Emergent BioSolutions is set to acquire Adapt Pharma, a pharmaceutical company focused on addressing the opioid overdose and addiction crisis, in a deal worth up to $735 million.

Novartis will sell selected portions of its Sandoz United States portfolio to Aurobindo Pharma USA for $900 million in cash, plus $100 million in potential earn-outs.

Lonza’s new PyroTec Pro Robotic Solution provides a fully automated workflow for endotoxin detection.

The pharmaceutical, clinical, and bioanalytical contract solutions provider has implemented advanced techniques for the collection and use of peripheral blood mononuclear cells (PBMCs) for early-phase clinical trials at its Clinical Pharmacology Unit in Antwerp, Belgium.

The purchase of Novartis’ cystic fibrosis products TOBI Podhaler and TOBI solution is expected to strengthen Mylan’s global respiratory portfolio.

The company is increasing manufacturing capacity at its Copenhagen, Denmark facility with the addition of six new bioreactors.

As it investigates the root cause of an impurity discovered in valsartan, FDA extends its studies to APIs with similar synthesis processes.

Skin-focused company LEO Pharma acquired Bayer’s prescription treatment portfolio.

A collaboration integrates Sartorius Stedim Biotech’s BIOSTAT STR bioreactors and Repligen’s XCell ATF cell-retention control technology to create simplified, scalable equipment for intensified cell culture.

Increasingly complex trial protocols have added to IMP manufacturing challenges.

The authors support the retiring of Ph. Eur. and USP heavy metal assays and propose a means of updating related specifications with minimal regulatory burden.

Alcami and the University of North Carolina Wilmington received a grant from the National Institute for Innovation in Manufacturing Biopharmaceuticals to prepare students for careers in pharmaceutical sciences.

The European Commission (EC) has approved GlaxoSmithKline’s (GSK) Nucala (mepolizumab) as an add-on treatment for severe refractory eosinophilic asthma in pediatric patients six to 17 years old.

Girish Malhotra argues in CPhI Annual Report that shorter approval times and financial incentives are needed to promote manufacturing improvements.

Flush solutions for liquid chromatography mass spectrometry (LC-MS) systems and ultrapure solvents for ultra-high-performance LC-MS systems from Thermo Fisher Scientific can minimize interference and maximize lab instrument uptime.

Shimadzu’s Imagereveal MS mass spectrometry imaging data analysis software can analyze large sets of data or simultaneously analyze multiple sets of data.

The acquisition strengthens Nelson Labs’ outsourced testing capabilities for the pharmaceutical and medical device industries.

Protagen Protein Services, a CRO, now offers quicker and more accurate characterization of biomolecular stability using differential scanning calorimetry (DSC).

PDA Technical Report 80 (TR 80): Data Integrity in Laboratory Systems is the first in a series of three technical reports PDA will publish on data integrity.

The TSQ Fortis Triple Quadrupole Mass Spectrometer from Thermo Fisher Scientific offers fast, robust liquid chromatography-mass spectrometry (LC-MS/MS) analysis for clinical research laboratories.

The Lumis electron backscatter diffraction (EBSD) detector incorporates a large-format complementary metal oxide semiconductor (CMOS) sensor to enable higher sample throughput, higher resolution measurements, and precise phase identification.

The company’s new electron microscopy and microanalysis solutions offer scientists enhanced research capabilities.

Bristol-Myers Squibb appointed a new executive vice-president and chief commercial officer from within the company, effective immediately.

The company is certified as a manufacturer of pressure vessels and components for use in China.

Pharma packaging manufacturer Sanner has expanded capacity at its site in Budapest, Hungary.

The European Commission (EC) has approved Novartis’ chimeric antigen receptor T cell (CAR-T) cell therapy Kymriah for the treatment of B-cell acute lymphoblastic leukemia and relapsed or refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy.

A wave of potentially impure drugs and APIs from China, India, and other foreign firms has prompted recalls and FDA warning letters.

The company is voluntarily recalling one lot of Hydrochlorothiazide Tablets USP 12.5 Mg because of a labeling mix-up.