Catalent has revealed that it is the recipient of a silver award from the Royal Society for the Prevention of Accidents (RoSPA) in recognition of its health and safety practices.

Novartis will acquire assets associated with Takeda Pharmaceuticals’ Xiidra (lifitegrast ophthalmic solution) 5%, an eye-care drug.

The guidance will assist sponsors in demonstrating a proposed therapeutic protein product is interchangeable with a reference product.

Lonza will provide development and manufacturing services to two of Alector’s neurodegeneration drug candidates.

AbCellera, Niaid Vaccine Research Center, and Ichor Medical Systems have formed a partnership to develop an end-to-end platform capable of developing field-ready, nucleic acid-based countermeasures against a pandemic strain of influenza.

Ashland introduces Klucel EXF Ultra HPC, a low friability, high strength binder.

Recipharm Inhalation Solutions is an integrated service for inhalation products.

The new guidance was issued to assist applicants in determining which abbreviated pathway to take for submitting marketing applications.

The new guidance document discusses reproductive toxicity testing and labeling recommendations.

The agency approved Ruzurgi (amifampridine) tablets for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in patients six to less than 17 years of age.

FDA sent a warning letter to Dong Yuan Technology Co., Ltd. detailing CGMP violations including failure to follow laboratory and process controls.

The companies have entered into a sub-licensing agreement to develop products based on Dyadic’s C1 expression platform and Alphazymes’ enzyme technology.

The acquisition is expected to strengthen SGS’s agriculture, food, and life business in the United States.

The companies will work together to develop observational research analytics to assess treatment outcomes for areas of unmet need in oncology.

A solar panel installation at Novo Nordisk’s North Carolina facility was initiated in March 2019 as part of the company’s commitment to zero environmental impact globally.

MilliporeSigma event scheduled to recognize biotech challenges and support development potential.

The agency is updating its warning requirements for eszopiclone, zaleplon, and zolpidem after reports of complex sleep behaviors.

The agency approved Benlysta (belimumab) intravenous infusion for treatment of children with systemic lupus erythematosus.

The Vaccine Development and Bioprocess Cell Culture Technology Day will take place on May 16, 2019 in Baltimore, MD.

The company is recalling one lot of Mycophenolate Mofetil for Injection, USP because of glass fragments found in a vial after reconstitution.

In collaboration with Pall Corportion, biotech company Freeline completed the first full-scale run at its newly commissioned, GMP gene-therapy manufacturing facility in the UK.

Dengvaxia is the first FDA-approved vaccine for dengue disease caused by all dengue virus serotypes for individuals ages 9 through 16 who have laboratory-confirmed previous dengue infection and who live in endemic areas.

Pharma delivers a positive message with renewed efforts to eradicate malaria.

The company is recalling one lot of Ketorolac Tromethamine Injection, USP, 60mg/2mL because of a lack of sterility assurance.

The EXcell 231 and EXcell 241 sensors from EXNER Process Equipment have updated software and connection features for improved flexibility and safety.

The company is voluntarily recalling the product due to difficulties with the delivery system.

NHS England and three pharma companies have agreed to work together to find and cure tens of thousands more people with hepatitis C, potentially leading to Britain becoming the first country to eliminate the virus.

The companies will join forces to use artificial intelligence (AI) and machine learning to discover and develop new treatments for two chronic diseases.