News

Dyadic International has announced its collaboration agreement with Serum Institute of India for the development and manufacture of up to 12 antibodies and vaccines using Dyadic’s C1 gene expression system.

EMA has launched a social media campaign aimed at highlighting how the agency and its network maintain safety and efficacy of medicines available in Europe.

It has been confirmed that both Bulgaria and Cyprus will now be able to perform GMP inspections at a level considered equivalent to the United States

The UK government announced during the ABPI’s recent conference that it is making improvements to the Accelerated Access Collaborative.

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.

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.

Samsung BioLogics will provide contract development organization services to drug developer GI Innovation.

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 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.

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.

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.

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 agency recommended marketing authorization for two orphan drugs and treatments for opioid dependence, HIV, cancer, and more.

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

Intertek has announced the expansion of its pharmaceutical services laboratory in Melbourn, near Cambridge, UK, through the acquisition of a new 20,000 sq. ft facility.

The company’s center of excellence for advanced analytical testing passed GMP inspection from the European Medicines Agency.

A new facility in Frederick County, MD, will expand the company’s cell therapy manufacturing capabilities.

Contract packaging and clinical supply service company Sharp invested $21 million to expand its packaging capacity and capabilities in Pennsylvania.

Biocatalysts, a global biotechnology company, has announced it has been named as one of the winners of the Queen’s Awards for Enterprise in Innovation.

The World Health Organization (WHO) has welcomed the launch of a malaria vaccine in a pilot program taking place in Malawi, Africa.

Sandoz’s new CEO will assume responsibilities no later than Aug. 1, 2019.