Pharma News

United States Food and Drug Administration (FDA) has approved a revision to the duration of the bolus delivery for the Aggrastat (tirofiban HCl) high-dose bolus (HDB) regimen launched by Medicure Inc, a specialty pharmaceutical company. Aggrastat is Antiplatelet drug. It is indicated to reduce the rate of thrombotic cardiovascular events (combined endpoint of death, myocardial infarction, or refractory ischemia/repeat cardiac procedure) in patients with non-ST elevation acute coronary syndrome (NSTE-ACS).

Firecrest eConsent is a next-generation electronic informed consent solution introduced by  ICON plc, a global provider of drug development solutions and services to the pharmaceutical, biotechnology and medical device industries, that incorporates key recommendations from the FDA’s recent draft guidance on informed consent.  It is designed to enhance the engagement of patient populations in the development process. One of the critical parts to improving this engagement is improving the informed consent process.

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The European Medicines Agency (EMA) has recommended approval for Opdivo (nivolumab). Opdivo is indicated for treatment  of adult patients with advanced (unresectable or metastatic) melanoma.

Fecal matter transplants are more successful in treating Clostridium difficile infections than previously thought, new research has found. The research shows that healthy changes to a patient's microbiome are sustained for up to 21 weeks after transplant, and has implications for the regulation of the treatment.

An important bacterial protein called UmuD may help prevent antibiotic resistance, scientists say. Penny Beuning from Northeastern University's college of science and colleagues are studying UmuD that regulates mutagenesis and may provide important clues about how to sto the process that eventually results in antimicrobial resistance.

Multitasking may hamper your performance and even damage your brain, new research has claimed. A study conducted at Stanford University found that people who are regularly bombarded with several streams of electronic information cannot pay attention, recall, or switch from one job to another as well as those who complete one task at a time.

Deerfield, Ill., U.S., April 28, and Osaka, Japan, April 29, 2015 – Takeda Pharmaceutical Company Limited and its wholly-owned subsidiary, Takeda Pharmaceuticals U.S.A., Inc., today announced that they have reached an agreement expected to resolve the vast majority of ACTOS (pioglitazone HCl) product liability lawsuits pending against Takeda in the U.S. Takeda will take a $2.7 billion charge against earnings in the fourth quarter of fiscal year 2014 to cover the settlement and the costs associated with defending remaining cases and for other related litigation. The settlement will become effective if 95 percent of current litigants and claimants opt into the settlement. Once that threshold is achieved, Takeda will pay $2.37 billion into a settlement fund. However, that figure will rise to $2.4 billion if 97 percent or more of the current litigants and claimants opt to participate in the settlement.

European Commission has granted marketing authorization in Europe for Toujeo® (insulin glargine [rDNA origin] injection, 300 U/mL), a next-generation basal insulin for the treatment of type 1 and type 2 diabetes mellitus in adults.

(Business Wire India); Biocon Ltd, Asia's premier biopharmaceuticals company, today announced that its Contract Research subsidiary Syngene International Ltd (“Syngene”) has filed the Draft Red Herring Prospectus (DRHP) with the Securities and Exchange Board of India (SEBI) on April 22, 2015, seeking approval for an Initial Public Offering (IPO). This is an offer for sale (OFS) by Biocon of a part of its shareholding in Syngene. Biocon along with its subsidiary Biocon Research Limited (BRL) currently holds an 84.5% equity stake in Syngene.

Novo Nordisk, a world leader in insulin and diabetes care,  has launched Saxenda (liraglutide 3 mg), the first glucagon-like peptide-1 (GLP-1) receptor agonist the United States.  Saxenda is a drug used to treat obesity.  Saxenda has approved in the US, EU and Canada.