Pharmaceutical Technology Editors

In a $13-billion transaction, GSK will purchase Novartis’ share of the Consumer Healthcare Joint Venture.

Cleanroom floor and wall solutions from Sika meet rigorous standards for pharmaceutical manufacturing facilities.

MedPharm has received a multi-million dollar investment by Ampersand Capital Partners to diversify its service offering and regional coverage.

Hitachi will manufacture regenerative medicines developed by Daiichi Sankyo and SanBio Group.

The agreement gives IncoCell Tianjin, a wholly-owned subsidiary of China-based Boyalife Group, access to Cesca’s celluar processing contract development and manufacturing services.

The agency’s Committee for Medicinal Products for Human Use recommended six drugs for approval at its March 2018 meeting.

The draft guidance addresses the agency’s policy on evaluating bulk drug substances in drug compounding.

The collaboration between the two companies aims to finish all necessary work needed to file for a first-in-human study by early 2019.

The company plans to install 4000-L disposable bioreactors from ABEC at its new commercial manufacturing facility in Wuxi city, China.

Helsinn will acquire the global rights to Valchlor/Ledaga (mechlorethamine/chlormethine), a topical skin-cancer drug, from Actelion Pharmaceuticals.

AbbVie and the International Myeloma Foundation will partner to study the role of a genetic mutation in outcomes of patients with multiple myeloma.

The agency’s Clinical Data Summary Pilot program will post redacted Clinical Study Reports in order to help stakeholders understand why FDA approved a new drug application.

The agency sent a warning letter to Malladi Drugs & Pharmaceuticals Limited after an inspection found CGMP violations that included the presence of vermin.

ISPE announced BioMarin Pharmaceutical, Shire, Vetter, and Wyeth Pharmaceuticals as FOYA Category winners.

An expanded pharma services supply chain facility in Germany boosts Thermo Fisher’s Pharma Services footprint in Europe.

The agency published two new guidance documents detailing postmarketing safety reporting requirements for combination products.

Emerson will provide Ireland’s National Institute of Bioprocessing Research and Training with technologies to help the institute prepare students for the transition to manufacturing digitization in the biopharmaceutical industry.

The European Medicines Agency has published a new tool that gives a transparent overview of the agency’s relocation to Amsterdam.

Hovione plans to continue to expand its sites in Portugal and Ireland for chemical synthesis, spray drying, and laboratory analysis.

Biogen will acquire an AMPA receptor potentiator for cognitive impairment associated with schizophrenia in a deal worth approximately $590 million.

The companies intend to jointly develop and commercialize Lenvima (lenvatinib mesylate) as a monotherapy and an in-combination therapy for treating multiple cancer types.

Sartorius Stedim Biotech has launched a new automated parallel bioreactor system for perfusion culture.

Sartorius has delivered to ABL’s Strasbourg facility, a GMP viral vector manufacturing package solution that includes single-use bioreactors and an automation platform for normal flow filtration, tangential filtration, and mixing.

The CDMO’s new blow-fill-seal machinery at its Kaysersberg site is now operational.

Nanologica AB has entered into a service agreement with CDMO Sterling Pharma Solutions for the large-scale production of silica particles.

The agency announced proposed research studies on how healthcare providers and patients understand drug promotional materials.

The contract development and manufacturing organization has expanded biologics capacity at its facility in Berkeley, CA.

Sensors and devices being developed by nGageIT Digital Health Solutions can track patient use of oral solid-dosage or injectable drugs.

The new 73,000-square-foot facility is one of several expansions to support the company’s biologics testing capabilities.

The $11.6-billion acquisition strengthens Sanofi's position in hematology and specialty medicines.