Re­call re­port: A-S pulls near­ly 200,000 ac­eta­minophen bot­tles off shelves; Apo­tex yanks AD­HD med

An­oth­er com­pa­ny has been forced to re­call bot­tles of its prod­uct af­ter a la­bel­ing mis­step.

A-S Med­ica­tion So­lu­tions is vol­un­tar­i­ly re­call­ing 100 count bot­tles of its Ac­eta­minophen Ex­tra Strength 500 mg tablets af­ter re­ports that the bot­tle con­tains an in­com­plete pre­scrip­tion drug la­bel as op­posed to the re­quired over-the-counter drug facts la­bel. The re­call is ex­pect­ed to be on 198,350 bot­tles of the pain and fever re­liev­er.

The use of ac­eta­minophen could be harm­ful if safe­ty warn­ings aren’t not­ed, in­clud­ed liv­er dam­age if the con­sumer takes more than the rec­om­mend­ed dose, ex­ces­sive con­sump­tion of al­co­hol, or is al­ler­gic to the ac­tive in­gre­di­ent, ac­cord­ing to the FDA.

The drug was dis­trib­uted by Hu­mana, and like­ly oc­curred be­tween Jan. 14 and March 15. Those bot­tles should have ex­pi­ra­tion dates of ei­ther Ju­ly 31, 2022, or Aug. 31, 2022.

This marks the fourth drug to be re­called for mis­la­bel­ing in 2021. Alem­bic re­called a shin­gles and her­pes drug a week ago, af­ter its telmis­ar­tan tablets were la­beled for half the strength they ac­tu­al­ly con­tained.

This week, Flori­da-based Apo­tex al­so re­called three lots of guan­facine ex­tend­ed-re­lease tablets due to trace amounts of que­ti­ap­ine fu­marate in one of the lots.

Guan­facine is an AD­HD treat­ment, and can be used with oth­er stim­u­lant med­ica­tions. Que­ti­ap­ine fu­marate is used to treat schiz­o­phre­nia, bipo­lar dis­or­der and de­pres­sion. Que­ti­ap­ine fu­marate was re­port­ed in lot RX1663, but lots RX1664 and RX1662 have al­so been re­called out of cau­tion.

A pa­tient who con­sumes the tablets with que­ti­ap­ine fu­marate could pos­si­bly ex­pe­ri­ence a drop in blood pres­sure, sleepi­ness and dizzi­ness, the FDA re­port said. So far, there have not been any re­ports of ad­verse events re­lat­ed to the re­call.

The three af­fect­ed lots were dis­trib­uted by Apo­tex through­out the US. Pa­tients who have re­ceived any of the im­pact­ed lots are en­cour­aged to con­tact their phar­ma­cy, and are ad­vised not to in­ter­rupt the use of the drug be­cause of the re­call.

No­var­tis reshuf­fles its wild cards; Tough sell for Bio­gen? Googling pro­teins; Ken Fra­zier's new gig; 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.

If you enjoy the People section in this report, you may also want to check out Peer Review, my colleagues Alex Hoffman and Kathy Wong’s comprehensive compilation of comings and goings in biopharma.

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Demis Hassabis, DeepMind CEO (Qianlong/Imaginechina via AP Images)

Google's Deep­Mind opens its pro­tein data­base to sci­ence — po­ten­tial­ly crack­ing drug R&D wide open

Nearly a year ago, Google’s AI outfit DeepMind announced they had cracked one of the oldest problems in biology: predicting a protein’s structure from its sequence alone. Now they’ve turned that software on nearly every human protein and hundreds of thousands of additional proteins from organisms important to medical research, such as fruit flies, mice and malaria parasite.

The new database of roughly 350,000 protein sequences and structures represents a potentially monumental achievement for the life sciences, one that could hasten new biological insights and the development of new drugs. DeepMind said it will be free and accessible to all researchers and companies.

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In­side Bio­gen's scram­ble to sell Aduhelm: Pro­ject 'Javelin' and pres­sure to ID as many pa­tients as pos­si­ble

In anticipation of Aduhelm’s approval for Alzheimer’s in June, Biogen employees were directed to identify and guarantee treatment centers would administer the drug through a program called “Javelin,” a senior Biogen employee told Endpoints News.

