FDA of­fers scathing re­view of Emer­gent plan­t's san­i­tary con­di­tions, em­ploy­ee train­ing af­ter halt­ing pro­duc­tion

The FDA wrapped up its in­spec­tion of Emer­gent’s trou­bled vac­cine man­u­fac­tur­ing plant in Bal­ti­more on Tues­day, af­ter halt­ing pro­duc­tion there on Mon­day. By Wednes­day morn­ing, the agency al­ready re­leased a se­ries of scathing ob­ser­va­tions on the cross con­t­a­m­i­na­tion, san­i­tary is­sues and lack of staff train­ing that caused the con­tract man­u­fac­tur­er to dis­pose of mil­lions of As­traZeneca and J&J vac­cine dos­es.

The first of nine ob­ser­va­tions in the Form 483, fol­low­ing a nine-day in­spec­tion, deals with the fact that Emer­gent failed to thor­ough­ly in­ves­ti­gate the vac­cine drug sub­stance mix-up that caused the firm to throw away 15 mil­lion dos­es of the J&J vac­cine.

“There is no as­sur­ance that oth­er batch­es have not been sub­ject to cross-con­t­a­m­i­na­tion,” the FDA writes.

The sec­ond ob­ser­va­tion deals with the fact that the fa­cil­i­ty is filthy.

In ad­di­tion to chip­ping paint on the walls and floors that mean the sur­faces can­not be ad­e­quate­ly cleaned, FDA notes that waste gen­er­at­ed dur­ing the man­u­fac­ture of vac­cine drug sub­stance is not de­con­t­a­m­i­nat­ed be­fore be­ing trans­port­ed through the ware­house and ad­ja­cent ar­eas.

Ac­cord­ing to se­cu­ri­ty cam­era footage, em­ploy­ees in one of the man­u­fac­tur­ing ar­eas in Jan­u­ary and Feb­ru­ary were “ob­served throw­ing un­sealed bags of spe­cial med­ical waste in­to the ser­vice el­e­va­tor ac­cess­ing the ware­house cor­ri­dor,” the 483 notes. The third ob­ser­va­tion al­so raised con­cerns about the size of the fa­cil­i­ty, which was over­crowd­ed with ma­te­ri­als read­ied to be man­u­fac­tured.

Em­ploy­ees were al­so ob­served in Feb­ru­ary and as re­cent­ly as mid-April drag­ging un­sealed bags of med­ical waste from one man­u­fac­tur­ing area across the floor to the ware­house, as well as re­mov­ing pro­tec­tive gar­ments on­to the ware­house floor where raw ma­te­ri­als were be­ing read­ied for man­u­fac­ture.

The fifth and sixth ob­ser­va­tions note that Emer­gent did not prop­er­ly han­dle and store vi­ral bulk drug sub­stances to pre­vent cross con­t­a­m­i­na­tion and did not have prop­er pro­ce­dures for de­con­t­a­m­i­nat­ing waste.

Emer­gent’s fail­ure to train em­ploy­ees is doc­u­ment­ed in the sev­enth ob­ser­va­tion, which notes per­son­nel in­volved in the man­u­fac­tur­ing op­er­a­tions en­tered in­to the man­u­fac­tur­ing area while pro­cess­ing of some bulk drug sub­stance was tak­ing place, and then en­tered oth­er op­er­a­tional rooms with­out prop­er­ly ad­her­ing to gown­ing pro­ce­dures.

“Per­son­nel in­volved in man­u­fac­tur­ing op­er­a­tions dragged non-dis­in­fect­ed and non-de­con­t­a­m­i­nat­ed spe­cial med­ical waste” from one man­u­fac­tur­ing area across the ware­house cor­ri­dor, FDA not­ed.

FDA said in a state­ment Wednes­day, “At the agency’s re­quest, Emer­gent BioSo­lu­tions has agreed to pause new pro­duc­tion while it works with the FDA to re­solve po­ten­tial qual­i­ty is­sues. For the vac­cines al­ready man­u­fac­tured, the prod­ucts will un­der­go ad­di­tion­al test­ing and will be thor­ough­ly eval­u­at­ed to en­sure their qual­i­ty be­fore any po­ten­tial dis­tri­b­u­tion.”

