As­traZeneca vet Jen­nifer But­ler takes charge of In­nate Phar­ma's US biz; C4 raids NI­BR

→ France’s In­nate Phar­ma has wooed As­traZeneca vet Jen­nifer But­ler to lead the US op­er­a­tions it has set up af­ter ac­quir­ing Lu­mox­i­ti from the British drug­mak­er in a rich add-on col­lab­o­ra­tion deal. But­ler’s of­fi­cial ti­tle will be EVP and gen­er­al man­ag­er of In­nate Phar­ma US. Most re­cent­ly, she was chief busi­ness of­fi­cer, chief com­mer­cial of­fi­cer and head of US op­er­a­tions at Tes­sa Ther­a­peu­tics.

→ Af­ter cel­e­brat­ing the ap­proval of a Parkin­son’s ther­a­py he helped ac­quired for Acor­da Ther­a­peu­tics, chief busi­ness of­fi­cer An­drew Hind­man has de­cid­ed to step down. Hind­man, who joined Acor­da in 2014, is now “in­ter­est­ed in pur­su­ing op­por­tu­ni­ties in the wider bio­phar­ma in­dus­try,” CEO Ron Co­hen said. Over the next few tran­si­tion­ing months, he will con­tin­ue to help eval­u­ate ex-US com­mer­cial part­ner­ships for In­bri­ja as the com­pa­ny awaits a Eu­ro­pean reg­u­la­to­ry de­ci­sion.

→ C4 Ther­a­peu­tics has raid­ed the No­var­tis In­sti­tutes of Bio­med­ical Re­search for its chief med­ical of­fi­cer. The biotech re­port­ed to­day that it’s hired on Adam Crys­tal for the spot, fol­low­ing a stint as a se­nior di­rec­tor at NI­BR. C4 is one of sev­er­al biotechs work­ing on pro­tein de­graders, which has al­so been a keen in­ter­est of NI­BR chief Jay Brad­ner. “Dr. Crys­tal’s deep un­der­stand­ing of the sci­ence of tar­get­ed pro­tein degra­da­tion, cou­pled to his proven clin­i­cal lead­er­ship and un­der­stand­ing of the pa­tient com­mu­ni­ty, will be in­stru­men­tal to ad­vanc­ing C4T’s pipeline,” said Andy Phillips, the CEO of C4.

John Lea­man is quit­ting his job as CFO and head of cor­po­rate strat­e­gy at Se­lec­ta Bio, a year and a half af­ter join­ing the Wa­ter­town, MA-based biotech. His res­ig­na­tion comes in the wake of a re­vamp that claimed 36% of the staff — most of them work­ing on a now de­funct on­col­o­gy team — and pro­mot­ed a gout drug to the lead po­si­tion.

→ San Diego-based Escient has tapped William Hod­der as its chief busi­ness of­fi­cer, adding a sea­soned BD ex­ec and one-time en­tre­pre­neur to its start­up lead­er­ship team. Less than a year in­to its of­fi­cial ex­is­tence, the biotech is still busy trans­lat­ing in­sights on Mas-re­lat­ed G-pro­tein re­cep­tors to a new class of GCPR-tar­get­ed drugs, and Hod­der will play a hand in the plan­ning and grow­ing process, CEO Alain Baron said. Be­fore a re­cent run as a con­sul­tant, Hod­der has worked for Pro­tag­o­nist Ther­a­peu­tics and Fi­bro­Gen, as well as found­ing and lead­ing Tren­ovus.

In­cyte’s head of clin­i­cal de­vel­op­ment in Eu­rope has jumped ship to shape a nascent pipeline at iOnc­tura, a Mer­ck KGaA spin­out based in Gene­va. As CMO, Michael Lahn will lead first-in-hu­man stud­ies of the biotech’s next-gen PI3Kδ in­hibitor and po­ten­tial first-in-class au­to­tax­in (ATX) in­hibitor. Lahn, an alum­ni of As­traZeneca and Eli Lil­ly, will work close­ly with Zoë John­son, who’s re­cent­ly been pro­mot­ed to CSO.

→ Is­rael’s burn and wound man­age­ment biotech Medi­Wound is part­ing ways with CEO Gal Co­hen af­ter 12 years. Sharon Mal­ka, who helped steer the com­pa­ny to a 2014 Nas­daq de­but along­side Co­hen dur­ing this time as CFO and COO, is step­ping up to the role. Co­hen’s tenure was marked by Eu­rope and Is­rael ap­provals for Nexo­Brid, Medi­Wound’s flag­ship, non-sur­gi­cal prod­uct for burn treat­ment. Now fi­nanced un­der a con­tract with BAR­DA, the ther­a­py has com­plet­ed a sec­ond Phase III that will hope­ful­ly prop up the case for an FDA ap­proval — some­thing that Mal­ka will over­see while sup­port­ing an “on­go­ing strate­gic process.”

