When he first stepped into the field of glycoproteomics, particularly the potential of truncated O-glycans as cancer targets, Constantine Theodoropulos, CEO of Go Therapeutics Inc., said the reaction from peers was less than encouraging.
When he first stepped into the field of glycoproteomics, particularly the potential of truncated O-glycans as cancer targets, Constantine Theodoropulos, CEO of Go Therapeutics Inc., said the reaction from peers was less than encouraging. “They said, ‘You’re nuts, it’s too complicated.’” Now, however, the company he co-founded has landed a deal with Astellas Pharma Inc.’s immuno-oncology-focused subsidiary, Xyphos Biosciences Inc., that brings $20.5 million up front, with the potential for up to $763 million in milestone and contingency payments down the road.
With its focus on transformative high-risk, high-reward research to drive biomedical breakthroughs, the new Advanced Research Projects Agency for Health (ARPA-H) may be a good concept, but it shouldn’t come at the expense of increased investment in basic research at the NIH, according to the bipartisan leadership of U.S. House appropriators.
Policymakers shouldn’t look to march-in rights as a simple solution to make medical products more affordable, according to experts speaking at an Information Technology & Innovation Foundation discussion on how using the march-in provisions of the Bayh-Dole Act as price controls would threaten America’s research universities.
There’s nothing like beginning-of-the-year price increases to turn up the heat on the prescription drug pricing debate in the U.S. This year is no exception. Citing a mean price increase of 5.1% on brand drugs in the first 25 days of 2022, 13 Democratic lawmakers, led by Sen. Elizabeth Warren (D-Mass.), wrote this week to Steven Ubl, president and CEO of the Pharmaceutical Research and Manufacturers of America, demanding an explanation for those hikes.
U.S. Health and Human Services Secretary Xavier Becerra is getting more pressure to take the unprecedented step of marching in on the patent rights protecting Astellas Pharma Inc.’s prostate cancer drug, Xtandi (enzalutamide), because of its U.S. price. Referencing the provision under the Bayh-Dole Act that allows federal agencies to march in on licensed patents stemming from federally funded research when the products are not available to the public on “reasonable terms,” a dozen Democratic congressional members wrote to Becerra Feb. 8 urging him to move forward on the Xtandi patents.
Japan’s Astellas Pharma Inc. is continuing its investment in gene therapies, following up its $3 billion acquisition of Audentes Therapeutics Inc. with a technology licensing deal with Dyno Therapeutics Inc. potentially worth more than $1.6 billion. Central to the deal is Cambridge, Mass.-based Dyno’s adeno-associated virus (AAV) vector technology, which can be used to direct gene therapies to skeletal and cardiac muscle.
Japan’s Astellas Pharma Inc. is continuing its investment in gene therapies, following up its $3 billion acquisition of Audentes Therapeutics Inc. with a technology licensing deal with Dyno Therapeutics Inc. potentially worth more than $1.6 billion. Central to the deal is Cambridge, Mass.-based Dyno’s adeno-associated virus (AAV) vector technology, which can be used to direct gene therapies to skeletal and cardiac muscle.
Astellas Pharma Inc. and Seagen Inc. received approval through a priority review from Japan's Ministry of Health, Labour and Welfare for Padcev (enfortumab vedotin) to treat radically unresectable urothelial carcinoma that has progressed after chemotherapy. The green light for the antibody-drug conjugate is based on the global phase III EV-301 clinical trial, which included sites in Japan.
A fourth child has died after developing liver complications on a trial of Astellas Pharma Inc.’s gene therapy for rare neuromuscular disease, after FDA advisers noted the problems on the ASPIRO study in a discussion on gene therapy safety. Last week, Astellas announced that it had stopped dosing on ASPIRO after a safety issue involving liver function emerged in the trial of the gene therapy AT-132, aimed at the life-threatening rare disease X-linked myotubular myopathy.
