Pharmaceutical Technology Editors

Collaboration will provide for unified development and manufacture of antibody drug conjugates.

The taskforce will work to identify opportunities to advance therapy manufacturing and the supply chain in the UK.

The company broke ground on a $79 million production facility at its Ravensburg Schuetzenstrasse site.

The partnership aims to facilitate the development of therapeutic and diagnostic candidates for European biopharmaceutical clients.

Generic drugs, market access, and foreign manufacturing are conference topics at CPhI Japan 2016.

The Human Vaccines Project brings together academic research centers, industrial partners, nonprofit organizations, and governments to address the primary scientific barriers to developing new vaccines and immunotherapies.

The conference discussed key industry issues including serialization, innovation, and patient-centricity.

The agency announced enhanced warnings for immediate-release opioids to inform prescribers and patients of risks related to use.

Hospira recalls one lot of 8.4% Sodium Bicarbonate Injection, USP, due to particulate matter found within a single-dose glass fliptop vial.

The agency now allows production of water for injection by non-distillation technologies.

The studies, conducted across eight countries with nearly 600 inflammatory bowel disease (IBD) patients, further support claims by Celltrion that Remsima is highly similar its reference product.

The new class of mAbs differs from approved anti-PD 1 mAbs because they do not block the PD-1-PD-L1 interaction.

The agency cited Emcure Pharmaceuticals with CGMP violations.

The merger creates a provider of sample prep, synthesis, and bioanalytical tools for biotherapeutics discovery, development, and manufacturing.

During a clinical trial of 48 participants, 100% of those that received the TV003 vaccine were protected from infection.

The European Medicines Board elects Christa Wirthumer-Hoche as chair of their Management Board.

PhRMA says the proposals are aimed at modernizing the drug discovery and development process, promoting value-driven health care, engaging and empowering consumers, and addressing market distortions.

ANGUS reveals ANGUS Life Sciences as a new company division that will serve pharmaceutical, biotechnology, and agriculture markets.

Sir Andrew Witty, CEO of GlaxoSmithKline, has said that he plans to retire from the company in March 2017, after nearly ten 10 years in the position.

The companies say the acquisition will assist in expediting the clinical development of RhoNova, a potential treatment targeting rhodopsin-linked autosomal dominant retinitis pigmentosa.

With a new name formed from the legacy company names, Alcami offers development services, analytical testing, and API and finished drug development and manufacturing.

Both agencies warn of increased rates of serious adverse events, including death, during clinical trials of Zydelig (idelalisib).

The EC approved the merger on March 10, 2016 on the condition that Teva and Allergan divest certain assets in Europe.

The company recalls one lot of amikacin sulfate injection USP, 1 gram/4mL (250 mg/mL) vials due to the potential presence of glass particulate in one vial.

The committee suggests there may be a connection between the Zika virus and other neurological disorders in some affected areas.

Hovione will operate a commercial-scale continuous manufacturing facility in New Jersey as part of an agreement with Vertex Pharmaceuticals.

The module was installed in the company’s Watson laboratory information management system in Poitiers, France.

The group is inviting additional industry stakeholders to participate in the technology roadmapping process to address complexity of the current industry structure, which the group says has held back innovation.

The company will showcase workflow solutions for sample prep and data analysis.

The investment includes facility upgrades and expansion of development capabilities.