Novartis, Gilead, GSK grab positive CHMPs; Menarini and Radius sign up to $350M partnership
→ The CHMP may have given a thumbs down on SOBI’s $568 million rare disease drug, but they handed out several positive opinions, including:
- Gilead and Galapagos’s JAK inhibitor filgotinib was recommended for moderate to severe rheumatoid arthritis. It will be known as Jyseleca should it be approved.
- Novartis’s sickle cell drug Adakveo, meant to reduce the number of painful sickle cell crises, was recommended for approval.
- Heron Therapeutics’ post-operative pain drug HTX-011 was recommended for approval, despite being slapped down by the FDA multiple times.
- GlaxoSmithKline’s antibody-drug conjugate belantamab mafodotin was recommended. The anti-BCMA drug was recently recommended by an FDA advisory committee for approval in the US, despite concerns about safety and efficacy.
→ More than a year after the Department of Justice indicted Indivior, the London-based biotech has reached a deal to resolve all lawsuits related to its opioid treatment, Suboxone. A subsidiary subbed Indivior Solutions has pleaded guilty to one count of making a false statement relating to health care matters in 2012, while the main company will pay $600 million to governments over 7 years.
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