The companies have entered into a manufacturing agreement for the production of Phase III clinical trial material.

The agency is planning to clean out its drug listing records and urges companies to update any inaccurate active drug listing submission.

Spectrum Laboratory Products received an FDA warning letter after violations were found at its New Brunswick, NJ facility.

A New Jersey court upheld the validity of patent claims for Amgen’s anti-inflammatory blockbuster biologic, Enbrel (etanercept).

AskBio’s acquisition of Synpromics will improve the efficacy of its adeno-associated virus gene therapy vectors.

Using Alternating Tangential Flow in a 3000-L perfusion bioreactor, the company expects to reduce production time by up to 30%

The acquisition strengthens BioLife’s position as a supplier of disruptive, enabling solutions used for manufacturing, storage, and distribution of cell and gene therapies.

The new facility will manufacture biopharmaceutical products under cGMP conditions.

The acquisition expands Eurofins Genomics’ gene portfolio while bolstering Blue Heron’s production capabilities.

Jack Bailey, president, US Pharmaceuticals, GlaxoSmithKline, will step down from his position at the end of 2019 and will be succeeded by a Merck KGaA executive.

The acquisition will expand BioIVT’s disease-state portfolio by volume and product range.

The new position will expand the company’s large-molecule and protein therapeutics services by partnering with biopharmaceutical clients who are navigating the large-molecule product development life cycle.

The Tridex Protein Analyzer from IDEX offers the ability to directly measure protein titer from a bioreactor in real time.

The acquisition will boost Bayer’s cell-therapy development programs, with an initial focus on neurology, cardiology, and immunology.

The facility will support gene therapy production and continued development of PTC’s pipeline of investigational medicines.

South Korea’s pharma/biotech space is projected to grow to $23.2 billion by 2022, and will likely attract foreign investment, according to a new market report by GlobalData.

The company has launched new services for mammalian cell bank manufacturing under GMP conditions.

The guidance answers questions about how the agency awards priority review vouchers to sponsors of treatments for rare pediatric diseases.

The guidance discusses clinical trial design features that can support approval of treatments of Fabry disease.

An affiliate of the Permira funds has signed an agreement to purchase Cambrex in an approximately $2.4-billion transaction.

A US District Court in Washington, DC upheld FDA’s interpretation of clinical need when choosing which substances are approved to use for drug compounding.

The agency is keeping Zolgensma on the market as it evaluates the accuracy of data submitted with the product’s biologics license application.

Under an agreement, Colorcon will incorporate TruTag’s edible microtag technology in its coatings.

Fifty years after the man walked on the Moon, space-based science is benefiting Earth.

As vaccines gain prominence within pharma, there is an expectation that specialized CDMO services will provide opportunities.

Pharmaceutical Technology Europe celebrates 30 years in publishing the latest insights, analysis, and developments of the bio/pharma industry.

The evolution of CDMOs has led to increased investment in new technologies, capabilities, and expertise.

Rapid change towards industry developing and manufacturing niche APIs is leading to smaller-scale facilities that offer higher containment and flexibility.