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.

Foundation Medicine to launch liquid biopsy companion diagnostic following FDA approval

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 CDx, on Aug. 10.

J&J to buy Momenta Pharmaceuticals for $6.5B

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.

Moderna secures more than $1.5B federal government deal to provide Covid-19 vaccine

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 to get speedy FDA review for Alzheimer’s drug despite not using voucher to request it

Dementia or brain damage and injury as a mental health and neurology medical symbol with a thinking human organ made of crumpled paper torn in pieces as a creative concept for alzheimer disease.

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.

BMS, bluebird refile FDA approval application for CAR-T therapy in myeloma

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.

Thrive raises $257M Series B round for registration study of blood test for early cancer detection

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.

Moderna snags another $472M from BARDA, launches Phase III Covid-19 vaccine trial

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 COVE.

Biogen to launch Phase IV study of spinal muscular atrophy drug in post-gene therapy patients

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.

Moderna publishes Phase 1 Covid-19 vaccine data showing robust immune responses

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.

Roche pays Blueprint $675M upfront for ex-U.S. development, commercialization rights to cancer drug

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.

Biogen, Eisai complete submission of controversial Alzheimer’s drug. The ball is in FDA’s court now.

Dementia or brain damage and injury as a mental health and neurology medical symbol with a thinking human organ made of crumpled paper torn in pieces as a creative concept for alzheimer disease.

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 drug’s clinical benefit.

‘The wondrous map’: how unlocking human DNA changed the course of science

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 human being. After 10 years of effort, the team – made up of thousands of scientists working on both sides of the Atlantic – revealed it had pinpointed all 3bn units of DNA that make up the human genome.

The result was “the most wondrous map ever created by humankind”, US President Bill Clinton told a special White House ceremony to mark the event. A parallel event, hosted by Tony Blair in Downing Street, also featured glittering praise for the effort.

DNA studies have helped to develop new drugs for conditions ranging from cystic fibrosis to asthma

We are sequencing samples of Sars-Cov-2 from different sources to see if the virus is mutating significantly

Related: Human code fully cracked

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