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.”

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

UP­DAT­ED: Boehringer nabs FDA's first in­ter­change­abil­i­ty des­ig­na­tion for its Hu­mi­ra com­peti­tor — but will it mat­ter?

The FDA late Friday awarded Boehringer Ingelheim the first interchangeability designation for its Humira biosimilar Cyltezo, meaning that when it launches in July 2023, pharmacists will be able to automatically substitute the Boehringer’s version for AbbVie’s mega-blockbuster without a doctor’s input.

The designation will likely give Boehringer, which first won approval for Cyltezo in 2017, the leg up on a crowded field of Humira competitors.

Bio­gen hit by ALS set­back with PhI­II fail­ure for tofersen — but fol­lows a fa­mil­iar strat­e­gy high­light­ing the pos­i­tive

Patients and analysts waiting to hear Sunday how Biogen’s SOD1-ALS drug tofersen fared in Phase III didn’t have to wait long for the top-line result they were all waiting for. The drug failed the primary endpoint on significantly improving the functional and neurologic decline of patients over 28 weeks as well as the extension period for continued observation.

In fact, there was very little difference in response.

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Jeffrey Nau, Oyster Point Pharma CEO

FDA OKs an in­haled ver­sion of smok­ing ces­sa­tion drug Chan­tix — for a com­mon eye dis­ease

Oyster Point Pharma now has its first FDA-approved product — Tyrvaya. And the biotech has taken a unique route to get there by using an old drug with a storied past.

The New Jersey biotech announced this morning that the FDA has approved their nasal spray product for dry eye disease on Friday — the first nasal spray to be approved for the disease. The product’s active ingredient is 0.03 mg of varenicline, also known as smoking cessation aid Chantix.

Omeros plunges deep­er af­ter FDA re­jects rare dis­ease drug, ask­ing for more in­for­ma­tion

Omeros practically warned investors that a complete response letter was coming when it disclosed that the FDA found deficiencies in its BLA for narsoplimab. But the agency did not elaborate on the specifics of those deficiencies for the drug, which was being positioned as a treatment for the rare but serious blood clotting disease known as hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA).

UP­DAT­ED: Third time's the charm: Adamis nabs ap­proval of high-dose nalox­one in­jec­tion af­ter two CRLs

If at first you don’t succeed, and at second you don’t succeed, try, try again.

That’s been the unofficial mantra for Adamis Pharmaceuticals’ high dose naloxone injection, which received two CRLs in the span of a year between the Novembers of 2019 and 2020. But on Monday, word came through that the FDA approved the drug on Adamis’ third attempt, giving doctors another tool to treat individuals who overdose on opioids.

Two drug­mak­ers hit with PDU­FA date de­lays from FDA amid back­log of in­spec­tions

As the FDA is weighed down with more and more pandemic responsibilities, the agency is beginning to miss PDUFA dates with more frequency too. Two different companies on Monday said they received notices that the FDA has not completed their drug reviews on time.

The review of an NDA for Avadel Pharmaceuticals’ candidate treatment for narcolepsy is not coming this month, the company said, and the review of UCB’s BLA for bimekizumab, used to treat moderate to severe plaque psoriasis, will miss its target date as well.

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Reshma Kewalramani, Vertex CEO (YouTube)

Ver­tex gets much-need­ed win with ‘ex­tra­or­di­nary’ first pa­tient re­sults on po­ten­tial di­a­betes cure

Vertex said Monday that the first patient dosed with its cell therapy for type 1 diabetes saw their need for insulin injections vanish almost entirely, a key early step in the decades-long effort to develop a curative treatment for the chronic disease.

The patient, who had suffered five potentially life-threatening hypoglycemic — or low blood sugar — episodes in the year before the therapy, was injected with synthetic insulin-producing cells. After 90 days, the patient’s new cells produced insulin steadily and ramped up their insulin production after a meal like normal cells do, as measured by a standard biomarker for insulin production.

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Mark Foley, Revance CEO (Revance via Vimeo)

UP­DAT­ED: FDA re­jects Re­vance's pitch for Botox com­peti­tor as biotech blames man­u­fac­tur­ing is­sues

The FDA has told Revance Therapeutics that, no, it won’t be able to turn those frowns upside down.

Regulators issued a CRL to the biotech for its botox-based therapy for moderate to severe glabellar lines, also known as frown lines, Revance announced Friday. As is agency policy, the FDA does not comment on these types of communications, but Revance said the rejection came from deficiencies at a manufacturing site.

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