Regulation

US FDA approves Sanofi’s new pediatric vaccine

The US Food and Drug Administration (FDA) has approved Sanofi’s pediatric hexavalent combination vaccine for use in children between six weeks and five years of age.

FDA accepts Kala Pharmaceuticals’ NDA for KPI-121 0.25%

The US Food and Drug Administration (FDA) has accepted a new drug application (NDA) submitted by Kala Pharmaceuticals for its KPI-121 0.25% product candidate.

FDA approves Ultomiris for use in treatment of rare blood disease

The US Food and Drug Administration (FDA) has approved Ultomiris (ravulizumab) injection for use in the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH).

AstraZeneca’s partner FibroGen gets approval in China for CKD treatment roxadustat

AstraZeneca’s partner FibroGen China has secured marketing approval from the China’s National Medical Products Administration (NMPA) for roxadustat to treat anemia in chronic kidney disease (CKD) patients on dialysis.

European CHMP adopts positive opinion for Pfizer’s oncology biosimilar Zirabev

Pfizer announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion and recommended marketing authorization for Zirabev (bevacizumab), a potential biosimilar to Avastin (bevacizumab).

Teva, Celltrion get FDA nod for Roche’s breast cancer drug biosimilar

Teva Pharmaceutical Industries, along with Celltrion, has secured approval from the US Food and Drug Administration (FDA) for breast cancer drug Herzuma (trastuzumab-pkrb), a biosimilar to Roche’s Herceptin.

Novartis gets EC approval for self-administration of Xolair across all indications

Novartis has secured approval from the European Commission (EC) for Xolair (omalizumab) prefilled syringe (PFS) for self-administration, allowing patients with severe allergic asthma (SAA) and chronic spontaneous urticaria (CSU) to administer their own treatment.

Alnylam, Silence Therapeutics settle patent dispute

RNAi therapeutics firm Alnylam Pharmaceuticals has entered into a settlement and license agreement with Silence Therapeutics, a biotechnology company that develops gene therapeutic technology based on RNA interference.

Momenta revises regulatory strategy for proposed Humira biosimilar

Momenta Pharmaceuticals has revised its regulatory strategy in the US for its anti-FcRn antibody M923, which is being proposed by the company as a biosimilar to Humira.