Andy Boy­er joins Te­va ex­o­dus; Achao­gen shuf­fles ex­ec­u­tive line­up

Te­va’s US chief Andy Boy­er has re­signed and is leav­ing the com­pa­ny at the end of Q1 next year, ac­cord­ing to Wells Far­go’s David Mar­ris. It has been a tur­bu­lent week at the Is­raeli gener­ics busi­ness, as new CEO Kåre Schultz un­veiled a mas­sive re­or­ga­ni­za­tion plan Thurs­day, which in­volves ax­ing 14,000 work­ers, shut­ter­ing R&D and man­u­fac­tur­ing fa­cil­i­ties and rad­i­cal­ly par­ing down $3 bil­lion in costs glob­al­ly. In a sig­nal of the in­tense fall­out, on Wednes­day, for­mer chair­man and in­ter­im CEO Yitzhak Pe­ter­burg abrupt­ly re­signed with im­me­di­ate ef­fect.

→ Next March, John Mar­tin of Gilead will tran­si­tion from ex­ec­u­tive chair­man to chair­man of the board of di­rec­tors. Mar­tin is a vet­er­an of the com­pa­ny $GILD, hav­ing served as CEO for two decades be­fore John Mil­li­gan took over. The brief an­nounce­ment did not cite a rea­son for the change, but it can be seen as a move to lessen op­er­a­tional in­volve­ment with the com­pa­ny in prepa­ra­tion for re­tire­ment.

→ Not on­ly did CMO David Apelian sell off his Achillion stock ear­li­er this month, he is now plan­ning to ex­it the New Haven, CT-based com­pa­ny at the end of the year.

→ Play­ing slow and steady, Achao­gen has an­nounced an ex­ec­u­tive switch up in the ex­ec­u­tive ranks in prepa­ra­tion for the ap­proval of its first drug, pla­zomicin. Pres­i­dent and COO Blake Wise will move to the CEO role, while cur­rent CEO Ken­neth Hillan takes the pres­i­dent po­si­tion and heads up R&D. One of the few late-stage play­ers in new an­tibi­otics, the biotech $AKAO has shown enough promise to gain in­vest­ment from the Gates Foun­da­tion. “… Blake’s ex­pe­ri­ence scal­ing and lead­ing com­mer­cial or­ga­ni­za­tions is per­fect­ly suit­ed to max­i­miz­ing this stage of growth, and val­ue, of the com­pa­ny,” said board chair­man Bryan Roberts in a state­ment. “At the same time, we are ex­treme­ly for­tu­nate to have Ken­neth in a role that ful­ly lever­ages his pas­sion and suc­cess at the in­ter­sec­tion of pre­clin­i­cal re­search and clin­i­cal drug de­vel­op­ment.”

→ Af­ter two decades at Glax­o­SmithK­line de­vel­op­ment busi­ness and pur­su­ing deals, Damien McDe­vitt has joined Aca­dia Phar­ma­ceu­ti­cals $ACAD as SVP, cor­po­rate de­vel­op­ment. The San Diego-based biotech is study­ing oth­er in­di­ca­tions for its Parkin­son’s drug Nu­plazid (pi­ma­vanserin), but al­so look­ing to “ex­plore the po­ten­tial for ex­pand­ing” their cen­tral ner­vous sys­tem port­fo­lio. In the same state­ment, the com­pa­ny not­ed that Jim Nash, SVP, tech­nol­o­gy de­vel­op­ment and op­er­a­tions, will be re­tir­ing from the com­pa­ny as of Jan­u­ary 2018. Bob Mis­chler will pick up Nash’s re­spon­si­bil­i­ties in a new role.

Pa­tri­cia Zil­liox is the new CEO at French biotech Eye­ven­sys, fol­low­ing pre­de­ces­sor Raffy Kazand­jian’s low pro­file de­par­ture in No­vem­ber (ac­cord­ing to LinkedIn). An oph­thalmic ex­pert, Zil­liox has had plen­ty of time to learn about the Paris-based com­pa­ny since join­ing its board in 2016. Pre­vi­ous­ly, she was chief drug de­vel­op­ment of­fi­cer of the Clin­i­cal Re­search In­sti­tute at the Foun­da­tion Fight­ing Blind­ness in Co­lum­bia, MD. Now, she is tasked with ad­vanc­ing Eye­ven­sys’ non-vi­ral gene ther­a­pies.

Aveo On­col­o­gy $AVEO has ap­point­ed Nikhil Mehta as its se­nior VP, reg­u­la­to­ry and qual­i­ty as­sur­ance. With big names like Bax­al­ta, Mer­ck and Shire un­der his belt, Mehta has a broad man­date to over­see all as­pects of the com­pa­ny’s reg­u­la­to­ry, qual­i­ty or tech­ni­cal op­er­a­tions. His ap­point­ment marks an­oth­er step to­wards the com­pa­ny’s quest for a do-over, as its FDA-re­ject­ed drug tivozanib scored an OK in the EU back in Au­gust.

