Pharma News

Individual choices in medicine carry a certain amount of uncertainty. An innovative partnership at The University of Texas at Austin takes aim at medicine down to the individual level by applying state-of-the-art computation to medical care.

"Medicine in its essence is decision-making under uncertainty, decisions about tests and treatments," said Radek Bukowski, MD, PhD, professor and associate chair of Investigation and Discovery in the Department of Women's Health at Dell Medical School at UT Austin.

Humans possess a formidable multi-layered defense system that protects us against viral infections. Better understanding of these defenses and the tricks that viruses use to evade them could open novel avenues for treating viral infections and possibly other diseases.

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.

Jazz Pharmaceuticals plc and GW Pharmaceuticals plc announced the companies have entered into a definitive agreement for Jazz to acquire GW for USD 220.00 per American Depositary Share (ADS), in the form of USD 200.00 in cash and USD 20.00 in Jazz ordinary shares, for a total consideration of USD 7.2 billion, or USD 6.7 billion net of GW cash. The transaction, which has been unanimously approved by the Boards of Directors of both companies, is expected to close in the second quarter of 2021.

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.

The University of Kentucky has been selected as a testing site for the Janssen Pharmaceutical Companies of Johnson & Johnson’s Phase 3 clinical research study ENSEMBLE 2, which is evaluating the safety and efficacy of a two-dose regimen of Janssen’s COVID-19 vaccine candidate.

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).

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.