→ Or­phan drug de­vel­op­er Mi­no­ryx Ther­a­peu­tics has re­cruit­ed Di­di­er Le Nor­mand to be CFO of its op­er­a­tions across Eu­rope and the gen­er­al man­ag­er of a new­ly es­tab­lished Bel­gian sub­sidiary. The ap­point­ment adds an­oth­er C-suite role to Le Nor­mand’s re­sume, which has been packed with sim­i­lar roles in phar­ma and medtech com­pa­nies.

→ Biotech vet Tony Fior­i­no — per­haps best known as the for­mer CEO of Brain­storm Ther­a­peu­tics — is tak­ing up the CMO post at elec­tro­Core $ECOR as it seeks FDA clear­ance of its non-in­va­sive bio­elec­tron­ic va­gus nerve stim­u­la­tor gam­ma­Core. Com­ing from an in­ter­im CEO role at strug­gling Im­mune Phar­ma, he re­places Pe­ter Staats, who will be­come a se­nior ex­ec­u­tive ad­vis­er. Al­so join­ing the com­pa­ny: Phar­ma­copeia vet Bri­an Pos­ner, elec­tro­Core’s new CFO.

→ While re­searchers at Sang­amo Ther­a­peu­tics $SG­MO con­tin­ue to tweak its gene edit­ing tech for its lead rare dis­ease pro­grams, the biotech is beef­ing up its cell ther­a­py team to grow the CAR-Tregs port­fo­lio. Ja­son Fontenot will now lead that ef­fort, in­clud­ing a part­ner­ship with Sanofi and a pact with Gilead’s Kite for he­mo­glo­binopathies and can­cer re­spec­tive­ly. He comes to his new role of SVP, cell ther­a­py by way of Im­mu­soft, Juno and Bio­gen.

→ Ex­pe­ri­enced medtech ex­ec Kevin Kalish has been re­cruit­ed to lead the R&D ef­fort at En­Clear Ther­a­pies, a neu­rode­gen­er­a­tion-fo­cused start­up that’s just raised $2 mil­lion in seed fund­ing to take a de­vice-based amy­otroph­ic lat­er­al scle­ro­sis ther­a­py to the clin­ic in two years. De­vel­oped by Kevin Eggan of the Broad In­sti­tute, the treat­ment would re­move tox­ic pro­teins be­lieved to dri­ve the dis­ease.

Cold Spring Har­bor Lab’s Mick­ey At­w­al has teased on Twit­ter that he will “soon be join­ing Re­gen­eron to head their ma­chine learn­ing and mol­e­c­u­lar pro­fil­ing ef­forts.” Hav­ing re­searched the in­ter­sec­tion of pop­u­la­tion ge­net­ics, ma­chine learn­ing and can­cer bi­ol­o­gy, de­vel­op­ing math­e­mat­i­cal and com­pu­ta­tion­al tools, he’s mov­ing on­to a new po­si­tion with “di­rect trans­la­tion­al op­por­tu­ni­ties ahead,” At­w­al said.

Tri­umvi­ra Im­muno­log­ics has named Cyn­thia Moli­na as VP of reg­u­la­to­ry af­fairs to dri­ve sub­mis­sions and in­ter­ac­tions with health agen­cies around the world. Moli­na has been im­mersed in the T cell can­cer ther­a­py world while serv­ing in a sim­i­lar role at Hous­ton-based Cell Med­ica for the past six years.

UP­DAT­ED: Roche bags 'break­through' an­ti-fi­bro­sis drug in $1.4B biotech buy­out deal

Roche is snapping up a “breakthrough” anti-fibrotic drug in a $1.4 billion buyout.

The pharma giant announced Friday that it is acquiring Promedior, primarily to get its hands on PRM-151, a recombinant form of human pentraxin-2 (PTX-2) protein that has nailed down mid-stage clinical data on idiopathic pulmonary fibrosis and demonstrating its potential for a range of fibrotic conditions.

