsible for forming high-caliber alliances with innovative start-ups.

FDA sent a warning letter to Dercher Enterprises, Inc., DBA Gordon Laboratories, for CGMP violations and adulterated drug products.

The guidance describes procedures for obtaining an additional National Drug Code for prescription drugs imported into the United States.

The European Medicines Agency and its European partners have launched a pilot program for cooperation in the inspection of facilities that manufacture sterile drug products.

Galderma, a Swiss-based dermatology company that the United States Food and Drug Administration (FDA) has granted breakthrough therapy designation to its investigational therapy, nemolizumab.

With support from academia, patient advocacy organizations, private and nonprofit companies, government organizations, and clinical trial networks funded by the NIH, a new plan was developed to focus on HBV biology, sharing tools and resources, and strategy creation.

While labor and tariff reforms in the revised North American trade agreement may have more visible impacts on the United States economy, the final document levels a major blow to exclusivity and patent protections important to innovator biotech and pharma companies.

FDA has an official new leader, following a Senate vote to confirm Stephen Hahn as the agency’s next commissioner.

Expert poll highlights strength of US pharma sector and advances by emerging markets.

GE Healthcare Life Sciences and Guangzhou Development District Investment Promotion Bureau have signed an agreement to jointly establish a training center for biopharmaceutical professionals.

BioMed X has announced the successful completion of its first joint research project in the fields of COPD and IPF that it had undertaken with Boehringer Ingelheim.

CPI has partnered with ImmunoBiology (ImmBio) for the development of a heat-stabilized formulation of a mutli-antigen vaccine candidate against Pneumococcal diseases.

Data released by the Cell and Gene Therapy Catapult (CGT Catapult) have shown that demands for specialist skills and investment in the cell and gene therapy industry in the United Kingdom are set to increase in the near future.

Iontas has entered into a collaboration agreement with Adaptate Biotherapeutics for the generation and optimization of antibodies for novel immune-oncology targets.

Horizon Discovery has announced its partnership with the Human Protein Atlas, which will see the incorporation of Horizon’s CRISPR-edited knockout cell models into the Cell Atlas program.

A NASEM report stresses the importance of information sharing by biopharma companies and cooperation among regulatory authorities.