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Data for Amgen’s talimogene laherparepvec (T-VEC) in advanced melanoma is among many abstracts that will be published ahead of the American Society of Clinical Oncology (ASCO) annual meeting. Abstracts will be available on May 15 at 6 p.m. ET. Click here to continue reading
by Andrew Berens, MD, Senior Healthcare Analyst, Bloomberg Industries Increasing demand in niche therapeutic areas has driven 11 percent revenue growth among specialty pharmaceutical companies during the last five years. The sector has benefited from new product launches, fresh income streams from label expansions and entry into diversified geographical markets. Mergers and acquisitions has [...]
By Jason M. Brocks, Legal Analyst,Bloomberg Law A recent U.S. District Court decision emphasizes the importance to research sponsors and contract research organizations(CROs) of understanding the terms set out in their agreements, particularly those terms relating to the responsibilities of each party upon termination of the arrangement. Pharmaceutical, medical device and biotechnology companies that sponsor [...]
by Andrew Berens, MD, Senior Healthcare Analyst and Grace Guo, Bloomberg Industries Avanir’s Nuedexta may receive a decision from the Committee for Medicinal Products for Human Use (CHMP) this week as a treatment for pseudobulbar affect (PBA). Approval in the EU would be the second regulatory nod for the drug. PBA is also called emotional [...]
by Sam Fazeli, Director Bloomberg Industries, Europe The diabetes market is rapidly growing in China, leading to a significant opportunity for companies with complete diabetes portfolios like Novo Nordisk and Sanofi. In addition to urbanization and obesity rates, diabetes prevalence has been fueled by the region’s aging population. The prevalence of the disease increased at [...]
By Asthika Goonewardene, Pharmaceuticals Equity Research Analyst, Bloomberg Industries The cost of allegations that process patents may have been infringed under a biosimilar application may deter small generic developers from pursuing approval through the 351(k) pathway, which was specifically set up for copies of cheaper biologic drugs. The FDA created an abbreviated pathway for generic [...]
Compiled by Michael Manns, Senior Equity Analyst, Jason McGorman, Equity Analyst, Bloomberg Industries and Elizabeth Krutoholow Additional data on Boston Scientific’s Watchman device may provide clarity on mixed results from the Prevail trial. A preliminary analysis of how effective the device was after 18 months yielded varied results as the study met one of two [...]
by Elizabeth Krutoholow Biogen’s hemophilia drugs may provide a breakthrough for patients by offering protection against bleeding with fewer infusions than standard agents, Dr. Jerry Powell, a hematologist with the UC Davis Comprehensive Cancer Center said in an interview. These drugs will compete against currently marketed recombinant factors like Baxter’s Advate and Pfizer’s [...]
Compiled by Andrew Berens, MD, Senior Healthcare Analyst, Bloomberg Industries and Elizabeth Krutoholow Arena and Eisai’s decision to price obesity drug Belviq at a premium to competitor Vivus may create a hurdle for the companies without broad coverage from insurers. Eisai disclosed that the wholesale acquisition cost of Belviq has been set at $199.50 for [...]
by Jason M. Brocks , Legal Analyst, Bloomberg Law Pharmaceutical companies may begin to rethink their pipeline and marketing strategies in light of the U.S. District Court’s highly technical analysis of the language of the Medicare law. The court’s opinion resulted in a denial of reimbursement to a Medicare Part D beneficiary for a drug [...]
