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.

A month after word first broke of the Trump Administration’s plan to rapidly accelerate the development and production of a Covid-19 vaccine, the White House has selected the five vaccine candidates they consider most likely to succeed, The New York Times reported.

Most of the names in the plan, known as Operation Warp Speed, will come as little surprise to those who have watched the last four months of vaccine developments: Moderna, which was the first vaccine to reach humans and is now the furthest along of any US effort; J&J, which has not gone into trials but received around $500 million in funding from BARDA earlier this year; the joint AstraZeneca-Oxford venture which was granted $1.2 billion from BARDA two weeks ago; Pfizer, which has been working with the mRNA biotech BioNTech; and Merck, which just entered the race and expects to put their two vaccine candidates into humans later this year.

In 2011, GlaxoSmithKline’s Benlysta became the first biologic to win approval for lupus patients. Nine years on, the British drugmaker has unveiled detailed positive results from a study testing the drug in lupus patients with associated kidney disease — a post-marketing requirement from the initial FDA approval.

Lupus is a drug developer’s nightmare. In the last six decades, there has been just one FDA approval (Benlysta), with the field resembling a graveyard in recent years with a string of failures including UCB and Biogen’s late-stage flop, as well as defeats in Xencor and Sanofi’s programs. One of the main reasons the success has eluded researchers is because lupus, akin to cancer, is not just one disease — it really is a disease of many diseases, noted Al Roy, executive director of Lupus Clinical Investigators Network, an initiative of New York-based Lupus Research Alliance that claims it is the world’s leading private funder of lupus research, in an interview.

Data on remdesivir — the first drug shown to benefit Covid-19 patients in a randomized, controlled trial setting — may be murky, but its maker Gilead could reap billions from the sales of the failed Ebola therapy, according to an estimate by a prominent Wall Street analyst. However, the forecast, which is based on a $5,000-per-course US price tag, triggered the ire of one top drug price expert.

There haven’t been a lot of big venture rounds for biotech companies looking to run a Phase II study in Alzheimer’s.

The field has been a disaster over the past decade. Amyloid didn’t pan out as a target — going down in a litany of Phase III failures — and is now making its last stand at Biogen. Tau is a comer, but when you look around and all you see is destruction, the idea of backing a startup trying to find complex cocktails to swing the course of this devilishly complicated memory-wasting disease would daunt the pluckiest investors.