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

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.

A previously published article presented difficulties with the revised European guidelines on sterile manufacturing. The authors included a brief summary of the comments developed on the draft document. This article expands upon that summary, outlines the authors' rationale, and highlights the most difficult aspects of the revision draft.

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

Revisions to chapters on glass containers and elastomeric closures were canceled following review of comments.

The European Medicines Agency has called for the immediate suspension and recall of AbbVie and Biogen's multiple sclerosis drug Zinbryta (daclizumab beta).

The FDA commissioner outlined the agency's initiatives to reward innovation and biosimilars development.

The new progesterone active pharmaceutical ingredient, used captively by Pfizer for the past four years, reduces carbon footprint by more than 70%

GlobalData reports the need to shift away from egg-based manufacturing of vaccines in light of influenza-related deaths.

Under this agreement, the companies will develop in parallel an antibody drug candidate and cell lines for other potential candidates.

With minimal damage to its manufacturing plant in Humacao, Puerto Rico, Colorcon has been able to restore full operations.

The agency has approved a new HIV treatment for patients with "limited treatment options".

Grand River Aseptic Manufacturing announces first planned investment in capacity expansion.

In selling its contrast media business, Hovione will focus on API and drug product development and manufacturing.

Fluid Imaging has introduced a new imaging flow microscope at Pittcon 2018 in Orlando, FL.

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.

FDA enforcement efforts and drug approvals trend upward.