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.”

Over­all, the project is ex­pect­ed to cre­ate about 100 new jobs, the com­pa­ny added. It’s As­traZeneca’s first man­u­fac­tur­ing fa­cil­i­ty to be built in the coun­try, re­ceiv­ing sup­port from Ire­land’s In­dus­tri­al De­vel­op­ment Agency as well as a full-throat­ed en­dorse­ment from Irish Prime Min­is­ter Micheál Mar­tin in the press re­lease.

The over­all goal is to “sig­nif­i­cant­ly re­duce com­mer­cial­i­sa­tion lead times, costs and in­tro­duce more sus­tain­able man­u­fac­tur­ing process­es,” As­traZeneca said. That, in turn, is ex­pect­ed to help the Eng­lish-Swedish phar­ma re­duce its car­bon foot­print through a “fu­ture proof” de­sign.

Small mol­e­cules are an im­por­tant part of any large phar­ma’s pipeline, but As­traZeneca has a par­tic­u­lar fo­cus on the drug class cur­rent­ly mak­ing its way through Phase III stud­ies. The AKT in­hibitor capi­vasert­ib, de­vel­oped in part­ner­ship with British biotech As­tex Phar­ma­ceu­ti­cals, is be­ing eval­u­at­ed in a va­ri­ety of can­cer in­di­ca­tions as part of com­bi­na­tion ther­a­pies.

Fil­ings for these pro­grams are ex­pect­ed in 2022 at the ear­li­est, As­traZeneca says.

There is al­so a slate of small mol­e­cule pro­grams in Phase II de­vel­op­ment for car­dio­vas­cu­lar dis­ease, as well as an asth­ma at­tack can­di­date that re­cent­ly read out two Phase III wins. If all goes well for that lat­ter pro­gram, As­traZeneca ex­pects to file for ap­proval in the first half of next year.

As­traZeneca’s com­mit­ment is the sec­ond time a Big Phar­ma com­pa­ny has set its sights on Ire­land this month. A few weeks ago, J&J an­nounced an ex­pan­sion of its Irish man­u­fac­tur­ing site, ap­ply­ing for a €150 mil­lion pro­gram in Ringask­id­dy that will in­crease the size by 8,202 square feet. The move comes af­ter J&J last ex­pand­ed the site in 2019.

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

All about Omi­cron; We need more Covid an­tivi­rals; GSK snags Pfiz­er’s vac­cine ex­ec; Janet Wood­cock’s fu­ture at FDA; and more

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Usama Malik

Ex-Im­munomedics CFO charged with in­sid­er trad­ing, faces up to 20 years in prison af­ter al­leged­ly tip­ping off girl­friend and rel­a­tives of a PhI­II suc­cess

The former CFO of Immunomedics, who helped steer the company to its $21 billion buyout by Gilead last year, has been charged with insider trading, the Department of Justice announced Thursday.

Usama Malik tipped off his then-girlfriend and four others that a Phase III study for Trodelvy would be stopped early four days before Immunomedics publicly announced the result in April 2020, DoJ alleged in its complaint. The individuals then purchased Immunomedics shares, selling them after the news broke and Immunomedics’ stock price doubled.

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Merck's new antiviral molnupiravir (Quality Stock Arts / Shutterstock)

As Omi­cron spread looms, oral an­tivi­rals ap­pear to be one of the best de­fens­es — now we just need more

After South African scientists reported a new Covid-19 variant — dubbed Omicron by the WHO — scientists became concerned about how effective vaccines and monoclonal antibodies might be against it, which has more than 30 mutations in the spike protein.

“I think it is super worrisome,” Dartmouth professor and Adagio co-founder and CEO Tillman Gerngross told Endpoints News this weekend. Moderna CEO Stéphane Bancel echoed similar concerns, telling the Financial Times that experts warned him, “This is not going to be good.”

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Ab­b­Vie tacks on a new warn­ing to Rin­voq la­bel as safe­ty frets crimp JAK class

The safety problems that continue to plague the JAK class as new data highlight some severe side effects are casting a large shadow over AbbVie’s Rinvoq.

As a result of a recent readout highlighting major adverse cardiac events (MACE), malignancy, mortality and thrombosis with Xeljanz a couple of months ago, AbbVie put out a notice late Friday afternoon that it is adding the new class risks to its label for their rival drug.

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Biospec­i­men M&A: Dis­cov­ery ac­quires Al­bert Li's he­pa­to­cyte project; PhI­II tri­al on Bay­er's Nube­qa reached pri­ma­ry end­point

Discovery Life Sciences has acquired what claims to be the Maryland-based host of the world’s largest hepatocyte inventory, known as IVAL, to help researchers select more effective and safer drug candidates in the future.

The combined companies will now serve a wider range of drug research and development scientists, according to Albert Li, who founded IVAL in 2004 and is set to join the Discovery leadership team as the CSO of pharmacology and toxicology.

Pfiz­er, Am­gen and Janssen seek fur­ther clar­i­ty on FDA's new ben­e­fit-risk guid­ance

Three top biopharma companies are seeking more details from the FDA on how the agency conducts its benefit-risk assessments for new drugs and biologics.

While Pfizer, Amgen and Janssen praised the agency for further spelling out its thinking on the subject in a new draft guidance, including a discussion of patient experience data as part of the assessment, the companies said the FDA could’ve included more specifics in the 20-page draft document.

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Re­searchers move clos­er to de­ci­pher­ing blood clots from As­traZeneca, J&J's Covid-19 vac­cines

Researchers may be nearing an answer for the mysterious and life-threatening blood clots that appeared on very rare occasions in people who received the J&J or AstraZeneca Covid-19 vaccine.

The new work builds on an early hypothesis researchers in Norway put forward last spring, when the cases first cropped up. They proposed the events were similar to blood clots that can occur in a small subset of patients who receive heparin, one of the most commonly used blood thinners.

Janet Woodcock (AP Images)

Janet Wood­cock plots her fu­ture at FDA, with se­nior ad­vi­sor role to fall back on if Califf wins con­fir­ma­tion

Acting FDA commissioner Janet Woodcock has been the face of just about every drug approval decision at the agency since the turn of the century. Since the pandemic began, she’s moved between the top of the drugs center to the head of therapeutics at Operation Warp Speed, leading the drive for work on Covid-targeted mAbs and antivirals.

Looking forward — and pending a quick Senate confirmation to cement Rob Califf’s return to the top of FDA early next year — Woodcock’s role at the agency will again be in flux.

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