Re­call re­port: Acel­la pulls thy­roid tablets af­ter a raft of side ef­fect re­ports; mis­la­bel­ing caus­es Pfiz­er's Hos­pi­ra to yank 2 lots of anes­thet­ics

Acel­la Phar­ma­ceu­ti­cals has pulled its NP Thy­roid tablets off US shelves af­ter rou­tine test­ing found dif­fer­ent ver­sions of the drug not hit­ting po­ten­cy marks. In this case, that screw-up had an im­me­di­ate ef­fect on pa­tients with 43 re­ports of se­ri­ous side ef­fects, the FDA said.

The 38 re­called lots con­tained less than 90% of their la­beled amount of lio­thy­ro­nine and levothy­rox­ine, the FDA said. Of those lots, 35 of them were 100-count bot­tles of ei­ther 15mg, 120mg, 30mg, 60mg or 90 mg tablets. An­oth­er three were sev­en-count bot­tles of 15mg, 30mg and 120mg tablets.

Pa­tients who take the hy­pothy­roidism med­ica­tion could ex­pe­ri­ence signs of an un­der­ac­tive thy­roid, which in­cludes fa­tigue, in­creased sen­si­tiv­i­ty to cold, con­sti­pa­tion, dry skin, puffy face, hair loss, slow heart rate, de­pres­sion and un­ex­plained weight loss or game. There is rea­son­able risk of se­ri­ous in­jury in new­born in­fants or preg­nant women as well, in­clud­ing ear­ly mis­car­riage or neur­al and skele­tal de­vel­op­ment im­pair­ments. El­der­ly pa­tients may ex­pe­ri­ence car­diac pain, heart pal­pi­ta­tions or car­diac ar­rhyth­mia.

“Acel­la is proac­tive­ly no­ti­fy­ing its con­signees to dis­con­tin­ue dis­tri­b­u­tion of the above ref­er­enced lots be­ing re­called and is ar­rang­ing for re­turn of all re­called prod­ucts,” the FDA said. “Pa­tients who are cur­rent­ly tak­ing NP Thy­roid from the lots be­ing re­called should not dis­con­tin­ue use with­out con­tact­ing their health­care provider for fur­ther guid­ance or a re­place­ment pre­scrip­tion.”

Pfiz­er’s Hos­pi­ra is al­so re­call­ing two lots of anes­thet­ics — one of bupi­va­caine hy­drochlo­ride in­jec­tion and one of li­do­caine hy­drochlo­ride in­jec­tion — af­ter switch­ing up the la­bels on both prod­ucts.

The is­sue was iden­ti­fied as an in­ves­ti­ga­tion of a cus­tomer re­port, the FDA said this week.

If the 0.5% bupi­va­caine were to be ad­min­is­tered to a pa­tient in­stead of the nec­es­sary 1% li­do­caine, an over­dose is pos­si­ble, which could lead to seizures, res­pi­ra­to­ry and heart ab­nor­mal­i­ties. If the 1% li­do­caine was ad­min­is­tered in­stead of the dose of bupi­va­caine, a pa­tient could be se­vere­ly un­der­dosed and the drug would not pro­vide ad­e­quate pain man­age­ment, Hos­pi­ra said.

“To date, Hos­pi­ra has not re­ceived re­ports of any ad­verse events as­so­ci­at­ed with this is­sue for these lots,” the FDA said.

The two lots, EG6023 for the bupi­va­caine and EG8933 for the li­do­caine, were set to ex­pire on Ju­ly 1, 2022, and Aug. 1, 2022, re­spec­tive­ly, and dis­trib­uted be­tween Dec. 29, 2020, to April 15, 2021.

Form 483s from FDA in­spec­tions at Hos­pi­ra’s plant found a num­ber of prob­lems with that plant’s op­er­a­tions, in­clud­ing in­ad­e­quate and in­com­plete im­pact and risk as­sess­ments and in­ad­e­quate­ly qual­i­fied mon­i­tor­ing of the man­u­fac­tur­ing process. Pro­ce­dures to pre­vent mi­cro­bi­o­log­i­cal con­t­a­m­i­na­tion of drug prod­ucts were al­so not es­tab­lished, the forms stat­ed.

Un­pack­ing the Aduhelm de­ci­sion, Ver­tex's half full glass, a $525M J&J breakup, and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

By now you have surely read about the FDA’s controversial approval of Biogen’s Alzheimer’s drug and all its reverberations. But I’d still recommend checking out the meaty recap below to make sure you didn’t miss all the angles that the Endpoints team has covered. If you’d rather look ahead, look no further than our three-day virtual panels next week at BIO, where we will discuss what the new normal means for every part of the industry.

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Aaron Kesselheim (Scott Eisen/AP Images for AIDS Healthcare Foundation)

Har­vard’s Aaron Kessel­heim re­signs from ex­pert pan­el in wake of ad­u­canum­ab OK, blast­ing FDA for ‘worst drug ap­proval de­ci­sion in re­cent U.S. his­to­ry'

A third member of the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee has resigned in the wake of Biogen’s controversial Aduhelm approval, slamming the agency as he left and further deepening the controversy surrounding the decision.

