In a rare block­buster per­for­mance for As­traZeneca, Tagris­so comes through on lung can­cer PhI­II

As­traZeneca CEO Pas­cal So­ri­ot

For a Big Phar­ma com­pa­ny that of­ten gets things wrong, Tagris­so has been As­traZeneca’s ace in the hole. Sped through the clin­ic to a first ap­proval in an as­ton­ish­ing two years, it was al­ready on the mar­ket when Clo­vis’ ri­val im­plod­ed on ar­rival at the FDA.

To­day, the phar­ma gi­ant is pulling back the veil off of new da­ta demon­strat­ing a 5.7-month im­prove­ment in pro­gres­sion-free sur­vival of non-small cell lung can­cer among pa­tients with an epi­der­mal growth fac­tor re­cep­tor (EGFR) T790M mu­ta­tion com­pared to plat­inum-based dou­blet chemother­a­py (10.1 months vs 4.4 months). And the PFS spread sig­nif­i­cant­ly fa­vored Tagris­so among the one-third of pa­tients with CNS metas­tases.

Tagris­so, As­traZeneca ex­ecs say now, is poised to be­come the stan­dard sec­ond-line treat­ment for lung can­cer pa­tients with this mu­ta­tion.

That is ex­act­ly the kind of thing As­traZeneca CEO Pas­cal So­ri­ot needs to hear a lot more about. So­ri­ot tapped Tagris­so as a $3 bil­lion an­nu­al earn­er, a key fea­ture in a big promise to de­liv­er $45 bil­lion in an­nu­al rev­enue in 2023.

The com­pa­ny has start­ed back­ing away from that over­all fig­ure, but ex­pand­ing the mar­ket for Tagris­so will go a long way to con­vinc­ing in­vestors there are bright spots in a year dom­i­nat­ed by set­backs.

As­traZeneca CMO Sean Bo­hen

Clo­vis helped. The biotech had played fast and loose with da­ta for its ri­val ro­ci, which at­tract­ed plen­ty of un­want­ed at­ten­tion at the FDA. The agency spurned the drug and Clo­vis opt­ed to re­struc­ture and dump the drug.

As­traZeneca CMO Sean Bo­hen had this to say:

“The con­fir­ma­to­ry Phase III da­ta sug­gest the po­ten­tial for Tagris­so to re­place chemother­a­py as the stan­dard of care for pa­tients who have pro­gressed fol­low­ing EGFR ty­ro­sine ki­nase in­hibitor treat­ment. As lung can­cer is the most com­mon type of can­cer to spread to the brain, it is al­so en­cour­ag­ing to see the ac­tiv­i­ty of Tagris­so in pa­tients with cen­tral ner­vous sys­tem metas­tases whose prog­no­sis is of­ten par­tic­u­lar­ly poor.”

Mov­ing Out of the Clin­ic with Dig­i­tal Tools: Mo­bile Spirom­e­try Dur­ing COVID-19 & Be­yond

An important technology in assessing lung function, spirometry offers crucial data for the diagnosis and monitoring of pulmonary system diseases, as well as the ongoing measurement of treatment efficacy. But trends in the healthcare industry and new challenges introduced by the COVID-19 pandemic are causing professionals in clinical practice and research to reevaluate spirometry’s deployment methods and best practices.

Paul Hudson (Getty Images)

Sanofi, Glax­o­SmithK­line jump back in­to the PhI­II race for a Covid vac­cine — as the win­ners con­gre­gate be­hind the fin­ish line

Sanofi got out early in the race to develop a vaccine using more of a traditional approach, then derailed late last year as their candidate failed to work in older people. Now, after likely missing the bus for the bulk of the world’s affluent nations, they’re back from that embarrassing collapse with a second attempt using GSK’s adjuvant that may get them back on track — with a potential Q4 launch that the rest of the world will be paying close attention to.

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Nader Pourhassan, CytoDyn CEO (Jeff Kravitz/FilmMagic for CytoDyn’s Pro, via Getty Images)

FDA to Cy­to­Dyn: Those 2 Covid tri­als you keep tout­ing both failed on all end­points and your sub­group analy­sis does­n't help. Are we clear now?

As a matter of official policy, the FDA doesn’t comment about unapproved drugs and the data gathered to back them.

As an unofficial policy, though, the agency can still be provoked by a seemingly unending stream of promotional releases to call a company out for a complete and utter failure.

So it was today with CytoDyn, a biotech company that has a habit of blasting statements out about their drug leronlimab, which has been touted as a potential treatment for Covid-19.

