Among a positively jam-packed multiple sclerosis market, Roche’s Ocrevus has managed to stand out for what the Swiss drugmaker is calling the most successful launch in its long history. But in order to press its advantage, Ocrevus is looking to earlier-stage patients, and new interim data should help build its case there.

After 48 weeks on Roche’s Ocrevus, 85% of newly diagnosed primary progressing or relapsing MS patients without a history of disease modifying therapy posted no disease activity, including disease progression or relapse, according to interim data set to be presented this weekend at the virtual American Academy of Neurology meeting.

Where other companies have gone big, Avrobio is going small. Its manufacturing operation is no different.

Instead of trying to keep up with the validation of new facilities — and spending money and precious time in the process — the company has opted for a different approach: small, automated pods that can be installed in rented clean rooms anywhere. Though production output isn’t as high as other companies, Avrobio avoids brick-and-mortar and is able to stay flexible and nimble to respond to fluctuations.

When the FDA calls the quality of a drugmaker’s products into question, the worst possible response is “we can’t prove what we make is up to par.” But that’s exactly how a Colombian API maker responded following a Form 483, and now the agency is reading the riot act.

The FDA issued a warning letter to Colombia’s Proquimes SA, accusing the firm of not providing validation documents for US-bound API following a request in April and a subsequent request in June. Proquimes makes calcium acetate, used to make severe kidney disease therapies, and aluminum sulfate.

With a “target-agnostic” approach to antibody development, the UK’s Alchemab has used lessons learned from patients with resistance to certain diseases to chase after conditions as far apart as Huntington’s and Covid-19. Now, investors are jumping on board the concept with an $86 million Series A.

The proceeds will go toward advancing the company’s target-agnostic drug discovery program, a release said. That approach looks at the antibody repertoires of patients who show resistance to typically destructive diseases regardless of genetic disposition.

The J&J vaccine will, at least for now, remain on hold.

An advisory convened by the CDC and FDA voted on Wednesday to request more information on the rare but potentially deadly blood-clotting disorder that appeared in six people who received the J&J shot before they decide whether to restrict or fully resume rolling the vaccine out. The decision will keep the vaccine on factory shelves and in pharmacy refrigerators for another week to ten days.

A year ago, Stéphane Bancel would have described Moderna as cautious — walking step-by-step to investigate whether mRNA vaccines could prevent a host of viruses. Then the pandemic hit, and the Cambridge, MA-based biotech got a multibillion-dollar windfall to produce the world’s second-ever authorized mRNA vaccine in a matter of months.

What’s next? Bancel is planning a big acceleration and expansion of the rest of the pipeline, including the company’s Phase III-ready candidate for cytomegalovirus (CMV), which was the lead program before Covid-19 came around.

A day before its second annual Vaccines Day, Moderna has posted an update on its crown jewel, including a 6-month look at the Covid-19 shot and new preclinical data that suggest its booster candidates stand a fighting chance against new variants.

Moderna’s variant-specific booster mRNA-1273.351, which was designed to target the B.1.351 mutation first identified in South Africa, “closed the neutralizing titer gap for variants of concern” in mice, the company said on Tuesday afternoon. When given at the 6-month mark, the booster elicited neutralizing titers against the variant that were comparable to those produced against the original virus.