AbbVie and partner Biogen are just months away from a European approval for their new multiple sclerosis mAb after the CHMP gave the drug a green light today. This is based on results from two clinical trials, Decide and Select, in which the drug, when injected every four weeks, improved results on key measures of MS disease activity in patients wi
Acorda Therapeutics Announces Preliminary Tender Offer Results and Acceptance of the Shares, American Depositary Shares, Stock Options, Share Units and Warrants in Biotie Therapies Corp. Tendered in Tender Offer. By a News Reporter-Staff News Editor at Obesity, Fitness& Wellness Week On 11 March 2016, Acorda Therapeutics, Inc. commenced a volunta
Attorney General Bob Ferguson today announced the recovery of millions in overcharges to Washington by Wyeth, a pharmaceutical company owned by Pfizer, Inc. The agreement in principle resolves allegations the company knowingly underpaid rebates owed to Medicaid. After accounting for the federal governments Medicaid program share, Washington will...
By a News Reporter-Staff News Editor at Marketing Weekly News The U.S. Treasury Department took another well-aimed blow at the pharmaceutical industry on Monday night when it announced significant measures to curb the use of "tax inversions." But making things harder on U.S. corporations doesn't help ordinary citizens all that much. "U.S. corpor
By a News Reporter-Staff News Editor at Obesity, Fitness& Wellness Week Astellas Pharma Inc. and Medivation, Inc. announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has issued a positive opinion recommending approval of a type II variation to include data from the head-to-head TERRAIN trial of enzal
By a News Reporter-Staff News Editor at Marketing Weekly News Cipher Pharmaceuticals Inc. announced that Rosemary A. Crane and Dr. Previously, Ms. Crane served as President and Chief Executive Officer of MELA Sciences, Inc. from 2013 to 2014. Ms. Crane was Head of Commercialization and a partner at Appletree Partners from 2011 to 2013. Ms. Crane
The drug pricing policy was finalized and approved in march 2015, and the DRAP had already increased the drug prices after a long period of 10 years by only 1.5% per annum on November 27, 2013 to provide interim relief to the ailing pharma industry. It has been learnt that SHC has categorically directed DRAP and Ministry for providing minutes of la
Ministry of National Health Services, Regulations Coordination and Pharmaceutical Manufacturers have agreed in principle to revisit the Essential Drug Availability and Pricing Policy. Fauji Foundation University Medical College, Islamabad and Dr. Inam ul Haq, Former Drugs Controller and Chairman Quality Control Authority and Dean and Director, Riph
-State and Community officials, including Charlie Baker, the Governor of Massachusetts; Kimberly Haugstad, Executive Director of the Hemophilia Federation of America; Travis McCready, President and Chief Executive Officer of the Massachusetts Life Sciences Center and Lisa Nelson, Senior District Representative to U.S. Congressman Joseph Kennedy III
-Immunomedics, Inc. today announced that objective durable responses have been achieved with sacituzumab govitecan, its lead antibody-drug conjugate, in a number of patients with advanced, metastatic solid cancers, after failing multiple prior therapies, some including checkpoint inhibitors. The ADC has previously been granted Breakthrough Therapy.
Aurobindo Pharma Limited has gained last sanctioning from the US Food& Drug Administration to manufacture and market Esomeprazole Magnesium Delayed-release Capsules USP, 20 mg and 40 mg. The launch of this item is depended on the settlement terms/ litigation results with AstraZeneca. The sanctioned ANDA is bioequivalent and therapeutically equivale
The federal government and 34 other states will share in the $784.6 million settlement from Wyeth, a subsidiary of Pfizer Inc., for not charging state Medicaid programs the best price available for two proton-pump inhibitors, used to treat peptic ulcers and acid reflux disease. Under the federal Medicaid Prescription Drug Rebate Program, pharmaceut
Takeda Pharmaceutical Company Limited today announced that results from the international, randomized, double-blind, placebo-controlled TOURMALINE-MM1 Phase 3 clinical study, evaluating once-weekly oral NINLARO capsules plus lenalidomide and dexamethasone versus placebo plus lenalidomide-dexamethasone in patients with relapsed and/or...
SHAREHOLDER ALERT: Pomerantz Law Firm Reminds Shareholders with Losses on their Investment in Horizon Pharma plc of Class Action Lawsuit and Upcoming Deadline HZNP. -Pomerantz LLP announces that a class action lawsuit has been filed against Horizon Pharma plc and certain of its officers. The class action, filed in United States District Court, Sout
By a News Reporter-Staff News Editor at Investment Weekly News Research and Markets has announced the addition of the "Vital Signs- Lowering Drug Development Costs with Genetically Modified Swine" report to their offering. The US pharmaceutical industry spends approximately $100 billion annually to develop new pharmaceutical drugs and medical dev
By a News Reporter-Staff News Editor at Drug Week A patent application by the inventors Hugerth, Andreas; Lindell, Katarina; Nicklasson, Fredrik; Thyresson, Kristina, filed on June 2, 2014, was made available online on April 14, 2016, according to news reporting originating from Washington, D.C., by NewsRx correspondents. This patent application
By a News Reporter-Staff News Editor at Drug Week AbbVie, a global biopharmaceutical company, announced new real-world data showing 96 percent of genotype 1 patients and 100 percent of genotype 4 patients achieved sustained virologic response at 12 weeks post-treatment. "Real-world studies complement randomized controlled trials and help to furt
AbbVie CEO Richard Gonzalez told investors on an earnings call Thursday morning that the incentives are critical to ensure AbbVie can retain Stemcentrx staff who have five experimental drugs in human trials, including a drug called Rova-T, which could be on the market as soon as 2018.. If approved, the cancer drugs would help AbbVie cope with growi
AbbVie's Investigational, Pan-Genotypic Regimen of ABT-493 and ABT-530 Shows High SVR Rates in Genotype 1 Hepatitis C Patients Who Failed Previous Therapy with Direct-Acting Antivirals. By a News Reporter-Staff News Editor at Drug Week AbbVie, a global biopharmaceutical company, announced that 91 percent of genotype 1 chronic hepatitis C virus in
Dr Edwin Moses, CEO of Ablynx, commented: "We are very pleased that Novartis will soon begin clinical development of this novel Nanobody against a GPCR. About the collaboration between Novartis and Ablynx. In December 2005, Ablynx and Novartis entered into an agreement to discover and develop novel Nanobody-based therapeutics against a number of di
Stefano Buono, AAA s CEO, commented, 2015 was a pivotal year for AAA. We also submitted an NDA and MAA in the U.S. and Europe, respectively, for Somakit, which could be the ideal in-vivo companion diagnostic for Lutathera.. With our Lutathera filing now complete and submitted to the FDA and the EMA and the anticipated Somakit approval in b
Allergan plc, a leading global pharmaceutical company, today announced that the Committee for Medicinal Products for Human Use has adopted a Positive Opinion for the Marketing Authorisation of ENZEPI in the European Union. 1 ENZEPI is a pancreatic enzyme replacement therapy for patients with exocrine pancreatic insufficiency due to cystic f
By a News Reporter-Staff News Editor at Drug Week Allergan plc, a leading global pharmaceutical company committed to developing new treatment options for infectious diseases, announced that new data from its anti-infective portfolio will be featured in 20 abstracts during the upcoming European Congress of Clinical Microbiology and Infectious...
By a News Reporter-Staff News Editor at Drug Week According to news reporting originating from Washington, D.C., by NewsRx journalists, a trademark application has been made for "SHARE SOLUTIONS SUPPORT. by Herschel Perel, representing Teva Pharmaceuticals USA. This application was made available to the public on April 08, 2016.