All The Most Important Pharmaceutical News Stories Of The Week – February 2018 – Week #2
Allergan Announces Positive Top Line Phase 3 Results for Ubrogepant – an Oral CGRP Receptor Antagonist for the Acute Treatment of Migraine
February 6, 2018
Allergan plc, a leading global pharmaceutical company today announced positive results from ACHIEVE I (UBR-MD-01), the first of two pivotal phase 3 clinical trials evaluating the efficacy, safety and tolerability of orally administered ubrogepant 50 mg and ubrogepant 100 mg compared to placebo in a single migraine attack in adults. The ACHIEVE I study included 1327 U.S. adult patients (modified ITT population) randomized (1:1:1) to placebo, ubrogepant 50 mg and 100 mg respectively, who were treated for a single migraine attack of moderate to severe headache intensity. Both doses showed a statistically significant greater percentage of ubrogepant patients achieving pain freedom at 2 hours after the initial dose as compared to placebo patients (50 mg vs placebo, p=0.0023, 100 mg vs placebo, p=0.0003) and a statistically significant greater percentage of ubrogepant patients achieving absence of the most bothersome migraine-associated symptom at 2 hours after the initial dose as compared to placebo patients (50 mg vs placebo, p=0.0023, 100 mg vs placebo, p=0.0023).
Celgene Corporation Announces Positive Results from the Pivotal Phase III ‘OPTIMISMM’ Study of POMALYST/IMNOVID® for the Treatment of Relapsed or Refractory Multiple Myeloma
February 6, 2018
Celgene Corporation has announced that the Phase III, randomized, open-label, international clinical study, OPTIMISMM, achieved its primary endpoint, showing a statistically significant and clinically meaningful improvement in progression-free survival (PFS) for the pomalidomide arm versus the comparator arm. OPTIMISMM evaluated the efficacy and safety of POMALYST/IMNOVID (pomalidomide) plus bortezomib and low-dose dexamethasone (PVd) versus bortezomib and low-dose dexamethasone in patients with relapsed/refractory multiple myeloma. It is the only phase III trial to investigate a triplet combination in patients who have all received prior lenalidomide (REVLIMID®), a population for which there is a growing unmet medical need.
GSK’s meningitis B vaccine Bexsero receives Breakthrough Therapy Designation from US FDA for prevention of Invasive Meningococcal Disease in children 2-10 years of age
February 7, 2018
GlaxoSmithKline plc has announced that it has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for its meningitis B vaccine Bexsero [Meningococcal group B Vaccine (rDNA, component, adsorbed)] for the development of the vaccine in the prevention of Invasive Meningococcal Disease (IMD) caused by serogroup B in children 2-10 years of age.
Brilinta significantly reduces CV events and coronary death beyond one year in heart attack survivors with multi-vessel disease
February 7, 2018
AstraZeneca has announced results from a new sub-analysis of the Phase III PEGASUS-TIMI 54 trial, demonstrating a risk reduction of 19% in MACE (the composite of CV death, myocardial infarction, or stroke) (HR 0.81; 95% CI, 0.7–0.95) and of 36% in coronary death (HR 0.64; 95% CI, 0.45–0.89) from treatment with Brilinta 60mg (ticagrelor), in combination with low dose aspirin, in people who had survived a heart attack and had stenosis (abnormal narrowing) in two or more coronary blood vessels, a condition known as multi-vessel disease (MVD).
U.S. Food and Drug Administration Approves Gilead’s Biktarvy® (Bictegravir, Emtricitabine, Tenofovir Alafenamide) for Treatment of HIV-1 Infection
Feb. 7, 2018
Gilead Sciences, Inc. has announced that the U.S. Food and Drug Administration (FDA) has approved Biktarvy® (bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg, BIC/FTC/TAF), a once-daily single tablet regimen (STR) for the treatment of HIV-1 infection. Biktarvy combines the novel, unboosted integrase strand transfer inhibitor (INSTI) bictegravir, with the demonstrated safety and efficacy profile of the Descovy® (FTC/TAF) dual nucleoside reverse transcriptase inhibitor (NRTI) backbone, and is the smallest INSTI-based triple-therapy STR available.
Janssen Enters into Worldwide Collaboration with Theravance Biopharma for oral, Pan-Jak Inhibitor Drug Candidate for the Treatment of Inflammatory Bowel Disease
February 7, 2018
The Janssen Pharmaceutical Companies of Johnson & Johnson has announced their entry into a worldwide collaboration with an affiliate of Theravance Biopharma, Inc. to develop TD-1473, a first-in-class oral, gastrointestinal (GI) restricted pan-Janus kinase (JAK) inhibitor for the treatment of inflammatory bowel disease (IBD), which includes Crohn’s disease and ulcerative colitis (UC).
February 8, 2018
ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, has announced the start of a phase III study designed to establish if adults with HIV-1 with current virologic suppression on a tenofovir alafenamide fumarate (TAF)-based regimen of at least three drugs are able to maintain viral suppression upon switching to a two-drug regimen (2DR) of dolutegravir (TIVICAY) and lamivudine (EPIVIR). TANGO will seek to enrol approximately 550 adults with HIV-1, from clinical trial sites in North America, Europe, Australia, and Japan.
Novartis receives FDA approval for Cosentyx® label update to include moderate-to-severe scalp psoriasis
February 8, 2018
Novartis has announced that the US Food and Drug Administration (FDA) has approved a label update for Cosentyx® (secukinumab), the first interleukin-17A (IL-17A) inhibitor approved to treat moderate-to-severe plaque psoriasis. The updated label includes Cosentyx data in moderate-to-severe scalp psoriasis – one of the difficult-to-treat forms of the disease, which affects approximately half of all psoriasis patients. The label update is effective in the US immediately, and is based on the proven efficacy and consistent safety profile of Cosentyx from a dedicated Phase III scalp psoriasis trial.
Fujifilm and Takeda Announce Collaboration to Develop Regenerative Medicine Therapies using Cardiomyocytes Derived from iPSC
February 8, 2018
FUJIFILM Corporation and Takeda Pharmaceutical Company Ltd. have announced a collaboration to develop regenerative medicine therapies using cardiomyocytes derived from iPSC for the treatment of heart failure.
February 9, 2018
Pieris Pharmaceuticals, Inc., a clinical-stage biotechnology company advancing novel biotherapeutics through its proprietary Anticalin® technology platform for cancer, respiratory and other diseases, and Seattle Genetics, Inc. have announced that they have entered into a collaboration and license agreement with the goal of developing multiple targeted bispecific immuno-oncology treatments for solid tumors and blood cancers. The collaboration leverages the expertise and core technologies of both companies to develop novel Antibody-Anticalin fusion proteins.
Bristol-Myers Squibb and Nektar Therapeutics Announce Global Development & Commercialization Collaboration for Nektar’s CD122-biased Agonist, NKTR-214
February 14, 2018
BMS and Nektar announced today the companies have executed a global strategic development and commercialization collaboration for Nektar’s lead immuno-oncology program, NKTR-214. Under the collaboration, the companies will jointly develop and commercialize NKTR-214 in combination with Opdivo and Opdivo plus Yervoy in more than 20 indications across 9 tumor types, as well as potential combinations with other anti-cancer agents from either of the respective companies and/or third parties. NKTR-214, a CD122-biased agonist, is an investigational immuno-stimulatory therapy designed to selectively expand cancer-fighting T cells and natural killer (NK) cells directly in the tumor micro-environment and increase PD-1 expression on those immune cells.Top Pharma News of the Week last edit: 2018-02-15T20:44:26+00:00 da