House Committee on Oversight and Reform Chairwoman Carolyn Maloney (Getty Images)

House De­moc­rats call on Emer­gent ex­ecs to tes­ti­fy on qual­i­ty is­sues next month

The House Over­sight Com­mit­tee is in­ves­ti­gat­ing Covid-19 vac­cine pro­duc­er Emer­gent BioSo­lu­tions, which se­cured a $628 mil­lion US gov­ern­ment con­tract to make As­traZeneca and J&J vac­cines de­spite “a long, doc­u­ment­ed his­to­ry” of qual­i­ty con­trol is­sues, De­moc­rats said in a let­ter to the con­tract man­u­fac­tur­er’s ex­ec­u­tives.

Emer­gent’s Bal­ti­more plant, which was shut­tered on Mon­day by FDA, has been em­broiled in con­tro­ver­sy af­ter be­ing forced to de­stroy mil­lions of As­traZeneca and J&J dos­es due to an in­gre­di­ent mix-up and pos­si­ble con­t­a­m­i­na­tion.

“FDA con­tin­ues to in­ves­ti­gate Emer­gent’s man­u­fac­tur­ing prob­lems. We are con­cerned by the costs to tax­pay­ers and the po­ten­tial im­pact on our na­tion’s vac­ci­na­tion ef­forts caused by Emer­gent’s failed at­tempts to man­u­fac­ture these vac­cines,” Reps. Car­olyn Mal­oney (D-NY) and James Clyburn (D-SC) wrote.

In ob­tain­ing its gov­ern­ment con­tracts, the rep­re­sen­ta­tives ex­plained in the let­ter how close­ly linked Emer­gent was with for­mer Pres­i­dent Trump’s ap­pointee to lead the Of­fice of the As­sis­tant Sec­re­tary for Pre­pared­ness and Re­sponse, Robert Kadlec, who pre­vi­ous­ly did con­sult­ing work for Emer­gent.

Robert Kadlec PHE

“Fol­low­ing Dr. Kadlec’s con­fir­ma­tion, Emer­gent re­ceived mil­lions of dol­lars in fed­er­al con­tracts from AS­PR, in­clud­ing con­tracts for the SNS [strate­gic na­tion­al stock­pile] that were award­ed with­out com­pet­i­tive bid­ding,” the let­ter notes.

Emer­gent al­so en­cour­aged over­sight of the SNS to be trans­ferred from the CDC to AS­PR, un­der Kadlec’s con­trol.

Mal­oney and Clyburn al­so said that short­ages of ba­sic med­ical sup­plies dur­ing the pan­dem­ic last year were di­rect­ly re­lat­ed to Emer­gent’s “out­sized in­flu­ence” over the price and pur­chase of its an­thrax vac­cines.

“Emer­gent has raised the gov­ern­ment pur­chas­ing price of the an­thrax vac­cine by 800% since ac­quir­ing the drug in 1998,” the let­ter says. “As a re­sult, through most of the last decade, near­ly half of the SNS’s  bud­get has been spent pur­chas­ing Emer­gent’s an­thrax vac­cine.”

The House Se­lect Sub­com­mit­tee on the Coro­n­avirus, which Clyburn chairs, is re­quest­ing that Robert Kramer, pres­i­dent and CEO of Emer­gent, and ex­ec­u­tive chair Fuad El-Hi­b­ri tes­ti­fy on May 19 on the com­pa­ny’s qual­i­ty con­trol and staffing is­sues.

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.

'Chang­ing the whole game of drug dis­cov­ery': Leg­endary R&D vet Roger Perl­mut­ter leaps back in­to work as a biotech CEO

Roger Perlmutter needs no introduction to anyone remotely involved in biopharma. As the R&D chief first at Amgen and then Merck, he’s built a stellar reputation and a prolific career steering new drugs toward the market for everything from cancer to infectious diseases.

But for years, he’s also held a less known title: science partner at The Column Group, where he’s regularly consulted about the various ideas the VCs had for new startups.

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FDA ex­tends re­search agree­ment with MIT-li­censed or­gan-on-chip sys­tems

The FDA on Wednesday extended its four-year agreement with CN Bio, a developer of single- and multi-organ-on-chip systems used for drug discovery, for another three years.

