Pharmaceutical Technology Editors

The pharma major will spin out six molecules in early stage inflammation and autoimmune programs into a new company called Viela Bio.

The company is recalling Methylprednisolone Sodium Succinate for Injection, USP, 40mg, 125mg, and 1g manufactured by Gland Pharma Ltd and distributed by Sagent due to out-of-specification impurity results.

The company is recalling three lots of Hydromorphone HCl Injection USP CII 10 mg/mL, 1 mL in 2 mL Single Dose Vials because of possibly empty or cracked vials.

The companies will work together to develop prescription digital therapeutics for patients with schizophrenia and multiple sclerosis.

The companies will join forces to develop next-generation ex vivo cell therapies in oncology.

The government is exploring terms by which the UK could still be part of EMA after its departure from the EU, Theresa May said in a key speech on Brexit.

LabVantage offers laboratory information management system solutions that include additional industry-specific functionalities.

CEM reports that the EDGE extraction system for rapid sample preparation of gas chromatography/liquid chromatography samples from CEM can prepare samples for molecular analysis within 5 min.

JLL, a real estate and investment management firm, recently released a new report on three trends shaping labs for the future of life sciences R&D.

The company showcased various updated and new analytical systems and solutions for food analysis and pharmaceutical, clinical research, and materials sciences applications.

New, user-friendly analytical systems provide high-throughput comprehensive characterization and quantitation of small and large molecules.

Shimadzu has added the compact MALDI-8020 for mass spectrometry applications.

Catalent completes $4.6 million expansion at Singapore clinical supply facility and marks 20 years in the region.

Johnson Matthey has manufactured a new Gusev catalyst for ester hydrogenation using technology that promotes sustainability and improved reactivity and selectivity, according to the company.

Merck & Co. has acquired oncology-focused biopharmaceutical company Viralytics to strengthen Merck's oncology pipeline.

GlaxoSmithKline has issued a voluntary recall of three lots of respiratory inhalers in the United Kingdom, including preventer and emergency relief inhalers.

A jury verdict requiring Gilead Sciences to pay $2.54 billion for patent infringement to competitor Merck & Co. over Gilead's Harvoni (ledipasvir and sofosbuvir) and Sovaldi (sofosbuvir), two best-selling hepatitis C drugs, has been overturned.

PharmaMar has released the results of MI130004, a novel antibody drug conjucate created using a molecule of marine origin.

Roche will acquire oncology-focused healthcare technology and services company Flatiron Health for $1.9 billion to further its personalized oncological healthcare strategy.

The contract development and manufacturing organization has entered it first manufacturing contract worth $148 million for its recently completed Plant 3 facility.

The agency clarifies recommendations found in ICH Q11 about chemical entities and biotechnology entities.

The company is voluntarily recalling three lots of Labetalol Hydrochloride Injection, USP, 100 mg/20 mL Vial and one lot of Labetalol Hydrochloride Injection, USP, Novaplus because of the potential of cracked glass at the rim of the vials.

The new training center, the Jefferson Institute for Bioprocessing, will prepare engineering students and industry professionals for the field of biologics manufacturing.

Avid Bioservices will provide commercial manufacture of an enzyme replacement therapy by Roivant Sciences' Enzyvant subsidiary.

The company aims to add the additional analytical services in the European Union throughout 2018.

The research partnership will focus on advancing regenerative medicine using porcine bioproducts.

The agreement follows the recent opening of WuXi STA's oligonucleotide R&D labs in China and the US.

The agency released draft guidance on the format for electronic submissions of NDA and BLA content regarding the planning of bioresearch monitoring inspections.

The companies have partnered to develop and commercialize vectorized antibodies against tau for Alzheimer's and other neurodegenerative diseases.

Divinity Products Distribution of Grain Valley has voluntarily agreed to destroy and recall kratom-containing dietary supplements as part of FDA's crackdown on the plant.