On the heels of un­prompt­ed EMA re­view of Covid drug, FDA sched­ules ad­comm for po­ten­tial EUA

The FDA is now fol­low­ing through on an emer­gency use fil­ing for a re­pur­posed can­cer drug that Eu­ro­pean reg­u­la­tors ini­tial­ly took an in­ter­est in.

The US agency said Wednes­day that it is con­ven­ing an ad­comm meet­ing of its Pul­monary-Al­ler­gy Drugs Ad­vi­so­ry Com­mit­tee, slat­ed for Oct. 6. The com­pa­ny be­hind the ad­comm is Veru, a Mi­a­mi-based biotech that orig­i­nal­ly start­ed out as a can­cer com­pa­ny.

The fed­er­al agency said in a pub­lic no­tice that as part of the ad­comm, one of the fo­cus­es of the ex­perts dur­ing dis­cus­sions will in­clude “the treat­ment ef­fect size in the con­text of the high place­bo mor­tal­i­ty rate, the lim­it­ed size of the safe­ty data­base, and iden­ti­fy­ing the pro­posed pop­u­la­tion.”

Veru filed an EUA re­quest to the FDA ear­li­er this year for its can­di­date sabiz­ab­u­lin to treat mod­er­ate to se­vere Covid-19 in­fec­tion in pa­tients that are at high risk for “acute res­pi­ra­to­ry dis­tress syn­drome.”

At the time, the biotech said in a pre-EUA meet­ing with the FDA that the reg­u­la­to­ry agency agreed that it has enough da­ta to sup­port both an EUA and NDA sub­mis­sion for the drug can­di­date.

As for the EMA, Veru’s can­di­date was shown in a clin­i­cal study pub­lished in NE­JM in Ju­ly to re­duce the rel­a­tive risk of death from Covid-19 by 55%. Over the course of 60 days, just over 45% of those in the place­bo group died, com­pared with just 20.2% of those who re­ceived the new drug.

Of the pa­tients en­rolled, all were hos­pi­tal­ized with Covid-19, 134 re­ceived the drug and 70 were giv­en place­bo. Veru said in April that the Phase III study for its Covid-19 treat­ment was shut down ear­ly by an in­de­pen­dent da­ta mon­i­tor­ing com­mit­tee due to the drug’s “over­whelm­ing ef­fi­ca­cy.”

How­ev­er, ex­perts have said to ex­er­cise cau­tion about over-in­ter­pret­ing the re­sults. Part of the rea­son­ing has been that over the last two years, there have been very few ef­fec­tive treat­ments for those hos­pi­tal­ized with Covid.

The Veru re­view from the EMA is the first to be trig­gered un­der Ar­ti­cle 18 of the new EU reg­u­la­tion that ex­pand­ed the agency’s role in the course of pub­lic health emer­gen­cies.

Shares of $VERU have fall­en 22% af­ter the mar­ket opened. How­ev­er, the biotech is still up 122% over the last six months.

Biotech in­vestors and CEOs see two paths to growth, but are they equal­ly vi­able?

The dynamic in the biotech market has been highly volatile in the last few years, from the high peaks immediately after the COVID vaccine in 2021, to the lowest downturns of the last 20 years in 2022. This uncertainty makes calling the exact timing of the market’s turn something of a fool’s errand, according to Dr. Chen Yu, Founder and Managing Partner of TCG Crossover (TCG X). He speaks with RBC’s Noël Brown, Head of US Biotechnology Investment Banking, about the market’s road ahead and two possible paths for growth.

User fees in ac­tion: FDA un­veils new short­ened sup­ple­ment re­view, rare dis­ease pi­lots

Thanks to PDUFA VII, signed into law last Friday by President Joe Biden, the FDA this week unveiled two new industry-friendly pilot programs to advance new rare disease endpoints via additional meetings, and to shorten FDA review times for supplemental apps aimed at unmet medical needs.

The agency this week released eagerly-awaited details behind the shortened pilot, known as the Split Real Time Application Review or STAR pilot program, which will speed up certain FDA reviews of efficacy supplements across all therapeutic areas (thanks to earlier submissions of data), but only for those that propose addressing an unmet medical need.

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Mar­ket­ingRx roundup: No­var­tis re­cruits NFL coach for Leqvio cam­paign; Pfiz­er pro­motes ‘Sci­ence’ merch on so­cial me­dia

Novartis is turning to a winning coach to talk about Leqvio and the struggles of high cholesterol — including his own. Bruce Arians, the retired NFL head coach of the Arizona Cardinals and Super Bowl-winning Tampa Bay Buccaneers, is partnering with the pharma for its “Coaching Cholesterol” digital, social and public relations effort.

