USP responds to FDA's draft guidance on the naming of biological products.

Croda Chocques SAS' excipient facility in France has received EXCiPACT certification from SGS ICS, making it the 24th manufacturing site to be certified to the scheme, which verifies that manufacturing of pharmaceutical-grade excipients meets current good manufacturing practices (cGMPs).  It is the third Croda site in Europe to receive this certification in the past year. Certification reflects a rigorous assessment program, both for the auditor and the audited, and the auditor's report had to be verified by an independent certification board.

Capsugel has launched its enTRinsic drug-delivery technology platform. Using pharmaceutically approved enteric polymers, the technology offers full enteric protection without the need for functional coatings and enables targeted release of gastric acid- and heat-sensitive active ingredients in the upper gastrointestinal tract. The new technology platform expands Capsugel’s range of modified- and targeted-release solutions and biotherapeutic formulation offering, and can be used for oral delivery of drugs, including vaccines, proteins, and peptides.

The new committee will attempt to recruit regulatory professionals outside of existing ICH members to improve overall global pharmaceutical regulatory harmonization.

Rx-360 announced that Mark S. Paxton has been appointed as the new chief executive office of the international pharmaceutical supply chain consortium. This appointment follows the successful growth of Rx-360 since its foundation in 2009 in the aftermath of the adulterated heparin tragedy. Rx-360 has 300 volunteers from more than 100 institutions that are organized in 17 working groups with activities in the US, Europe, China, and India.

The PRIME program is a drug development scheme to enable accelerated assessment of medications for conditions with unmet need.

According to a third-quarter earnings report, Pfizer’s vaccine business contributed nearly 14% to its total revenue.

The authors look at key factors driving the risk-sharing agreements that have been implemented to reduce drug expenditures across Europe.

Dow introduces solvent-free productivity technology for coating barrier membranes.

Eight researchers are honored at the 2015 AAPS annual meeting for contributions to the pharmaceutical sciences.

Association recognizes top scientists and students at the annual meeting for research achievements.

EMD Millipore, the life-science division of Merck KGaA, has introduced Parteck SRP 80, a new functional excipient for oral sustained-release formulations. The excipient is polyvinyl alcohol (PVA)-based and fully synthetic-according to EMD Millipore, this feature ensures batch-to-batch and performance consistency and facilitates quality by design (QbD) and validation processes.

Bottles of the affected lot were marked with a lower strength of 325 mg instead of 500 mg and pose a risk of drug overdose that can lead to liver toxicity or liver failure.

An industry-led strategy was launched in September 2015, in which senior experts from life-sciences and chemical companies set out how Scotland provides the infrastructure, connectivity, and academic excellence necessary to sustain a thriving manufacturing base.

Valeant faces increased scrutiny for allegedly using its in-house mail-order pharmacy, Philidor, to keep drug prices artificially high.

Univercells will integrate its single-use bioprocess with the Takeda vaccines production platform to allow local production.

Melanoma treatment, Imlygic, received a positive opinion from CHMP, and several other products received extension of indications.

The agency provides terms and recommendations for packaging and labeling of injectable medical products.

Biovest’s mAbVault provides supply-chain redundancy for antibodies that enables customers to lock in price-per-gram protein production.

This year, experts took on topics ranging from innovation to market access and the impact of mega trade pacts.

The excipient supplier's cGMP practices have been certified as meeting EXCiPACT standards

AstraZeneca and Lilly will evaluate the safety and efficacy of a range of additional combinations for solid tumors across both companies’ complementary portfolios.

Impax Laboratories announced that FDA has approved its generic version of guanfacine extended-release tablets 1 mg, 2 mg, 3 mg, and 4 mg.

A rheometer and powder flow tester can measure how pharmaceutical materials, such as powders from a hopper, flow.

Wetteny Joseph has been appointed as president of Catalent’s Clinical Supply Services.

Athenex will build two facilities for high-potency, oncology API ingredients in Chongqing, China.

The agency gives an update on the regulation of combination medical products.

The FDA grants to the Rutgers-led C-SOPS research consortium will support the introduction of continuous manufacturing techniques for pharmaceuticals.