Ox­ford gets £100M to seize a 'break­through mo­men­t' in fight­ing su­per­bugs

Close to 70 years af­ter Ox­ford sci­en­tists pu­ri­fied peni­cillin and con­firmed its ef­fect as an an­tibac­te­r­i­al drug, the uni­ver­si­ty is es­tab­lish­ing a new re­search in­sti­tute at the fore­front of com­bat­ing an­timi­cro­bial re­sis­tance.

The In­eos Ox­ford In­sti­tute for AMR Re­search will ini­tial­ly be pow­ered by a $136 mil­lion (£100 mil­lion) do­na­tion from In­eos, the UK-based chem­i­cals gi­ant found­ed by bil­lion­aire Jim Rat­cliffe, that al­so plays a hand in man­u­fac­tur­ing med­ical and phar­ma prod­ucts.

Tim­o­thy Walsh

“Covid-19 has been like an earth­quake,” Tim­o­thy Walsh, a vet­er­an AMR re­searcher who’s tak­ing the aca­d­e­m­ic lead on the mi­cro­bi­ol­o­gy side, said in a video. “So it’s been rapid, sud­den, where­as an­timi­cro­bial re­sis­tance you can’t see it, you can’t feel it, but nonethe­less it’s in­creas­ing year on year.”

Re­sis­tance to ex­ist­ing an­tibi­otics — most of which are decades old and dirt cheap — has been emerg­ing as a top con­cern for pub­lic health of­fi­cials and re­searchers world­wide. Even though a hand­ful of biotechs have man­aged to bring new drugs to the mar­ket, in­creas­ing aware­ness of an­tibi­ot­ic stew­ard­ship and rigid re­im­burse­ment struc­tures could put com­pa­nies in a Catch-22 where clin­i­cians try to lim­it their use to the most crit­i­cal cas­es, there­by al­so lim­it­ing rev­enue and of­ten dri­ving the drug­mak­ers in­to bank­rupt­cy. The re­sult had been an ex­o­dus from the field, even though cer­tain Big Phar­ma play­ers and pub­lic-pri­vate coali­tions have been try­ing to change that.

Econ­o­mist Jim O’Neill — who has helped doc­u­ment the dire sit­u­a­tion and ar­gued for ur­gent ac­tion in the “arms race against bac­te­ria” — said the col­lab­o­ra­tive ap­proach “could be the break­through mo­ment the glob­al AMR chal­lenge needs.”

Louise Richard­son

Louise Richard­son, vice chan­cel­lor of the Uni­ver­si­ty of Ox­ford, sug­gest­ed that In­eos might help trans­late the re­search. In ad­di­tion to ex­plor­ing new hu­man drugs, the group is mak­ing de­sign­ing an­i­mal-spe­cif­ic an­tibi­otics one of its goals giv­en that agri­cul­ture ac­counts for the ma­jor­i­ty of glob­al an­tibi­ot­ic con­sump­tion.

Chris Schofield, head of or­gan­ic chem­istry at Ox­ford, will be the aca­d­e­m­ic lead for chem­istry.

Chris Schofield

“The IOI pro­vides us with a won­der­ful op­por­tu­ni­ty to link world class syn­thet­ic chem­istry and mi­cro­bi­ol­o­gy with­in a sin­gle in­sti­tute with the aim of en­abling break­through new treat­ments in med­i­cine and agri­cul­ture,” he said in a state­ment.

Then there’s the mis­use of an­tibi­otics — overus­ing them, not fin­ish­ing a full pre­scribed dose — to tack­le, with re­searchers tasked with propos­ing bet­ter man­age­ment and en­gag­ing with pol­i­cy­mak­ers.

So­cial im­age: Shut­ter­stock

The DCT-OS: A Tech­nol­o­gy-first Op­er­at­ing Sys­tem - En­abling Clin­i­cal Tri­als

As technology-enabled clinical research becomes the new normal, an integrated decentralized clinical trial operating system can ensure quality, deliver consistency and improve the patient experience.

The increasing availability of COVID-19 vaccines has many of us looking forward to a time when everyday things return to a state of normal. Schools and teachers are returning to classrooms, offices and small businesses are reopening, and there’s a palpable sense of optimism that the often-awkward adjustments we’ve all made personally and professionally in the last year are behind us, never to return. In the world of clinical research, however, some pandemic-necessitated adjustments are proving to be more than emergency stopgap measures to ensure trial continuity — and numerous decentralized clinical trial (DCT) tools and methodologies employed within the last year are likely here to stay as part of biopharma’s new normal.

Onno van de Stolpe, Galapagos CEO (Thierry Roge/Belga Mag/AFP via Getty Images)

Gala­pa­gos chops in­to their pipeline, drop­ping core fields and re­or­ga­niz­ing R&D as the BD team hunts for some­thing 'trans­for­ma­tive'

Just 5 months after Gilead gutted its rich partnership with Galapagos following a bitter setback at the FDA, the Belgian biotech is hunkering down and chopping the pipeline in an effort to conserve cash while their BD team pursues a mission to find a “transformative” deal for the company.

