The U.K.'s cost-effectiveness gatekeepers have flip-flopped on Novartis' Xolair before, withdrawing support for the drug in 2012 before expanding its approval for asthma the following year. Now, the National Institute for Health and Clinical is asking the drugmaker to pony up more information about the product before recommending it to treat chronic spontaneous urticarial (CSU), or psoriasis.
Roche's Avastin is now two-for-two on converting recent FDA priority review designations into label expansions. Just three months after the cancer giant nabbed the agency's blessing for use in cervical cancer, regulators have approved the drug in combination with chemotherapy as a treatment for platinum-resistant, recurrent ovarian cancer.
Roche's Genentech unit is facing more pushback over distribution-channel changes for its three best-selling cancer treatments. Leaders from top U.S. teaching hospitals and medical institutions are asking Congress for an "expedited review" of the Roche unit's decision.
Roche never publicly described what went wrong with its early-stage BACE drug for Alzheimer's when it killed the program. But a new study from the pharma giant's Genentech unit outlines the potential threat one of their BACE efforts posed to patients--and how they've managed to adjust for it in animal studies that may well open the door to new human trials.
Biotech powerhouse Genentech is going all in with Ames, IA-based NewLink Genetics, partnering on an early-stage cancer program which has been billed as an important example of a new class of checkpoint inhibitor. And Genentech says that it plans to build a portfolio of programs pairing this therapeutic with Roche's closely watched PD-L1 drug.
Carving out a successful career in biopharma isn't easy, for men or women. The failure rate of experimental drugs is astronomically high. And just because a company wins an approval is no...
One hospital chain has struck back at Roche's Genentech unit for switching its top 3 cancer treatments to specialty distributors. Ascension Health, a Roman Catholic-based group of more than 130 hospitals, is barring Genentech sales reps at the door.
Roche's Genentech unit is getting some high-profile blowback from a change to its distribution model on three top cancer meds. Hospital and pharmacy executives claim the new regime--which restricts Avastin, Rituxan and Herceptin to a half-dozen specialty distributors--will cost them big money.
Following up on a successful mid-stage study for the AMD eye drug lampalizumab, Genentech has triggered a pair of Phase III studies to see if it can extend its blockbuster-making R&D rep beyond the cancer drug sphere.
An Alzheimer's treatment from AC Immune and Genentech posted mixed results in a midstage study, missing its coprimary endpoints but performing well in patients with milder symptoms. That leaves Roche, Genentech's parent company, with a big decision to make on whether to take the plunge into Phase III.