Regulation

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).

Teva’s migraine treatment AJOVY receives EU approval

Teva Pharmaceutical Industries announced that the European Commission (EC) has granted the marketing authorization for AJOVY (fremanezumab) 225 mg solution for injection in pre-filled syringe for the prophylaxis of migraine in adults who have at least four migraine days per month.

FDA approves TUDORZA PRESSAIR sNDA to include data for reduction of COPD exacerbations and hospitalizations

Circassia Pharmaceuticals announced that the US Food and Drug Administration (FDA) added new data to the TUDORZA PRESSAIR (aclidinium bromide inhalation powder) prescribing information that includes data from the ASCENT trial showing that TUDORZA PRESSAIR reduces exacerbations in chronic obstructive pulmonary disease (COPD) and does not increase major adverse cardiovascular events (MACE) in COPD patients with cardiovascular disease and/or significant cardiovascular risk factors.

CHMP recommends approval of REVLIMID and IMNOVID-based triplet combo regimens for multiple myeloma

Celgene Corporation (NASDAQ:CELG), today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted positive opinions for two triplet regimens based on Celgene’s proprietary IMiD medications, REVLIMID (lenalidomide) and IMNOVID (pomalidomide).

FDA approves treatment for patients with non-radiographic axial spondyloarthritis

The US Food and Drug Administration has approved Cimzia (certolizumab pegol) injection for treatment of adults with a certain type of inflammatory arthritis called non-radiographic axial spondyloarthritis (nr-axSpA), with objective signs of inflammation.