The agency raised sim­i­lar con­cerns with the plant, fol­low­ing an in­spec­tion in April 2020.

Emer­gent said in a state­ment that it’s com­mit­ted to “work­ing with the FDA and John­son & John­son to quick­ly re­solve the is­sues iden­ti­fied.”

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In­no­v­a­tive MedTech De­mands Spe­cial­ist Clin­i­cal Tri­al Reg­u­la­to­ry Af­fairs and De­sign

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Mathai Mammen (Rob Tannenbaum, Endpoints News at BIO 2018)

Math­ai Mam­men makes an abrupt ex­it as head of the big R&D group at J&J

In an after-the-bell shocker, J&J announced Monday evening that Mathai Mammen has abruptly exited J&J as head of its top-10 R&D group.

Recruited from Merck five years ago, where the soft-spoken Mammen was being groomed as the successor to Roger Perlmutter, he had been one of the top-paid R&D chiefs in biopharma. His group spent $12 billion last year on drug development, putting it in the top 5 in the industry.

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Illustration: Kim Ryu for Endpoints News

Why non-opi­oid pain drugs keep fail­ing — and what's next for the field

In 1938, Rita Levi-Montalcini was forced to move her lab into her bedroom in Turin, as Mussolini’s facist government expelled Jewish people from studying or working in schools in Italy. Levi-Montalcini, then just a few years out of medical school and using sewing needles as scalpels in her makeshift lab, would soon discover nerve growth factor, or NGF, in chicken embryos.

Her discoveries formed the basis of our understanding of the peripheral nervous system and how cells talk to each other, and Levi-Montalcini went on to win the Nobel Prize in 1986. Much later, NGF was hailed as a promising target for new pain therapies, with some analysts quoting an $11 billion market. However, the latest anti-NGF candidate, Pfizer and Eli Lilly’s tanezumab, was rejected by the FDA last year because of a side effect that dissolved bone in some of its patients.

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Samantha Du, Zai Lab CEO

Any­one still look­ing for a CD47? Zai Lab shelves PhI pro­gram af­ter re­view­ing 'com­pet­i­tive land­scape'

Over the past few years, the promise of blocking CD47 — a “don’t eat me” signal co-opted by cancer cells — has sent drugmakers big and small into a frenzy. But one biotech is now bowing out.

Zai Lab is deprioritizing ZL-1201, its CD47 inhibitor, scrapping plans for a Phase II trial. It will now “pursue out-licensing opportunities,” the company said in its Q2 update. The decision was based on a review of the competitive landscape, it added, without going into further details.

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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Andy Jassy, Amazon CEO (Isaac Brekken/AP Images for NFL, File)

Up­dat­ed: FDA slaps Ama­zon with a warn­ing let­ter for sell­ing OTC mole re­moval prod­ucts

The FDA’s Center for Drug Evaluation and Research on Tuesday released a warning letter sent last week to Amazon CEO Andy Jassy in Seattle for selling mole removal products over-the-counter, or, as the FDA explains, “introducing, delivering, or causing the introduction or delivery into interstate commerce of products that are unapproved new drugs.”

“There are no over-the-counter (OTC) drugs that can be legally sold for mole or skin tag removal, and FDA has safety concerns about drugs marketed OTC directly to consumers for these uses,” the agency said in its Aug. 4 warning.

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, less than two weeks after its supplemental BLA was accepted. 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.

Civi­ca, Mayo Clin­ic and oth­ers sound off on FDA draft guid­ance to mit­i­gate drug short­ages

Several pharma groups are laying out the positives and negatives of new FDA draft guidance on how best to handle drug shortages.

The draft is intended to help companies develop and implement risk management plans (RMPs) to assist with any shortages of drugs or biologics. The guidance recommends a framework and factors for stakeholders to develop RMPs for their establishments, API manufacturers and others.

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