All News

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.

Under the agreement, Almirall will leverage WuXi Biologics’ proprietary WuXiBody platform to develop bispecific antibodies for dermatological diseases.

The event is set to take place from Feb. 23–26, 2020 at the Bethesda North Marriott in North Bethesda, Maryland.

Roche will apply ProBioGen’s proprietary GlymaxX technology to boost the antibody-dependent cellular cytotoxicity activity of antibodies.

The joint venture will develop next-generation cell and gene therapies incorporating Affimer proteins.

Catalent completes purchase of biologics fill-finish and oral solid dose facility in Anagni, Italy

The new GMP conditioning product offering is designed to support clinical phase and commercialization stages of cell and gene therapy production.

The Ireland-based company can now offer complete elemental impurities testing services.

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.

Catalent’s planning service is designed to assist in evaluating needs for launching and maintaining clinical trials.

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

Sartorius and the German Research Center for Artificial Intelligence have established a research laboratory for AI in the biopharmaceutical industry.

By consolidating legacy buildings, Colorcon enhances environmental and production efficiencies at West Point, PA facility.

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.

The acquisition expands Charles River’s scientific capabilities in cell therapy development.

The deal was approved by the Federal Trade Commission following a 10-month investigation.

The company has filed an NDA for lurbinectedin and is seeking accelerated approval for treatment of relapsed small cell lung cancer.

The expansion plans to build upon the company’s high potent drug manufacturing and development capabilities, including both clinical and commercial supply.

The rapid-onset CNS neuroactive nasal spray is distributed to patients in microgram doses and activates nasal chemosensory receptors that trigger neural circuits in the brain that suppress fear and anxiety associated with everyday social, work, or performance situations.

Through the acquisition, Merck will gain access to ArQule’s lead investigational candidate, ARQ 531, a novel, oral Bruton’s tyrosine kinase (BTK) inhibitor currently in a Phase II dose expansion study for the treatment of B-cell malignancies.

Through the collaboration, Charles River plans to expand its suite of authentic human cells by utilizing Bit Bio’s target discovery, validation, and screening services to further the development of therapies with a higher chance of success in patients.

Sanofi Pasteur will expand clinical development and manufacturing of an adjuvanted recombinant pandemic vaccine at its site in Pennsylvania.

According to a consent decree of permanent injunction issued in September 2019, the health and wellness companies must recall and stop distributing products until the companies comply with the Federal Food, Drug, and Cosmetic Act and other requirements included in the consent decree.

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.