CN Bio said the scope of the research performed by the FDA’s Center for Drug Evaluation and Research has expanded to include the exploration of the company’s lung-on-a-chip system to help with the agency’s evaluation of inhaled drugs, in addition to the agency’s work on its liver model.

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In quest to meet user fee goals, FDA’s per­for­mance con­tin­ues down­ward trend

A recent update to the FDA’s running tally of how it’s meeting its user fee-related performance goals during the pandemic shows an agency that is not out of the woods yet.

The latest numbers reveal that for a second straight quarter in 2021, the FDA has met its user fee goal dates for 93% of original new drug applications, which compares with 94% and 98% for the previous two quarters in 2020, respectively.

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Thomas Schall, ChemoCentryx CEO (file photo)

Chemo­Cen­tryx plunges as FDA rais­es ques­tions about rare dis­ease drug ahead of ad­comm

ChemoCentryx’s stock price on Wednesday was cut in half by the release of FDA briefing documents ahead of a Thursday adcomm, raising questions on the company’s clinical data to support avacopan as a treatment for adults with a rare and serious disease known as anti-neutrophil cytoplasmic autoantibody (ANCA)-vasculitis.

ANCA-associated vasculitides (AAV) affect small to medium-size blood vessels that can be fatal in less than a year if left untreated, according to FDA. Only Roche’s Rituxan is currently FDA-approved for the treatment of AAV, while glucocorticoids are approved for the broader indication of vasculitis.

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UP­DAT­ED: Pfiz­er hits the brakes on their piv­otal tri­al for a BC­MA/CD3 bis­pe­cif­ic on safe­ty con­cerns while FDA road­block is hold­ing up Duchenne MD PhI­II

Pfizer’s ambitious plan to take a Phase II study of its BCMA CD3-targeted bispecific antibody elranatamab (PF-06863135) and run it through to an accelerated approval has derailed.

The pharma giant said in a release this morning that they have halted enrollment for their MagnetisMM-3 study after researchers tracked three cases of peripheral neuropathy in the ongoing Phase I. They are now sharing info with the FDA as they explore the red safety flag.

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Ngozi Okonjo-Iweala, Director general of WTO (AP Photo/Keystone/Alessandro Della Bella)

Opin­ion: Waiv­ing Covid-19 vac­cine IP could save lives, but where is the man­u­fac­tur­ing ca­pac­i­ty?

Droves of House Democrats in Washington and members of the European Parliament have now glommed onto a major push by India and South Africa at the WTO to abolish all IP around Covid-19 vaccines.

At first blush, waiving this IP sounds like an easy win: More Covid-19 vaccines made locally for more people means more lives saved. Simple enough, especially as low-income countries have received just a tiny fraction of the world’s vaccine allotment so far.

Al­ta­sciences, true to its word, ex­pands its foot­print with ac­qui­si­tion of Penn­syl­va­nia CRO

A Canadian CDMO with roots in Seattle is coming to the east coast.

Altasciences announced the acquisition of Calvert Laboratories Wednesday, a preclinical CRO in Pennsylvania. The move will complement Altasciences’ Seattle-area operations.

Headquartered in Laval, Canada, Altasciences operates six facilities that run the gamut on early drug development: preclinical safety testing, clinical pharmacology, bioanalytical, CRO services, and even CDMO capacity. Novo Holdings scooped them up in February with the goal of courting small and medium-sized biopharma clients. CEO Chris Perkin said back in February that the move would help the company foster its ambitious growth plan, and this acquisition and the presence it brings to the east coast is evidence.

Re­gen­eron’s gold­en goose Eylea may stave off biosim­i­lar com­pe­ti­tion un­til 2024 or be­yond

Almost 10 years have passed since its first FDA approval and Regeneron’s macular degeneration injection Eylea continues to pile up sales to the tune of about $5 billion per year, or more than half of Regeneron’s annual revenues.

Those billions are not expected to go anywhere anytime soon thanks to competition, even as Novartis subsidiary Sandoz announced Monday that it’s beginning a Phase III trial for an Eylea biosimilar in 460 patients across 20 countries.