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.

Gilead is mounting its counterfeit drug lawsuit, naming two “kingpins” and a complex network of conspirators who allegedly sold imitation bottles of its HIV meds, some of which ended up in US pharmacies.

The pharma giant on Wednesday provided an update on what it called a “large-scale, sophisticated counterfeiting conspiracy,” accusing two new defendants of “leading and orchestrating” a scheme to sell hundreds of millions of dollars in illegitimate drugs posing as meds such as Biktarvy and Descovy.

It was great getting back to a live ESMO conference/webinar in Paris followed by a live pop-up event for the Endpoints 11 in Boston. We’re staying on the road in October with our return for a live/streaming EUBIO22 in London.

Silicon Valley Bank’s Nooman Haque and I are once again jumping back into the thick of it with a slate of virtual and live events on October 12. I’ll get the ball rolling with a virtual fireside chat with Novo Nordisk R&D chief Marcus Schindler, covering their pipeline plans and BD work.

While it is not uncommon for a biotech to go down the route of having the product manufactured by a contract organization, one small biotech is looking to keep its card close to its chest.

Vor Biopharma has started manufacturing operations at an in-house facility at its HQ in Cambridge, MA after beginning construction last summer.

According to the biotech, the facility aims to develop Vor’s hematopoietic stem cells (eHSCs) and CAR-T therapies for patients with blood cancers. The site will initially manufacture a clinical supply of its candidate VCAR33allo to support its IND, which is slated to be submitted in the first half of next year. It also plans to transfer the production of VOR33 to the facility. Vor is getting to work quickly as engineering runs for VCAR33allo has started this week.

While colder temperatures are fast approaching, the situation surrounding the rise of energy prices in Europe is hitting businesses of every kind, including generic drug manufacturers.

Medicines for Europe, a group that represents the generic industry on the continent, sent a letter addressed to energy ministers and commissioners concerning inflation and the costs of energy on the supply of generic medicines.