Namandjé Bumpus (L) and Hilary Marston

FDA adds some fresh se­nior lead­er­ship with new chief sci­en­tist, chief med­ical of­fi­cer

While the FDA is typ­i­cal­ly known for its ever-ex­pand­ing hir­ing needs, thanks to an in­dus­try where top sci­en­tists can make dou­ble or triple in the pri­vate in­dus­try ver­sus the FDA, com­mis­sion­er Rob Califf on Thurs­day an­nounced two new lead­ers at the agency.

Johns Hop­kins’ Na­mand­jé Bum­pus will be the FDA’s new chief sci­en­tist, re­plac­ing Denise Hin­ton, who moved on in Oc­to­ber 2021 to ad­vise and sup­port the US Sur­geon Gen­er­al, and Hi­lary Marston, a White House se­nior pol­i­cy ad­vi­sor on Covid-19, will take over as chief med­ical of­fi­cer, which was a role pre­vi­ous­ly held by Janet Wood­cock.

Lu­ciana Bo­rio, ven­ture part­ner at ARCH and for­mer FDA act­ing chief sci­en­tist, told End­points News that she’s worked with Marston over the years “and am thrilled to see her in this po­si­tion. Na­mand­jé has a stel­lar rep­u­ta­tion. It is en­cour­ag­ing to see them at the FDA.”

Bum­pus re­ceived her PhD in phar­ma­col­o­gy at the Uni­ver­si­ty of Michi­gan in 2007 and will join the FDA af­ter serv­ing as the di­rec­tor of the de­part­ment of phar­ma­col­o­gy and mol­e­c­u­lar sci­ences at Johns Hop­kins School of Med­i­cine. She’s al­so the pres­i­dent-elect of the Amer­i­can So­ci­ety for Phar­ma­col­o­gy & Ex­per­i­men­tal Ther­a­peu­tics.

Ac­cord­ing to Hop­kins, Bum­pus’ lab­o­ra­to­ry stud­ies drug me­tab­o­lism and us­es mass spec­trom­e­try and mol­e­c­u­lar phar­ma­col­o­gy-based ap­proach­es to in­ves­ti­gate the trans­for­ma­tion of clin­i­cal­ly used drugs by the cy­tochromes P450s, which are re­spon­si­ble for the me­tab­o­lism of an es­ti­mat­ed 75% of cur­rent­ly mar­ket­ed drugs.

Marston, mean­while, served re­cent­ly as the Na­tion­al Se­cu­ri­ty Coun­cil’s di­rec­tor of med­ical and biode­fense pre­pared­ness (for about one year) and pre­vi­ous­ly worked at the Na­tion­al In­sti­tutes of Al­ler­gy and In­fec­tious Dis­eases for about nine years.

Marston wrote a pre­scient per­spec­tive, along­side NI­AID di­rec­tor Tony Fau­ci, in the New Eng­land Jour­nal of Med­i­cine on the use of mon­o­clon­al an­ti­bod­ies for emerg­ing in­fec­tious dis­eases — two years be­fore the Covid pan­dem­ic.

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In­no­v­a­tive MedTech De­mands Spe­cial­ist Clin­i­cal Tri­al Reg­u­la­to­ry Af­fairs and De­sign

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FDA commissioner Rob Califf (Tom Williams/CQ Roll Call via AP Images)

With drug pric­ing al­most done, Con­gress looks to wrap up FDA user fee leg­is­la­tion

The Senate won’t return from its summer recess until Sept. 6, but when it does, it officially has 18 business days to finalize the reauthorization of the FDA user fee programs for the next 5 years, or else thousands of drug and biologics reviewers will be laid off and PDUFA dates will vanish in the interim.

FDA commissioner Rob Califf recently sent agency staff a memo explaining how, “Our latest estimates are that we have carryover for PDUFA [Prescription Drug User Fee Act], the user fee funding program that will run out of funding first, to cover only about 5 weeks into the next fiscal year.”

Pascal Soriot, AstraZeneca CEO (David Zorrakino/Europa Press via AP Images)

As­traZeneca and Dai­ichi Sankyo sprint to mar­ket af­ter FDA clears En­her­tu in just two weeks

Regulators didn’t keep AstraZeneca and Daiichi Sankyo waiting long at all for their latest Enhertu approval.

