Along with its partner, Astellas, Roche has won FDA approval for a new, first-line use for its lung cancer drug Tarceva in patients whose cancers test positive for specific mutations of the EGFR gene. Roche also got the nod for a diagnostic test to identify eligible patients.
Roche's surging diagnostics arm scored a major win this week, gaining FDA approval what is being billed as the first companion diagnostic meant to detect a specific mutation connected to metastatic non-small cell lung cancer.
Who wants Optimer Pharmaceuticals and its high-powered antibiotics? A handful of drugmakers, apparently.
Tokyo-based Astellas Pharma is rolling out a major R&D restructuring effort, shuttering facilities at its OSI Pharmaceuticals and Perseid Therapeutics subsidiaries and cutting back its work at the Astellas Research Institute of America to focus solely on CNS diseases.
GlaxoSmithKline CEO Andrew Witty has high hopes for an experimental pill his company is developing for anemia, as the drug could offer an oral alternative to injected EPO therapies.
Drugmakers are circling Optimer Pharmaceuticals, the antibiotics maker that says it's considering a sale. And that includes GlaxoSmithKline, Astellas Pharma, AstraZeneca and Cubist Pharmaceuticals, Bloomberg sources say, for a deal worth as much as $1 billion.
Lexington, MA-based Cubist Pharmaceuticals has bought out Astellas' rights to ceftolozane, putting up $25 million in cash for an antibiotic that has demonstrated some promising outcomes in clinical studies.
The market for prostate cancer drugs is expected to double by 2021 to $9.1 billion, thanks in part to the debut of new, more expensive drugs. According to Decision Resources, Johnson & Johnson's ($JNJ) Zytiga, along with Medivation ($MDVN) and Astellas Pharma's new Xtandi, will help drive sales growth in 7 major drug markets.
Cambridge, MA-based Ironwood cleared a major milestone in its development this morning, winning an FDA approval for linaclotide and paving the way for its big leap into commercialization.
Medivation has added another set of stellar data on enzalutamide, its promising prostate cancer treatment now up for a priority review at the FDA. New late-stage results published in the New England Journal of Medicine indicate that advanced stage, therapy-resistant patients in the drug arm survived 5 months longer than the control group.