Covid-19 has roiled clin­i­cal tri­al plans around the world, rais­ing con­cerns over the in­dus­try’s fu­ture on new drug ap­provals

Over the past 4 months, a group of an­a­lysts at Glob­al­Da­ta tracked 322 bio­phar­ma com­pa­nies — biotechs, phar­mas, CROs and such — re­port­ing on the trou­ble Covid-19 has caused for their clin­i­cal de­vel­op­ment plans.

Slight­ly more than half — 179 — are US op­er­a­tions, with about 1 in 4 scat­tered through­out Eu­rope and in Cana­da. And the dis­rup­tions are clus­tered around mid-stage de­vel­op­ment, though a hefty num­ber of late-stage de­rail­ments may well blunt the stream of ap­provals down the road.

“The ma­jor­i­ty of dis­rupt­ed clin­i­cal tri­als are in Phase II, at 44.8%, fol­lowed by Phase I with 26.1%, Phase III with 21.7%, and Phase IV with 7.4%,” says Brooke Wil­son, as­so­ciate di­rec­tor, tri­als in­tel­li­gence at Glob­al­Da­ta. “Of these tri­als, 12% are specif­i­cal­ly Piv­otal/Reg­is­tra­tional, giv­ing an in­di­ca­tion that there will be an im­pact on reg­u­la­to­ry ap­provals in the fu­ture.”

Glob­al­Da­ta al­so con­clud­ed that:

(T)he ma­jor­i­ty of dis­rupt­ed clin­i­cal tri­als — 67.3% — were due to the sus­pen­sion of en­roll­ment. The de­layed ini­ti­a­tion of planned tri­als fol­lows at 18.4%, then, fi­nal­ly, 14.4% of tri­als are cur­rent­ly be­ing im­pact­ed due to slow en­roll­ment. With­in the 14.4% of tri­als af­fect­ed by slow en­roll­ment, 20.7% of these are specif­i­cal­ly due to the avail­abil­i­ty of sites and in­ves­ti­ga­tors.

The big fo­cus now will be how fast the de­vel­op­ers can move these de­layed tri­als along, or re­place them with fresh ef­forts. Reg­u­la­to­ry groups on both sides of the At­lantic have been help­ing out with new rules that al­low tri­als to con­tin­ue, when pos­si­ble, with home drug de­liv­ery and at-home mon­i­tor­ing and the use of telemed­i­cine a more com­mon fea­ture.

Al­so of note, while we’ve seen plen­ty of ev­i­dence of wide­spread dis­rup­tion, a host of bio­phar­ma com­pa­nies have been ramp­ing up new work on drugs and vac­cines for Covid-19, strik­ing a whole new set of deals and di­vert­ing re­sources to new pro­grams. So it’s not a ze­ro-sum game.

Glob­al­Da­ta has been track­ing more than 700 drugs — from dis­cov­ery through piv­otal pro­grams — linked to Covid-19. “There are now over 2,000 clin­i­cal tri­als glob­al­ly – 398 of these clin­i­cal tri­als are for chloro­quine or hy­drox­y­chloro­quine and 22 of these tri­als are for remde­sivir,” the com­pa­ny re­port­ed a week ago. “There are al­so over 583 com­pa­nies and in­sti­tu­tions dri­ving pro­phy­lac­tic and cu­ra­tive in­no­va­tion.”

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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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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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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.

UP­DAT­ED: 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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As­traZeneca caps PD-L1/CT­LA-4/chemo com­bo come­back with OS win. Is treme­li­mum­ab fi­nal­ly ready for ap­proval?

AstraZeneca’s closely-watched POSEIDON study continues to be the rare bright spot in its push for an in-house PD-L1/CTLA-4 combo.

Combining Imfinzi and tremelimumab with physicians’ choice of chemotherapy helped patients with stage IV non-small cell lung cancer live longer, the company reported — marking the first time the still-experimental tremelimumab has demonstrated an OS benefit.

For AstraZeneca and CEO Pascal Soriot, the positive readout — which is devoid of numbers — offers much-needed validation for the big bet they made on Imfinzi plus tremelimumab, after the PD-L1/CTLA-4 regimen failed multiple trials in head and neck cancer as well as lung cancer.

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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.

Ron DePinho (file photo)

A 'fly­over' biotech launch­es in Texas with four Ron De­Pin­ho-found­ed com­pa­nies un­der its belt

In his 13 years at Genzyme, Michael Wyzga noticed something about East Coast drugmakers. Execs would often jet from Boston or New York to San Francisco to find more assets, and completely miss the work being done in flyover states, like Texas or Wisconsin.

“If it doesn’t come out of MGH or MIT or Harvard, probably not that interesting,” he said of the mindset.

Now, he and some well-known industry players are looking to change that, and they’ve reeled in just over $38 million to do it.

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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.