Regulation

BioMarin submits Pegvaliase BLA to FDA for treatment of phenylketonuria

BioMarin Pharmaceutical has submitted a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for pegvaliase, a PEGylated recombinant phenylalanine ammonia lyase enzyme product, to reduce blood phenylalanine (Phe) levels in adult patients with PKU who have uncontrolled blood Phe levels on existing management.

Japan’s MHLW approves Olumiant to treat rheumatoid arthritis

Eli Lilly and Company and Incyte announced that Japan's Ministry of Health, Labor and Welfare (MHLW) granted marketing approval for Olumiant (baricitinib) 2-mg and 4-mg tablets for the treatment of rheumatoid arthritis (RA) (including the prevention of structural injury of joints) in patients with inadequate response to standard-of-care therapies.

FDA approves Triptodur to treat central precocious puberty

Arbor Pharmaceuticals and Debiopharm International announced that the US Food and Drug Administration (FDA) has approved Triptodur for the treatment of pediatric patients 2 years and older with central precocious puberty (CPP). CPP occurs when a child shows signs of puberty sooner than normal - before age 8 in girls and 9 nine in boys.

European Commission approves Pfizer’s hard-to-treat leukemia drug Besponsa

Pfizer has secured approval from the European Commission for BESPONSA (inotuzumab ozogamicin) as monotherapy for the treatment of adults with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL).

Adamis’ Epinephrine pre-filled syringe secures FDA approval

Adamis Pharmaceuticals’ Epinephrine Injection, USP, 1:1000 (0.3 mg Pre-filled single dose syringe) (“PFS”) has secured approval from the US Food and Drug Administration (FDA) for the emergency treatment of allergic reactions (Type I) including anaphylaxis.

UK’s NICE approves Roche’s breast cancer drug Kadcyla for routine use

The UK National Institute for Health and Care Excellence (NICE) has granted approval for Roche’s breast cancer drug Kadcyla for routine use within the NHS region.

FDA asks Endo to withdraw opioid painkiller over abuse risks

The US Food and Drug Administration (FDA) has asked Endo Pharmaceuticals to withdraw its Opana ER (oxymorphone hydrochloride) from the market owing to increased abuse of the reformulated opioid pain medication.

FDA accepts Synergy’s sNDA for Trulance to treat adults with IBS-C

The US Food and Drug Administration (FDA) has accepted Synergy Pharmaceuticals’ supplemental New Drug Application (sNDA) Trulance (plecanatide) for the treatment of adults with irritable bowel syndrome with constipation (IBS-C).

ViiV Healthcare seeks EMA, FDA approvals for two-drug regimen to treat HIV-1 infection

ViiV Healthcare, a joint venture of GlaxoSmithKline (GSK), Pfizer, and Shionogi, is seeking approval from the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) for the HIV maintenance regimen with two medicines.