Catalyst Pharmaceuticals Inc., under fire for a high price tag on a rare disease drug, sued the U.S. Food and Drug Administration to challenge the recent approval of a lower-cost rival medicine.
Allergan will cut 1,000 positions, about 5 percent of its workforce, as the company looks to cut costs.
Acorda Therapeutics Inc. said five people died in clinical trials for the company’s Parkinson’s disease drug, the latest in a series of setbacks for the drugmaker.
Major drugmakers including GlaxoSmithKline and Pfizer face no competition in Mexico from generics readily available elsewhere, partly because of regulatory failings, Mexico’s antitrust body said.
Eli Lilly entered into a settlement agreement with generic companies to resolve pending patent litigation regarding the Cialis (tadalafil) unit dose patent.
“Failing to plan is planning to fail” states time management guru Alan Lakein. Nowhere does this axiom ring more true than in the tightly controlled world of Rx launches. Given the time and expense required to bring a prescription drug to market, coupled with its limited exclusive lifespan, we must maximize every moment from market conditioning to loss of exclusivity (LOE).
The U.S. Food and Drug Administration approved Egalet Corp.’s Arymo ER and will allow the company to claim the long-acting opioid painkiller deters abuse by those seeking to dissolve and inject it.
The U.S., which spends more on drugs than any other country, might contain costs by limiting market exclusivity for brand name medicines and changing coverage requirements for government health plans, some doctors argue.
AstraZeneca has entered into an agreement with Sandoz, the generic pharmaceuticals division of Novartis, to resolve Faslodex patent litigation in the U.S.
After years of intensive and expensive brand building, when a drug hits the patent wall, its equity evaporates overnight. Over the last few years, loss of exclusivity (LOE) has slashed the market share of the most well-known drugs in a matter of months.