→ Pro­tal­ix Bio­Ther­a­peu­tics has filed a BLA for their Fab­ry Dis­ease treat­ment, pe­gu­ni­gal­si­dase al­fa. The drug is a re­com­bi­nant en­zyme grown in plant cell cul­tures and de­signed to sup­ple­ment the lyso­so­mal en­zyme that is de­fi­cient in pa­tients with the ge­net­ic dis­or­der. Chiesi Glob­al Rare Dis­eases has signed up to com­mer­cial­ize the drug, in a deal that’s worth up to $760 mil­lion. A phase III study showed the Is­raeli biotech’s drug led to much high­er con­cen­tra­tion of en­zyme than Fab­razyme, the long­time stan­dard-of-care from Sanofi Gen­zyme.

→ Just days af­ter lin­ing up $145 mil­lion to pay for their first for­ay in­to the clin­ic, the Rally­bio team is go­ing back to Alex­ion for their lat­est hire. They’ve re­cruit­ed Róisín Arm­strong, who will head the de­vel­op­ment of RLYB211, a plas­ma-de­rived hy­per­im­mune glob­u­lin in de­vel­op­ment for the pre­ven­tion of fe­tal and neona­tal al­loim­mune throm­bo­cy­tope­nia. Arm­strong served as VP and Glob­al Med­i­cine Team leader at Alex­ion.

→.Macro­Gen­ics $MGNX was buoyed by the news that the FDA isn’t plan­ning on hold­ing an ex­pert com­mit­tee meet­ing to re­view its ap­pli­ca­tion for mar­ge­tux­imab. That re­moves one po­ten­tial bar­ri­er as they close in on a PDU­FA date of De­cem­ber 18.

→ Ver­sant Ven­tures, the Basel-based dis­cov­ery en­gine, an­nounced its lat­est com­pa­ny: Monte Rosa Ther­a­peu­tics. Backed with $32.5 mil­lion in Se­ries A funds, the com­pa­ny will work on de­vel­op­ing small mol­e­cules that de­grade dis­ease-caus­ing pro­teins, a rapid­ly grow­ing field.

London Stock Exchange-listed PureTech Health announced Wednesday that it’s looking to extend to Nasdaq. But due to its “strong cash position,” the biotech says it isn’t issuing any new shares in the potential secondary listing.

The company’s shares closed at £256.50 Tuesday on the London Stock Exchange. Its candidate LYT-100 is currently in Phase I development for various indications, including lymphatic flow disorders and fibrotic and inflammatory disorders. PureTech is expecting a Phase Ib readout in lymphatic flow disorders later this year, and is also planning to launch a Phase II study for the drug to treat respiratory conditions experienced after Covid-19.

The FDA has been insisting for months that a Covid-19 vaccine had to be at least 50% effective – a measure of transparency meant to shore public trust in the agency and in a vaccine that had been brought forward at record speed and record political pressure. But now, with concerns of a Trump-driven authorization arriving before the election, the agency may be raising the bar.

The FDA is set to release new guidance that would raise safety and efficacy requirements for a vaccine EUA above earlier guidance and above the criteria used for convalescent plasma or hydroxychloroquine, The Washington Post reported. Experts say this significantly lowers the odds of an approval before the election on November 3, which Trump has promised despite vocal concerns from public health officials, and could help shore up public trust in the agency and any eventual vaccine.

The top career staff at the FDA has vowed not to let politics overrule science when looking at vaccine data this fall. But Alex Azar, who happens to be their boss’s boss, apparently won’t even give them a chance to stand in the way.

In a new memorandum issued Tuesday last week, the HHS chief stripped the FDA and other health agencies under his purview of their rule making ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.

NeuroRx, the tiny biotech that came under fire last week after Politico reported they selected a congressman and two other acquaintances of the CEO to supervise their Covid-19 drug trial, announced today that they will ask the FDA to authorize their drug based on the results of just 21 patients.

Such an application would test the agency’s standards of evidence for an EUA, which have already come under scrutiny after controversial authorizations for convalescent plasma and hydroxychloroquine. The only other company to discuss their intention to file for an EUA, Eli Lilly, did so after results came back from a randomized control study testing their antibody in over 450 patients.

Along with the initiation of its Phase III Covid-19 vaccine study announced Wednesday morning, Johnson & Johnson also released its trial protocol, giving an inside look at how the company is conducting its late-stage research.

The move comes after the other three companies conducting Phase III’s in the US — Moderna, Pfizer and AstraZeneca — each disclosed their own trial blueprints within the last week. Though the release of such protocols is typically done after trials have been completed, drug developers had come under intense pressure after a brief safety scare in an AstraZeneca trial and amid growing concern of a politically motivated vaccine authorization.