Lori Clapper

The European Committee for Medicinal Products for Human Use (CHMP) approved Regeneron’s EYLEA Injection for the treatment of visual impairment due to diabetic macular edema (DME). The decision of the European Commission is expected in the second half of 2014, the company announced last Friday.  Continue Reading..

Endo International reached a $575 million agreement Tuesday to acquire DAVA Pharmaceuticals, a privately-held company specializing in marketed, pre-launch, and pipeline generic pharmaceuticals. The deal, which is expected to be completed in late 2014, also includes an additional $25 million contingent on the achievement of certain sales milestones.  Continue Reading..

People who take aspirin daily for up to 10 years could reduce their risk of pancreatic cancer by nearly 50 percent, according to a study published in Cancer Epidemiology, Biomarkers & Prevention, a journal of the American Association for Cancer Research (AACR).  Continue Reading..

After refusing AbbVie's third multibillion dollar acquisition offer last week, Shire's board feels stronger than ever about its goals to more than double its 2013 annual product sales to $10 billion by 2020. To do this, the company stands behind its focused business strategy, high-performance management team, and a lean operating model.  Continue Reading..

Curis, an oncology-focused biotechnology company developing novel drug candidates for cancer treatment, today announced that Roche filed an investigational new drug (IND) application with the U.S. Food and Drug Administration (FDA) to initiate a multicenter, Phase 2 clinical study of Erivedge (vismodegib) in patients who suffer from the debilitating lung disease idiopathic pulmonary fibrosis (IPF).  Continue Reading..

After reviewing Valeant’s takeover proposal last week, Allergan today announced it has deemed the offer “grossly inadequate,” leading the botox maker’s board turned down the bid in a unanimous vote.  Continue Reading..

The US Pharmacopeial Convention (USP), with the assistance of the U.S. Agency for International Development (USAID)- funded Promoting the Quality of Medicines (PQM) program, has announced that the first active pharmaceutical ingredient (API) for injectables used in the treatment of multi-drug resistant tuberculosis (MDR-TB) has been given prequalification status by the World Health Organization (WHO).  Continue Reading..

Benvenue Medical, a developer of minimally invasive solutions for spine repair, has raised $64 million to build its U.S. commercial presence and scale up manufacturing of its spinal implant, as well as fund overall corporate growth activities.  Continue Reading..

Shire announced last week that it rejected what it calls an" unsolicited and highly conditional proposal" from American drugmaker AbbVie, a company that spun off from Abbott Laboratories in 2013.  Continue Reading..

At its 3rd annual ISPE-FDA CGMP Conference, ISPE announced Monday it has officially launched its Metrics Pilot Program, geared to help identify and define metrics that indicate quality in the pharmaceutical manufacturing industry. The pilot program is spearheaded by ISPE’s PQLI® Quality Metrics Team, and is now open to any drug manufacturing company that is registered with the FDA.  Continue Reading..