Bris­tol-My­ers vet Car­o­line Loew heads up Glympse Bio; Kalei­do nabs GSK's CMO Katharine Kno­bil

Bris­tol-My­ers Squibb vet Car­o­line Loew has trad­ed an R&D strat­e­gy and plan­ning role for the top job at Glympse Bio. Af­ter a 20-year ca­reer in drug de­vel­op­ment, with stints at Mer­ck and PhRMA, Loew will now lead the Arch-backed start­up in ad­vanc­ing its in vi­vo dis­ease-mon­i­tor­ing ac­tiv­i­ty sen­sors.  

Katharine Kno­bil

Kalei­do Bio­sciences has scooped Katharine Kno­bil from Glax­o­SmithK­line to be­come its CMO and head up R&D. Found­ed by Flag­ship Pi­o­neer­ing in 2015 and boost­ed by a $101 mil­lion mega-round this year, the biotech is de­vel­op­ing a pipeline of mi­cro­bio­me-based ther­a­pies that Kno­bil is tasked with steer­ing in­to Phase II in 2019.

Thomas Can­nell has brought fel­low phar­ma vet Den­nis Kim to his team at Sesen Bio as he steers the new­ly re­named com­pa­ny through a Phase III tri­al for the blad­der can­cer treat­ment Vicini­um (VB4-845). Be­tween Ipsen, Spec­trum, No­var­tis, Bio­gen and Am­gen, the new CMO has been in­volved in the ap­proval and com­mer­cial­iza­tion of more than 10 prod­ucts in on­col­o­gy and im­munol­o­gy, the com­pa­ny says.

→ Gene ther­a­py de­vel­op­er Pre­vail Ther­a­peu­tics is shak­ing up its C-suite for the new year. Brett Ka­plan, a man­ag­ing di­rec­tor at Ever­core, is join­ing as CFO while Cel­gene vet Emi­ly Minkow gets a pro­mo­tion to chief busi­ness of­fi­cer from EVP of BD and strat­e­gy.

→ As Eiger Bio­Phar­ma­ceu­ti­cals $EIGR ral­lies for a po­ten­tial piv­ot in­to com­mer­cial stage, it’s re­cruit­ed sea­soned fi­nan­cial ex­ec Sri Ryali to its lead­er­ship. Most re­cent­ly at Aim­mune, where he helped lead an IPO, Ryali’s pre­vi­ous work ex­pe­ri­ence spans Jazz, Onyx and Am­gen. He re­places James Welch as CFO.

→ In con­junc­tion with an or­ga­ni­za­tion­al over­haul that in­volves cut­ting a quar­ter of its staff, MiMedx is al­so re­struc­tur­ing its C-suite. Chris Cash­man is out as the strug­gling biotech elim­i­nates the chief com­mer­cial of­fi­cer post that he oc­cu­pied. And then there’s the string of pro­mo­tions: Mark Landy to chief strat­e­gy of­fi­cer, David Ma­son to chief med­ical of­fi­cer (re­plac­ing Don­ald Fer­rerolf, who’s re­tir­ing); and John Har­ris to SVP, mar­ket­ing and busi­ness de­vel­op­ment.

→ On the heels of its first pos­i­tive da­ta read­out in months, Lund­beck an­nounced An­ders Gersel Ped­er­sen is re­tir­ing from his role as head of R&D af­ter 19 years with the com­pa­ny.

Thomas Wes­sel

→ Build­ing on decades of ex­pe­ri­ence in neu­ro­log­i­cal drug de­vel­op­ment — fea­tur­ing CMO stints at Acor­da and Flex Phar­maThomas Wes­sel has tak­en up a new chal­lenge to lead Swiss biotech As­ceneu­ron’s ex­pan­sion in­to the US as its CMO. He will over­see reg­u­la­to­ry and clin­i­cal de­vel­op­ment for de­men­tia treat­ment ASN120290 from the com­pa­ny’s new of­fices in Cam­bridge, MA.

→ On the verge of start­ing Phase III tri­als for reza­fun­gin, Cidara Ther­a­peu­tics $CDTX has tapped for­mer Gold­man Sachs man­ag­ing di­rec­tor James Levine as CFO. Al­so join­ing the com­pa­ny: Jes­si­ca Oien, gen­er­al coun­sel and sec­re­tary.

→ Af­ter 30 years launch­ing and mar­ket­ing drugs for the likes of Cel­gene, J&J and Bris­tol-My­ers Squibb, Mark Kre­ston is tak­ing his com­mer­cial chops Knopp Bio­sciences. As chief com­mer­cial of­fi­cer, he is tasked with de­vis­ing a glob­al strat­e­gy for the com­pa­ny’s treat­ments for in­flam­ma­to­ry and neu­ro­log­i­cal dis­eases, some of which are poised for Phase II and III stud­ies.

→ Two ex­ecs on Cel­gene’s CAR-T team have jumped to Omeros. Daniel Kir­by has been named VP and head of com­mer­cial, while Justin Mc­Cue will be­come VP of chem­istry, man­u­fac­tur­ing and con­trols, with re­spon­si­bil­i­ties over all of Omeros’ pro­grams rang­ing from eye ther­a­py to blood clot treat­ment.

→ Eye­ing an en­try in­to the clin­ic next year, Re­lay Ther­a­peu­tics has hired Mary Mad­er from Eli Lil­ly to be VP of chem­istry and Ve­rastem’s Ma­hesh Pad­val as SVP of phar­ma­ceu­ti­cal drug de­vel­op­ment.