Harvard University professor Aaron Kesselheim quit in protest Thursday afternoon, calling the Aduhelm OK “probably the worst drug approval decision in recent U.S. history.” Kesselheim follows both Joel Perlmutter, a neurologist from Washington University in St. Louis, and David Knopman, a neurologist from the Mayo Clinic, out the door.

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David Knopman (Mayo Clinic via YouTube)

A sec­ond ad­comm mem­ber aban­dons his post in af­ter­math of con­tro­ver­sial ad­u­canum­ab de­ci­sion

As the fallout from the FDA’s approval of Alzheimer’s med aducanumab grows, a second member of the adcomm overseeing that drug’s review has walked away. But even with two experts now having resigned from that committee in protest, is there enough broad-level outrage to prevent another aducanumab from getting approved?

The FDA on Wednesday lost another member of its Peripheral and Central Nervous System Drugs Advisory Committee as Mayo Clinic neurologist David Knopman hit the exit over the agency’s decision to approve Biogen’s Alzheimer’s drug Aduhelm despite the committee’s near-unanimous vote against it.

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What does a clear ma­jor­i­ty of the bio­phar­ma in­dus­try think of the FDA ap­proval of ad­u­canum­ab? 'Hor­ri­fy­ing' 'Dan­ger­ous' 'Con­fus­ing' 'Dis­as­ter'

Over the years, we’ve become used to seeing a consensus emerge early in our industry polls at Endpoints News. And when we took the pulse of drug hunters on the heels of a controversial FDA approval for aducanumab this week, it became immediately apparent that the vast majority of our readers — heavily concentrated among biopharma staffers and execs — were incensed by what they had just witnessed.

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FDA au­tho­rizes about 10M J&J vac­cine dos­es, trash­es 60M more from trou­bled Emer­gent plant

The FDA on Friday released about 10 million doses of J&J’s vaccine for use, and disposed of another 60 million doses that were manufactured at the now-shuttered Emergent BioSolutions facility in Baltimore where cross-contamination occurred.

The agency said it’s not yet ready to allow the Emergent plant to be included in the J&J EUA, but that may occur soon. FDA came to the decision to authorize some of the doses after reviewing facility records and quality testing results.

FDA plans new stud­ies on ac­cel­er­at­ed ap­proval dis­clo­sures in bio­phar­ma ads

When people read biopharma companies’ websites about new drugs approved via the FDA’s accelerated pathway, like Biogen’s new Alzheimer’s drug, do they understand that these drugs may only be reasonably likely to predict clinical benefit and still require confirmatory studies?

That’s what the FDA’s Office of Prescription Drug Promotion wants to firm up as an agency analysis of direct-to-consumer websites for accelerated approval drugs previously found that only 21% of the disclosures used language directly from the label.

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As it ex­pands its foot­print, Mod­er­na reach­es deal to man­u­fac­ture Covid-19 vac­cine dos­es in Mid­dle East

While the UAE leads the world with the highest percentage of residents vaccinated, neighboring Saudi Arabia — home to nearly 35 million people — has lagged behind significantly. On Friday, Moderna announced that it has partnered with the Saudi pharmaceutical company Tabuk to manufacture its jab and future variant-specific boosters in the country.

Tabuk will hold marketing authorization for the vaccine in Saudi Arabia, and the agreement gives them the possibility of distributing future Moderna mRNA products.

An ex­pen­sive watch, shell com­pa­nies and fake in­voic­es: How two Is­raeli traders tapped in­to a $100M glob­al biotech in­sid­er trad­ing ring

It appears that we have reached the end of the saga about the global insider trading ring that collectively reaped $100 million from placing “timely, profitable” trades in biotech stocks like Ariad, Pharmacyclics and Receptos.

Tomer Feingold and Dov Malnik — Israeli traders living in Switzerland — were the last out of eight to be charged as the SEC unraveled the scheme, which ran from 2013 through 2017. Together, according to a statement in March, the pair had pocketed more than $4 million.

Janet Woodcock, acting FDA commissioner, at Thursday's Senate Appropriations hearing (Bill Clark/CQ Roll Call via AP Images)

Sen­a­tors lam­bast new Alzheimer’s drug’s price but give Janet Wood­cock a free pass on the ap­proval de­ci­sion

Senate Finance Democrats took aim at Biogen’s pricey new Alzheimer’s drug on Thursday, but members on both sides of the aisle at a separate appropriations hearing didn’t question acting FDA commissioner Janet Woodcock on the approval.

“I was appalled that Biogen priced their Alzheimer’s drug approved by the FDA at $56,000 per year — I’m not going to debate whether this is effective or not, but it’s double the household median income for Michiganders over the age of 65,” Sen. Debbie Stabenow (D-MI) said at the finance hearing.