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Roche's dedicated haematology testing solution, the cobas m 511 integrated haematology analyser, is now available for countries accepting the CE Mark. This launch marks the entry for Roche Diagnostics in the haematology market, with a Roche developed system.
Concert Pharmaceuticals Inc. announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for CTP-656, Concert's next generation CFTR potentiator being developed for the treatment of cystic fibrosis. In December 2016, Concert initiated a Phase 2 trial in the U.S. evaluating CTP-656 in cystic fibrosis patients with gating mutations. Topline results from the Phase 2 trial are expected by year-end 2017.
Merck agreed to enter into a settlement and license agreement with Bristol-Myers Squibb company and Ono Pharmaceutical Co., Ltd., resolving the worldwide patent infringement litigation related to the use of an anti-PD-1 antibody for the treatment of cancer, such as Keytruda (pembrolizumab).
Synergy Pharmaceuticals has announced that the US Food and Drug Administration (FDA) has approved Trulance (plecanatide) for the treatment of adults with chronic idiopathic constipation (CIC). Trulance is the first drug designed to replicate the function of uroguanylin, a naturally occurring and endogenous human gastrointestinal (GI) peptide that is thought to stimulate fluid secretion which results in a stool consistency associated with more regular bowel function.
Symbiomix, a biopharmaceutical company bringing innovative medicines to market for prevalent gynecological infections, has announced submission of a new drug application (NDA) for Solosec (secnidazole oral granules) for the treatment of bacterial vaginosis (BV) to the U S Food and Drug Administration (FDA). Solosec is a potent, next-generation, investigational 5-nitroimidazole antibiotic with enhanced pharmacokinetic properties, and is anticipated to be the first and only single-dose oral therapy approved for BV.
Kaleo, a privately-held pharmaceutical company, has announced the Auvi-Q (epinephrine injection, USP) auto-injector will be available by prescription starting February 14, and announced Auvi-Q affordability, a first-of-its-kind access programme for Auvi-Q. Through this new programme, patients with commercial insurance, even those with high-deductible plans, will have an out-of-pocket cost of USD 0. For patients who do not have government or commercial insurance, and have a household income of less than USD 100,000, Auvi-Q will be available free of charge. In addition, the cash price for Auvi-Q is USD 360 and will be available to those patients without government or commercial insurance. Each Auvi-Q prescription includes two auto-injectors and one trainer for Auvi-Q.
“We met with patients and physicians and listened to the very real challenges in the current healthcare environment with obtaining access to affordable medicines,” said Spencer Williamson, president and chief executive officer of kaléo. “As a result, starting February 14, for more than 200 million Americans with commercial insurance, including those with high-deductible plans, the out-of-pocket cost for Auvi-Q will be USd 0.”
Auvi-Q is a FDA-approved prescription medicine used to treat life-threatening allergic reactions, including anaphylaxis, in people who are at risk for or have a history of serious allergic reactions. It is an epinephrine auto-injector with innovative features such as voice instructions that help guide a user with step-by-step instructions through the epinephrine delivery process and an automatic retractable needle system, a first for epinephrine auto-injectors, that injects the epinephrine and retracts the needle back into the device within seconds.
“We know how important it is that severely allergic patients have an epinephrine auto-injector that can be with them at all times and used correctly, even without training, during a panic-stricken allergic emergency,” said Eric Edwards M.D., Ph.D, vice president of product strategy at kaléo. “We are excited to make Auvi-Q, an epinephrine auto-injector with innovative features, available for millions of patients living with severe, life-threatening allergies.”
Gilead Sciences, Inc., a biopharmaceutical company, announced that the company's Marketing Authorization Application (MAA) for the investigational, once-daily, single tablet regimen of sofosbuvir 400 mg, velpatasvir 100 mg and voxilaprevir 100 mg (SOF/VEL/VOX) for the treatment of chronic hepatitis C virus (HCV)-infected patients has been fully validated and is now under assessment by the European Medicines Agency (EMA).
Shire plc announced that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of the Class 2 resubmission of a New Drug Application (NDA) for SHP465, a long-acting, triple-bead, mixed amphetamine salts formulation. SHP465 is being evaluated as a potential once-daily treatment for Attention-Deficit/Hyperactivity Disorder (ADHD). The FDA is expected to provide a decision on or around June 20, 2017, the designated Prescription Drug User Fee Act (PDUFA) action date. Shire resubmitted the NDA for SHP465 in response to the Approvable Letter from the FDA (May 18, 2007) that requested additional clinical studies and classified the response as a Class 2 resubmission with a review goal of six months.
Swedish Orphan Biovitrum AB (publ) (Sobi), an international specialty healthcare company, announces that the first patients have been enrolled in the A-SURE study (NCT02976753). A-SURE is a 24-month real-world study evaluating the effectiveness of Elocta compared to conventional FVIII products in the prophylactic treatment of patients with haemophilia A in Europe.
Siemens Healthineers and Biogen announced that the companies plan to jointly develop magnetic resonance imaging (MRI) applications with the intent of quantifying key markers of multiple sclerosis (MS) disease activity and progression. Biogen is a leading biotechnology company with a deep focus on neurological and autoimmune conditions, which for two decades has been at the forefront of delivering therapies to MS patients. Siemens Healthineers aims to enable healthcare providers to meet their current challenges and excel in their respective environments. To execute this strategy in the field of neurology, Siemens Healthineers will cooperate with Biogen and contributes its strength in medical imaging.
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