1. GlaxoSmithKline said it plans to seek regulatory approval for 20 new drugs between 2021 and 2025. The forecast came in a statement from the UK–based drugmaker in advance of an investor presentation, reported Bloomberg Business. GSK is partnering with other drugmakers, including Merck, Regulus Therapeutics and MorphoSys, to develop new drugs.
2. Pfizer partnered with South Africa’s Biovac Institute to develop a pneumonia vaccine for infants, reported Reuters. The five-year agreement allows Biovac to produce Pfizer’s Prevnar 13 vaccine. Pneumonia accounts for 15% of deaths worldwide of children younger than 5 years old, according to the World Health Organization. The South African government owns a 47.5% stake in Biovac.
3. The FDA issued guidance that provides recommendations to drugmakers developing therapeutic biologic products to treat HIV, reported The Hill. The recommendation also extends to antiretroviral drugs and covers all stages of development from research to treatment.
4. The CMS issued a final rule on biosimilar reimbursement pricing, according to BioCentury. The rule sets a single reimbursement price for all biosimilars of a given reference product covered under Medicare Part B. The rule was opposed by biosimilar drugmakers when it was first proposed in July.
5. Amarin and the FDA want more time to settle their off-label promotion lawsuit, reported BioCentury. Amarin had filed a suit against the agency in May after the FDA warned it would interpret off-label promotion of the drugmaker’s prescription fish-oil pill, Vascepa, a treatment for high triglycerides, as misbranding. A judge ruled in favor of Amarin earlier this summer. The parties were scheduled to submit a settlement last week but have asked for a Dec. 17 extension.
