Alp­na Seth

⇨ Long­time Bio­gen ex­ec Alp­na Seth has de­cid­ed to head west, way west, to re­join ex-Bio­gen CEO George Scan­gos as COO of his up­start biotech. He left the big com­pa­ny in Ju­ly, ac­cord­ing to the Boston Busi­ness Jour­nal.

⇨ With Ed­uar­do Sanchiz fol­low­ing through on step­ping down from the helm at Almi­rall, the com­pa­ny has re­cruit­ed a se­nior Sanofi ex­ec­u­tive for its new CEO. Pe­ter Guenter has spent the past 22 years at Sanofi, most re­cent­ly as ex­ec­u­tive vice pres­i­dent di­a­betes and car­dio­vas­cu­lar glob­al busi­ness unit.

⇨ PhRMA has brought in a top clin­i­cal re­search ex­pert — and se­nior FDA vet — to help guide its lob­by­ing work in Wash­ing­ton, DC. Richard Mosci­c­ki is jump­ing from his post as deputy di­rec­tor for sci­ence op­er­a­tions at CDER right over to a new role as chief med­ical of­fi­cer at PhRMA, which has been do­ing its best to spot­light the in­dus­try’s multi­bil­lion-dol­lar in­vest­ment in drug R&D as it seeks a help­ful stance from the fed­er­al gov­ern­ment on a score of key is­sues. Af­ter an in­ter­nal re­view that led the group to cut ties with com­pa­nies that had a less-than-stel­lar track record in in­vest­ing in R&D, Mosci­c­ki will bring an in­sid­er’s knowl­edge of the agency to his new role lead­ing sci­ence and reg­u­la­to­ry ad­vo­ca­cy ef­forts

Fred Cal­lori

⇨ Chris­t­ian Mey­er is the new chief med­ical of­fi­cer at Ther­a­chon. Mey­er’s re­sume in­cludes a stint as the CMO at uniQure where he had a help­ing hand in bring­ing the world’s most ex­pen­sive but no longer in pro­duc­tion drug Gly­bera to the mar­ket.

⇨ Cona­tus Phar­ma­ceu­ti­cals has bagged Kei­th Mar­shall for their EVP-COO-CFO com­bo gig.

⇨ Karolin­s­ka De­vel­op­ment’s lat­est CEO is Vik­tor Dr­vota, who re­placed Jim Van heus­den. Chair­man Bo Jes­per Hansen al­so de­cid­ed to step down and was re­placed by board mem­ber Niclas Adler.

⇨ Hu­mani­gen shares $HGEN were blitzed this week, right af­ter the com­pa­ny named Greg Jester as its new CFO.

⇨ Chris Garabe­di­an’s new com­pa­ny Xon­toge­ny has named Fred Cal­lori as SVP of cor­po­rate de­vel­op­ment. Cal­lori is a for­mer part­ner at Choate Hall & Stew­art with ex­pe­ri­ence cre­at­ing and fund­ing life sci­ences com­pa­nies.

The FDA hasn’t detected any potential safety signals, including for stroke, in people aged 65 years and older who have received Pfizer’s bivalent Covid booster, one senior official told members of the agency’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Thursday.

The update comes as the FDA and CDC investigate a “preliminary signal” that may indicate an increased risk of ischemic stroke in older Americans who received Pfizer’s updated shot.

The FDA has stopped use of another drug as a result of the new coronavirus variants. On Thursday, the agency announced that AstraZeneca’s antibody combo Evusheld, which was an important prevention option for many immunocompromised people and others, is no longer authorized.

The FDA said it made its decision based on the fact that Evusheld works on fewer than 10% of circulating variants.

Evusheld was initially given emergency authorization at the end of 2021. However, as Omicron emerged, so did studies that showed Evusheld might not work against the dominant Omicron strain. In October, the FDA warned healthcare providers that Evusheld was useless against the Omicron subvariant BA.4.6. It followed that up with another announcement earlier this month that it did not think Evusheld would work against the latest Omicron subvariant XBB.1.5.

Magenta Therapeutics is pausing an early-stage clinical trial after a patient died. The death was deemed to be possibly related to its drug, MGTA-117.

The biotech said the pause of the Phase I/II trial is voluntary and gives it time to review all available data before deciding what to do next. It’s also reported the known information to the FDA.

The dose-escalation trial was designed to test whether MGTA-117, an antibody-drug conjugate, could serve as a more targeted alternative to high-intensity chemotherapy as a conditioning agent for cancer patients who are set to receive a stem cell transplant. It recruited patients with relapsed/refractory acute myeloid leukemia and myelodysplastic syndrome.

Regeneron has won a patent case against Swiss pharma giant Novartis over the delivery system for its eye drug Eylea.

The US Patent Trial and Appeal Board ruled that Novartis’ pre-filled syringe for injecting its eye medication Lucentis was “unpatentable” and handed the victory to Regeneron and its AMD drug Eylea.

In the initial complaint in 2020, Novartis alleged to the US International Trade Commission that certain pre-filled syringes for the intravitreal injection, and ultimately Regeneron’s delivery system for Eylea, were infringing on Novartis’ patent. Regeneron filed a petition to review Novartis’ claims in 2021.