USFDA

The U.S. Food and Drug Administration (FDA) has approved the PD-1 inhibitor Libtayo® (cemiplimab-rwlc) as the first immunotherapy indicated for patients with advanced basal cell carcinoma (BCC) previously treated with a hedgehog pathway inhibitor (HHI) or for whom an HHI is not appropriate. Full approval was granted for patients with locally advanced BCC and accelerated approval was granted for patients with metastatic BCC.

Rhizen Pharmaceuticals, a clinical-stage oncology-focused biopharmaceutical company, announced that its novel next generation PI3K-delta inhibitor, Umbralisib, which was licensed to TG Therapeutics has secured USFDA accelerated approval for the treatment of : (1) adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least one prior anti-CD20 based regimen, and (2) adult patients with relapsed or refractory follicular lymphoma (FL) who have received at least three prior lines of systemic therapy.

Bristol Myers Squibb announced that the U.S.

Biogen Inc announced that the U.S. Food and Drug Administration (FDA) has approved a new intramuscular (IM) injection route of administration for PLEGRIDY® (peginterferon beta-1a) for the treatment of relapsing forms of multiple sclerosis (MS). The new IM administration offers people living with relapsing MS the well-characterized efficacy and safety of PLEGRIDY with the potential for significantly reduced injection site reactions.

Glenmark Pharmaceuticals Limited (Glenmark) has received final approval by the United States Food & Drug Administration (U.S. FDA) for Amphetamine Sulfate Tablets USP, 5 mg and 10 mg, the generic version of Evekeo®1 Tablets, 5 mg and 10 mg, of Arbor Pharmaceuticals, LLC.

According to IQVIATM sales data for the 12 month period ending November 2020, the Evekeo® Tablets, 5 mg and 10 mg market2 achieved annual sales of approximately $21.5 million*.

United States Food and Drug Administration (USFDA) has granted ‘Orphan Drug Designation’ (ODD) to Saroglitazar for the treatment of patients with Primary Biliary Cholangitis (PBC). Orphan drug designation provides eligibility for certain development incentives, including tax credits for qualified clinical testing, prescription drug user fee exemptions and seven-year marketing exclusivity upon FDA approval. This follows the grant of ‘Fast Track Designation’ by the USFDA to Saroglitazar Mg for PBC in December 2020.

Alembic Pharmaceuticals Limited announced it has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Midodrine Hydrochloride Tablets USP, 2.5 mg, 5 mg, and 10 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), ProAmatine Tablets, 2.5 mg, 5 mg, and 10 mg, of Takeda Pharmaceuticals USA, Inc. (Takeda). Midodrine Hydrochloride Tablets are indicated for the treatment of symptomatic orthostatic hypotension (OH).

ViiV Healthcare, the global specialist HIV company majority owned by GlaxoSmithKline plc with Pfizer Inc. and Shionogi Limited as shareholders, announced that the US Food and Drug Administration (FDA) approved Cabenuva, the first and only complete long-acting regimen for the treatment of HIV-1 infection in adults.