FarmaKology Newsletter - Issue #62

Oct 20, 2020

Today's Startup

Deep Genomics

Deep Genomics is using artificial intelligence to build a new universe of life-saving genetic therapies. The future of medicine will rely on artificial intelligence, because biology is too complex for humans to understand. At Deep Genomics, our geneticists, molecular biologists and chemists develop new ways of detecting and treating disease using our biologically accurate artificial intelligence technology.

News

Aptinyx Reports Positive, Statistically Significant, Top-line Data From Phase 2 Study of NYX-783 in Patients With Post-Traumatic Stress Disorder

Aptinyx Inc., a clinical-stage biopharmaceutical company developing transformative therapies for the treatment of brain and nervous system disorders, today announced positive results from the first Phase 2 study of its novel NMDA receptor modulator, NYX-783, in 153 patients with post-traumatic stress disorder (PTSD). In the Phase 2 study, NYX-783 demonstrated statistically significant and clinically meaningful efficacy results and a favorable adverse event and tolerability profile. Based on these results, the company expects to initiate a pivotal study in 2021.

U.S. Food and Drug Administration Accepts for Priority Review Applications for OPDIVO® (nivolumab) in Combination with CABOMETYX® (cabozantinib) in Advanced Renal Cell Carcinoma

Bristol Myers Squibb and Exelixis, Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) and supplemental New Drug Application (sNDA), respectively, for OPDIVO® (nivolumab) in combination with CABOMETYX® (cabozantinib) for patients with advanced renal cell carcinoma. The FDA granted Priority Review to both applications and assigned a Prescription Drug User Fee Act goal date, or target action date, of February 20, 2021.

AbbVie Submits Regulatory Applications to FDA and EMA for RINVOQ™ (upadacitinib) in Atopic Dermatitis

AbbVie announced that it has submitted applications to the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) seeking approval for RINVOQ™ (upadacitinib) for the treatment of adults (15 mg and 30 mg, once daily) and adolescents (15 mg, once daily) with moderate to severe atopic dermatitis.

Roche announces full FDA approval for Venclexta combinations for acute myeloid leukaemia

Roche today announced that the US Food and Drug Administration (FDA) has granted full approval of Venclexta® (venetoclax) in combination with azacitidine, or decitabine, or low-dose cytarabine for the treatment of newly diagnosed acute myeloid leukaemia in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. Venclexta was previously granted provisional approval in this setting under the FDA’s accelerated approval programme in November 2018. Today’s FDA approval converts Venclexta’s accelerated approval in this setting to a full approval.