The White House's proposed FY 2015 budget gives an additional 1% to the FDA.
PMLive has documents that outline a strategy to keep intellectual property laws from relaxing in South Africa.
Purdue Pharma says it will appeal.
Three drug purchasing companies have taken the Denmark drugmaker to court in the US. The charge: wrongfully keeping generics off the market.
Teva said a settlement will allow it to sell a copy of the blockbuster ED pill prior to the official LOE.
A court refuses to compel a government agency to schedule the firm's epilepsy drug, as the med's patent clock ticks.
Researchers say it's not just payers supporting the switch, and all ages appear to be brand agnostic.
The generics maker says it may take five years for its iteration of the GSK asthma/COPD brand to hit the market.
Echoing a strategy similar to that posed by Merck, the drug maker told investors that its strategy for hitting revenue targets includes efficiencies. It also depends on a regulatory-friendly pipeline.
Eisai lobbies to push back Belviq's patent clock; a case against Paula Deen is dismissed; Merck and Avanir team up to promote Januvia; and another healthcare-reform measure is pushed back
GSK seeks a new ovarian cancer indication for Votrient; a bill that would extend exclusivity for some combination drugs is introduced in Congress; Otsuka's tolvaptan gets a thumbs-down from an FDA advisory committee; NICE rejects Roche's Perjeta; India tosses Herceptin patents; and China revokes Gilead's patent on Viread
The positive way to frame the companies' quarterly results: "less bad," as generics continued to plague their balance sheets.
The Indiana drug maker logged a 6% sales increase over the same period last year. Higher prices were responsible for the majority of the growth.
GlaxoSmithKline second-quarter sales rose 2% over the same period last year. CEO Andrew Witty says it is too early to tally the impact of China's corruption allegations.
GSK says change is afoot in China; Vivus fight reportedly results in a new CEO; Biogen Idec enters a collaboration in Edinburgh; Astellas wins and FDA approval; Myriad's patent fight continues
The FDA's priority review for the Phase III chronic lymphocytic leukemia drug comes on top of Breakthrough Therapy designation, which the agent won in May.
CHMP recommended two Remicade biosimilars for approval. Its nod comes with an added shakeup: the European agency sanctioned the copies for indications beyond RA.
The effectiveness of new drugs is in decline, says an analysis, and researchers say comparative studies should look beyond efficacy measures.
The drug maker eases the burden on its Symbicort franchise by scooping up Pearl for $510 million.
Two studies released show that the story behind lower consumer healthspend isn't about generics improving health.
Baxter's Alzheimer's treatment is out of the running; Eli Lilly has upped its layoffs; insured consumers are spending less on healthcare; stains and prostate cancer may have an amicable relationship; doctors aren't screening teens for HIV.
Sales fell more sharply during the quarter than execs expected, and Merck said it has put more Januvia-only reps behind its diabetes franchise.
Brass-plated brands Plavix and Seroquel continue to lose luster on the two drug makers' balance sheets.
AstraZeneca cuts a deal with OCB to test unnamed cancer drug; an Enbrel biosimilar launches in India; BMS and Santaris seal an mRNA tech deal; Merck expands its China presence; Alzheimer's advocacy group parents a spin-off.
After a skeptical Supreme Court hearing, diagnostics and biopharma patent lawyers are sweating the outcome of Association for Molecular Pathology vs. Myriad Genetics, in which the Court could decide whether or not swatches of genes are patentable.
Expiring patents force a sales staff slim-down, but the drug maker emphasizes it is not eliminating its sales force.
Execs told Booz & Co researchers that the relationships web in emerging markets needs to be deeper than one-on-one sales pitches.
Eight December approvals helped the agency pass its 2011 total with ease. But it's not all about the pace—the agency needs drugs to approve to keep tallies climbing.
The drugmaker told investors Tuesday that generics will remain its standby, but novel therapeutic entities are also in its future.
Forest Labs may have settled a patent challenge from generics maker Hetero, but the drugmaker has yet to come to terms with six others.