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No­var­tis' En­tresto takes its 2nd fail­ure of the week­end at ACC, show­ing no ben­e­fit in most dire heart fail­ure pa­tients

Novartis’ Entresto started the ACC weekend off rough with a trial flop in heart attack patients, slowing the drug’s push into earlier patients. Now, an NIH-sponsored study is casting doubt on Entresto’s use in the most severe heart failure patients, another black mark on the increasingly controversial drug’s record.

Entresto, a combination of sacubitril and valsartan, could not beat out valsartan alone in an outcomes head-to-head for severe heart failure patients with a reduced ejection fraction (HFrEF), according to data presented Monday at the virtual American College of Cardiology meeting.

SCO­TUS de­clines to re­view En­brel biosim­i­lar case, tee­ing up 30+ years of ex­clu­siv­i­ty and $20B more for Am­gen’s block­buster

As the House Oversight Committee is set to grill AbbVie CEO Richard Gonzalez on Tuesday over tactics to block competition for its best-selling drug of all time, another decision on Capitol Hill on Monday opened the door for billions more in Amgen profits over the next eight years.

The Supreme Court on Monday denied Novartis subsidiary Sandoz’s petition to review a Federal Circuit’s July 2020 decision concerning its biosimilar Erelzi (etanercept-szzs), which FDA approved in 2016 as a biosimilar to Amgen’s Enbrel (etanercept). Samsung’s Enbrel biosimilar Eticovo also won approval in 2019 and remains sidelined.

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How to man­u­fac­ture Covid-19 vac­cines with­out the help of J&J, Pfiz­er or Mod­er­na? Bi­ol­yse sees the dif­fi­cul­ties up close

When Biolyse, an Ontario-based manufacturer of sterile injectables, forged a deal with Bolivia last week to manufacture up to 50 million J&J Covid-19 vaccine doses, the agreement kicked off what will prove to be a test case for how difficult the system of compulsory licenses is to navigate.

The first problem: When Biolyse asked J&J, via a March letter, to license its Covid-19 vaccine, manufacture it in Canada and pay 5% royalties on shipments to needy, low-income countries, J&J rejected the offer, refusing to negotiate. J&J also did not respond to a request for comment.

In­cyte keeps rolling on top­i­cal cream for JAK in­hibitor, pass­ing two PhI­II tests in vi­tili­go

As Incyte prepares to potentially hit the market with a topical formulation of its cash cow ruxolitinib in atopic dermatitis, the Wilmington, DE-based company is beefing up its data package for another indication: vitiligo.

Incyte released Phase III results from two of its clinical vitiligo programs Monday morning, saying both studies met their primary endpoints of patients achieving at least 75% improvement from baseline in repigmentation of the face. The data will likely lead Incyte to ask for approval in both the US and Europe for those older than 12 before the end of the year.

Tim Mayleben (L) and Sheldon Koenig (Esperion)

On the heels of a sting­ing Q1 set­back, Es­pe­ri­on's long­time cham­pi­on is ex­it­ing the helm and turn­ing the wheel over to a mar­ket­ing pro

Just days after getting stung by criticism from a badly disappointed group of analysts, there’s a big change happening today at the helm of Esperion $ESPR.

Longtime CEO Tim Mayleben, who championed the company for 9 years from early clinical through a lengthy late-stage drive to successfully get their cholesterol drug approved for a significant niche of patients in the US, is out of the C suite, effective immediately. Sheldon Koenig — hired at the end of 2020 with a resume replete with Big Pharma CV sales experience —  is stepping into his place, promising to right a badly listing commercial ship that’s been battered by market forces.

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Days ahead of Am­gen split, Cy­to­ki­net­ics reads out post-hoc da­ta sug­gest­ing heart drug works bet­ter in sick­er pa­tients — but can the CEO win over skep­tics?

While Cytokinetics’ heart drug technically met its primary endpoint back in November, it missed a key secondary endpoint — reduction in cardiovascular death — which eventually cost the company two partnerships. Now the team is back with data suggesting the drug works better in sicker patients, and it’s planning a trip to the FDA.

In a post-hoc analysis, which can be a very difficult sale at the FDA, Cytokinetics separated patients from the Phase III GALACTIC-HF study into four quartiles based on ejection fraction, a measurement of how well the left ventricle pumps blood with each heartbeat. Patients in the lower two quartiles — those with an EF of 22% or lower, and between 29% to 32% — saw a 15% and 17% relative risk reduction of heart failure events and cardiovascular death combined, Cytokinetics reported at ACC. No difference was seen in the upper two quartiles.