Health Cana­da is­sues two re­calls for Pfiz­er blood pres­sure drugs over im­pu­ri­ty

Last year, Pfiz­er stopped dis­tri­b­u­tion of megablock­buster smok­ing ces­sa­tion drug Chan­tix over an in­creased lev­el of car­cino­genic ni­trosamines.

Now, two of the Big Phar­ma’s blood pres­sure drugs have been re­called in Cana­da this week af­ter Cana­da’s health au­thor­i­ty found lev­els of a type of ni­trosamine too high to be al­lowed in the drugs.

Pfiz­er Cana­da re­called all 8 lots of blood pres­sure drug Ac­curet­ic yes­ter­day af­ter high­er-than-ap­proved lev­els of N-ni­troso-quinapril were found. That re­call was just two days af­ter the phar­ma sub­sidiary re­called 15 lots of In­der­al-LA, an­oth­er blood pres­sure drug, over sim­i­lar con­cerns over ni­trosamines.

The reg­u­la­tor said in re­call no­tices for the two drugs that there’s no im­me­di­ate risk in tak­ing Pfiz­er’s meds, at least tem­porar­i­ly. The agency ad­vised, “there is no im­me­di­ate risk in con­tin­u­ing to tem­porar­i­ly take the re­called Ac­curet­ic med­ica­tion since the po­ten­tial risk of can­cer is with long-term ex­po­sure (every day for 70 years) to the ni­trosamine im­pu­ri­ty above the ac­cept­able lev­el.”

How­ev­er, pa­tients on those drugs should talk to a doc­tor about treat­ment al­ter­na­tives, ac­cord­ing to Health Cana­da.

“Con­tin­ue tak­ing your med­ica­tion un­less you have been ad­vised to stop by your health care provider. Not treat­ing your con­di­tion pos­es a greater health risk,” the reg­u­la­tor added.

Pfiz­er Cana­da kept it sim­ple — say­ing in a state­ment to End­points News, “In re­sponse to re­quests from var­i­ous reg­u­la­to­ry au­thor­i­ties, man­u­fac­tur­ers across the phar­ma­ceu­ti­cal in­dus­try have been eval­u­at­ing the po­ten­tial for the pres­ence or for­ma­tion of cer­tain im­pu­ri­ties, called ni­trosamines, in phar­ma­ceu­ti­cal prod­ucts. There is no im­me­di­ate risk to pa­tients tak­ing this med­ica­tion.”

7 of the 8 lots that were re­called for Ac­curet­ic are ex­pir­ing in Ju­ly, with the last one ex­pir­ing some­time next year. For In­der­al-LA, all but two of the lots of drugs ex­pire in 2023 and 2024.

Pfiz­er halt­ed dis­tri­b­u­tion of its an­ti-smok­ing med Chan­tix, re­call­ing four lots of the drug last June — a year af­ter the FDA found high lev­els of the ni­trosamine ND­MA in the gener­ic di­a­betes drug met­formin. That be­gan a mul­ti-month saga when the FDA said it would still al­low cer­tain man­u­fac­tur­ers to dis­trib­ute batch­es of the drug that have more than the usu­al ni­trosamine lev­els, so long as the im­pu­ri­ty re­mains un­der the in­ter­im ac­cept­able lim­it.

Susan Galbraith, AstraZeneca EVP, oncology R&D, at EUBIO22 (Rachel Kiki for Endpoints News)

Up­dat­ed: As­traZeneca jumps deep­er in­to cell ther­a­py 2.0 space with $320M biotech M&A

Right from the start, the execs at Neogene had some lofty goals in mind when they decided to try their hand at a cell therapy that could tackle solid tumors.

Its founders have helped hone a new approach that would pack in multiple neoantigen targets to create a personalized TCR treatment that would not just make the leap from blood to solid tumors, but do it with durability. And they managed to make their way rapidly to the clinic, unveiling their first Phase I program for advanced tumors just last May.

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Ei­sai’s ex­pand­ed Alzheimer’s da­ta leave open ques­tions about safe­ty and clin­i­cal ben­e­fit

Researchers still have key questions about Eisai’s investigational Alzheimer’s drug lecanemab following the publication of more Phase III data in the New England Journal of Medicine Tuesday night.

In the paper, which was released in conjunction with presentations at an Alzheimer’s conference, trial investigators write that a definition of clinical meaningfulness “has not been established.” And the relative lack of new information, following topline data unveiled in September, left experts asking for more — setting up a potential showdown to precisely define how big a difference the drug makes in patients’ lives.

