R&D channel feed

Severin Schwan, Roche CEO (Georgios Kefalas/Keystone via AP Images)

Look­ing to ce­ment its lead in packed MS mar­ket, Roche's Ocre­vus un­corks new da­ta in ear­ly-stage pa­tients

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.

Geoff MacKay, Avrobio

Avro­bio is us­ing 'pod­s' to cre­ate gene ther­a­pies, and it be­lieves the ap­proach could change the game al­to­geth­er

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.

FDA blasts Colom­bian drug man­u­fac­tur­er in warn­ing let­ter for not prop­er­ly ad­dress­ing API flaws

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.

Alex Leech, Alchemab CEO (SV Health Investors)

Alchemab bags fresh round of in­vestor for tar­get-ag­nos­tic an­ti­body de­vel­op­ment for Hunt­ing­ton's, Covid-19

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.

Emma Walmsley, Getty Images

Ac­tivist in­vestor grabs a multi­bil­lion-pound stake in Glax­o­SmithK­line, trig­ger­ing buzz about a loom­ing show­down at the list­less gi­ant

Murmurs of investors’ growing unease about GlaxoSmithKline’s struggling revival strategy spilled out into the public on Thursday as the Financial Times reported that activist hedge fund Elliott Management has built up a multibillion-pound stake in the pharma giant, portending a high profile showdown over CEO Emma Walmsley’s reign.

Shares had been down 14% since Walmsley became CEO and brought in Hal Barron to spur a makeover in the pipeline. Now, the FT reports, some of the unhappy investors are making unfavorable comparisons between Walmsley and Pascal Soriot, the CEO credited with a major turnaround at that other UK pharma giant — AstraZeneca.

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Mer­ck scraps their $425M Covid-19 drug in lat­est pan­dem­ic set­back

Seven months after paying $425 million cash to acquire it, Merck is scrapping a Covid-19 drug they hoped could provide one of the only treatments for severe hospitalized patients.

Merck’s decision comes after they faced significant and unexpected regulatory delays in getting the drug, known as MK-7110 or CD24Fc, across the finish line. The Big Pharma licensed the drug under the belief that it had already shown sufficient benefit in severe patients and they could help scale it up far faster than OncoImmune, its former owner, could. But in February, the company reported that the FDA insisted Merck run a new trial before seeking authorization.

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Covid-19 roundup: J&J shot re­mains on hold af­ter CDC pan­el vote

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.

Hal Barron, GlaxoSmithKline R&D chief (GSK via YouTube)

Glax­o­SmithK­line scraps two key mid-stage tri­als for their ICOS drug in the lat­est set­back for the field

Another ICOS cancer drug program is running into stormy weather, with more bad news for GlaxoSmithKline R&D chief Hal Barron.

GSK put out word on Wednesday evening that it has decided to scrap two mid-stage trials for feladilimab (GSK3359609) — an investigational inducible T cell co-stimulatory (ICOS) agonist — which wasn’t a huge surprise after Jounce got trounced with their mid-stage effort for vopratelimab last fall.

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Stéphane Bancel, Moderna CEO (Jeff Rumans)

'Learned a lot last year': Af­ter Covid-19 suc­cess, Mod­er­na's Stéphane Ban­cel plans to give rest of pipeline a big push

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.

Stéphane Bancel, Moderna CEO (Adam Glanzman/Bloomberg via Getty Images)

UP­DAT­ED: Mod­er­na says Covid-19 boost­ers stand a fight­ing chance against new vari­ants

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.