Mixed results underscore orphan launch hurdles
Early sales of NPS’s Gattex have soared, while those of Protalix’s Elelyso have been sluggish, underscoring the challenges of rare-disease launches.
Orphan Drug
Approval clears Boehringer to enter oncology space
FDA’s afatinib approval enables the drug maker set up shop in a new therapy space.
Business briefs: Lilly, Novartis, Activartis, plus policy news
Eli Lilly and Boehringer Ingelheim submit a glargine biosimilar to the EMA; Novartis pipeline claims an Enbrel-superior treatment; Activartis med gets orphan drug status; generics makers may have to pay more attention to labels; Administration tweaks healthcare reform implementation over the long weekend.
Culture of innovation has a sales value, study says
Why executives evaluating biotech acquisitions shouldn’t overlook the cultural dimension: A new paper finds a link to revenue performance.
Drug for ultrarare lipid disorder OK’d by FDA
Aegerion’s Juxtapid is first to market for treating the ultrarare inherited cholesterol condition HoFH, or homozygous familial hypercholesterolemia.
FDA committee set to review chronic fatigue drug
Notes to the advisory committee indicate that recycled data has perceived weak spots.
Company news: Burson-Marsteller, Corcept and Orexigen
PR firm Burson-Marsteller launched a new healthcare subsidiary, Orexigen’s net loss widened in Q2, and Corcept closed out its first full quarter with orphan treatment Korlym.
Company news: Corcept Therapeutics and Daiichi Sankyo
Corcept Therapeutics said its Cushing’s syndrome drug will be launched three weeks earlier than expected.
Shire exits Fabry’s market, citing costs as FDA weighs more research
Shire has pulled its drug, Replagal, from FDA review. The company was set to go before the agency next month, but preliminary talks indicated the FDA was going to require more testing.
Company news: ViroPharma and DIME
Specialty drug company ViroPharma teamed with several medical societies on the launch of a program designed to unite specialists treating patients with the orphan condition hereditary angioedema (HAE).
