Valneva said on April 25 that the European Medicines Agency (EMA) had asked for more data on the company’s COVID-19 vaccine, precipitating a sharp fall in the French drugmaker’s shares.

Takeda

The U.S. Food and Drug Administration Antimicrobial Drugs Advisory Committee (AMDAC) voted unanimously to recommend use of Takeda Pharmaceutical Company Limited’s maribavir (TAK-620) for the treatment of refractory cytomegalovirus (CMV) infection and disease withgenotypic resistance to ganciclovir, valganciclovir, foscarnet or cidofovir in transplant recipients.

The European medicines watchdog recommended approving AstraZeneca’s treatments for a form of heart failure and a lung disorder, the British drugmaker said.

Novartis

Swiss drugmaker Novartis grabbed a key European panel’s recommendation for Leqvio, clearing the way for the prospective cholesterol drug’s approval in the next couple of months.

The European Medicines Agency (EMA) recommended approval for Lynparza in patients with a form of prostate cancer and as a first-line maintenance treatment for a form of advanced ovarian cancer, the British drugmaker AstraZeneca said.

A panel of the European Medicines Agency recommended approving GlaxoSmithKline’s experimental treatment for a common form of blood cancer, days after a similar nod from a U.S. Food and Drug Administration panel.

Swiss drugmaker Novartis won a key European recommendation for the company’s gene therapy Zolgensma against spinal muscular atrophy (SMA), clearing a hurdle for $2.1 million per patient treatment for approval in Europe within months.

Pfizer Inc. announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted positive opinions recommending that two Pfizer hematology medicines be granted marketing authorizations in the European Union.

AstraZeneca and Merck announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion, recommending a marketing authorization of Lynparza (olaparib) tablets (300 mg twice daily) for use as a maintenance therapy for patients with platinum-sensitive relapsed high grade, epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete response or partial response to platinum-based chemotherapy.

Janssen-Cilag International NV announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use recommended broadening the existing marketing authorization for Zytiga (abiraterone acetate) plus prednisone/prednisolone to include an earlier stage of prostate cancer than its current indications.