After shunning public attention for more than a year, cancer immunotherapy startup Flexus Biosciences is ready for the limelight now that it is headed toward the clinic, has banked its first two venture rounds totaling $38 million and boasts impressive management, board and advisory rosters.
Roche's Lucentis may now have a bigger jump on Eylea in diabetic retinopathy. The Swiss drugmaker's Genentech unit won the FDA's "breakthrough" designation for that indication on Monday. And Lucentis was already on the FDA's priority review track, with a decision date in February.
Having shepherded Genentech's R&D operations through the takeover by Roche, Richard Scheller will retire at the end of 2014. Roche has lined up Michael Varney, Genentech's head of small molecule drug discovery, to replace Scheller.
The flu season's most common viral strain has mutated, meaning this year's shots may not fully protect against it. But the so-called "drifted" strain may open up an opportunity for antiviral makers like Roche's Genentech and GlaxoSmithKline, with the CDC urging earlier use of anti-flu drugs to combat potentially severe symptoms.
How did Genentech persuade physicians to switch from $50-a-dose Avastin to $2000-a-dose Lucentis? According to The New York Times, consultation payments may have had something to do with it.
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.