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Amarin emerges from an ex­pert pan­el re­view with a clear en­dorse­ment for Vas­cepa and high odds of suc­cess when the FDA weighs in for­mal­ly

Several FDA experts who gathered Thursday to consider the landmark approval of Vascepa to reduce cardio events in an at-risk population voiced their unease about various aspects of the efficacy and safety data, or ultimately the population it should be used to treat. But the overwhelming belief that the data pointed to the drug’s benefit and clearly outweighed risks carried the day for Amarin.

The panel voted unanimously (16 to 0) to support the company’s positive data presentation — backing an OK for expanding the label to include reducing cardio risk. The vote points Amarin $AMRN down a short path to a formal decision by the FDA, with the odds heavily in its favor. Chances are the rest of the questions about the future of this drug will be hashed out in the label’s small print.

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Federal Trade Commission commissioner Rohit Chopra testifies on Capitol Hill (AP Photo/Susan Walsh)

FTC clears Bris­tol-My­ers’ $74B deal to buy Cel­gene — but Dems sig­nal a po­ten­tial hard shift against Big Phar­ma M&A

Bristol-Myers Squibb’s record $74 billion takeover of Celgene is a done deal. And it will all be over — except for the lingering complaints from die-hard Celgene investors — on Wednesday.

Like much else that’s going on in Washington these days, the vote among the 5 FTC commissioners split along party lines, with the 3 Republicans voting to clear the way and the 2 Democrats steamed over what they see as a major M&A move that will lessen competition and innovation. And that split has big implications for the M&A side of the business if the Dems take the White House in 2020.

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No­var­tis spin­out’s first an­ti-ag­ing PhI­II is a flop, so now they’ll turn to Parkin­son’s chal­lenge as shares wilt

Novartis spinout resTORbio is grappling with the collapse of its lead clinical program this morning — an anti-aging R&D failure that will badly damage their rep in the field.

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BeiGene CEO John Oyler at an Endpoints event in Shanghai, October 2018 (Credit: Endpoints News/PharmCube)

UP­DAT­ED: In a first, FDA green-lights use of a Chi­nese built can­cer ther­a­py — and more are com­ing

Weeks after Amgen took a $2.7 billion stake in BeiGene, the Beijing-based biotech has secured its first-ever FDA approval for zanubrutinib, a BTK inhibitor, months ahead of schedule.

BeiGene’s drug, branded as Brukinsa, has secured accelerated approval for adult patients with mantle cell lymphoma (MCL) — a typically aggressive, rare, form of blood cancer — who have received at least one prior therapy.

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What does $62B buy you these days? A lot, says Take­da ex­ecs as the phar­ma play­er promis­es a block­buster R&D fu­ture

First comes the $62 billion buyout. Then comes the asset auction and reorganization to pay down debt. Now comes the detailed pledge of a bigger, brighter future in drug development.

That’s where Takeda finds itself on R&D day today, about 11 months after closing on their Shire acquisition. R&D chief Andy Plump is joining CEO Christophe Weber and other top members of the team to outline a new set of priorities in the greatly expanded pipeline at Takeda, which has jumped into the top ranks of the world’s pharma giants in the wake of the Shire deal.

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GSK's asth­ma bi­o­log­ic Nu­cala scores in rare blood dis­or­der study

GlaxoSmithKline’s asthma drug Nucala, which received a resounding FDA rejection for use in chronic obstructive pulmonary disease (COPD) last year, has shown promise in a rare blood disorder.

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Mer­ck buys a fledg­ling neu­rode­gen­er­a­tive biotech spawned by an old GSK dis­cov­ery al­liance. What’s up with that?

Avalon Ventures chief Jay Lichter has a well-known yen for drug development programs picked up in academia. And what he found in Haoxing Xu’s lab at the University of Michigan pricked his interest enough to launch one of his umbrella biotechs in San Diego.

Xu’s work laid the foundation for Avalon to launch Calporta, which has been working on finding small molecule agonists of TRPML1 (transient receptor potential cation channel, mucolipin subfamily, member 1) for lysosomal storage disorders. And that pathway, they believe, points to new approaches on major market neurodegenerative diseases like Parkinson’s, ALS and Alzheimer’s.

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No­var­tis scores its lat­est FDA OK — this time for a new sick­le cell dis­ease drug picked up in a $665M deal

Novartis’ decision to buy Oklahoma-based biotech Selexys 3 years ago for up to $665 million has paid off with an FDA approval today.

Blessed with the FDA’s breakthrough drug designation for a speedy review, the pharma giant has pinned down an approval for crizanlizumab, a new therapy designed to reduce the frequency of painful incidents of vaso-occlusive crises among sickle cell disease patients 16 or older.

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