FDA sends warn­ing let­ter to com­mu­ni­ty hos­pi­tal re­view board over re­search con­cerns

An in­sti­tu­tion­al re­view board (IRB) for a hos­pi­tal in South Flori­da has been hit with a warn­ing let­ter from the FDA over con­cerns raised dur­ing an in­spec­tion late in 2021.

The let­ter, sent ear­li­er this month to Sima Marzban, the VP of re­search and aca­d­e­m­ic af­fairs for the Larkin Com­mu­ni­ty Hos­pi­tal In­sti­tu­tion­al Re­view Board, states that an in­spec­tion was con­duct­ed in No­vem­ber to see if the hos­pi­tal’s hu­man stud­ies com­plied with FDA re­quire­ments. The site was is­sued a Form ‘483, how­ev­er, in­ves­ti­ga­tors no­ticed af­ter re­view­ing the IRB’s re­sponse that it “did not ad­here to ap­plic­a­ble statu­to­ry re­quire­ments” that gov­ern the pro­tec­tion of hu­man sub­jects.

Specif­i­cal­ly, in­ves­ti­ga­tors took is­sue with how the IRB re­viewed pro­posed re­search. The agency ac­cused the IRB of re­view­ing and ap­prov­ing re­search at meet­ings in which a ma­jor­i­ty of mem­bers (in­clud­ing one “non­sci­en­tist”) were not present, go­ing against re­quire­ments. In the re­sponse to the FDA, the IRB promised it would take steps to cor­rect this, but the agency wasn’t com­plete­ly sat­is­fied.

“We are un­able to per­form an in­formed eval­u­a­tion of the IRB’s writ­ten re­sponse be­cause you did not pro­vide a cor­rec­tive ac­tion plan that, if prop­er­ly car­ried out, would pre­vent the re­cur­rence of this type of vi­o­la­tion in the fu­ture. Specif­i­cal­ly, you did not pro­vide suf­fi­cient de­tails on the pro­ce­dures you are ini­ti­at­ing and how you will en­sure that a ma­jor­i­ty of the IRB mem­bers, in­clud­ing at least one mem­ber whose pri­ma­ry con­cerns are in non­sci­en­tif­ic ar­eas, will be present at con­vened meet­ings when pro­posed FDA-reg­u­lat­ed re­search is un­der re­view,” the let­ter said.

The let­ter al­so said that the IRB did not main­tain doc­u­men­ta­tion of its ac­tiv­i­ties, in­clud­ing a list of cur­rent mem­bers, and that it had failed to en­sure its process for pro­vid­ing pa­tients with in­for­ma­tion as a part of in­formed con­sent was up to code.

More specif­i­cal­ly, in­ves­ti­ga­tors ac­cused the IRB of  fail­ing to make sure that the in­formed con­sent doc­u­ments for two clin­i­cal tri­als con­tained a state­ment no­ti­fy­ing the pa­tient that their tri­al in­for­ma­tion “has been or will be sub­mit­ted for in­clud­ing in the clin­i­cal tri­al reg­istry data­bank.”

The re­sponse to the FDA did note that “ac­tions were in mo­tion to es­tab­lish best prac­tices” and that fu­ture tri­al doc­u­ments would in­clude the state­ment. How­ev­er, the let­ter notes that the re­sponse did not in­clude an ac­tion plan for pre­vent­ing the re­cur­rence of this vi­o­la­tion in the fu­ture.

“Specif­i­cal­ly, you did not pro­vide suf­fi­cient de­tails on the best prac­tices you are es­tab­lish­ing and how you will en­sure that the ICDs will con­tain the state­ment,” the let­ter said.

End­points News reached out to Larkin Com­mu­ni­ty Hos­pi­tal, but did not re­ceive a re­sponse by press time.

Am­gen lays off about 300 work­ers, cit­ing 'in­dus­try head­wind­s'

Amgen has laid off about 300 employees, a company spokesperson confirmed to Endpoints News via email Sunday night.

Employees posted to LinkedIn in recent days about layoffs hitting Amgen last week. The Thousand Oaks, CA-based biopharma, which employs about 24,000 people, said the reduction “mainly” impacted US-based workers on its commercial team.

Drug developers of all sizes, including small upstarts and pharma giants, have let employees go in recent months as the biopharma market drags through a quarters-long winter doldrum.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Bob Bradway, Amgen CEO (Stephen Lam/Reuters)

Am­gen launch­es the first US Hu­mi­ra biosim­i­lar at two dif­fer­ent list prices

The bizarre dynamics of the US prescription drug market were on full display once again this morning as Amgen announced that it would launch the first US biosimilar for Humira, the best-selling drug of all time, at two completely different list prices.

