Business-In-Brief

This article is part of our special focus on "traditional" pharma: The Small Molecule Manufacturer (read more here). You can find more articles from The Small Manufacturer here.

• GSK’s decision to delay the market availability of paroxetine, an antidepressant, could be considered anti-competitive, Juliane Kokot, a legal advisor to the European Court of Justice (ECJ) has warned. The company was previously hit with a £37.6 million fine in 2016 for the “pay-for-delay” deals it had cut with generic companies.
• Novo Nordisk’s blockbuster drug, Ozempic, a medication that stimulates insulin production in Type II diabetics, has won extended label approval from the FDA. The expansion was granted due to the drug’s ability to treat cardiovascular disease, non-fatal heart attack and non-fatal stroke in patients living with Type II diabetes.
• The European Medicines Agency (EMA) celebrated its 25th anniversary on January 27. Guido Rasi, the EMA’s Executive Director commended the work of the agency in a recent statement: “25 years is a significant milestone for EMA. Together with our partners and stakeholders from national authorities, EU institutions and civil society, we harmonized and improved medicines’ evaluation, stimulated innovation, improved safety monitoring and management, fostered transparency and dialogue, built relationships with international partners, and helped to make medicines accessible to those who need them.”
• Colorcon has received an EXCiPACT GMP and GDP Certificate from SGS, one of EXCIPACT’s internationally recognized certification bodies. The certificate was awarded to Colorcon for its Westpoint site in Pennsylvania, US for its capacity to manufacture and distribute lake pigments (wet and dry) and polyvinyl acetate phthalate (phthalin-coating materials) for use as pharmaceutical excipients.