William West­lin is the new EVP of R&D at eGe­n­e­sis, lead­ing the xeno­trans­plan­ta­tion re­search and prod­uct de­vel­op­ment work for the George Church spin­out. He pre­vi­ous­ly held sim­i­lar roles at Nim­bus Ther­a­peu­tics and Avi­la Ther­a­peu­tics, but har­vest­ing an­i­mal or­gans for hu­man use will be a new field for him.

Grow­ing ac­cep­tance of ac­cel­er­at­ed path­ways for nov­el treat­ments: but does reg­u­la­to­ry ap­proval lead to com­mer­cial suc­cess?

By Mwango Kashoki, MD, MPH, Vice President-Technical, and Richard Macaulay, Senior Director, of Parexel Regulatory & Access

In recent years, we’ve seen a significant uptake in the use of regulatory options by companies looking to accelerate the journey of life-saving drugs to market. In 2018, 73% of the novel drugs approved by the U.S. Federal Drug Administration (FDA) were designated under one or more expedited development program categories (Fast Track, Breakthrough Therapy, Priority Review, and Accelerated Approval).ᶦ

Bio­gen touts new ev­i­dence from the gene ther­a­py com­pa­ny it wa­gered $800M on

A year ago, Biogen made a big bet on a small gene therapy company. Now they have new evidence one of their therapies could work.

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Sanofi out­lines big API plans as coro­n­avirus out­break re­port­ed­ly threat­ens short­age of 150 drugs

As the world becomes increasingly dependant on Asia for the ingredients of its medicines, Sanofi sees business to be done in Europe.

The French drugmaker said it’s creating the world’s second largest active pharmaceutical ingredients (API) manufacturer by spinning out its six current sites into a standalone company: Brindisi (Italy), Frankfurt Chemistry (Germany), Haverhill (UK), St Aubin les Elbeuf (France), Újpest (Hungary) and Vertolaye (France). They have mapped out €1 billion in expected sales by 2022 and 3,100 employees for the new operations headquartered in France.

In fi­nal re­port, ICER ap­pears to have a change of heart on new acute mi­graine ther­a­pies

ICER appears to have reversed course on the fresh crop of acute migraine therapies.

The cost-effectiveness watchdog in November issued a draft report suggesting that existing generic medicines are more effective and cheaper than Allergan’s December-approved CGRP ubrogepant, Biohaven rival molecule, rimegepant (which is under FDA review), and Lilly’s October-sanctioned lasmiditan, which binds to 5-HT1F receptors.

Anthony Fauci (AP Images)

UP­DAT­ED: NIH-part­nered Mod­er­na ships off its PhI-ready coro­n­avirus vac­cine can­di­date to a sea of un­cer­tain­ty

Off it goes.

Moderna has shipped the first batch of its mRNA vaccine against SARS-CoV-2 from its manufacturing facility in Norwood, Massachusetts, to the National Institute of Allergy and Infectious Diseases in Bethesda, Maryland, for a pioneering Phase I study.

It’s a hectic race against time. In the 42 days since Moderna selected the sequence they would use to develop their vaccine — a record time, no less — the number of confirmed cases around the world has surged astronomically from a few dozen to over 80,000, per WHO and Johns Hopkins estimates.

The candidate that they came up with, mRNA-1273, encodes for a prefusion stabilized form of the spike protein, which gives the virus its crown shape and plays a key role in transmission. The Coalition for Epidemic Preparedness Innovations, the Oslo-based group better known as CEPI, funded the manufacture of this batch.

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Bi­cy­cle Ther­a­peu­tics takes Roche's Genen­tech on an up to $2B im­muno-on­col­o­gy ride

Bicycle Therapeutics — which is developing a new class of chemically synthesized drugs designed to be pharmacologically as active as biologics, yet manufactured as small molecules —  has scored another big partner: Roche’s Genentech.

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When drug val­ue as­sess­ment meets re­al-world ev­i­dence: ICER en­lists Ae­tion in pric­ing eval­u­a­tion

In a union of two of the hottest trends in the US biopharma world, ICER is teaming up with a high-profile company to integrate real-world evidence in their assessment of treatment value.

The drug pricing watchdog — formally the Institute for Clinical and Economic Review — said it will utilize Aetion’s evidence platform in “select upcoming assessments” and their new 24-month re-evaluations of drugs granted accelerated approval by the FDA.

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First US Covid-19 tri­als set to get un­der­way in Ne­bras­ka and Wash­ing­ton, backed by NIH

The first US clinical trials on the novel coronavirus are scheduled to get underway next month at the University of Nebraska Medical Center, where American passengers were taken after being evacuated from the Diamond Princess cruise ship, and at the Kaiser Permanente Washington Health Research Institute. Both trials are sponsored by the NIH’s National Institute for Allergy and Infectious Diseases, which has led the US’s medical response to the outbreak.

Mallinck­rodt, once the na­tion’s largest oxy­codone pro­duc­er, an­nounces ten­ta­tive $1.6B set­tle­ment

Three years after it first paid out fines for its role in the US opioid abuse epidemic, Mallinckrodt has announced an agreement-in-principle that will see the company pay out $1.6 billion and place its generics unit in bankruptcy.

The tentative deal would settle hundreds of lawsuits from state and local governments over Mallinckrodt’s role in the epidemic, while also helping address the company’s increasingly mountainous debt. Although Purdue Pharma has drawn the bulk of both public and legal acrimony for opioid sales, documents made public earlier this year showed that Mallinckrodt subsidiary SpecGx, along with the generic subsidiaries of Teva and Endo Pharmaceuticals, accounted for the vast majority of the 76 billion opioid pills distributed from 2006 to 2012. Mallinckrodt was at the top of that list.