• GSK,Tanzeum,pharmacies,diet,exercise,FDA,medicine

GSK (LSE/NYSE: GSK) today announced that once-weekly Tanzeum (albiglutide), a prescription injectable treatment for type 2 diabetes in adults, as an adjunct to diet and exercise, is now available in pharmacies throughout the U.S.

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  • Boehringer Ingelheim,Jentadueto,hydrochloride,linagliptin

The U.S. Prescribing Information for Jentadueto? (linagliptin and metformin hydrochloride) tablets now includes clinical trial data that showed linagliptin co-administered with metformin provided statistically significant decreases in blood glucose compared with linagliptin alone in treatment-naive* adults with type 2 diabetes and high baseline A1C levels (A1C of > /=8.5 to Read more

  • Alexion,Soliris,European,Myasthenia Gravis,Pharmaceuticals

Alexion Pharmaceuticals (NASDAQ:ALXN) today announced that the European Commission has granted orphan drug designation (ODD) to Soliris? (eculizumab) for the treatment of patients with Myasthenia Gravis (MG), a rare, debilitating neurologic disorder caused by uncontrolled complement activation.

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  • Vertex,KALYDECO,G551D,European,VRTX,CFTR

Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the European Commission has approved KALYDECO? (ivacaftor) for people with cystic fibrosis (CF) ages 6 and older who have one of eight non-G551D gating mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.

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  • GSK, Genmab A/S,GEN, PROLONG,Arzerra,IDMC

GlaxoSmithKline plc and Genmab A/S announced today that an Independent Data Monitoring Committee (IDMC) interim analysis of a phase III study, PROLONG (OMB 112517), reached the predefined significance level for efficacy (p≤0.001).

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  • BI-Lilly,JARDIANCE,Eli Lilly,Boehringer Ingelheim

Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI) and Eli Lilly and Company (NYSE: LLY) today announced the U.S. Food and Drug Administration (FDA) approved Jardiance? (empagliflozin) tablets as an adjunct to diet and exercise to improve glycemic control, or blood glucose levels, in adults with type 2 diabetes (T2D).

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  • Sanofi,Regeneron,alirocumab,hypercholesterolemia

Regeneron and Sanofi Report Positive Top-Line Results from Nine Phase 3 Trials of Alirocumab in People with Hypercholesterolemia Primary efficacy endpoints met in all nine new trials of investigational PCSK9 inhibitor

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  • eloxis,Envarsus,European Commission,Chiesi,Liver Transplant Patients

European Commission (EC) has granted marketing authorization for Envarsus for the prevention of organ rejection in adult kidney and liver transplant patients in the European unio (EU).

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Merck announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for bezlotoxumab, an investigational antitoxin for prevention of Clostridium difficile (C. difficile) infection recurrence.

Sanofi and Regeneron Announce Sarilumab Biologics License Application Accepted for Review by US FDA

Sanofi and Regeneron Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for sarilumab.

First data backs efficacy of BMS' novel HIV drug

A Bristol-Myers Squibb (BMS) drug that causes immature HIV particles to be released from cells early, interrupting their lifecycle, has cleared a proof-of-concept study.

EU Rules Could Restrict Genetic Testing

Genetic testing describes the application of laboratory methods to look at a person’s genes (the inherited DNA instructions). Genetic tests can be used to diagnose a genetic condition; screen for a risk of developing a particular health problems; for the selection of treatments; or to assess responses to treatments.

CHMP adopts positive opinion of Edurant in adolescents with HIV-1

The CHMP has adopted a positive opinion recommending a change to the terms of the marketing authorisation for Janssen’s Edurant (rilpivirine) in the EU to extend the indication to adolescent patients aged 12 to <18 years with human immunodeficiency virus-1 (HIV-1) infection

FDA finds mystery 'deficiencies' with Neos' long-acting Ritalin on the eve of approval

Neos Therapeutics got an ominous note from the FDA just weeks ahead of the expected approval date for its long-acting ADHD treatment, clouding the future of the company's lead asset.

Pfizer's once-failed cancer drug wins the FDA's 'breakthrough' tag

Pfizer has found new hope for a former pipeline standout, picking up the FDA's coveted breakthrough therapy designation for a Phase III reclamation project in oncology.