Johnson & Johnson Inc and two of its subsidiaries have agreed to pay about $2 billion to the US government and state Medicaid programmes to settle a drug mis-selling case and related matters in which the company is alleged to have improperly promoted the antipsychotic drug Risperdal (risperidone) to elderly patients with dementia.
The US Food and Drug Administration has approved Roche’s Gazyva (obinutuzumab) in combination with the chemotherapy chlorambucil for patients with previously untreated chronic lymphocytic leukaemia (CLL).
UCB SA has confirmed that its underlying profitability will improve this year led by a trio of new products that address immune and central nervous system disorders. The company recently won expanded indications for one of these products, Cimzia (certolizumab pegol).
Since 2007, legislation known as the Advanced Therapy Medicinal Products Regulation (ATMP) has been in place to set regulatory standards for assessing gene, cell and tissue-engineered products. Yet in this time only four ATMPs have been approved for marketing.
The Committee for Medicinal Products for Human Use has given positive opinions to a new drug for depression developed by H. Lundbeck A/S, and one for pulmonary arterial hypertension (PAH) by Actelion Ltd. The decisions were announced on 25 October.
The European Medicines Agency’s main scientific committee has recommended that patients with chronic hepatitis C virus infection before or after a liver transplantation be given the opportunity to be treated with the experimental drug sofosbuvir.
An advisory panel of the US Food and Drug Administration has unanimously recommended approval of the Johnson & Johnson/Medivir AB treatment for patients infected with hepatitis C virus, simeprevir, in combination with interferon and ribavirin.
The US Food and Drug Administration has approved Opsumit (macitentan), a new drug for the treatment of pulmonary arterial hypertension. The developer is Switzerland-based Actelion Ltd.
The German reimbursement authority, the Federal Joint Committee (G-BA), has given a positive opinion to an ophthalmic product developed by ThromboGenics NV of Belgium for the treatment of vitreomacular traction, a condition that affects many older people.
The US Food and Drug Administration has agreed to give Alkermes Plc’s candidate drug for the adjunctive treatment of major depressive disorder a ‘fast track’ designation which means the company can have more frequent interactions with the regulator.