War in Ukraine may re­quire sig­nif­i­cant tri­al changes, EMA says in new guid­ance

As the war in Ukraine rages on, the Eu­ro­pean Med­i­cines Agency is look­ing to help spon­sors of on­go­ing clin­i­cal tri­als nav­i­gate the dis­rup­tions that are ex­pect­ed to con­tin­ue.

But the EMA isn’t ready to put to­geth­er a one-size-fits-all ap­proach for tri­als im­pact­ed by the on­go­ing con­flict.

“At this point in time, it is not pos­si­ble to pro­vide gen­er­al ad­vice on how dif­fer­ent as­pects re­lat­ed to dis­rup­tions caused by the war in Ukraine should be han­dled, as im­pli­ca­tions on clin­i­cal tri­als are ex­pect­ed to be man­i­fold,” the agency said in new guid­ance pub­lished late last week.

While fo­cus­ing on es­ti­mands (i.e. hy­poth­e­sized treat­ment ef­fects), the new guid­ance notes that the emer­gence of new, un­fore­seen dis­rup­tive events may re­quire the re­vi­sion of the pre-spec­i­fied es­ti­mand and/or the ad­di­tion of es­ti­mands may be war­rant­ed. But any sub­stan­tial changes in the de­sign and con­duct of a tri­al should be ap­pro­pri­ate­ly doc­u­ment­ed, and fol­low the lo­cal reg­u­la­tions.

Since the be­gin­ning of the con­flict, 635 tri­als in var­i­ous re­cruit­ing and en­roll­ment stages were on­go­ing in the coun­try, as phar­ma com­pa­nies have al­so been pro­vid­ing aid to the na­tion while ceas­ing any tri­al ac­tiv­i­ty in Rus­sia.

The EMA makes clear that the safe­ty of study par­tic­i­pants is its top pri­or­i­ty, re­gard­less of any po­ten­tial con­se­quences for an on­go­ing tri­al.

When fea­si­ble, the guid­ance says that pa­tients should be of­fered the op­tion to con­tin­ue re­ceiv­ing treat­ment even if this might re­quire un­blind­ing in the tri­al, al­though the EMA sup­ports par­tic­i­pants stay­ing in the tri­al if this does not im­ply a safe­ty risk.

While more se­vere dis­rup­tions are ex­pect­ed for sci­en­tists and com­pa­nies op­er­at­ing in Ukraine, oth­er coun­tries are al­so ex­pect­ed to be af­fect­ed in sev­er­al ways, not just in the col­lec­tion, analy­sis and in­ter­pre­ta­tion of clin­i­cal tri­al da­ta, but the ar­rival of refugees flee­ing from Ukraine and the im­pact of im­posed sanc­tions. The di­rect and in­di­rect im­pact of war-re­lat­ed events on tri­al par­tic­i­pants, sites and lo­gis­tics is al­so like­ly to in­ter­fere with on­go­ing tri­als in sev­er­al coun­tries.

As for Covid-19 tri­als, the EMA en­cour­ages spon­sors to con­sult the EMA’s pre­vi­ous guid­ance on Covid-19 and method­olog­i­cal as­pects of on­go­ing tri­als. Like­wise, it is rec­om­mend­ed to seek sci­en­tif­ic ad­vice ear­ly in the process if sub­stan­tial mod­i­fi­ca­tions to the cur­rent pro­to­col or analy­sis plan are con­sid­ered nec­es­sary.

Any as­pects re­lat­ed to the im­pact of the war on tri­al de­sign el­e­ments, re­cruit­ment, da­ta col­lec­tion, analy­sis and in­ter­pre­ta­tion of re­sults will be thor­ough­ly re­flect­ed up­on dur­ing re­quests for EMA sci­en­tif­ic ad­vice and the as­sess­ment of af­fect­ed clin­i­cal tri­al da­ta sub­mit­ted to the EMA for mar­ket­ing au­tho­riza­tion, the guid­ance says.

Vas Narasimhan (Photographer: Jason Alden/Bloomberg via Getty Images)

No­var­tis de­tails plans to axe 8,000 staffers as Narasimhan be­gins sec­ond phase of a glob­al re­org

We now know the number of jobs coming under the axe at Novartis, and it isn’t small.

The pharma giant is confirming a report from Swiss newspaper Tages-Anzeiger that it is chopping 8,000 jobs out of its 108,000 global staffers. A large segment will hit right at company headquarters in Basel, as CEO Vas Narasimhan axes some 1,400 of a little more than 11,000  jobs in Switzerland.

The first phase of the work is almost done, the company says in a statement to Endpoints News. Now it’s on to phase two. In the statement, Novartis says:

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How pre­pared is bio­phar­ma for the cy­ber dooms­day?

One of the largest cyberattacks in history happened on a Friday, Eric Perakslis distinctly remembers.

