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.”

So­cial: Get­ty Im­ages

For a look at all End­points News coro­n­avirus sto­ries, check out our spe­cial news chan­nel.

IDC: Life Sci­ences Firms Must Em­brace Dig­i­tal Trans­for­ma­tion Now

Pre-pandemic, the life sciences industry had settled into a pattern. The average drug took 12 years and $2.9 billion to bring to market, and it was an acceptable mode of operations, according to Nimita Limaye, Research Vice President for Life Sciences R&D Strategy and Technology at IDC.

COVID-19 changed that, and served as a proof-of-concept for how technology can truly help life sciences companies succeed and grow, Limaye said. She recently spoke about industry trends at Egnyte’s Life Sciences Summit 2022. You should watch the entire session, free and on-demand, but here’s a brief recap of why she’s urging life sciences companies to embrace digital transformation.

Tom Barnes, Orna Therapeutics CEO

UP­DAT­ED: 'We have failed to fail': Mer­ck gam­bles $250M cash on a next-gen ap­proach to mR­NA — af­ter punt­ing its big al­liance with Mod­er­na

Merck went in deep on its collaboration with Moderna on new mRNA programs, and dropped them all over time, including their RSV partnership. But after writing off what turned out as one of the most successful infectious disease players in the business, Merck is coming in this morning with a new preclinical alliance — this time embracing a biotech that hopes to eventually outdo the famously successful mRNA in a new run at vaccines and therapeutics.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 148,200+ biopharma pros reading Endpoints daily — and it's free.

Bayer's first DTC ad campaign for chronic kidney disease drug Kerendia spells out its benefits

Bay­er aims to sim­pli­fy the com­plex­i­ties of CKD with an ABC-themed ad cam­paign

Do you know the ABCs of CKD in T2D? Bayer’s first ad campaign for Kerendia tackles the complexity of chronic kidney disease with a play on the acronym (CKD) and its connection to type 2 diabetes (T2D).

Kerendia was approved last year as the first and only non-steroidal mineralocorticoid receptor antagonist to treat CKD in people with type 2 diabetes.

In the TV commercial launched this week, A is for awareness, B is for belief and C is for cardiovascular, explained in the ad as awareness of the connection between type 2 and kidney disease, belief that something can be done about it, and cardiovascular events that may be reduced with treatment.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 148,200+ biopharma pros reading Endpoints daily — and it's free.

James Mock, incoming CFO at Moderna

Mod­er­na taps new CFO from PerkinElmer af­ter for­mer one-day CFO oust­ed

When Moderna hired a new CFO last year,  it didn’t expect to see him gone after only one day. Today the biotech named his — likely much more vetted — replacement.

The mRNA company put out word early Wednesday that after the untimely departure of then brand-new CFO Jorge Gomez, it has now found a replacement in James Mock, the soon-to-be former CFO at diagnostics and analytics company PerkinElmer.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 148,200+ biopharma pros reading Endpoints daily — and it's free.

Kate Haviland, Blueprint Medicines CEO

Blue­print met all its end­points in bid for ex­pand­ed Ay­vak­it la­bel — but stock trends low­er any­way

Blueprint Medicines announced this morning that the second part of its study on Ayvakit in non-advanced systemic mastocytosis (SM) — a rare disease in which a type of white blood cells known as mast cells builds up — met all endpoints, but the biopharma left key questions unanswered.

In 212 patients, with 141 in the treatment arm and 71 in the control arm, patients who got Ayvakit saw an average 15.6-point decrease in their symptom scores compared to a 9.2-point decrease in the placebo arm at 24 weeks. In an extension study, those on Ayvakit saw their symptom scores drop by 20.2 points by week 48.

Paul Hudson, Sanofi CEO (Eric Piermont/AFP via Getty Images)

Up­dat­ed: Hit by an­oth­er PhI­II flop, Sanofi culls breast can­cer drug — sound­ing alarm for the class

Sanofi is officially giving up on its oral SERD.

The French drugmaker put out word Wednesday morning that it will discontinue the global development program of amcenestrant, the selective estrogen receptor degrader once billed as a top late-stage prospect. Having already failed a Phase II monotherapy test earlier this year, a combo with the drug also missed the bar in a second trial for breast cancer, triggering the decision to drop the whole program.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 148,200+ biopharma pros reading Endpoints daily — and it's free.

Etleva Kadilli, director of UNICEF’s supply division

GSK lands first-ever UNICEF con­tract for malar­ia vac­cine worth $170M

GSK has landed a new first from UNICEF the first-ever contract for malaria vaccines, worth up to $170 million for 18 million vaccine doses distributed over the next three years.

The vaccine, known as Mosquirix or RTS,S, won WHO’s backing last October after a controversial start, but UNICEF said these doses will potentially save thousands of lives every year.

“We hope this is just the beginning,” Etleva Kadilli, director of UNICEF’s supply division, said. “Continued innovation is needed to develop new and next-generation vaccines to increase available supply, and enable a healthier vaccine market. This is a giant step forward in our collective efforts to save children’s lives and reduce the burden of malaria as part of wider malaria prevention and control programmes.”

Joe Jonas (Photo by Anthony Behar/Sipa USA)(Sipa via AP Images)

So­lo Jonas broth­er car­ries Merz's new tune in Botox ri­val cam­paign

As the lyrics of his band’s 2019 pop-rock single suggest, Joe Jonas is only human — and that means even he gets frown lines. The 33-year-old singer-songwriter is Merz’s newest celebrity brand partner for its Botox rival Xeomin, as medical aesthetics brands target a younger audience.

Merz kicked off its “Beauty on Your Terms” campaign on Tuesday, featuring the Jonas brother in a video ad for its double-filtered anti-wrinkle injection Xeomin.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 148,200+ biopharma pros reading Endpoints daily — and it's free.

Paul Perreault, CSL Behring CEO

CSL CEO Paul Per­reault de­ter­mined to grow plas­ma col­lec­tion af­ter full-year sales dip

As the ink dries on CSL’s $11.7 billion Vifor buyout, the company posted a dip in profits, due in part to a drop in plasma donations amid the pandemic.

However, CEO Paul Perreault assured investors and analysts on the full-year call that the team has left “no stone unturned” when assessing options to grow plasma volumes. The chief executive also spelled out positive results for the company’s monoclonal antibody garadacimab in hereditary angioedema (HAE), though he isn’t revealing the exact numbers just yet.