News

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

Molecular taggants from Applied DNA Sciences and Colorcon’s Opadry coating target counterfeit and falsified medications.

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.

The new site can manufacture oligonucleotide APIs at large scale.

Through the acquisition, Johnson & Johnson will gain access to Taris’ lead clinical-stage product, TAR-200.

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

The promise of new therapies is tempered by the need for affordability, safety, and ethics.

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

Aurobindo Pharma USA, Inc. voluntarily recalled Mirtazapine Tablets due to an error on the label that listed the incorrect strength.

FDA’s approval rate slowed, but the US agency is still ahead of its international counterparts in green-lighting new drugs for market.

In 2020, European regulators are expected to start to be even more active in encouraging drugs innovations rather than hindering them through legal restrictions.

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.