One price for Amgen’s Amjevita (adalimumab-atto) will be 55% below the current Humira list price, which is about $84,000 per year, and another at a list price 5% below the current Humira list price, but presumably (pharma companies don’t disclose rebates) with high rebates to attract PBMs and payers.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 157,800+ biopharma pros reading Endpoints daily — and it's free.

Boehringer In­gel­heim touts pre­ven­tion re­sults in rarest form of pso­ri­a­sis

Boehringer Ingelheim uncorked some positive results suggesting that Spevigo can help prevent flare-ups in patients with a severe form of psoriasis, months after the drug was approved to treat existing flares.

Spevigo, an IL-36R antibody also known as spesolimab, met its primary and a key secondary endpoint in the Phase IIb EFFISAYIL 2 trial in patients with generalized pustular psoriasis (GPP), Boehringer announced on Monday. While the company is keeping the hard numbers under wraps until later this year, it said in a news release that it anticipates sharing the results with regulators.

As­traZeneca, No­vo Nordisk and Sanofi score 340B-re­lat­ed ap­peals court win over HHS

AstraZeneca, Novo Nordisk, and Sanofi won an appeals court win on Monday, as the US Court of Appeals for the Third Circuit found that the companies cannot be forced to provide 340B-discounted drugs purchased by hospitals from an unlimited number of community and specialty pharmacies.

“Legal duties do not spring from silence,” the decision says as the court makes clear that the federal government’s interpretation of the “supposed requirement” that the 340B program compels drugmakers to supply their discounted drugs to an unlimited number of contract pharmacies is not correct, noting:

Ap­peals court toss­es J&J's con­tro­ver­sial 'Texas two-step' bank­rupt­cy case

A US appeals court has ruled against Johnson & Johnson’s use of bankruptcy to deal with mounting talc lawsuits, deciding that doing so would “create a legal blind spot.”

The Third Circuit Court of Appeals reversed a previous bankruptcy court decision on Monday, calling for the dismissal of a Chapter 11 filing by J&J’s subsidiary LTL Management.

Faced with more than 38,000 lawsuits alleging its talc-based products caused cancer, J&J spun its talc liabilities into a separate company called LTL Management back in October 2021 and filed for bankruptcy, a controversial move colloquially referred to as a “Texas two-step” bankruptcy. Claimants argued that the strategy is a misuse of the US bankruptcy code — and on Monday, a panel of judges agreed.

Credit: Shutterstock

New York City in­vests $20M in­to biotech 'in­no­va­tion space' at the Brook­lyn Navy Yard

New York City is investing $20 million in biotech this year in the form of a 50,000-square-foot “innovation space” at the Brooklyn Navy Yard, complete with offices, research laboratories and events and programming space to grow biotech startups and companies.

Mayor Eric Adams said during his State of The City Address last Thursday that there will be an “emphasis” on making more opportunities for women and people of color to further diversify the industry. The City first reported the news.

Dirk Thye, Quince Therapeutics CEO

Af­ter piv­ot­ing from Alzheimer's to bone con­di­tions, biotech piv­ots again — and halves its head­count

When troubled public biotech Cortexyme bought a private startup named Novosteo and handed the keys to its executive team, the company — which changed its name to Quince Therapeutics — said it would shift its focus from an unorthodox Alzheimer’s approach to Novosteo’s bone-targeting drug platform.

Less than a year later, Quince is pivoting again.

The biotech has decided to out-license its bone-targeting drug platform and its lead drug, NOV004, and instead look for clinical-stage programs to in-license or acquire, according to a press release.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 157,800+ biopharma pros reading Endpoints daily — and it's free.

Troy Tazbaz, FDA's newly-named director of the Digital Health Center of Excellence (Oracle via YouTube)

Or­a­cle ex­ec­u­tive Troy Tazbaz named new FDA di­rec­tor of dig­i­tal health

The FDA has found a brand new director of the Digital Health Center of Excellence in Troy Tazbaz, a former senior vice president at Oracle.

According to Tazbaz’s LinkedIn, he took a five-month break after leaving an 11-year career at Oracle before joining the FDA in January. Stat News first reported the hire. Tazbaz also said on his LinkedIn that he biked all the way from Chesapeake Bay to the San Francisco Bay over 58 days during his career break.

Richard Gonzalez, AbbVie CEO (Chris Kleponis/picture-alliance/dpa/AP Images)

Up­dat­ed: $100B+ in sav­ings? Why the in­com­ing Hu­mi­ra biosim­i­lars will take time to catch on

The 20-year reign of AbbVie’s best-selling biologic of all time — the autoimmune disease biologic Humira (adalimumab) that has brought in upwards of $200 billion during its monopoly — is coming to an end tomorrow with the launch of Amgen’s biosimilar Amjevita.

The launch comes more than four years after Europe saw the exact same competition, leading to steep discounts in price, higher uptake, and big cost savings across the board.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 157,800+ biopharma pros reading Endpoints daily — and it's free.