AbbVie escaped the wrath of the FTC in a pay-for-delay suit over AndroGel generics, as a federal judge who previously threw out antitrust claims against the company rejected the agency's attempts to reconsider its case.
The cost of a priority review voucher for the FDA keeps going up. AbbVie is forking over a record $350 million to acquire a voucher from United Therapeutics, giving them an option at shaving four months off the agency's standard 10-month review process.
Galapagos has started the countdown to the day on which AbbVie must decide whether to hand over $200 million (€181 million) in exchange for its Phase III-ready rheumatoid arthritis drug. The timer started ticking down this week when Galapagos handed over the final Phase II data set.
A new oncology compound from AbbVie and Roche's Genentech division cleared its primary hurdle in a Phase II blood cancer trial, opening the door to an FDA filing by year's end.
Galapagos has presented a surprise-free update on the trial of its AbbVie-partnered rheumatoid arthritis drug, filgotinib. The data led observers to cut the odds of AbbVie of taking up its $200 million (€182 million) buy-in option--or even making a bid to acquire Galapagos outright--and led to the company's stock hitting an all-time high on Euronext Amsterdam.
For the second quarter AbbVie on a July 24 earnings call saw Rick Gonzalez, chairman and CEO, put Bristol-Myers Squibb and Gilead on notice that approval for hepatitis C therapy in Japan is expected in the second half of the year.
Huge sales leaps for AbbVie's Humira have been powering revenue forecast beats for the company in recent quarters. But this time, international sales of the drug took a hit, leading the Illinois pharma to fall short of analysts' top-line expectations.
The year's 10 highest-paid development executives pulled in $124.4 million in total compensation, a roughly 35% jump over 2013's top earners. And while each entrant benefited from meeting individual company goals, the whole group benefited from biopharma's macroeconomic moment in the sun, as the value of stock awards skyrocketed alongside the industry index.
Payers continue to grouse about the cost of hepatitis C fighters from Gilead Sciences and AbbVie, as more and more patients seek treatment with the pricey meds. But as Bloomberg reports, a forthcoming analysis could throw a big wrench into some insurers' ongoing efforts to limit access to the drugs.
South Korea-based Samsung Bioepis is ready to head to regulators with a biosimilar of AbbVie's Humira (adalimumab) after successfully completing Phase III trials on its candidate now dubbed SB5. The company says SB5 met its primary endpoint and showed equivalence to the original version in patients with moderate to severe rheumatoid arthritis who did not respond to methotrexate therapy.