Regulation

Lynparza secures European approval for type of advanced breast cancer

The European Commission has expanded the approval of AstraZeneca and MSD’s Lynparza (olaparib) to cover the treatment of a form of advanced breast cancer.

Amgen gets FDA approval for Evenity to treat osteoporosis in postmenopausal women

Amgen has secured approval from the US Food and Drug Administration (FDA) for its Evenity (romosozumab-aqqg) to treat osteoporosis in postmenopausal women at high risk for fracture.

OTITOPIC pursues additional new indication for dry powder inhalation of aspirin as treatment for NSCLC

OTITOPIC recently announced a new additional indication for treatment of lung cancer for its aspirin inhalation product.

ViiV Healthcare gets FDA approval for HIV drug Dovato

ViiV Healthcare has secured approval from the US Food and Drug Administration (FDA) for its Dovato (dolutegravir/lamivudine) for treatment-naïve HIV-1 adults.

Gilead seeks FDA approval for once-daily Descovy to treat HIV pre-exposure prophylaxis

Gilead Sciences has announced that it is seeking approval from the US Food and Drug Administration (FDA) for its once-daily Descovy tablets to treat HIV pre-exposure prophylaxis (PrEP).

Three pharma firms agree to pay $122.6m to settle kickback allegations

Jazz Pharmaceuticals, Lundbeck and Alexion Pharmaceuticals have agreed to pay a total of $122.6m to resolve allegations of paying kickbacks through copay assistance foundations.

Pfizer gets EC approval for Vizimpro lung cancer monotherapy

Pfizer has secured approval from the European Commission (EC) for its Vizimpro (dacomitinib) as a monotherapy for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR)-activating mutations.

Sandoz resubmits biosimilar pegfilgrastim application to US FDA

Sandoz, a Novartis division and a global leader in biosimilars, today announced resubmission of its Biologics License Application (BLA) for a proposed biosimilar pegfilgrastim to the US Food and Drug Administration (FDA) to address an FDA complete response letter received in June 2016.

AstraZeneca, Merck secure FDA breakthrough therapy status for selumetinib

AstraZeneca and Merck have secured breakthrough therapy designation (BTD) from the US Food and Drug Administration (FDA) for selumetinib to treat pediatric patients aged three years and older with neurofibromatosis type 1 (NF1) symptomatic and inoperable plexiform neurofibromas (PN).