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 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.

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

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

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.

Newron Pharmaceuticals has received communications from the United States Food and Drug Administration (FDA) suggesting it discusses its proposed statistical plan in a Type A meeting.

Life science and healthcare business accelerator, Start Codon, and membership organization, One Nucleus, have partnered up to support the life science ecosystem in the United Kingdom.

Swiss-based specialist pharma R&D company, MetP Pharma, has been granted a Notice of Allowance from the Unites States Patent and Trademark Office (USPTO) for its patent titled, “Treatment of Demyelineating Diseases.”

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.

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.

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.

The acquisition boosts Sanofi’s pipeline of immuno-oncology product candidates with a lead candidate in development for treating solid-tumor-type cancers.

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.

Under the restructuring, Sanofi will gain sole global rights to Kevzara (sarilumab) and sole ex-US rights to Praluent (alirocumab), while Regeneron will gain sole US rights to Praluent.

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

The biologic is a novel bone builder that has a dual effect of increasing bone formation and reducing bone loss.

GE Healthcare Life Sciences and Advanced Solutions Life Sciences (ASLS) are partnering on 3D-printing of tissues that can be used for discovery and cytotoxicity testing.

The new Technology Excellence Center, located in Boston, MA, will further the company’s presence in the United States biopharma drug development landscape.

The new technical service center at the Memphis International Airport will service inbound and outbound traffic for the company’s CSafe RKN and CSafe RAP active container systems.

The expansion will enhance the company’s specialty drug product capabilities.

The new software lets users choose the volume and cell concentration from initial cell preparation through transduction to final resuspension, without compromising cell viability and virus stability.

The app, CURE ID, is designed to allow the clinical community to report their experiences treating infectious diseases with novel uses of existing FDA-approved drugs.

The agency has approved three applications for generic versions of Gilenya (fingolimod), Novartis’ blockbuster multiple sclerosis drug.