With their third-to-mar­ket spinal mus­cu­lar at­ro­phy drug ris­diplam now cruis­ing on the FDA’s VIP lane to­ward a May de­ci­sion, Roche is think­ing through its pric­ing strat­e­gy.

You can ex­pect them to take a page out of their Hem­li­bra play­book as they tried to lure pa­tients away from No­vo Nordisk and Take­da, Bill An­der­son — CEO of the phar­ma group — told Reuters.

“With Hem­li­bra, we priced at about half of by­pass­ing agent,” An­der­son said in an in­ter­view with the news agency. “We aim to un­der­whelm with our price” with ris­diplam, he added.

They wouldn’t have to go far. No­var­tis’ gene ther­a­py, Zol­gens­ma, is the world’s most ex­pen­sive med­i­cine by one-time cost at $2.1 mil­lion. And while Bio­gen’s Spin­raza has a list price of $750,000 in the first year and $375,000 in sub­se­quent years, the an­nu­al prices could quick­ly add up to the mil­lions for an an­ti­sense oligonu­cleotide pa­tients are sup­posed to take for life.

Un­like the two ri­val ther­a­pies, which are ad­min­is­tered in­tra­venous­ly and in­trathe­cal­ly re­spec­tive­ly, ris­diplam is an oral med­ica­tion to be tak­en dai­ly. By mod­i­fy­ing how the SMN2 gene is spliced, the drug sup­pos­ed­ly in­creas­es func­tion­al SMN pro­tein lev­els in both the cen­tral ner­vous sys­tem and pe­riph­er­al tis­sues.

Zol­gens­ma’s ap­proval is al­so lim­it­ed to in­fants up to 2 years old, and an at­tempt to ex­pand in­to old­er pa­tients through in­trathe­cal ad­min­is­tra­tion has been stalled by a par­tial clin­i­cal hold.

Roche’s drug, which it first li­censed from PTC Ther­a­peu­tics, is be­ing tout­ed as ap­plic­a­ble for a broad age range from new­borns to 60-year-olds, though the piv­otal tri­al sub­mit­ted to the FDA en­rolled pa­tients be­tween 2 and 25.

In ad­di­tion to pri­or­i­ty re­view — which gives it a PDU­FA date of May 24 — the drug al­so en­joys the FDA’s or­phan and fast track des­ig­na­tions.

Biotech is one of the smartest, best educated industries on the planet. PhDs abound. We’ve had a long enough track record to see a new generation of savvy, experienced execs coming together to run startups.

And in these times, they are being tested as never before.

Biotech is going through quite a rough patch right now. For 2 years, practically anyone with a decent resume and some half-baked ideas on biotech could start a company and get it funded. The pandemic made it easy in many ways to pull off an IPO, with traditional road shows shut down in exchange for a series of quick Zoom meetings. Generalist investors flocked as the numbers raised soared into the stratosphere.

It looks like Warren Buffett is sticking to ice cream and railroads for the moment.

The billionaire CEO of Berkshire Hathaway backed out of two major holdings in the pharma industry, Forexlive first reported, including a $410 million investment in AbbVie and a $324.4 million stake in Bristol Myers Squibb.

The move comes after Berkshire abandoned its Teva shares just last quarter, Bloomberg reported.

Nearly a year ago, more than 200 workers at Novartis’ Grimsby, UK, facility were able to hang on to their jobs after the pharma closed a Switzerland site as a part of its workforce restructuring plan. Now, it looks like those employees’ time is up, as the site has been sold, Grimsby Telegraph reported today.

The manufacturing site has been sold to Humber Industrials, a subsidiary of International Process Plants. None of the current staff members will be working with the new owners, however.

New research published in Health Affairs today highlights the way in which the FDA’s inhaler regulations have rewarded incremental adjustments to older products, thereby enabling companies to skirt around cheaper competition.

A DC appeals court clerk and researchers from Harvard and the University of Calgary dug through all the patents and regulatory exclusivities granted to inhalers approved by the FDA between 1986 and 2020, finding that of the 62 inhalers approved, 53 (or 85%) were brand-name products, with a median of 16 years of protection from generic competition.