A research collaboration between medical centers, drugmaker Biogen Idec and a biotechnology institute have identified a gene that could lead to new drug targets for sporadic amyotrophic lateral sclerosis—or Lou Gehrig's disease.
The biotech exec speaks about the global launch of his firm's lead product, Duchenne drug Translarna.
The drugmaker announced it will acquire OncoEthix and its oncology candidate OTX015 in a deal worth up to $365 million
Canadian firm presents FDA with its third biosimilar application.
Blood-cancer drug Kyprolis outperformed standard treatment in a late-stage trial testing the drug in patients with multiple myeloma, said Amgen.
Innovation is still valued in the orphan-drug space, but the reimbursement bar is rising. NPS Pharma's Eric Pauwels, who's launched five ultra-rare disease products, explains how these biotech brands can demonstrate their value. Marc Iskowitz reports
The fast-tracked drug netted another indication today, this one for a form of leukemia. Lower dosage of the drug for that indication shrinks the price compared to lymphoma.
If the HCV drug's trajectory continues, it could exceed Q1 and 2014 sales forecasts, despite payers' reported unease over price.
The firm has vowed to appeal an FDA rejection that otherwise complicates its bid to expand in multiple sclerosis.
Two months after it was pulled from the US market, Iclusig is returning with a narrower approval.
A 15% increase in sales came on the back of HIV franchise meds Stribild and Complera/Eviplera.
The prostate cancer drug company is reportedly seeking a buyer to turn things around.
Sanofi named in China corruption probe; GlaxoSmithKline starts a venture capital fund; and European non-profit AllTrials outlines its transparency goals
The ad watchdog flagged the drug maker for what it said was yet another misleading Ampyra promotional piece.
The drug maker added biotechs Optimer and Trius to the fold, a bid to dominate in hard-to-treat infections.
While a strong launch of CF drug Kalydeco helped to hike the biotech's forecast, hep. C contender VTX-135 was hit with a partial clinical hold.
Biogen Idec raised its full-year guidance on Tecfidera launch sales, as the MS market continues its growth trajectory.
A two-year study shows Gilead's Quad pill outpaces an older combination drug over two years, and GSK is seeking to expand its oncology presence.
Mayo Clinic says 70% of adults are on an Rx, with 25% of older women on an anti-depressant; GSK sinks $24M into rare-disease venture fund; Lundbeck restructures, and may kill 50 jobs; and Tecfidera is reportedly on-track for blockbuster sales estimates but still faces reimbursement hurdles.
Roger Perlmutter has begun to trim the fat off Merck's lackluster pipeline.
Medical science liaisons will educate nuclear-medicine clinicians as part of the launch of a new Navidea diagnostic agent for use in breast and skin cancer.
Health-seeking consumers continue social-media push; Scioderm scores FDA's "Breakthrough" designation for bullosa agent; and GSK files NDA for airway treatment.
Having finally accepted that external R&D is the future, big pharmas are snapping up earlier-stage biotechs and biologics, but they're not betting the farm on them, thanks to pre-nup-like earnout deals.
Phase III findings on sofosbuvir, released in a medical journal, suggest no cause for concern from a safety perspective.
BIO chief Jim Greenwood talks policy priorities and previews the group's International Convention, now underway in Chicago.
One is a sales aid, and one is a consumer brochure, but both ads -- for CSL Behring's Zemaira and for Talecris' Prolastin -- are false or misleading, FDA said in a pair of untitled letters.
Far from sapping promotional budgets, biosimilars could spur marketing by makers of follow-on and original biologic alike, experts say.
Sandoz, the generics division of Novartis, is soliciting pre-orders for Sanofi-Aventis blood thinner Lovenox—actions that seem to suggest generic approval of the megablockbuster may be coming soon, one analyst says.
The Senate health reform bill would maintain the ban on price controls in the Medicare prescription drug benefit and establish a 12-year data exclusivity period for biologics.
EMD Serono is partnering with Men's Health Network on a patient education campaign aimed at raising awareness of male infertility.
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