Regulation

Pain Therapeutics appeals FDA decision on abuse-deterrent opioid Remoxy

Clinical-stage biopharmaceutical firm Pain Therapeutics has petitioned the Food and Drug Administration (FDA) regarding a complete response Letter (CRL) for Remoxy issued in August this year.

Lynparza maintenance therapy secures FDA priority review for ovarian cancer

AstraZeneca and Merck have secured priority review from the US Food and Drug Administration (FDA) for Lynparza as a maintenance therapy for patients with newly-diagnosed, BRCA-mutated (BRCAm) advanced ovarian cancer.

Seattle Genetics files supplemental application in US for expanded use of Adcetris

Seattle Genetics has filed a supplemental Biologics License Application (BLA) to the US Food and Drug Administration (FDA) seeking approval for Adcetris (brentuximab vedotin) in combination with chemotherapy for the frontline treatment of CD30-expressing peripheral T-cell lymphoma (PTCL), based on data from the phase 3 ECHELON-2 trial.

Pfizer gets FDA nod for lung cancer drug Lorbrena

Pfizer has secured approval from the US Food and Drug Administration (FDA) for its Lorbrena (lorlatinib) for previously-treated ALK-positive metastatic non-small cell lung cancer (NSCLC).

Venclyxto and MabThera combo gets approval in Europe for CLL

AbbVie and Roche have secured approval from the European Commission (EC) for the combination of Venclyxto (venetoclax) and MabThera (rituximab) to treat relapsed/refractory (R/R) chronic lymphocytic leukaemia (CLL) in adult patients who had received at least one prior therapy.

Novartis’ Sandoz division secures FDA approval for biosimilar Hyrimoz

Sandoz, a division of Novartis, has secured approval from the US Food and Drug Administration (FDA) for Hyrimoz (adalimumab-adaz), its biosimilar of AbbVie’s Humira (adalimumab) for use in all indications as the reference medicine.

FDA refuses to approve Regeneron’s Eylea pre-filled syringe

The US Food and Drug Administration has refused to approve Regeneron’s pre-filled syringe version of eye-drug Eylea (aflibercept).

FDA approves Roche’s Xofluza to treat influenza

Roche has secured approval from the US Food and Drug Administration (FDA) for its Xofluza (baloxavir marboxil) to treat acute, uncomplicated influenza, or flu in people aged 12 years and older.

Eiger’s lonafarnib secures RPD designation from FDA to treat Progeria

Eiger BioPharmaceuticals has secured the Rare Pediatric Disease (RPD) designation from the US Food and Drug Administration (FDA) for lonafarnib to treat both Hutchinson-Gilford Progeria Syndrome (HGPS or progeria) and progeroid laminopathies.