
As a new decade has begun, this editorial reviews some of the biggest, brightest, and boldest happenings from the industry over the past 10 years.

As a new decade has begun, this editorial reviews some of the biggest, brightest, and boldest happenings from the industry over the past 10 years.

A selection of interesting conferences, technical presentations, and Learning Lab presentations as chosen by the editorial team of Pharmaceutical Technology Europe.

A coalition establishes a secure, direct link between a physical tablet and a digital backend for supply chain integrity.

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 divestment of the pharma and food ingredients business is in line with Ferrer’s new strategy to focus on the core business of branded pharmaceuticals.

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

Glenmark Pharmaceuticals is recalling unexpired lots of Ranitidine Tablets due to potential presence of N-nitrosodimethylamine (NDMA).

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

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.

Catalent recently completed the clinical production of Bridge’s opioid addiction development therapeutic product and investigational new drug, BT-219, which will be used with Catalent’s Zydis orally disintegrating tablet technology.

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.