Perakslis, who was head of Takeda’s R&D Data Sciences Institute and visiting faculty at Harvard Medical School at the time, had spent that morning completing a review on cybersecurity for the British Medical Journal. Moments after he turned it in, he heard back from the editor: “Have you heard what’s going on right now?”

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Sanofi to cut in­sulin prices for unin­sured from $99 to $35, match­ing the in­sulin cap com­ing through Con­gress

As the House-passed bill to cap the monthly price of insulin at $35 nationwide makes its way for a Senate vote soon, Sanofi announced Wednesday morning that beginning next month it will cut the monthly price of its insulins for uninsured Americans to $35, down from $99 previously.

The announcement from Sanofi, which allows the uninsured to buy one or multiple Sanofi insulins (Lantus, Insulin Glargine U-100, Toujeo, Admelog, and Apidra) at $35 for a 30-day supply effective July 1, follows House passage (232-193) of the monthly cap in March, with just 12 Republicans voting in favor of the measure.

Bob Nelsen (Lyell)

As bear mar­ket con­tin­ues to beat down biotech, ARCH clos­es a $3B ear­ly-stage fund

One of the biggest names in biotech investing has a whole lot of new money to spend.

ARCH Venture Partners closed its 12th venture fund early Wednesday morning, the firm said, bringing in almost $3 billion to invest in early-stage biotechs. The move comes about a year and a half after ARCH announced its previous fund, for almost $2 billion back in January 2021.

In a statement, ARCH managing director and co-founder Bob Nelsen appeared to brush off concerns about the broader market troubles, alluding to the downturn that’s seen several biotechs downsize and the XBI fall back to almost pre-pandemic levels.

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Lina Gugucheva, NewAmsterdam Pharma CBO

Phar­ma group bets up to $1B-plus on the PhI­II res­ur­rec­tion of a once dead-and-buried LDL drug

Close to 5 years after then-Amgen R&D chief Sean Harper tamped the last spade of dirt on the last broadly focused CETP cholesterol drug — burying their $300 million upfront and the few remaining hopes for the class with it — the therapy has been fully resurrected. And today, the NewAmsterdam Pharma crew that did the Lazarus treatment on obicetrapib is taking another big step on the comeback trail with a €1 billion-plus regional licensing deal, complete with close to $150 million in upfront cash.

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(AP Photo/Gemunu Amarasinghe)

Some phar­ma com­pa­nies promise to cov­er abor­tion-re­lat­ed trav­el costs — while oth­ers won't go that far yet

As the US Department of Health and Human Services promises to support the millions of women who would now need to cross state lines to receive a legal abortion, a handful of pharma companies have said they will pick up employees’ travel expenses.

GSK, Sanofi, Johnson & Johnson, BeiGene, Alnylam and Gilead have all committed to covering abortion-related travel expenses just four days after the Supreme Court overturned Roe v. Wade and revoked women’s constitutional right to an abortion.

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Aurobindo Pharma co-founders P. V. Ram Prasad Reddy (L) and K. Nityananda Reddy

Au­robindo Phar­ma re­ceives warn­ing let­ter from In­di­a's SEC fol­low­ing more FDA ques­tion marks

Indian-based generics manufacturer Aurobindo Pharma has been in the crosshairs of the FDA for several years now, but the company is also attracting attention from regulators within the subcontinent.

According to the Indian business news site Business Standard, a warning letter was sent to the company from the Securities Exchange Board of India, or SEBI.

The letter is related to disclosures made by the company on an ongoing FDA audit of the company’s Unit-1 API facility in Hyderabad, India as well as observations made by the US regulator between 2019 and 2022.

Bristol Myers Squibb (Alamy)

CVS re­sumes cov­er­age of block­buster blood thin­ner af­ter price drop fol­lows Jan­u­ary ex­clu­sion

Following some backlash from the American College of Cardiology and patients, Bristol Myers Squibb and Pfizer lowered the price of their blockbuster blood thinner Eliquis, thus ensuring that CVS Caremark would cover the drug after 6 months of it being off the major PBM’s formulary.

“Because we secured lower net costs for patients from negotiations with the drug manufacturer, Eliquis will be added back to our template formularies for the commercial segment effective July 1, 2022, and patient choices will be expanded,” CVS Health said in an emailed statement. “Anti-coagulant therapies are among the non-specialty products where we are seeing the fastest cost increases from drug manufacturers and we will continue to push back on unwarranted price increases.”

#Can­nes­Lions2022: Con­sumer health ex­ecs call on agen­cies to in­volve pa­tients in cre­ative process

CANNES — When Tamara Rogers joined GSK back in 2018, “science was king and R&D were the gods.” Now the global chief marketing officer of consumer healthcare wants to make room for another supreme being: the consumer.

As health and wellness becomes more relevant to consumers amid the pandemic, four health-focused executives called on marketers to involve patients in their creative process in a panel discussion at the Cannes Lions advertising creativity festival.

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