The filgotinib disaster didn’t warrant a mention as Galapagos laid out its Darwinian restructuring plans. Forced to make choices, the company is ditching its IPF molecule ’1205, while moving ahead with a Phase II IPF study for its chitinase inhibitor ’4617.

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Angela Merkel (AP Photo/Michael Sohn)

Covid-19 roundup: Pfiz­er sub­mits vac­cine for full ap­proval; Merkel op­pos­es Biden pro­pos­al to sus­pend IP for vac­cines

Pfizer and BioNTech said Friday that they’ve submitted a biologics license application to the FDA for full approval of their mRNA vaccine for those over the age of 16.

How long it will take the FDA to decide on the BLA will be set once it’s been formally accepted by the agency.

Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, previously told Endpoints News that the review of the BLA should take between three and four months, but it may be even faster than that.

An­oth­er failed tri­al for Or­p­hazyme's 'pipeline-in-a-pro­duc­t' leaves shad­ow on drug's fu­ture

The tumultuous ride for Orphazyme continued on Friday as the company announced that a pivotal trial for its lead drug arimoclomol failed yet again, this time in the treatment of ALS, seeding doubt in a drug that had recently been cleared by the FDA for priority review. The latest failure casts a darker shadow on the upcoming decision despite Orphazyme’s upbeat outlook.

In a statement, the Danish biotech announced that the drug did not meet its primary or secondary endpoints evaluating function and survival. But the company has not announced any data surrounding the failure, instead saying that it will publish the complete results later this year.

In­cyte ponies up $12M to set­tle char­i­ty foun­da­tion kick­back claims; US ex­er­cis­es op­tion for more dos­es of mon­key­pox vac­cine

One in a string of lawsuits targeting copay charity foundations, the DOJ has been hunting drugmaker Incyte for what prosecutors alleged was a kickback scheme to court patients. Now, Incyte is clearing its name.

Incyte will shell out $12.6 million to settle claims it funneled funds through a charity foundation to cover federal copays for patients taking its JAK inhibitor Jakafi, the DOJ said this week.

Stéphane Bancel, Getty

Mod­er­na CEO brush­es off US sup­port for IP waiv­er, eyes more than $19B in Covid-19 vac­cine sales in 2021

Moderna is definitively more concerned with keeping pace with Pfizer in the race to vaccinate the world against Covid-19 than it is with Wednesday’s decision from the Biden administration to back an intellectual property waiver that aims to increase vaccine supplies worldwide.

In its first quarter earnings call on Thursday, Moderna CEO Stéphane Bancel shrugged off any suggestion that the newly US-backed intellectual property waiver would impact his company’s vaccine or bottom line. Still, the company’s stock price fell by about 9% in early morning trading.

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CEO Khurem Farooq (Gyroscope)

Hours be­fore ex­pect­ed de­but, Gy­ro­scope post­pones its IPO as 2 oth­er biotechs hold the line on their march to Nas­daq

Editor’s note: Interested in following biopharma’s fast-paced IPO market? You can bookmark our IPO Tracker here.

In a surprising turn of events, UK-based Gyroscope Therapeutics has postponed its IPO mere hours before it was set to debut on Nasdaq.

Working on a gene therapy for wet AMD, Gyroscope was all set and ready to go public earlier this week, setting terms for a $142 million raise with a price range of $20 to $22. But in the wee hours of Friday morning, the company put out a press release saying they would delay their debut “in light of market conditions,” CEO Khurem Farooq said in a statement.

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Karyopharm taps long­time Pfiz­er, Am­gen vet to steer the ship; With Mer­ck in the rearview mir­ror, Roger Perl­mut­ter stakes his claim to a CEO job — and it's a sur­pris­ing choice

Like many who work in biopharma, Richard Paulson got started in the field because of a love of science.

Paulson had just finished business school and was looking to start a career that married his two passions. While looking for jobs, he thought of his grandmother who had struggled with Alzheimer’s disease, recalling how he saw first-hand what innovative medicines can do for patients. Ultimately, he started his first job in the space as a sales rep at Glaxo Wellcome, one of GlaxoSmithKline’s predecessors before its merger with SmithKline Beecham in 2000.

EMA safe­ty com­mit­tee seeks more in­fo on heart in­flam­ma­tion fol­low­ing Pfiz­er Covid-19 vac­cine

The European Medicines Agency’s safety committee said Friday that it’s aware of cases of inflammation of the heart muscle and inflammation of the membrane around the heart, mainly reported following vaccination with Pfizer’s Covid-19 vaccine, known in Europe as Comirnaty.

“There is no indication that these cases are due to the vaccine,” the EMA’s Pharmacovigilance Risk Assessment Committee said.

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