June Raine, MHRA CEO (Tolga Akmen/Pool photo via AP Images)

UK reg­u­la­tors cau­tion against switch­ing be­tween com­mon AD­HD meds

UK reg­u­la­tors have a mes­sage for AD­HD pa­tients and their providers: Take cau­tion when switch­ing be­tween long-act­ing forms of com­mon meds such as No­var­tis’ block­buster Ri­tal­in LA and Janssen’s Con­cer­ta XL.

The coun­try’s Med­i­cines and Health­care prod­ucts Reg­u­la­to­ry Agency (MHRA) is­sued a warn­ing on Mon­day about chang­ing long-act­ing for­mu­la­tions of methylphenidate, the ac­tive in­gre­di­ent in Ri­tal­in, Con­cer­ta and a host of oth­er drugs used to treat AD­HD.

Ri­tal­in was first ap­proved in the US back in 1955. How­ev­er, No­var­tis re­cent­ly di­vest­ed the Eu­ro­pean rights to Ri­tal­in LA cap­sules, which ac­count­ed for rough­ly 30% of to­tal sales, to Ger­many-based In­fec­toPharm. MHRA al­so named Janssen’s Con­cer­ta XL, Take­da’s Equasym XL, Fly­nn Phar­ma’s Medikinet XL and gener­ics in its state­ment.

Long-act­ing forms of methylphenidate con­sist of two com­po­nents, one for im­me­di­ate re­lease and an­oth­er de­signed for a slow­er, ex­tend­ed re­lease. How­ev­er, those pro­por­tions vary across prod­ucts, mean­ing many methylphenidate drugs re­quire unique dos­ing sched­ules and in­struc­tions, such as whether or not to take the med with food.

Pa­tients may al­so ex­pe­ri­ence dif­fer­ences in side ef­fects or ef­fi­ca­cy, MHRA not­ed.

“The re­sponse to methylphenidate varies great­ly from pa­tient to pa­tient and there­fore the doc­tor will need to in­crease or de­crease a dose to find one that suits the pa­tient (dose-find­ing phase),” MHRA wrote to clin­i­cians. “Due to these dif­fer­ences, chang­ing prepa­ra­tions means that the dose may have to be ad­just­ed to avoid the po­ten­tial for over­dose or un­der­dose.”

In ad­di­tion to ad­vis­ing clin­i­cians to watch those la­bels when switch­ing drugs, MHRA cau­tioned against fre­quent changes al­to­geth­er.

“Changes to med­ica­tion should on­ly be made in the con­text of in­di­vid­ual re­view and should be com­mu­ni­cat­ed to pa­tients, who should be ad­vised to re­port any changes to their symp­toms or de­vel­op­ment of side ef­fects,” MHRA warned. “We will con­tin­ue to mon­i­tor safe­ty in­for­ma­tion and will seek to in­tro­duce this word­ing in oth­er long-act­ing methylphenidate for­mu­la­tions as ap­pro­pri­ate.”

A cou­ple years ago, MHRA joined a con­sor­tium of drug reg­u­la­tors that was formed in an ef­fort to bet­ter align reg­u­la­to­ry and pol­i­cy ap­proach­es for phar­ma­ceu­ti­cals around the world. Last sum­mer, the group un­veiled plans to im­prove their work-shar­ing process and boost the num­ber and va­ri­ety of new drug ap­pli­ca­tions as­sessed through 2024.

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 Center” 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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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.

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.

Mer­ck sues Johns Hop­kins for li­cens­ing Keytru­da patents in se­cret and in con­flict with re­search col­lab­o­ra­tion

Merck filed a lawsuit against Johns Hopkins University in Maryland federal court on Tuesday, arguing that the storied university obtained illegal patents as part of its research collaboration with the company and related to its blockbuster cancer drug Keytruda (pembrolizumab).

Merck alleges that the Baltimore-based university obtained and licensed Keytruda-related patents in secret while claiming that Keytruda was developed before and independent of a 2013 research collaboration between the two organizations. Hopkins also sought “hundreds of millions of dollars” tied to Keytruda sales because of the patents, Merck contends.

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