Pharma News

Johnson & Johnson and Actelion Ltd, announced that they have entered into a definitive transaction agreement under which Johnson & Johnson will launch an all-cash tender offer in Switzerland to acquire all of the outstanding shares of Actelion for $280 per share, payable in U.S. dollars, which equates to CHF 280.08 per share as of January 25, 2017. The transaction, which was unanimously approved by the Boards of Directors of both companies, is expected to be immediately accretive to Johnson & Johnson adjusted earnings per share and accelerate Johnson & Johnson revenue and earnings growth rates. Johnson & Johnson will fund the transaction with cash held outside the United States.

Allergan's Rhofade cream is approved by the US Food and Drug Administration (FDA) for the topical treatment of persistent facial erythema (redness) associated with rosacea in adults. Approval was based on two clinical studies that evaluated the primary efficacy endpoint on day 29.

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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.

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.