Re­call re­port: BRP Phar­ma pulls 47 bot­tles of gener­ic di­uret­ic spirono­lac­tone af­ter mix­ing dif­fer­ent strength pills

It’s been a rel­a­tive­ly qui­et year for drug re­calls with the FDA fac­ing a work back­log, but that doesn’t mean the agency isn’t watch­ing for of­fend­ers. Now, a gener­ic di­uret­ic mak­er is be­ing forced to with­draw af­ter mix­ing dos­es of its meds in the same bot­tles.

Bryant Ranch Prepack (BRP) has re­called 47 bot­tles across four lots of spirono­lac­tone ta­bles due to in­cor­rect la­bel­ing of the drug’s strength on its pack­ag­ing, the FDA said this week.

The agency said prepack­aged bot­tles la­beled spirono­lac­tone 50 mg may con­tain spirono­lac­tone 25 mg tablets, and prepack­aged bot­tles of spirono­lac­tone 25 mg may con­tain spirono­lac­tone 50 mg tablets.

A di­uret­ic used to treat high-blood pres­sure, spirono­lac­tone tak­en in less-than-pre­scribed dos­es may cause an el­e­va­tion in blood pres­sure or ede­ma over time. The FDA warned pa­tients could ex­pe­ri­ence a de­crease in potas­si­um if tak­ing half of the ex­pect­ed dose, which could lead to hy­pokalemia, a con­di­tion as­so­ci­at­ed with car­diac ar­rhyth­mias.

Pa­tients who take dou­ble their pre­scribed dose could ex­pe­ri­ence an in­crease in potas­si­um, which could be life threat­en­ing, the agency said. As of Tues­day, BRP had not re­ceived any side-ef­fect re­ports. The lots and ex­pi­ra­tions dates for the re­call in­clude:

  • 148969 (7/31/2022)
  • 148791 (7/31/2022)
  • 148991 (7/31/2022)
  • 148992 (5/31/2022)

It’s been a qui­et year for re­calls at the FDA amid an agency-wide pinch for re­sources and a chron­ic back­log of site in­spec­tions that are of­ten the pre­cur­sor for re­calls.

Last month, Apo­tex launched a vol­un­tary re­call of two batch­es of the blood thin­ner in­jec­tion enoxa­parin sodi­um this week af­ter dis­cov­er­ing that some sy­ringes were mis­la­beled and could’ve re­sult­ed in pa­tients ac­ci­den­tal­ly get­ting more of the drug than need­ed. Blamed on a pack­ag­ing er­ror, Apo­tex said the dis­crep­an­cy was dis­cov­ered through a cus­tomer com­plaint in­ves­ti­ga­tion.

A few days ear­li­er, Nos­trum Lab­o­ra­to­ries pulled one lot of met­formin HCl ex­tend­ed re­lease tablets, USP 750 mg, a Type 2 di­a­betes drug (the gener­ic equiv­a­lent to Glu­cophage tablets) af­ter test­ing dis­cov­ered el­e­vat­ed lev­els of ni­trosamine, the prob­a­ble car­cino­gen. It was an ex­pan­sion of Nos­trum’s ear­li­er re­call and the lat­est of a string of drug­mak­ers to pull their gener­ic ver­sions of the Type 2 di­a­betes meds off shelves based on car­cino­gen con­cerns.

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

David Meek, new Mirati CEO (Marlene Awaad/Bloomberg via Getty Images)

Fresh off Fer­Gene's melt­down, David Meek takes over at Mi­rati with lead KRAS drug rac­ing to an ap­proval

In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.

Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.

Who are the women su­per­charg­ing bio­phar­ma R&D? Nom­i­nate them for this year's spe­cial re­port

The biotech industry has faced repeated calls to diversify its workforce — and in the last year, those calls got a lot louder. Though women account for just under half of all biotech employees around the world, they occupy very few places in C-suites, and even fewer make it to the helm.

Some companies are listening, according to a recent BIO survey which showed that this year’s companies were 2.5 times more likely to have a diversity and inclusion program compared to last year’s sample. But we still have a long way to go. Women represent just 31% of biotech executives, BIO reported. And those numbers are even more stark for women of color.

