Intertek seeks to bring cost efficiencies to the pharmaceutical supply chain through confidential shared audits.

Catalent expands the scope of the OptiForm Solution Suite to bridge gap from late-stage discovery to Phase I trials.

The addition of 20,000 sq. ft. of manufacturing and office space increases Avecia’s Milford, Ma, oligonucleotide capacity to 3.0 mol.

Alcami will move its headquarters to Durham, NC while maintaining its manufacturing and laboratory operations in Wilmington, NC.

Researchers have demonstrated how an investigational drug currently in testing works against Niemann-Pick type C1, which may lead to treatments for other similar disorders.

The agency cited the Italian company for aseptic processing failures.

The National Academies of Sciences, Engineering, and Medicine released a report on its findings on the opioid abuse epidemic, citing the need for a prescribing culture change.

GSK plans to deliver up to 40 million doses of its quadrivalent flu vaccine for the 2017–2018 season.

Higher-flow peristaltic pumps from Watson-Marlow Fluid Technology Group are designed for upstream and downstream bioprocessing with single-use fluid path assemblies.

Respondents cited instrument maintenance and downtime, complexity of testing requirements, and time-consuming sample preparation as the top challenges in their laboratories.

A June conference at Johns Hopkins examined the potential for digital ledgers and smart contracts in pharma and healthcare

BIO and PhRMA issued statements expressing the groups’ approval of the continuation of user fee programs.

The agency sent a warning letter to Vista Pharmaceuticals Limited for CGMP failures related to equipment cleaning and process control.

The company has entered into a settlement agreement with generic-drug companies to resolve patent litigation.

The National Institutes of Health says researchers have found a way to block a step in the HIV invasion process that may lead to the development of new drugs.

The company is voluntarily recalling Sten Z and M1 Alpha capsules because the product contains derivatives of anabolic steroids, which makes them unapproved drugs.

One day after Ocular Therapeutix sent FDA a detailed response highlighting manufacturing improvements, FDA rejected its application for Dextenza, a new drug designed to alleviate post-operative eye pain.

Pfizer’s new format of ibuprofen (AdvilR Liqui-GelsR Minis) uses Catalent’s softgel technology to deliver the formulation in a more concentrated fill, resulting in smaller capsules.

FDA advisory committee has recommended for approval Novartis CAR-T cell therapy CTL019 for the treatment of relapsed and refractory B-cell acute lymphoblastic leukemia in pediatric and young adult patients.

New study shows that an antimicrobial peptide packaged in a silicon nanoparticle significantly reduced bacteria load in the lungs of mice infected with Pseudomonas aeruginosa.

The agency is asking the public to share their experiences with the drug so EMA can determine its safety.

The acquisition will add recombinant-based influenza vaccine to Sanofi Pasteur’s portfolio

The 2017 CPhI Pharma Awards program features 20 categories covering achievements in the pharma industry.

GE Healthcare’s Dharmacon business and CordenPharma contract manufacturing enter a strategic collaboration to accelerate the oligonucleotide development process.

In an FDAVoice blog post, the CDER director highlighted two recent scientific advances.

The assay assesses the ability of antibodies to neutralize the Ebola virus.

FDA sent a warning letter to Shandong Analysis and Test Center for CGMP violations including data integrity issues and insufficient testing procedures.

The agency’s Pharmacovigilance Risk Assessment Committee made recommendations on the risk of multiple sclerosis treatments, injectable methylprednisolone medicines, and the use of gadolinium contrast agents.