In the campaign, Arians talks about the potential for “great comebacks” in football and heart health. Once nicknamed a “quarterback whisperer,” he is now retired from fulltime coaching (although still a front-office consultant for Tampa Bay), and did a round of media interviews for Novartis, including one with People and Forbes.

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Amy West, Novo Nordisk head of US digital innovation and transformation (Illustration: Assistant Editor Kathy Wong for Endpoints News)

Q&A: No­vo Nordisk dig­i­tal in­no­va­tion chief Amy West dis­cuss­es phar­ma pain points and a health­care 'easy but­ton’

Amy West joined Novo Nordisk more than a decade ago to oversee marketing strategies and campaigns for its US diabetes portfolio. However, her career path shifted into digital, and she hasn’t looked back. West went from leading Novo’s first digital health strategy in the US to now heading up digital innovation and transformation.

She’s currently leading the charge at Novo Nordisk to not only go beyond the pill with digital marketing and health tech, but also test, pilot and develop groundbreaking new strategies needed in today’s consumerized healthcare world.

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Casey McPherson shows his daughters Rose (left) and Weston around Everlum Bio, a lab that he co-founded to spark a treatment for Rose and others with ultra-rare conditions. (Ilana Panich-Linsman)

Fa­ther starts lab af­ter in­tel­lec­tu­al prop­er­ty is­sues stymie rare dis­ease drug de­vel­op­ment

Under bright lab lights, Casey McPherson holds his 6-year-old daughter, Rose. His free hand directs Rose’s gaze toward a computer screen with potential clues in treating her one-of-a kind genetic condition.

Gray specks on the screen show her cells that scientists reprogrammed with the goal of zeroing in on a custom medicine. McPherson co-founded the lab, Everlum Bio, to spark a treatment for Rose — and others like her. A regarded singer-songwriter, McPherson never imagined going into drug development.

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Benjamine Liu, TrialSpark CEO

Paul Hud­son and Tri­alSpark's mu­tu­al de­sire to speed up de­vel­op­ment con­verges in three-year, six-drug goal

A unicorn startup that originally set out to hasten clinical studies for biopharma partners dug further into its revised path of internal drug development by linking arms with Sanofi in a pact that the biotech’s CEO said originated from the top.

TrialSpark and the Big Pharma on Tuesday committed to in-licensing and/or acquiring six Phase II/Phase III drugs within the next three years.

“I’ve known Paul Hudson for a while and we were discussing the opportunity to really re-imagine a lot of different parts of pharma,” TrialSpark CEO Benjamine Liu told Endpoints News, “and one of the things that we discussed was this opportunity to accelerate the development of new medicines in mutual areas of interest.”

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Marc Dunoyer, Alexion CEO (AstraZeneca via YouTube)

Up­dat­ed: As­traZeneca nabs a small rare dis­ease gene ther­a­py play­er for 667% pre­mi­um

AstraZeneca is kicking off the fourth quarter with a little M&A Monday for a gene editing player recently overcoming a second clinical hold to its only program in human studies.

The Big Pharma and its subsidiary Alexion are buying out little LogicBio for $2.07 per share. That’s good for a massive 667% premium over its Friday closing price, when it headed into the weekend at 27 cents and just weeks after Nasdaq said LogicBio would have to delist, which has been put on hold as the biotech requests a hearing. It’s one of two biotech deals to commence October, alongside the news of Incyte buying a vitiligo-focused biotech.

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Dave Marek, Myovant CEO

My­ovant board balks as ma­jor­i­ty own­er Sum­it­o­mo swoops in with a $2.5B deal to buy them out

Three years after Sumitomo scooped up Roivant’s 46% stake in the publicly traded Myovant $MYOV as part of a 5-company, $3 billion deal, they’re coming back for the whole thing.

But these other investors at Myovant want more than what the Japanese pharma company is currently offering to pay at this stage.

Sumitomo is bidding $22.75 a share for the outstanding stock, which now represents 48% of the company after Sumitomo bumped its ownership since the original deal with Roivant. Myovant, however, created a special committee on the board, and they’re shaking their heads over the offer.

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Big Phar­ma heavy­weights seek tweaks to FDA's clin­i­cal out­come as­sess­ment guid­ance

Pfizer, GSK, Janssen, Regeneron, Boehringer Ingelheim and at least a half dozen other companies are calling on the FDA to provide significantly more clarity in its draft guidance from this summer on clinical outcome assessments, which are a type of patient experience.

The draft is the third in a series of four patient-focused drug development guidance documents that the FDA had to create as part of the 21st Century Cures Act, and they describe how stakeholders (patients, caregivers, researchers, medical product developers and others) can collect and submit patient experience data and other relevant information for medical product development and regulatory decision-making.

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