→ En­ter­ing a new phase of growth, Kalei­do Bio­sciences has named Gen­zyme vet Al­i­son Law­ton as its pres­i­dent and COO. Af­ter a 20-plus-year run at Gen­zyme, Law­ton test­ed wa­ters at small­er biotechs like Au­ra Bio­sciences and Ova­Science be­fore join­ing the Flag­ship Ven­tures-backed start­up zoom­ing in­to the mi­cro­bio­me.

→ Rapid di­ag­nos­tics de­vel­op­er At­las Ge­net­ics has brought in Marc Jones as COO and CFO, who will team up with CEO Jef­frey Lu­ber in strate­gic di­rec­tion and ex­e­cu­tion out­side of his main func­tions. Jones and Lu­ber are old part­ners, hav­ing worked to­geth­er at Good Start Ge­net­ics in the ex­act same roles. Af­ter Good Start was ac­quired by In­vi­tae, Lu­ber got the top job at At­las al­most im­me­di­ate­ly. Now that the young com­pa­ny has ad­vanced from clin­i­cal proof of con­cept to a com­mer­cial phase, he is count­ing on his friend’s wide range of CFO ex­pe­ri­ence which al­so in­cludes T2 Biosys­tems and Ivenix.

→ Hav­ing worked on the fi­nan­cial side of things, An­drew Oh is giv­ing biotech a try as the CFO at Ru­bius Ther­a­peu­tics. An in­vestor and an­a­lyst, Oh was most re­cent­ly the chief in­vest­ment of­fi­cer and chief op­er­at­ing of­fi­cer of Leerink Phar­ma­ceu­ti­cal In­vest­ments. “Ru­bius is one of the most ex­cit­ing biotech com­pa­nies I have seen in my in­vest­ing ca­reer and has the po­ten­tial to trans­form care for peo­ple suf­fer­ing from a broad range of se­ri­ous dis­eases,” said Oh in a state­ment. “I am hon­ored to be part of a team ded­i­cat­ed to pi­o­neer­ing the next gen­er­a­tion of cel­lu­lar ther­a­pies and the de­vel­op­ment of break­through ther­a­pies for pa­tients in need.”

→ Sin­ga­pore’s Tes­sa Ther­a­peu­tics has ap­point­ed Desmond Lim as CFO. Lim joins the biotech, which fo­cus­es on cel­lu­lar im­munother­a­py for sol­id tu­mors, from out­sourc­ing com­pa­ny Hep­ta­gon.

→ At Flex­ion Ther­a­peu­tics, Scott Kel­ley has been pro­mot­ed as CMO to suc­ceed Yamo Deniz. Kel­ley moves up from VP of med­ical af­fairs, a po­si­tion he took af­ter a stint at Sanofi over­see­ing glob­al da­ta. A new as­set un­der his watch will be non-opi­oid painkiller for the knee FX-201, which Flex­ion $FLXN just ac­quired from GeneQuine Bio­ther­a­peu­tics.

→ In de­vel­op­ing AML drug Id­hi­fa, Agios had en­joyed work­ing with Cel­gene vet Jack­ie Fouse so much that it has brought her on­to its board of di­rec­tors. Since leav­ing Cel­gene, Fouse had start­ed run­ning Der­ma­vant — an­oth­er “vant” by Vivek Ra­maswamy that works on med­ical der­ma­tol­ogy.

Im­mune Phar­ma­ceu­ti­cals has re­cruit­ed John Zhang from Tesaro as VP of R&D. Zhang’s fo­cus will be on non-clin­i­cal as­pects of drug de­vel­op­ment, but will al­so pro­vide sup­port for clin­i­cal, reg­u­la­to­ry and man­u­fac­tur­ing ac­tiv­i­ties.

The DCT-OS: A Tech­nol­o­gy-first Op­er­at­ing Sys­tem - En­abling Clin­i­cal Tri­als

As technology-enabled clinical research becomes the new normal, an integrated decentralized clinical trial operating system can ensure quality, deliver consistency and improve the patient experience.

The increasing availability of COVID-19 vaccines has many of us looking forward to a time when everyday things return to a state of normal. Schools and teachers are returning to classrooms, offices and small businesses are reopening, and there’s a palpable sense of optimism that the often-awkward adjustments we’ve all made personally and professionally in the last year are behind us, never to return. In the world of clinical research, however, some pandemic-necessitated adjustments are proving to be more than emergency stopgap measures to ensure trial continuity — and numerous decentralized clinical trial (DCT) tools and methodologies employed within the last year are likely here to stay as part of biopharma’s new normal.

Onno van de Stolpe, Galapagos CEO (Thierry Roge/Belga Mag/AFP via Getty Images)

Gala­pa­gos chops in­to their pipeline, drop­ping core fields and re­or­ga­niz­ing R&D as the BD team hunts for some­thing 'trans­for­ma­tive'

Just 5 months after Gilead gutted its rich partnership with Galapagos following a bitter setback at the FDA, the Belgian biotech is hunkering down and chopping the pipeline in an effort to conserve cash while their BD team pursues a mission to find a “transformative” deal for the company.