The partners pulled a win on Friday in HER2-low breast cancer patients who’ve already failed on chemotherapy, just two weeks after submitting a supplemental BLA. While this isn’t the FDA’s fastest approval — Bristol Myers Squibb won an OK for its blockbuster checkpoint inhibitor Opdivo in just five days back in March — it comes well ahead of Enhertu’s original Q4 PDUFA date.

Uğur Şahin, BioNTech CEO (Kay Nietfeld/picture-alliance/dpa/AP Images)

De­spite falling Covid-19 sales, BioN­Tech main­tains '22 sales guid­ance

While Pfizer raked in almost $28 billion last quarter, its Covid-19 vaccine partner BioNTech reported a rise in total dose orders but a drop in sales.

The German biotech reported over $3.2 billion in revenue in Q2 on Monday, down from more than $6.7 billion in Q1, in part due to falling Covid sales. While management said last quarter that they anticipated a Covid sales drop — CEO Uğur Şahin said at the time that “the pandemic situation is still very much uncertain” — Q2 sales still missed consensus by 14%.

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Ted Love, Global Blood Therapeutics CEO

Up­dat­ed: Pfiz­er scoops up Glob­al Blood Ther­a­peu­tics and its sick­le cell ther­a­pies for $5.4B

Pfizer is dropping $5.4 billion to acquire Global Blood Therapeutics.

Just ahead of the weekend, word got out that Pfizer was close to clinching a $5 billion buyout — albeit with other potential buyers still at the table. The pharma giant, flush with cash from Covid-19 vaccine sales, apparently got out on top.

The deal immediately swells Pfizer’s previously tiny sickle cell disease portfolio from just a Phase I program to one with an approved drug, Oxbryta, plus a whole pipeline that, if all approved, the company believes could make for a $3 billion franchise at peak.

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FDA's vac­cine ad­comm to re­view first fe­cal trans­plant to treat C. dif­fi­cile in­fec­tions

Back in 2018, Swiss drugmaker Ferring Pharmaceuticals made a big bet on Minnesota-based Rebiotix, buying up the company for its experimental poop-based drug implant to treat an infection caused by C. difficile, a potentially dangerous bacteria, in a new way.

Four years later, Ferring’s fecal microbiota transplant, dubbed RBX2660 or Rebyota, will face the FDA’s adcomm of outside vaccine experts on Sept. 22, debating whether the agency should license the transplant as a treatment for adults following antibiotic treatment for recurrent C. difficile infection.

David Reese, Amgen R&D chief

UP­DAT­ED: In a fresh dis­ap­point­ment, Am­gen spot­lights a ma­jor safe­ty is­sue with KRAS com­bo

Amgen had hoped that its latest study matching its landmark KRAS G12C drug Lumakras with checkpoint inhibitors would open up its treatment horizons and expand its commercial potential. Instead, the combo spurred safety issues that blunted efficacy and forced the pharma giant to alter course on its treatment strategy, once again disappointing analysts who have been tracking the drug’s faltering sales and limited therapeutic reach.

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GSK and IQVIA launch plat­form of US vac­ci­na­tion da­ta, show­ing drop in adult rates

Throughout the Covid-19 pandemic, the issue of vaccine uptake has been a point of contention, but a new platform from GSK and IQVIA is hoping to shed more light on vaccine data, via new transparency and general awareness.

The two companies have launched Vaccine Track, a platform intended to be used by public health officials, medical professionals and others to strengthen data transparency and display vaccination trends. According to the companies, the platform is intended to aid in increasing vaccine rates and will provide data on trends to assist public health efforts.

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Ab­b­Vie sur­veys emo­tion­al im­pact of chron­ic leukemia con­di­tion, finds 'roller coast­er' of emo­tions

Rare diseases often have more than just physical effects on patients — especially when it comes to chronic conditions. In the case of the rare slow-growing blood cancer chronic lymphocytic leukemia (CLL), AbbVie wanted to try to assess the mental and emotional toll on patients.

So it surveyed more than 300 CLL patients, caregivers and physicians. While each group differed in how they felt — caregivers overwhelmingly (81%) felt positive about their role, for instance — patients described a “roller coaster” of emotions traversing diagnosis to treatment to remission and even relapse for some.