Esketamine Phase 2 Data Published in JAMA Psychiatry Showed Significant Improvement of Depressive Symptoms in People with Treatment-Resistant Depression
December 28, 2017
Janssen Research & Development, LLC, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, has announced that data from a Phase 2 clinical study of intranasal esketamine showed a significant, clinically meaningful, rapid improvement of depressive symptoms as compared to intranasal placebo, in patients with treatment-resistant depression. During the study, all participants continued to take the oral antidepressants, considered to be standard of care, that they were taking at study entry. Change in the Montgomery-Asberg Depression Rating Scale (MADRS) total scores, measured in the study, demonstrated the improvement in patients’ depressive symptoms. Decreases in MADRS total score indicate clinical improvement.
Merck’s KEYTRUDA® (pembrolizumab) Approved in Japan for Use in the Treatment of Patients with Urothelial Carcinoma That is Unresectable with Radical Surgery Who Have Progressed Following Cancer Chemotherapy
January 2, 2018
Merck, known as MSD outside the United States and Canada, has announced that KEYTRUDA® (pembrolizumab), the company’s anti-PD-1 therapy, has been approved by the Japanese Ministry of Health, Labor and Welfare (MHLW) for the treatment of patients with radically unresectable urothelial carcinoma who progressed after cancer chemotherapy. The approval is based on data from the phase 3 KEYNOTE-045 trial, which demonstrated superior overall survival (OS) for KEYTRUDA versus investigator-choice chemotherapy (paclitaxel, docetaxel, vinflunine) (HR, 0.73 [95% CI, 0.59, 0.91], p=0.002).
Sangamo And Pfizer Announce Collaboration for Development of Zinc Finger Protein Gene Therapy for ALS
January 3, 2018
Sangamo Therapeutics, Inc. and Pfizer Inc. have announced a collaboration for the development of a potential gene therapy using zinc finger protein transcription factors (ZFP-TFs) to treat amyotrophic lateral sclerosis (ALS) and frontotemporal lobar degeneration (FTLD) linked to mutations of the C9ORF72 gene. ALS and FTLD are part of a spectrum of neurodegenerative disorders caused by mutations in the C9ORF72 gene that involves hundreds of additional repetitions of a six base pair sequence of DNA. This ultimately leads to the deterioration of motor neurons, in the case of ALS, or neurons in the frontal and temporal lobes, in the case of FTLD. Currently, there are no cures to halt or reverse the progression of ALS or FTLD. The C9ORF72 mutation is linked to approximately one-third of cases of familial ALS.
Novartis Kisqali® received FDA Breakthrough Therapy designation for initial endocrine-based treatment in premenopausal women with HR+/HER2- advanced breast cancer
January 3, 2018
Novartis has announced that Kisqali® (ribociclib) received US Food and Drug Administration (FDA) Breakthrough Therapy designation for initial endocrine-based treatment of pre- or perimenopausal women with hormone-receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer in combination with tamoxifen or an aromatase inhibitor.
Landmark Schizophrenia Data that Bring Hope in Breaking the Cycle of Hospitalization and Incarceration Receive FDA Approval for Inclusion in Invega Sustenna (paliperidone palmitate) Label
January 3, 2018
Janssen Pharmaceuticals, Inc., has announced that INVEGA SUSTENNA® (paliperidone palmitate), a once-monthly schizophrenia treatment, is the first and only antipsychotic to have the U.S. Food and Drug Administration (FDA) approve the inclusion of real-world data in its product labeling. These data come from the Paliperidone Palmitate Research in Demonstrating Effectiveness (PRIDE) study and demonstrate:
- The superior effectiveness of INVEGA SUSTENNA® versus a group of seven commonly prescribed oral antipsychotics in delaying time to relapse, and
- The time to first psychiatric hospitalization or arrest and/or incarceration was significantly longer for people treated with INVEGA SUSTENNA® versus these same commonly prescribed oral antipsychotics.
Novartis drug Promacta® receives FDA Breakthrough Therapy designation for first-line use in severe aplastic anemia (SAA)
January 4, 2018
Novartis has announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to Promacta®(eltrombopag) for use in combination with standard immunosuppressive therapy for the treatment of patients with severe aplastic anemia (SAA) as a first-line therapy. Promacta, which is marketed as Revolade® in most countries outside the US, is already approved as a second-line therapy in the refractory setting in SAA. Promacta is also approved for adults and children with chronic immune thrombocytopenia (ITP), for patients who are refractory to other treatments.
Takeda and Denali Therapeutics Collaborate to Develop and Commercialize Therapies for Neurodegenerative Diseases
January 5, 2018
Takeda Pharmaceutical Company Limited and Denali Therapeutics have announced that they have entered into a strategic option and collaboration agreement to develop and commercialize up to three specified therapeutic product candidates for neurodegenerative diseases. Each program is directed to a genetically validated target for neurodegenerative disorders, including Alzheimer’s disease and other indications, and incorporates Denali’s ATV platform for increased exposure of biotherapeutic products in the brain.
FDA Approves XGEVA® (denosumab) For The Prevention Of Skeletal-Related Events In Patients With Multiple Myeloma
January 5, 2018
Amgen has announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for XGEVA®(denosumab) to expand the currently approved indication for the prevention of skeletal-related events in patients with bone metastases from solid tumors to include patients with multiple myeloma. The approval is based on data from the pivotal Phase 3 ‘482 study, the largest international multiple myeloma clinical trial ever conducted, which enrolled 1,718 patients.
January 5, 2018
Takeda Pharmaceutical Company Limited has announced its intention to acquire TiGenix NV, an advanced biopharmaceutical company developing novel stem cell therapies for serious medical conditions, and as a result has entered into an offer and support agreement with TiGenix which provides for a recommended potential voluntary public takeover bid for TiGenix. The Takeda agreement has the unanimous support of the TiGenix board of directors (including its CEO). The acquisition is a natural extension of an existing partnership agreement between Takeda and TiGenix, which aims to bring new treatment options to patients with gastrointestinal disorders.Top Pharma News of the Weeklast edit: 2018-01-09T17:16:08+00:00da