Company News

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.

ViiV Healthcare, the global specialist HIV company majority owned by GlaxoSmithKline plc with Pfizer Inc.

The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the European Commission (EC) has authorised the expanded use of SPRAVATO® (esketamine nasal spray), co-administered with oral antidepressant therapy in adults with a moderate to severe episode of MDD, as acute short term treatment, for the rapid reduction of depressive symptoms, which according to clinical judgement constitute a psychiatric emergency.

Takeda Pharmaceutical Company Limited announced that it has submitted an application to the Japanese Ministry of Health, Labour and Welfare to manufacture and market darvadstrocel (development code: Cx601) for the treatment of complex perianal fistulas in adult patients with non-active/mildly active luminal Crohn’s disease (CD).

Bristol Myers Squibb announced that the U.S.

In a joint press briefing today together with German Health Minister Jens Spahn, Minister-President of North Rhine-Westphalia, Armin Laschet, and Chief Executive Officer of CureVac N.V., Franz-Werner Haas, Member of the Board of Management, Bayer AG and President of the Bayer’s Pharmaceuticals Division, Stefan Oelrich, made the following statement  “Following discussions with the German government it has become clear that current manufacturing capacities for vaccines need to be increased, particularly for potential variants of the SARS-CoV-2 virus.

Eisai Co., Ltd announced that Eisai Korea Inc., Eisai’s subsidiary in South Korea, has launched the Parkinson’s disease treatment Equfina® (safinamide mesilate, “safinamide”). This is the first launch of Equfina in the Asian region excluding Japan.

Takeda Pharmaceutical Company Limited announced that it has completed the previously announced sale of TachoSil Fibrin Sealant Patch (TachoSil) to Corza Health, Inc for €350 million.

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*.