Company News

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*.

BioArctic AB announced that the European Patent Office (EPO) has issued a decision to grant European patent EP 2 448 968 B1 for novel antibodies that could be developed into a treatment for Alzheimer’s disease. The antibodies target a shorter (truncated) form of amyloid beta (pE3-Aβ) and are linked to the company’s project AD1503. The patent enters into force on 27 January 2021 and expires in 2030.

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.