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Studies suggest that extending treatment leads to 54–55% reductions in risk of recurrence and death. FDA approved a label amendment to Novartis’ oral anticancer therapy Glivec™/Gleevec™ (imatinib), recommendin…
Read guide →Last week’s Congressional hearing on the fifth authorization of the Prescription Drug User Fee Act (PDUFA V) didn’t get much news coverage beyond outlets covering the industry. Some sobering statistics brought…
Read guide →Company has 180 days of exclusivity in this $639-million market. Dr. Reddy’s Laboratories received approval for its generic version of GSK’s Zofran, which is indicated for the prevention of nausea and vomiting…
Read guide →New clearances follow swiftly behind CHMP’s recommendation that Gilenya be sanctioned by the EC. The Swiss and Australian regulatory authorities have both cleared Novartis’ Gilenya® (fingolimod) as first-line …
Read guide →Gilenya NDA covers highly active relapsing-remitting MS and rapidly evolving severe relapsing-remitting MS. While the EMA’s Committee for Medicinal Products for Human Use (CHMP) doled out negative opinions for…
Read guide →Deal supersedes previous co-promotion arrangement inherited from Procter & Gamble Pharmaceuticals. Novartis has sold the U.S. marketing rights to its overactive bladder drug, Enablex® (darifenacin) extended-re…
Read guide →Single pill comprises aliskiren, amlodipine, and hydrochlorothiazide. FDA has approved Novartis’ Amturnide™ triple combination pill for the treatment of hypertension in patients whose blood pressure remains un…
Read guide →Agreement will exploit Proteus’ technologies designed to provide feedback on factors such as patient physiology and compliance. Proteus Biomedical will receive $24 million worth of cash and equity investments …
Read guide →Pill combines firm’s rennin inhibitor, Tekturna, with diuretic. FDA approved Novartis’ Tekturna HCT® tablets as initial therapy for hypertensive patients likely to need multiple blood pressure medications. The…
Read guide →Firm has two systemic therapies and one topical treatment in Phase I. Nabriva Therapeutics closed a E15 million (about $22.18 million) financing round to bolster its program with drug-resistant antibiotics. Th…
Read guide →Firms will work together to boost vaccine pipeline and introduce Novartis vaccines into China. Novartis has negotiated a $125 million cash deal to purchase 85% of Chinese vaccines company Zhejiang Tianyuan Bio…
Read guide →Combined worldwide sales during the first three quarters of 2009 were $628 million. Japanese regulatory authorities sanctioned three Novartis drugs: Exforge® for high blood pressure, Afinitor® (everolimus) for…
Read guide →Long-time Roche chairman Franz B. Humer has decided not to run for re-election in 2014. Roche says it will nominate a successor for the chairmanship later this year. The successor will also serve as nonexecuti…
Read guide →Alex Philippidis Senior News Editor Genetic Engineering & Biotechnology News Blockbusters Do Better, with One Newcomer Reaching #2 in its First Year Bad press didn’t hurt Sovaldi™ (sofosbuvir) after all. The H…
Read guide →New collaborations will exploit Adimab’s yeast-based platform to identify fully human antibodies against two targets each. Antibody discovery specialist Adimab announced signing separate collaborations with Bi…
Read guide →Trials in other diseases involving IL-1 beta are ongoing. EMEA granted Novartis’ Ilaris® accelerated approval as a treatment for cryopyrin-associated periodic syndrome (CAPS) in adults and children aged four y…
Read guide →Firm claims lipopeptide technology modulates receptors’ intracellular binding sites. Anchor Therapeutics (previously Ascent Therapeutics) secured $10 million in a Series B fundraising led by current investors.…
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