News

Emergent will offer up its drug substance manufacturing services with support by investments from Johnson & Johnson starting in 2020.

The approval was based off of positive results from a Phase III study that showed patients 70 years or younger treated with the BTK inhibitor lived longer without disease progression.

Bayer will provide CAD $1.5 million (USD$1 million) toward two studies to evaluate its chloroquine and interferon beta-1b combination therapies.

Wavelength Pharmaceuticals expanded production of APIs for certain pharmaceutical products needed to manage respiratory critical care patients in the COVID-19 pandemic.

Catalent Biologics increased capacity at its Bloomington, IN Facility.

US government and industry partners will coordinate to bring the most promising COVID-19 vaccine and treatment candidates to clinical trials.

The company is recalling the product because of out-of-specification results for high molecular weight polymers.

The company is voluntarily recalling 13 lots of the product because of particulate matter found in reserve sample vials.

The companies will collaborate on the discovery and development of next-generation drug and engineered cell therapies focused on natural killer cells.

With hundreds of clinical trials for potential coronavirus therapies in the works concerns have mounted about the emergence of conflicting data, useless results, and wasted efforts from multiple overlapping efforts.

The phase-II, randomized, double-blind, placebo-controlled trial will study the efficacy and safety of the live biotherapeutic in 90 individuals with COVID-19 symptoms.

The company will build an additional commercial-scale, contract manufacturing facility for viral vectors and gene therapies near its existing site in Carlsbad, CA.

Through the agreement, BARDA will support the advancement of the vaccine candidate to FDA licensure and will handle all late-stage clinical development programs, as well as the scale-up of mRNA-1273 manufacture in 2020.

The report outlines the company’s approaches to product quality, safety, environmental sustainability, and diversity and inclusion.

The company is recalling Tetracycline HCl Capsules USP, 250 mg and 500 mg, 100-count bottles because of failed dissolution specifications.

The International Safe Transit Association’s Pharma Committee published a guideline on the passive thermal packaging qualification process.

The Commission of Human Medicines Expert Working Group has concluded that there is insufficient evidence to link ibuprofen, or other non-steroidal anti-inflammatory drugs (NSAIDs), with susceptibility for contracting COVID-19 or worsening symptoms.

Medical dermatology company based in Denmark, Leo Pharma, has entered into a license agreement with two Eastern-Asian companies for the development and commercialization of FB825, a novel atopic dermatitis and allergic asthma drug candidate.

Dutch company HALIX has announced it is joining a consortium of partners that are all under the guidance of the University of Oxford to provide good manufacturing practice (GMP) manufacturing services for a COVID-19 vaccine.

Biopharmaceutical company, TScan Therapeutics, has entered into a collaboration agreement with Novartis that is aimed at the discovery and development of novel T-cell receptor (TCR) therapies for solid tumors.

This milestone achievement will allow the companies to move forward with developing a GMP-compliant manufacturing process for clinical testing.

The technology center is dedicated to developing greener, safer chemistries for manufacturing pharmaceutical raw materials and intermediates.

The lab is expected to open in April 2020 and will increase the company’s capacity for diagnostic testing of rare genetic diseases along with its COVID-19 capabilities.

The guidance document describes the agency’s temporary policy for the compounding of drugs during the COVID-19 pandemic.

The company is recalling three lots of Nizatidine Oral Solution, 15 mg/mL (75 mg/5mL) due to potential N-Nitrosodimethylamine (NDMA) contamination.

Experts to discuss strategies for ensuring supply of quality drug products during a pandemic in April 28 online event.

Late-stage pharmaceutical company based in San Diego, MEI Pharma, and Japanese drug discovery company, Kyowa Kirin, have entered into a global license, development, and commercialization agreement for ME-401.

AstraZeneca has announced it will be commencing a randomized, global clinical trial to assess the efficacy and safety of Calquence (acalabrutinib) in treating the exaggerated immune response of patients with COVID-19.

Sanofi and GlaxoSmithKline (GSK) have revealed that they are joining forces to develop an adjuvanted vaccine using their respective technologies that can be used to fight COVID-19.

ISPE’s Facility of the Year Awards for 2020 go to bio/pharma companies in eight award categories, including two winners in the new Social Impact category.