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.

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.

Closing the summer of 2015, the ChemOutsourcing conference examined contract services from both a sponsor’s and a CMO or CRO’s perspective

The site is expected to become fully operational in 2017 and will produce approximately 40 million packs and 850 million tablets of some 30 innovative medicines every year.

Under the terms of the agreement, Hikma will have the exclusive rights to register, distribute and market Zevtera in the Middle East and North America.

Hovione is investing in specialized formulation capabilities, beginning with the acquisition of a formulation facility adjacent to the current process chemistry and particle engineering facility in Loures, Portugal, the company announced on Oct. 19, 2015. This acquisition is a strategic investment to further boost development and manufacturing capabilities for both inhalation and oral dosage forms.

The company celebrates the 10th anniversary of its filler-binder excipient at CPhI Worldwide.

The two companies will combine life-sciences marketing and a consulting firm to create a life sciences-centered consulting service.

FDA issued a warning letter to API manufacturer Unimark Remedies Ltd. for cGMP violations at its facility in India.

Flexsafe 3D Pre-Designed Solutions feature appropriate components, functionalities, and quality controls that meet the specific requirements of each step in upstream and downstream processing and in final filling.

Merck relaunches brand identity to reflect transformation into a science and technology company.

Senator McCaskill deemed J. Michael Pearson’s response letter on drug pricing “inadequate.”

Scottish injectable-drug manufacturer Symbiosis Pharmaceutical Services plans to expand its sterile filling facility.

At CPhI Worldwide 2015, The Dow Chemical Company announced the global commercial availability of AFFINISOL HPMC HME, a new generation of cellulosic polymer for drug solubilization. The polymer is designed for use by pharmaceutical companies looking to enhance the solubilization and inhibit the recrystallization of APIs in hot-melt extrusion (HME) formulations.