FDA Advisory Committee recommends approval of Pfizer's proposed biosimilar to Epogen® / Procrit® across all indications
- Details
- Category: Pfizer
Pfizer Inc. (NYSE:PFE) today announced the United States (U.S.) Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) recommended approval of the Company's proposed epoetin alfa biosimilar across all indications. This marks the first time a biosimilar erythropoiesis-stimulating agent (ESA) has been recommended for approval by a U.S. FDA Advisory Committee.
New data at ATS add to the body of evidence for Roche's Esbriet (pirfenidone) in idiopathic pulmonary fibrosis (IPF)
- Details
- Category: Roche
Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced new retrospective data analyses for Esbriet® (pirfenidone) in idiopathic pulmonary fibrosis (IPF) that were presented at the American Thoracic Society (ATS) 2017 International Conference. Three post hoc analyses of the pooled phase III ASCEND and CAPACITY studies indicated that IPF patients treated with Esbriet may experience a reduction in the risk of death,
Sanofi and Regeneron announce FDA Approval of Kevzara® (sarilumab) for the treatment of moderately to severely active rheumatoid arthritis in adult patients
- Details
- Category: Sanofi
Sanofi and Regeneron Pharmaceuticals, Inc. have announced the U.S. Food and Drug Administration (FDA) approval of Kevzara® (sarilumab) for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more disease modifying antirheumatic drugs (DMARDs), such as methotrexate (MTX).
AstraZeneca enters agreement with Recordati for Seloken in Europe
- Details
- Category: AstraZeneca
AstraZeneca announced today that it has entered into an agreement with Recordati S.p.A (Recordati) for the commercial rights to Seloken/Seloken ZOK (metoprolol tartrate and metoprolol succinate respectively) and associated Logimax fixed-dose combination (metoprolol succinate and felodipine) treatments in Europe.
Novartis receives positive CHMP opinion for first-line use of Zykadia® in ALK-positive advanced non-small cell lung cancer (NSCLC)
- Details
- Category: Novartis
Novartis announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of expanding the use of Zykadia® (ceritinib) to include the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive.
100 healthy years - are kids prepared?
- Details
- Category: Merck Group
Merck, a leading science and technology company, convened experts from diverse reputable organizations such as UN, UNICEF, UNAIDS, World Obesity Federation and McKinsey at the company's headquarters in Darmstadt, Germany, to debate relevant questions such as: What are the most urgent threats to our children's long-term health? What can be done both inside and outside the classroom? And how do schools, parents and communities share responsibility?
Novartis Foundation and partners launch initiative to tackle hypertension and its root causes in low-income urban communities
- Details
- Category: Novartis
On World Hypertension Day 2017, the Novartis Foundation and its partners, including Intel Corporation, the NCD Alliance, city governments and local partners, announce the launch of Better Hearts Better Cities, an innovative initiative to address the high rates of high blood pressure (hypertension) in low-income urban communities.
More Pharma News ...
- Boehringer Ingelheim inaugurates world-class biopharmaceutical manufacturing facility in China
- Imfinzi significantly reduces the risk of disease worsening or death in the Phase III PACIFIC trial for Stage III unresectable lung cancer
- Sangamo Therapeutics and Pfizer announce collaboration for Hemophilia A gene therapy
- SERMO unveils first global physician-to-physician drug ratings tool
- Merck acquires Grzybowski Scientific Inventions to expand chemical synthesis offering
- Abbott announces CE Mark and first use of the world's first smartphone compatible insertable cardiac monitor
- Novartis exercises exclusive option agreement with Conatus for the treatment of NASH