Regulation

Pfenex’ Forteo biosimilar PF708 secures FDA approval for osteoporosis

Pfenex has secured approval for PF708, a biosimilar of Forteo (teriparatide injection), from the US Food and Drug Administration (FDA) for the treatment of osteoporosis in certain patients who are highly prone to fracture.

Fasenra approved in the US for self-administration in a new pre-filled auto-injector, the Fasenra Pen

AstraZeneca announced that the US Food and Drug Administration (FDA) has approved the self-administration of Fasenra (benralizumab) in a pre-filled, single-use auto-injector (the Fasenra Pen).

DBV Technologies announces FDA acceptance of BLA filing for Viaskin Peanut to treat peanut allergy

DBV Technologies, a clinical-stage biopharmaceutical company, announced that the US Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for its investigational Viaskin Peanut immunotherapy for the treatment of peanut-allergic children ages 4 to 11 years.

FDA approves Gilead’s HIV PrEP drug Descovy

Gilead Sciences has secured approval from the US Food and Drug Administration (FDA) for HIV pre-exposure prophylaxis (PrEP) indication of Descovy (emtricitabine 200 mg and tenofovir alafenamide 25 mg tablets; F/TAF).

Merck’s KEYTRUDA approved as monotherapy in China for first-line treatment of certain patients with advanced NSCLC

Merck announced that KEYTRUDA, Merck’s anti-PD-1 therapy, has been approved by the National Medical Products Administration (NMPA) in China as monotherapy for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 (tumor proportion score [TPS] ≥1%) as determined by a NMPA-approved test, with no EGFR or ALK genomic tumor aberrations.

GSK, Innoviva file sNDA to seek US approval for Trelegy Ellipta in asthma

GlaxoSmithKline (GSK) and Innoviva have filed an application for their respiratory drug Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol or FF/UMEC/VI) in the US seeking its use for the treatment of asthma in adults.

Roche gets FDA nod for Rituxan to treat children with two blood vessel disorders

Roche has secured approval from the US Food and Drug Administration (FDA) for its Rituxan (rituximab), in combination with glucocorticoids, to treat granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) in paediatric patients two years of age and older.

FDA approves Ipsen’s Dysport to treat upper limb spasticity in children

Ipsen Biopharmaceuticals has secured approval from the US Food and Drug Administration (FDA) for its Dysport (abobotulinumtoxinA) to treat upper limb spasticity in children.

Aldeyra Therapeutics receives fast track designation for ADX-2191 for prevention of proliferative vitreoretinopathy

Aldeyra Therapeutics announced that the US Food and Drug Administration (FDA) has granted fast track designation to ADX-2191 for the prevention of proliferative vitreoretinopathy (PVR). PVR is a serious, sight-threatening condition with no approved treatment.