Sen. Richard Burr (R-NC) (Shawn Thew/Pool via AP)

Re­tir­ing Re­pub­li­can sen­a­tor lam­basts Biden ap­pointees' re­sponse to mon­key­pox out­break

In like­ly his fi­nal Sen­ate Health, Ed­u­ca­tion, La­bor and Pen­sions com­mit­tee meet­ing, Sen. Richard Burr (R-NC) be­gan by call­ing the Biden ad­min­is­tra­tion’s re­sponse to the mon­key­pox out­break a “cat­a­stroph­ic fail­ure,” and end­ed with an en­thu­si­as­tic push to the heads of the CDC, FDA, NI­AID and AS­PR to do more in prepa­ra­tion for any fu­ture out­breaks.

While point­ing to the longer-than-ex­pect­ed time­lines for ramp­ing up test­ing and vac­cines, sim­i­lar to the Covid-19 re­sponse, Burr said he will con­tin­ue to be a re­source to the var­i­ous agency lead­ers “be­cause I on­ly have one goal,” and that’s “for the next one, we have to re­spond a hell of a lot faster than we did for Covid, and we have do much bet­ter than we did for mon­key­pox. Be­cause on the oth­er side of this, there’s po­ten­tial­ly one that gets out of con­trol with mas­sive loss of life.”

Burr lament­ed the turf wars be­tween the agen­cies, as some claimed own­er­ship of cer­tain re­sponse ac­tiv­i­ties like test­ing, not­ing, “It isn’t a ques­tion of au­thor­i­ty or mon­ey, it’s a ques­tion of lead­er­ship and fo­cus, and squash­ing the bu­reau­crat­ic road blocks,” he said.

But Biden’s ap­pointees de­fend­ed their re­sponse to mon­key­pox, high­light­ing their work to ease ac­cess to test­ing and vac­cines.

While the NIH helped with the tri­als for both the Bavar­i­an Nordic vac­cine, known as Jyn­neos, and more re­cent­ly with Siga’s an­tivi­ral Tpoxx (tecovir­i­mat), the health and sci­ence lead­ers as­sured the sen­a­tors that vac­cine sup­plies are ad­e­quate as cas­es be­gin to de­cline na­tion­al­ly.

De­spite Burr’s time­line com­ments on slow­ness of the re­sponse, Dawn O’Con­nell, as­sis­tant sec­re­tary for pre­pared­ness and re­sponse, de­fend­ed her with­draw­al of vac­cines from the na­tion­al stock­pile, not­ing that when there were on­ly 35 known mon­key­pox cas­es in the US, she or­dered hun­dreds of thou­sands of dos­es of the vac­cine to dis­trib­ute to states.

Cur­rent­ly, 1.1 mil­lion vials have been made avail­able of the two-dose shot, O’Con­nell said, and the US has pur­chased 5.5 mil­lion more dos­es, which are ar­riv­ing in the com­ing months.

CDC Di­rec­tor Rochelle Walen­sky not­ed more than 22,000 mon­key­pox cas­es, in­clud­ing one death, and lament­ed some of the ex­ist­ing da­ta gaps, such as the fact that the CDC doesn’t know how many peo­ple with mon­key­pox have been hos­pi­tal­ized.

NI­AID Di­rec­tor Tony Fau­ci, who’s re­tir­ing in De­cem­ber and fend­ed off fur­ther at­tacks from Sen. Rand Paul (R-KY), al­so ex­plained how the mon­key­pox vac­cine is like­ly to pro­tect for longer than the Covid-19 vac­cines, ex­plain­ing how the dura­bil­i­ty of the small­pox vac­cine is mea­sured in decades.

FDA com­mis­sion­er Robert Califf not­ed the FDA’s work around ex­pe­dit­ing the ap­proval for Bavar­i­an’s Den­mark-based man­u­fac­tur­ing site ear­li­er this sum­mer to ex­pand mon­key­pox vac­cine pro­duc­tion, as well as around the switch from sub­cu­ta­neous to in­tra­der­mal shots for the mon­key­pox vac­cine, which helped to sig­nif­i­cant­ly ex­pand the num­ber of dos­es avail­able.

But even De­moc­rats sought an­swers on mon­key­pox, and sought to hear more about what the agen­cies need.

Sen­ate HELP chair Pat­ty Mur­ray (D-WA) said she was en­cour­aged by the de­clin­ing num­ber of mon­key­pox cas­es but still not­ed that she’d heard it was dif­fi­cult to find mon­key­pox tests and vac­cines, adding, “Some se­ri­ous stum­bles were made this year.”

The White House Mon­key­pox Re­sponse Team and fed­er­al pub­lic health of­fi­cials said they will hold a press brief­ing to­mor­row morn­ing to pro­vide up­dates on the re­sponse.

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.

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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Astel­las, Pan­th­er­na add or­gan to mR­NA tie-up; Rock­et launch­es sale of six fig­ures worth of stock

Astellas and Pantherna have expanded their November 2021 pact surrounding the latter’s mRNA platform to include a new target organ, the duo announced Tuesday morning, though they did not specify what that target is.

German biotech Pantherna is home to two platform technologies — one that designs mRNAs for non-vaccine therapies and another that designs LNPs. Astellas and Pantherna’s deal appears to mainly revolve around the first platform, which Astellas said it is using to research direct reprogramming, or turning cells from one kind into another without an intermediate stem cell phase.