Top Pharma News of the Week – May 21st

All The Most Important Pharmaceutical News Stories Of The Week – May 2018 – Week #4

TapImmune and Marker Therapeutics Announce Entry into Merger Agreement, Creating a Transformational Immuno-Oncology Platform

May 15, 2018

TapImmune Inc. has announced that it has entered into a definitive merger agreement to acquire Marker Therapeutics, Inc. (“Marker”), a privately-held clinical-stage developer of a transformative, non-genetically engineered, multi-antigen T cell therapy platform. The proposed transaction will be a merger-of-equals under which the stockholders of TapImmune and Marker will each own approximately 50% of the combined company, prior to any issuances of additional shares in a contemplated financing. The proposed merger remains subject to certain conditions, including that financing and the approval of TapImmune stockholders.

Amgen Receives European Commission Approval for Repatha® (Evolocumab) To Prevent Heart Attack and Stroke in Adults with Established Cardiovascular Disease

May 16, 2018

Amgen has announced that the European Commission (EC) has approved a new indication in the Repatha® (evolocumab) label for adults with established atherosclerotic cardiovascular disease (myocardial infarction, stroke or peripheral arterial disease) to reduce cardiovascular risk by lowering low-density lipoprotein cholesterol (LDL-C) levels. With the expanded label now in place, Amgen is working with payers in Europe to remove prescribing barriers and expand access in order to reach patients with established cardiovascular disease who are at risk of another event.

Novo Nordisk increases commitment to stem cell-based therapies

May 16, 2018

Novo Nordisk has announced an increased commitment to stem cell-based therapies and an expansion of the focus on type 1 diabetes into other serious chronic diseases. This has been made possible through an exclusive collaboration with the University of California San Francisco (UCSF) in which a first milestone in the development of human embryonic stem cell lines has been reached.

Lyrica® (Pregabalin) Oral Solution CV Phase 3 Trial In Pediatric Epilepsy Meets Primary Endpoint

May 17, 2018

Pfizer Inc. has announced positive top-line results of a Phase 3 study examining the use of LYRICA® (pregabalin) Oral Solution CV as adjunctive therapy for partial onset seizures in pediatric epilepsy patients one month to less than four years of age. Results showed that adjunctive treatment with LYRICA 14 mg/kg/day resulted in a statistically significant reduction in seizure frequency versus placebo, the primary efficacy endpoint. Treatment with LYRICA at the lower dose (7 mg/kg/day) did not result in a statistically significant reduction in seizure frequency versus placebo. The study was a post-marketing requirement by the U.S. Food and Drug Administration (FDA). LYRICA is not approved as adjunctive therapy for partial onset seizures in pediatric epilepsy patients one month to less than four years of age.

Update on Janssen’s BACE Inhibitor Program

May 17, 2018

For the past several years, Janssen has been studying an investigational drug called a BACE inhibitor. The goal of this research is to slow cognitive decline in people at risk for Alzheimer’s dementia. Elevations of liver enzymes, which were serious in nature, have been observed in some study participants who received the Janssen BACE inhibitor, atabecestat. After a thorough evaluation of all available liver safety data from our studies, Janssen has concluded that the benefit-risk ratio is no longer favorable to continue development of atabecestat for people who have late-onset preclinical stage Alzheimer’s disease. The company is stopping the screening, randomization and dosing of atabecestat in our Phase 2b/3 EARLY study in late-onset preclinical stage Alzheimer’s disease and in a Phase 2 long-term safety study.

Novartis and Amgen announce FDA approval of Aimovig(TM) (erenumab), a novel treatment developed specifically for migraine prevention

May 17, 2018

Novartis has announced that the US Food and Drug Administration (FDA) has approved AimovigTM (erenumab) for the preventive treatment of migraine in adults. Aimovig is a novel therapeutic approach as the first and only FDA-approved treatment specifically developed to prevent migraine by blocking the calcitonin gene-related peptide receptor (CGRP-R), which is believed to play a critical role in migraine. Aimovig 70 mg is self-administered once monthly via Amgen’s device, the SureClick® autoinjector and does not require a loading dose. Some patients may benefit from a dosage of 140 mg once monthly.

Follow-up phase III data showed Roche’s Alecensa helped people with ALK-positive metastatic non-small cell lung cancer live a median of almost three years without their disease worsening or death

May 17, 2018

Roche has announced follow-up data from the phase III ALEX study, showing that, as an initial treatment, Alecensa® (alectinib) significantly reduced the risk of disease progression or death (progression-free survival; PFS) by 57% (hazard ratio [HR]= 0.43, 95% CI: 0.32-0.58) compared to crizotinib after two years of follow-up in people with anaplastic lymphoma kinase (ALK)-positive metastatic (advanced) non-small cell lung cancer (NSCLC), as assessed by the investigator. The median PFS for people who received Alecensa was more than tripled compared to those who received crizotinib (34.8 months [95% CI: 17.7 months-NE) versus 10.9 months [95% CI: 9.1-12.9 months)], respectively, as assessed by the investigator.

ERLEADA™ Significantly Reduced Risk of Prostate Specific Antigen (PSA) Progression in Patients with Non-Metastatic Castration-Resistant Prostate Cancer

May 18, 2018

The Janssen Pharmaceutical Companies of Johnson & Johnson has presented a post-hoc analysis from the Phase 3 SPARTAN study that showed treatment with ERLEADA™ (apalutamide) significantly reduced the risk of prostate specific antigen (PSA) progression in patients with non-metastatic castration-resistant prostate cancer (nmCRPC) who had a rapidly rising PSA while receiving continuous androgen deprivation therapy (ADT).

Lokelma approved in the US for the treatment of adults with hyperkalaemia

May 18, 2018

The US Food and Drug Administration (FDA) has approved Lokelma (sodium zirconium cyclosilicate), formerly ZS-9, for the treatment of adults with hyperkalaemia, a serious condition characterised by elevated potassium levels in the blood associated with cardiovascular, renal and metabolic diseases.

Roche’s Hemlibra reduced treated bleeds by 96 percent compared to no prophylaxis in phase III HAVEN 3 study in haemophilia A without factor VIII inhibitors

May 21, 2018

Roche has announced full results from the phase III HAVEN 3 study evaluating Hemlibra® (emicizumab) prophylaxis administered every week or every two weeks in people with haemophilia A without factor VIII inhibitors and the phase III HAVEN 4 study evaluating Hemlibra prophylaxis administered every four weeks in people with haemophilia A with or without factor VIII inhibitors. In the phase III HAVEN 3 study, adults and adolescents aged 12 years or older without factor VIII inhibitors who received Hemlibra prophylaxis every week or every two weeks showed a 96% (p<0.0001) and 97% (p<0.0001) reduction in treated bleeds, respectively, compared to those who received no prophylaxis.

Top Pharma News of the Week – May 21st last edit: 2018-05-23T20:56:36+00:00 da Luca

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