The filgotinib disaster didn’t warrant a mention as Galapagos laid out its Darwinian restructuring plans. Forced to make choices, the company is ditching its IPF molecule ’1205, while moving ahead with a Phase II IPF study for its chitinase inhibitor ’4617.

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Stéphane Bancel, Getty

Mod­er­na CEO brush­es off US sup­port for IP waiv­er, eyes more than $19B in Covid-19 vac­cine sales in 2021

Moderna is definitively more concerned with keeping pace with Pfizer in the race to vaccinate the world against Covid-19 than it is with Wednesday’s decision from the Biden administration to back an intellectual property waiver that aims to increase vaccine supplies worldwide.

In its first quarter earnings call on Thursday, Moderna CEO Stéphane Bancel shrugged off any suggestion that the newly US-backed intellectual property waiver would impact his company’s vaccine or bottom line. Still, the company’s stock price fell by about 9% in early morning trading.

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Angela Merkel (AP Photo/Michael Sohn)

Covid-19 roundup: Pfiz­er sub­mits vac­cine for full ap­proval; Merkel op­pos­es Biden pro­pos­al to sus­pend IP for vac­cines

Pfizer and BioNTech said Friday that they’ve submitted a biologics license application to the FDA for full approval of their mRNA vaccine for those over the age of 16.

How long it will take the FDA to decide on the BLA will be set once it’s been formally accepted by the agency.

Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, previously told Endpoints News that the review of the BLA should take between three and four months, but it may be even faster than that.

Karyopharm taps long­time Pfiz­er, Am­gen vet to steer the ship; With Mer­ck in the rearview mir­ror, Roger Perl­mut­ter stakes his claim to a CEO job — and it's a sur­pris­ing choice

Like many who work in biopharma, Richard Paulson got started in the field because of a love of science.

Paulson had just finished business school and was looking to start a career that married his two passions. While looking for jobs, he thought of his grandmother who had struggled with Alzheimer’s disease, recalling how he saw first-hand what innovative medicines can do for patients. Ultimately, he started his first job in the space as a sales rep at Glaxo Wellcome, one of GlaxoSmithKline’s predecessors before its merger with SmithKline Beecham in 2000.

UP­DAT­ED: EMA safe­ty com­mit­tee seeks more in­fo on heart in­flam­ma­tion fol­low­ing Pfiz­er Covid-19 vac­cine

The European Medicines Agency’s safety committee said Friday that it’s aware of cases of inflammation of the heart muscle and inflammation of the membrane around the heart, mainly reported following vaccination with Pfizer’s Covid-19 vaccine, known in Europe as Comirnaty.

“There is no indication that these cases are due to the vaccine,” the EMA’s Pharmacovigilance Risk Assessment Committee said.

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As­traZeneca caps PD-L1/CT­LA-4/chemo com­bo come­back with OS win. Is treme­li­mum­ab fi­nal­ly ready for ap­proval?

AstraZeneca’s closely-watched POSEIDON study continues to be the rare bright spot in its push for an in-house PD-L1/CTLA-4 combo.

Combining Imfinzi and tremelimumab with physicians’ choice of chemotherapy helped patients with stage IV non-small cell lung cancer live longer, the company reported — marking the first time the still-experimental tremelimumab has demonstrated an OS benefit.

For AstraZeneca and CEO Pascal Soriot, the positive readout — which is devoid of numbers — offers much-needed validation for the big bet they made on Imfinzi plus tremelimumab, after the PD-L1/CTLA-4 regimen failed multiple trials in head and neck cancer as well as lung cancer.

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Ron DePinho (file photo)

A 'fly­over' biotech launch­es in Texas with four Ron De­Pin­ho-found­ed com­pa­nies un­der its belt

In his 13 years at Genzyme, Michael Wyzga noticed something about East Coast drugmakers. Execs would often jet from Boston or New York to San Francisco to find more assets, and completely miss the work being done in flyover states, like Texas or Wisconsin.

“If it doesn’t come out of MGH or MIT or Harvard, probably not that interesting,” he said of the mindset.

Now, he and some well-known industry players are looking to change that, and they’ve reeled in just over $38 million to do it.

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An­oth­er failed tri­al for Or­p­hazyme's 'pipeline-in-a-pro­duc­t' leaves shad­ow on drug's fu­ture

The tumultuous ride for Orphazyme continued on Friday as the company announced that a pivotal trial for its lead drug arimoclomol failed yet again, this time in the treatment of ALS, seeding doubt in a drug that had recently been cleared by the FDA for priority review. The latest failure casts a darker shadow on the upcoming decision despite Orphazyme’s upbeat outlook.

In a statement, the Danish biotech announced that the drug did not meet its primary or secondary endpoints evaluating function and survival. But the company has not announced any data surrounding the failure, instead saying that it will publish the complete results later this year.