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Severin Schwan (AP Images)

Roche CEO Schwan puts 3-time Alzheimer's los­er gan­tenerum­ab back in the spot­light as FDA's con­tro­ver­sial Aduhelm OK in­spires block­buster fore­casts

Four years after Roche opted to resurrect its late-stage effort on their Alzheimer’s program for gantenerumab following a clear failure, Roche CEO Severin Schwan is signaling some fresh enthusiasm for its blockbuster prospects in the wake of the controversial Aduhelm OK.

Schwan told reporters that company execs are engaged in ongoing talks with the FDA as speculation continues to percolate around its chances based on biomarker data alone, now that regulators have established a precedent using an accelerated approval pathway process with no convincing evidence of efficacy in helping patients retain their cognitive skills. In Aduhelm’s case, the drug reduced the amount of amyloid in the brain and Biogen was able to win the accelerated approval on what the FDA called a reasonable expectation of success.

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Pharmacist Clint Hopkins holds bottles of the HIV prevention drugs Descovy (L) and Truvada, Oct. 7, 2019, in Sacramento, CA (Rich Pedroncelli, AP Images)

In 60 days, most in­sur­ers will be re­quired to cov­er HIV pre­ven­tion drugs and re­lat­ed ser­vices with no cost-shar­ing

The federal government issued guidance Monday stating that almost all health insurers must cover HIV prevention drugs — such as Gilead’s Truvada and Descovy — with no cost-sharing, as well as associated lab testing and follow-up visits.

Insurers were already required to quit charging out-of-pocket fees for the drugs, called HIV Preexposure Prophylaxis (PrEP), by January of this year. But now insurers have 60 days to comply with the additional requirements, including no-cost services like baseline and follow-up testing, as well as monitoring, according to the guidance.

Outside Biogen's headquarters in Cambridge, MA (Steven Senne/AP Images)

How cozy is too cozy? FDA and Bio­gen of­fer up a test case

As the saga over how to pay for Aduhelm plays out, biopharma companies are now looking closely at how Biogen was able to keep such a special relationship with FDA officials ahead of the drug’s accelerated approval, and whether or not they might be able to leverage those takeaways into their own relationships with the agency.

What makes Biogen unique, however, is how deep its relationship with the FDA ran, and the way in which FDA’s neuroscience head Billy Dunn worked alongside the company for years prior to Aduhelm’s quick OK. For instance, back in 2017, Dunn co-chaired a data sharing initiative at the nonprofit C-Path Institute alongside Biogen SVP Samantha Budd Haeberlein, as first reported by the New York Times. In 2018, Dunn and Budd Haeberlein also jointly presented on strengthening communication across the Alzheimer’s drug development community.

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Sanofi's sleep­ing sick­ness drug wins FDA OK and a lu­cra­tive pri­or­i­ty re­view vouch­er too

The FDA on Tuesday approved the first oral treatment for sleeping sickness (human African trypanosomiasis) from Sanofi and the Drugs for Neglected Diseases initiative, and provided the partners with a priority review voucher that they may sell for about $100 million.

Sleeping sickness is a parasitic disease that’s transmitted through being bitten by tsetse flies and affects people living in remote, sub-Saharan Africa, which puts about 65 million people at risk of infection. But Sanofi has been able to drastically reduce the number of sleeping sickness cases in sub-Saharan Africa by about 97% from 2001 and 2020, and fexinidazole, its oral-only drug, offers an advantage over other sleeping sickness treatments that require infusions or injections, and which are challenging to administer to patients in remote parts of Africa.

New study shows small­er bio­phar­ma com­pa­nies strug­gle more than larg­er ones with clin­i­cal tri­al trans­paren­cy

As clinical trial transparency and the sharing of positive and negative trial results slowly become the norm rather than the exception, a new study published in the BMJ revealed struggles from smaller companies to keep up with their larger rivals when it comes to transparency.

AbbVie, Amgen, Bayer, Merck KGaA/EMD Serono, Novartis, Roche and Takeda all tied for the top spot as the most transparent biopharma companies, the study found.

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Ron Cooper, Albireo CEO

Al­bireo caps a big week with back-to-back ap­provals in the US/EU for the first drug to treat a se­vere liv­er dis­ease

Albireo $ALBO CEO Ron Cooper is getting his long-awaited shot at marketing the first drug approved for pruritus in all subtypes of progressive familial intrahepatic cholestasis.

The biotech put out word Tuesday afternoon that the FDA came through with the approval right on deadline, something that had been expected since the agency handed the company a priority review for the drug. That now gives them a green light to see how much of a head start they can get before Mirum finds out about the ultimate fate of its own PFIC program.

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FDA re­jects pro­fes­sor’s pe­ti­tion seek­ing to pull ‘dan­ger­ous’ Ot­su­ka kid­ney dis­ease drug

The FDA on Monday denied a petition from an emeritus professor at Ohio State University who had sought to revoke the approval of Otsuka’s kidney disease drug tolvaptan, which he said is “dangerous” and offered “negligible efficacy.”

Approved by the FDA in 2018 to treat the genetic disease known as autosomal dominant polycystic kidney disease, Otsuka’s tolvaptan — marketed in the US as Jynarque — faced a long and rocky road to marketing but quickly amassed more than $700 million in worldwide sales in 2020, up almost 40% from 2019.

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In­dus­try groups warn of drug short­ages linked to wide­spread car­cino­gen test­ing as FDA dou­bles down on its ap­proach

With the recent and unexpected discovery of probable human carcinogen impurities prompting recalls of popular heartburn drugs like Zantac and nizatidine, as well as metformin diabetes medicines, ARBs and more, the FDA has made clear the need for an industry-wide risk assessment for the so-called nitrosamines in even more drugs that may be at risk.

But industry groups are pushing back on the need for such widespread testing, arguing that the FDA should be more consistent and collaborative with other regulators in its approach, and that the timelines for such testing are too constricted and may lead to serious drug shortages.

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Arde­lyx craters af­ter FDA stuns an­a­lysts and re­jects their kid­ney dis­ease pitch

Three months after revealing the FDA had asked for more information to support their application for a chronic kidney disease drug, Ardelyx announced that the agency has rejected it.

The California and Massachusetts-based biotech said that the agency was concerned with how effective the drug, known as tenapanor, actually was, raising questions about the magnitude of improvement seen in the company’s Phase III trials and whether they would actually translate into a tangible benefit for CKD patients.

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Janet Woodcock, acting FDA commissioner (Bill Clark/CQ Roll Call via AP Images)

UP­DAT­ED: FDA’s do­mes­tic bio­phar­ma in­spec­tions re­turn to nor­mal as agency faces back­log of 8,000+

For the first time since March 2020, the FDA’s inspections of US-based biopharma sites have returned to normal, FDA acting commissioner Janet Woodcock said Monday at a small business regulatory event.

“I’m pleased to say that as of this month, we’ve begun transitioning back to standard operations for domestic inspections while continuing to prioritize mission-critical work for foreign inspections,” Woodcock said.