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
Microsoft will buy up healthcare AI partner Nuance for $19.7 billion. Nuance makes speech-recognition tools for clinical documentation, as well as security tools.
RA Capital led Ventus Therapeutics’ Series B financing, which the startup will use to develop its pipeline of medicines for “undruggable” disease targets. CEO Marcelo Bigal said the cash also gives Ventus the flexibility to consider an IPO.
Mobidiag offers multiplex testing, which is the ability to test for multiple pathogens from a single test sample. Hologic said the acquisition will enable the company to enter the acute care test market, which is projected to grow in a post-pandemic world.
Virtual primary care startup Firefly Health plans to launch a benefit plan after raising $40 million in new funding. The company currently offers virtual and in-person access to a primary care team.
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.
Alexandra Sierra carried boxes of food to her kitchen counter, where her 7-year-old daughter, Rachell, stirred a pitcher of lemonade. This story also ran on USA Today and GateHouse Media. It can be republished for free. “Oh, my God, it smells so good!” Sierra, 39,… Read More »Need Amid Plenty: Richest US Counties Are Overwhelmed by Surge in Child Hunger
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.
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.
Cuando los hospitales de todo el país luchan contra la nueva ola de la pandemia, no son camas ni ventiladores lo que escasean. Son las personas que cuidan de los enfermos. Pero existe mano de obra altamente calificada de médicos, enfermeras y otros trabajadores de… Read More »Estados permiten contratar profesionales de salud extranjeros por la pandemia
Despite lower sales, lack of profits and heavy R&D spending, biotech companies that went public between 1997 and 2016 reached similar market caps as non-biotech companies, according to an academic study.
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.
In August, Robert Pettigrew was working a series of odd jobs. While washing the windows of a cellphone store he saw a sign, one that he believes the “good Lord” placed there for him. “Facing eviction?” the sign read. “You could be eligible for up… Read More »Evictions Damage Public Health. The CDC Aims to Curb Them ― For Now.
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
Leslie Cutitta said yes, twice, when clinicians from Massachusetts General Hospital in Boston called asking whether she wanted them to take — and then continue — extreme measures to keep her husband, Frank Cutitta, alive. The first conversation, in late March, was about whether to… Read More »Another COVID Mystery: Patients Survive Ventilator, But Linger in a Coma
The study, by researchers at Harvard, MIT, The Broad and other institutions, used genomic analysis of cases linked to the Biogen meeting, linking much of the community transmission in the Boston area to a European genetic variant of SARS-CoV-2 that first appeared at the meeting.
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.
It’s a familiar moment. The kids want their cereal and the coffee’s brewing, but you’re out of milk. No problem, you think — the corner store is just a couple of minutes away. But if you have COVID-19 or have been exposed to the coronavirus,… Read More »Contact Tracers in Massachusetts Might Order Milk or Help With Rent. Here’s Why.
The company’s software system is designed to streamline the work done by staff at clinical trial sites, such as manually copying information about patient recruitment and enrollment.
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 company said in its 2Q earnings that it would halt development of ALXN2040 for C3 glomerulopathy, or C3G, citing the drug’s lack of potency. However, it may develop a second, more potent drug from the Achillion acquisition, ALXN2050, in the same disease.
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 companies will test Biofourmis’ sensor and artificial intelligence system in a clinical trial of more than 120 women with endometriosis.
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.
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.