Timing of the launch, how to identify new patients and the retry for approval in Europe along with, of course, price became topics of talk in the aftermath of Kynamro's approval Tuesday by the FDA for homozygous familial hypercholesterolemia (HoFH).
Less than a month after BioMarin Pharmaceutical Inc. acquired Zacharon Pharmaceuticals Inc. for $10 million up front plus potential milestone payments, Avalon Ventures has scored another win in Afraxis Inc.'s potential $187.5 million licensing deal with Genentech, a member of the Roche Group.
The FDA's marketing clearance of three alogliptin-containing drugs for Type II diabetes as adjuncts to diet and exercise sent Furiex Pharmaceuticals Inc. on a happy Wall Street ride, at the same time causing onlookers to speculate about what the approvals might mean for the obesity candidate Contrave, which – like alogliptin – is partnered with Takeda Pharmaceutical Co. Ltd.
Detailing mixed fourth-quarter financial results, Amgen Inc.'s officials adopted a look-ahead approach in the earnings conference call, putting forth optimistic guidance for 2013 and pledging more detail on pipeline strategies during the business review slated for early next month.
Stock buyers are putting their faith in AVEO Oncology Inc. to the tune of about $50 million in gross proceeds, coming the firm's way through a public offering expected to close later this month.
Riding high after laying to rest its patent skirmish, Alnylam Pharmaceuticals Inc. priced its public offering of 8 million shares without a discount, selling them at Tuesday's closing price of $21.32, for net proceeds of about $151.1 million, or about $173.8 million if the underwriters exercise their full overallotment option of 1.2 million shares.
Beating the decision deadline by two days, the FDA cleared for marketing Santarus Inc.'s oral formulation of the corticosteroid budesonide, branded Uceris, for mild to moderate ulcerative colitis.
As FDA-mandated Phase III trials near their finish with MannKind Corp.'s beleaguered inhaled insulin product Afrezza, Alfred Mann, CEO and major funder of the company, took to the lectern at the J.P. Morgan Healthcare Conference to deliver a familiar message: It works, the device is simple and patients will use it.
During a first-of-the-day session at the J.P. Morgan Healthcare Conference, Spectrum Pharmaceuticals Inc.'s chairman, president and CEO, Rajesh Shrotriya, took on squarely the "much-talked about" matter of boosting Fusilev sales.