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Paul Hudson, Sanofi CEO (Romuald Meigneux/Sipa via AP Images)

Sanofi and DN­Di aim to elim­i­nate sleep­ing sick­ness in Africa with promis­ing Ph II/III re­sults for new drug

The Drugs for Neglected Diseases initiative (DNDi) and Sanofi today said that their potential sleeping sickness treatment saw success rates of up to 95% from a Phase II/III study investigating the safety and efficacy of single-dose acoziborole.

The potentially transformative treatment for sleeping sickness would mainly be targeted at African countries, according to data published today in The Lancet Infectious Diseases medical journal. The clinical trial was led by DNDi and its partners in the Democratic Republic of the Congo (DRC) and Guinea, with the authors noting:

Digital render of CPI's Medicines Manufacturing Innovation Centre in Glasgow, Scotland (Image: uk-cpi.com)

CPI opens the doors to a new $100M+ man­u­fac­tur­ing fa­cil­i­ty in Scot­land

A manufacturing site that has received interest and investments from large pharma companies and the UK government is opening its doors in Scotland.

The manufacturer CPI (Centre for Process Innovation) has opened a new £88 million ($105 million) “Medicines Manufacturing Innovation Centre” in Glasgow, Scotland, to accelerate the development of manufacturing tech and solve longstanding challenges in medicine development and manufacturing.

Illustration: Assistant Editor Kathy Wong for Endpoints News

Twit­ter dis­ar­ray con­tin­ues as phar­ma ad­ver­tis­ers ex­tend paus­es and look around for op­tions, but keep tweet­ing

Pharma advertisers on Twitter are done — at least for now. Ad spending among the previous top spenders flattened even further last week, according to the latest data from ad tracker Pathmatics, amid ongoing turmoil after billionaire boss Elon Musk’s takeover now one month ago.

Among 18 top advertisers tracked for Endpoints News, only two are spending: GSK and Bayer. GSK spending for the full week through Sunday was minimal at just under $1,900. Meanwhile, German drugmaker Bayer remains the industry outlier upping its spending to $499,000 last week from $480,000 the previous week. Bayer’s spending also marks a big increase from a month ago and before the Musk takeover, when it spent $16,000 per week.

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Vi­a­tris with­draws ac­cel­er­at­ed ap­proval for top­i­cal an­timi­cro­bial 24 years lat­er

After 24 years without confirming clinical benefit, the FDA announced Tuesday morning that Viatris (formed via Mylan and Pfizer’s Upjohn) has decided to withdraw a topical antimicrobial agent, Sulfamylon (mafenide acetate), after the company said conducting a confirmatory study was not feasible.

Sulfamylon first won FDA’s accelerated nod in 1998 as a topical burn treatment, with the FDA noting that last December, Mylan told the agency that it wasn’t running the trial.

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Pro­tect­ing its megablock­buster, Janssen chal­lenges Am­gen's Ste­lara biosim­i­lar ahead of planned 2023 launch

Johnson & Johnson unit Janssen on Wednesday sued Amgen over the company’s proposed biosimilar to its megablockbuster Stelara (ustekinumab), after Amgen said it was ready to launch next May or as soon as the FDA signs off on it.

If Amgen carries through with that plan, Janssen told the Delaware district court that the Thousand Oaks, CA-based company will infringe on at least two Janssen patents.

Lex­i­con slams FDA over hear­ing de­nial fol­low­ing a CRL for its SGLT2 in­hibitor can­di­date

Lexicon Pharmaceutical is not giving up on its Type I diabetes candidate, despite FDA’s repeated rejections. This week the company laid out is argument again for a hearing on sotagliflozin in response to the FDA’s most recent denial.

The issue goes back to March 2019 when the FDA made very clear to Lexicon and its now departed partner Sanofi that it would not approve their application for a potential Type I diabetes drug because it does not appear to be safe.

Uğur Şahin, BioNTech CEO (ddp images/Sipa USA/Sipa via AP Images)

BioN­Tech bets on dif­fi­cult STING field via small mol­e­cule pact with a Pol­ish biotech

BioNTech is beefing up its relatively thin small molecule pipeline by adding weight to a clinically difficult corner of oncology R&D: STING agonists. To do so, BioNTech is teaming up with a 15-year-old Polish biotech and doling out €40 million, about $41.5 million, to start.

The deal is broken into two parts: First, BioNTech obtains an exclusive global license to develop and market Ryvu Therapeutics’ STING agonist portfolio as small molecules, whether alone or in combination with other agents.

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