The program identified about 800 centers for use, he said, and Biogen now pays for the use of bioassays to identify beta amyloid in potential patients having undergone a lumbar puncture procedure, the employee said — and one center preparing to administer the drug confirmed its participation in the bioassay program.

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EMA re­jects FDA-ap­proved Parkin­son's drug, signs off on Mod­er­na vac­cine use in ado­les­cents ahead of FDA

The European Medicines Agency on Friday rejected Kyowa Kirin’s Parkinson’s disease drug Nouryant (istradefylline), which the US FDA approved in 2019 under the brand name Nourianz.

EMA said it considered that the results of the clinical studies used to support the application “were inconsistent and did not satisfactorily show that Nouryant was effective at reducing the ‘off’ time. Only four out of the eight studies showed a reduction in ‘off’ time, and the effect did not increase with an increased dose of Nouryant.”

6 top drug­mak­ers of­fer per­spec­tives on FDA's new co­vari­ates in RCTs guid­ance

Back in May, the FDA revised and expanded a 2019 draft guidance that spells out how to adjust for covariates in the statistical analysis of randomized controlled trials.

Building on the ICH’s E9 guideline on the statistical principles for clinical trials, the 3-page draft was transformed into an 8-page draft, with more detailed recommendations on linear and nonlinear models to analyze the efficacy endpoints in RCTs.

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Vas Narasimhan, Novartis CEO (Jason Alden/Bloomberg via Getty Images)

No­var­tis dis­cards one of its ‘wild card’ drugs af­ter it flops in key study. But it takes one more for the hand

Always remember just how risky it is to gamble big on small studies.

A little more than 4 years ago, Novartis reportedly put up a package worth up to $1 billion for the dry eye drug ECF843 after a small biotech called Lubris put it through its paces in a tiny study of 40 moderate to severe patients, tracking some statistically significant markers of efficacy.

By last fall, the program had risen up to become one of CEO Vas Narasimhan’s top “wild card” programs in line for a potential breakthrough year in 2021. These drugs were all considered high-risk, high-reward efforts. And in this case, risk won.

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No­var­tis to pay near­ly $178M in law­suit over BRAF drug — and will be on the hook for roy­al­ty

After a four-year battle over a cancer drug patent, Novartis has been ordered by a California judge to pay a Daiichi Sankyo subsidiary $177.8 million.

Plexxikon filed a lawsuit against the pharma giant in 2017, alledging that Tafinlar, a rival to its melanoma drug Zelboraf that was brought to market in collaboration with Roche, has stepped on its intellectual property. The jury ruled in its favor, adding that the infringement is in fact willful.

Al Sandrock, Biogen R&D chief (Biogen via YouTube)

Bio­gen has a shaky end to H1 with a $542M write-off adding to its woes — but an­a­lysts see big rev­enue ahead for Aduhelm

All eyes at Biogen’s Q2 earnings call Thursday were on Aduhelm, but investors also got a glimpse of what Biogen would have faced had the FDA not opted to approve their controversial Alzheimer’s drug.

That glimpse, revealing a combination of declining sales, growing competition and failed medicines, underscores the stakes of the big biotech’s Aduhelm efforts, as execs punch back at the criticism they’ve engendered in the political and medical world and vigorously pushes its sales staff to roll out the drug as fast as possible.

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Michel Vounatsos, Biogen CEO (Credit: World Economic Forum/Valeriano Di Domenico)

Bio­gen de­fends slow roll­out of new Alzheimer's drug, crit­i­cizes neg­a­tive me­dia at­ten­tion

As Biogen execs bemoaned the negative media coverage around Aduhelm’s approval a month ago, the biotech isn’t gaining much traction yet in using its new drug, largely due to a lack of insurance coverage, according to an earnings call Thursday.

Management indicated that of the nearly 900 sites that were prepped and ready following Aduhelm’s approval, 325 of those, or about 35%, have completed a positive pharmacy and therapeutics (P&T) review or won’t require one. The review is a step some hospitals or health systems take prior to using a new drug. Some major sites, however, have said they won’t participate.