When ef­fi­ca­cy is bor­der­line: FDA needs to get more con­sis­tent on close-call drug ap­provals, agency-fund­ed re­search finds

In the exceedingly rare instances in which clinical efficacy is the only barrier to a new drug’s approval, new FDA-funded research from FDA and Stanford found that the agency does not have a consistent standard for defining “substantial evidence” when flexible criteria are used for an approval.

The research comes as the FDA is at a crossroads with its expedited-review pathways. The accelerated approval pathway is under fire as the agency recently signed off on a controversial new Alzheimer’s drug, with little precedent to explain its decision. Meanwhile, top officials like Rick Pazdur have called for a major push to simplify and clarify all of the various expedited pathways, which have grown to be must-haves for sponsors of nearly every newly approved drug.

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Jacob Van Naarden (Eli Lilly)

Ex­clu­sives: Eli Lil­ly out to crash the megablock­buster PD-(L)1 par­ty with 'dis­rup­tive' pric­ing; re­veals can­cer biotech buy­out

It’s taken 7 years, but Eli Lilly is promising to finally start hammering the small and affluent PD-(L)1 club with a “disruptive” pricing strategy for their checkpoint therapy allied with China’s Innovent.

Lilly in-licensed global rights to sintilimab a year ago, building on the China alliance they have with Innovent. That cost the pharma giant $200 million in cash upfront, which they plan to capitalize on now with a long-awaited plan to bust up the high-price market in lung cancer and other cancers that have created a market worth tens of billions of dollars.

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FDA hands ac­cel­er­at­ed nod to Seagen, Gen­mab's so­lo ADC in cer­vi­cal can­cer, but com­bo stud­ies look even more promis­ing

Biopharma’s resident antibody-drug conjugate expert Seagen has scored a clutch of oncology approvals in recent years, finding gold in what are known as “third-gen” ADCs. Now, another of their partnered conjugates is ready for prime time.

The FDA on Monday handed an accelerated approval to Seagen and Genmab’s Tivdak (tisotumab vedotin-tftv, or “TV”) in second-line patients with recurrent or metastatic cervical cancer who previously progressed after chemotherapy rather than PD-(L)1 systemic therapy, the companies said in a release.

Vicente Anido (University of West Virginia via YouTube)

Aerie fires CEO af­ter lead pro­gram flop, com­ments about pri­ma­ry end­points be­ing 'not re­quired'

Aerie Pharmaceuticals CEO Vicente Anido has left the company less than a week after trying to chart a Phase III study in the wake of a serious Phase IIb flop.

Anido’s last day at Aerie was Friday, the biotech announced in a news release Tuesday morning, and Benjamin McGraw is taking his place in an interim role. The now former CEO was terminated without cause, according to an SEC filing.

The board has started looking for a full-time chief to take his place.

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With plans to spend $360M, As­traZeneca will build its first-ever man­u­fac­tur­ing site in Ire­land

AstraZeneca is planning to spend a pretty penny for a new manufacturing facility in Dublin.

The Big Pharma will shell out $360 million to build an API plant for small molecules at its Alexion campus in College Park, Dublin, it announced Tuesday morning. AstraZeneca said the focus of the facility will be late-stage development and early commercial supply for small molecule therapies.

“The future manufacturing of APIs for our medicines includes compounds with highly complex synthesis, requiring next generation technologies and capabilities that can respond quickly and nimbly to rapidly-changing clinical and commercial needs,” AstraZeneca global ops chief Pam Cheng said in a statement. “This significant investment will ensure the AstraZeneca supply network is fit for the future.”

Take­da snaps up the Japan­ese rights to an old Shire cast-off; Boehringer In­gel­heim ac­quires Abexxa Bi­o­log­ics

A week before the FDA is set to decide on Mirum Pharmaceuticals’ lead liver disease drug — an old Shire cast-off called maralixibat — Takeda is swooping in to secure the rights in Japan.

Maralixibat’s roots trace back to Lumena, which was snapped up by Shire for $260 million-plus back in 2014. While the candidate had failed mid-stage studies at Shire, Mirum believes better trial design and patient selection will deliver the wins it needs. The drug is currently in development for Alagille syndrome (a condition called ALGS in which bile builds up in the liver), progressive familial intrahepatic cholestasis (PFIC, which causes progressive liver disease) and biliary atresia (a blockage in the ducts that carry bile from the liver to the gallbladder).