Amylyx’s ALS drug met the goals of a mid-stage study, paving the way for regulatory submissions in Europe and Canada. But the FDA is requiring data from a larger Phase 3 clinical trial and that study is slated to begin later this year.
Tango Therapeutics’ SPAC merger will infuse the biotech with $353 million to fund clinical trials for its cancer drugs based on synthetic lethality. Tango’s lead program is on track to reach the clinic next year.
With two cancer programs already making progress, Repertoire Immune Medicines will use the Series B financing to expand its immune synapse research to autoimmune disorders and infectious disease. CEO John Cox said his startup’s approach could advance immune medicines beyond the scope of currently available… Read More »Biotech startup Repertoire adds $189M to expand array of immune medicines
The FDA increased the maximum number of doses permitted for each vial of Moderna’s Covid-19 vaccine, a change intended to make more doses available. The regulator also authorized storage changes for the vaccines at vaccination sites.
Omega Therapeutics has raised more than $210 million in the past eight months for R&D of medicines that regulate genes. The company’s lead therapeutic candidate addresses a validated but elusive cancer target.
AstraZeneca reported that its Covid-19 vaccine was 79% effective at preventing severe infection and 100% effective at preventing hospitalization. The company expects to file a submission seeking FDA emergency use authorization in coming weeks.
In two pivotal studies years apart, Aveo Oncology’s drug tivozanib did not help kidney cancer patients live longer overall compared to the standard of care. The FDA approved still approved it, the latest development in a long saga that includes several regulatory stumbles.
The FDA decision gives Sarepta Therapeutics its third approved drug for Duchenne muscular dystrophy. The accelerated approval requires the biotech to conduct additional clinical testing to confirm the drug’s benefit.
Cancer is a known risk of lentiviral-based gene therapies. Though bluebird says its gene therapy is engineered to avoid that risk, the company is suspending two clinical trials pending the outcome of its inquiry.
The Neurocrine decision follows a clinical hold placed on the Parkinson’s program in December. It’s Voyager’s second loss of an R&D partner in the past year; AbbVie previously ended an alliance aiming to develop gene therapies for Parkinson’s and Alzheimer’s.
The latest funding brings total investment in the company to $750 million. The money has gone, in part, toward licensing of promising drug candidates in breast, lung and other cancers.
Moderna’s Covid-19 vaccine shows antibody, T-cell responses a month after second dose in interim Phase I data
The company published interim data from the Phase I study of mRNA-1273 in 40 older and elderly adults, showing responses comparable to those seen in younger adults. The vaccine is being tested in a 30,000-participant Phase III trial.
The six-year-old Google-backed company was founded by three MIT physicists and hopes to use its technology to make drug discovery faster and less cumbersome by combining physics, AI and cloud computing.
The company announced Wednesday the FDA approval of its liquid biopsy test, the second to win an agency nod in less than a month, saying it would launch the product on Friday. The FDA acquired the first ever liquid biopsy companion diagnostic, Guardant Health’s Guardant360… Read More »Foundation Medicine to launch liquid biopsy companion diagnostic following FDA approval
The biotech company reached a deal with the European Commission to supply an initial 80 million doses, while European Union member states will have the option to purchase 80 million more.
The drugmaker emphasized the full global rights it would acquire to Momenta’s lead asset, nipocalimab, which it is developing for several autoantibody-driven diseases and that in certain indications could have peak sales of more than $1 billion.
The agreement, which includes 100 million doses of mRNA-1273 and an option to acquire 400 million more, brings the total amount of money the biotech company has received from the federal government for its vaccine efforts to nearly $2.5 billion.
Biogen and Eisai said the FDA had accepted and given priority review to their application for aducanumab. The drug will undergo an advisory committee meeting at an undisclosed date. Biogen’s stock rose 10%, but analysts had mixed opinions.
The companies’ resubmission of their application Wednesday seeking approval for idecabtagene vicleucel was in line with the timeline they provided in May, when the FDA sent a refuse-to-file letter in response to their initial submission.
The study design is still being finalized, and the company is thus not yet divulging too many details. However, CEO David Daly said it would be significantly larger than the previous DETECT-A, multi-center and would include both men and women.
The company had received $483 million from BARDA in April to fund the development of the vaccine, mRNA-1273, through Phase III, but that amount was based on a smaller anticipated number of participants than the 30,000 it now plans to enroll into the trial, named… Read More »Moderna snags another $472M from BARDA, launches Phase III Covid-19 vaccine trial
The company plans to enroll 60 patients who have received its drug, Spinraza, following suboptimal response to Novartis’ Zolgensma, which was approved last year. The trial, RESPOND, is anticipated to start enrolling in the first quarter of 2021, pending regulatory approval.
The company, whose drug-discovery efforts are focused on protein motion and detection of interactions that occur anywhere on a protein rather than only at active sites, filed to go public last month.
Evaluation of durability is still under evaluation, but the responses to mRNA-1273 show neutralizing antibody titers multiple times higher than those of recovered patients. Additionally, T-cell responses suggest potentially lower risk of enhanced respiratory disease.
Under the deal, Blueprint will additionally be eligible for more than $900M in milestone payments plus royalties for the RET inhibitor pralsetinib. The deal includes exclusive rights for Roche in ex-U.S. markets other than China and shared rights in the U.S.
The company said it is on track to start its 30,000-participant Phase III trial this month and has finished manufacturing enough supplies of the vaccine to do so.
Biogen, Eisai complete submission of controversial Alzheimer’s drug. The ball is in FDA’s court now.
The FDA has 60 days to decide whether or not to accept the application. An analyst wrote that the agency accepting it with a priority or standard review may signal whether the agency is seriously considering approval or has continued reservations about the amyloid beta-targeting… Read More »Biogen, Eisai complete submission of controversial Alzheimer’s drug. The ball is in FDA’s court now.
Thanks to the success of the Human Genome Project, 20 years ago this week, scientists can track biology and disease at a molecular level Twenty years ago this week, an international group of scientists announced it had put together the first genetic blueprint of a… Read More »‘The wondrous map’: how unlocking human DNA changed the course of science