Bob Nelsen (Getty Images)

Bob Nelsen ex­its board and pres­i­dent steps down at Uni­ty as fall­out from the an­ti-ag­ing biotech's PhII miss con­tin­ues

Uni­ty Biotech­nol­o­gy is still reel­ing rough­ly four months af­ter ax­ing its lead pro­gram, as it saw sig­nif­i­cant change at the ex­ec­u­tive lev­el Mon­day.

The com­pa­ny an­nounced that ARCH Ven­ture Part­ners’ Bob Nelsen, one of Uni­ty’s co-founders back in 2011, has left the board. In ad­di­tion, pres­i­dent and co-founder Ned David is step­ping down at the end of the year, and an­oth­er board mem­ber, David Lacey, is al­so leav­ing the biotech.

With the de­par­tures, Uni­ty is ap­point­ing Gilmore O’Neill to the board to chair the com­pa­ny’s sci­ence com­mit­tee.

“We are in­cred­i­bly grate­ful to Ned, Bob and Dave for their ser­vice,” chair­man Kei­th Leonard said in a state­ment. “Ned’s ear­ly re­search in­to fun­da­men­tal path­ways of ag­ing bi­ol­o­gy form the foun­da­tion of UNI­TY. Bob played an in­stru­men­tal role in cre­at­ing and shap­ing a com­pa­ny tar­get­ing dis­eases of ag­ing, and David’s drug dis­cov­ery in­sights have shaped our pipeline.”

Mon­day’s moves were not the first de­par­tures since Uni­ty’s lead pro­gram flopped a ma­jor Phase II in os­teoarthri­tis of the knee in Au­gust. That whiff set this re­struc­tur­ing in mo­tion, and Nelsen had long been one of the head­lin­ers in a celebri­ty group of in­vestors that al­so in­clud­ed Jeff Be­zos and Pe­ter Thiel. Uni­ty had raised more than $200 mil­lion over the last decade, hop­ing its big-name part­ners could vault it to the fore­front of the buzzy an­ti-ag­ing field.

The com­pa­ny pre­vi­ous­ly said in Sep­tem­ber it was slash­ing its work­force by 30% in or­der to con­tin­ue its re­fo­cus­ing to­ward oph­thal­mol­o­gy and neu­rol­o­gy, putting the San Fran­cis­co-based biotech on track to em­ploy 75 full-timers by the end of 2020.

Au­gust’s tri­al miss it­self in­volved a 183-per­son study for what was then Uni­ty’s on­ly clin­i­cal pro­gram, UBX0101. Pa­tients in the treat­ment arms showed vir­tu­al­ly no dif­fer­ence com­pared to those tak­ing place­bo, and the can­di­date didn’t even reg­is­ter a dose-de­pen­dent re­sponse.

On­ly pa­tients who re­ceived the low­est dose nu­mer­i­cal­ly out­per­formed the con­trol, but the p-val­ue clocked in at an abysmal p=0.52.

Uni­ty’s big the­o­ry re­volves around what are known as senes­cent cells — non-di­vid­ing cells that clut­ter an ag­ing body. Uni­ty says the buildup in such cells is as­so­ci­at­ed with the re­lease of dozens of pro­teins that pro­mote in­flam­ma­tion, and re­mov­ing them, with­out al­ter­ing the bal­ance of cells the body needs, could pro­mote a longer, health­i­er life.

With the os­teoarthri­tis pro­gram scrapped, Uni­ty is now fo­cus­ing on a dif­fer­ent group of senes­cent cells for eye dis­eases. The next ex­per­i­men­tal drug is UBX1325, which is de­signed to tar­get Bcl-xL. And if all goes ac­cord­ing to plan, Uni­ty ex­pects to dose the first pa­tients in a Phase I study for the can­di­date lat­er this year.

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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Scoop: Boehringer qui­et­ly shut­ters a PhII for one of its top drugs — now un­der re­view

Boehringer Ingelheim has quietly shut down a small Phase II study for one of its lead drugs.

The private pharma player confirmed to Endpoints News that it had shuttered a study testing spesolimab as a therapy for Crohn’s patients suffering from bowel obstructions.

A spokesperson for the company tells Endpoints:

Taking into consideration the current therapeutic landscape and ongoing clinical development programs, Boehringer Ingelheim decided to discontinue our program in Crohn’s disease. It is important to note that this decision is not based on any safety findings in the clinical trials.

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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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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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Photo: Clara Bui for Endpoints News

#Can­nes­Lions2022: Phar­ma and health mar­keters lose spot­light at cre­ativ­i­ty ad fest, but does it mat­ter?

Pharma advertising has long been considered second-tier when compared to the rest of the advertising industry. And there are some legitimate reasons why. Nike sneakers and Coca-Cola soda ads will likely always be more entertaining or exciting than regulated campaigns for diabetes and heart disease.

Still, the Cannes Lions advertising festival of creativity was pharma and healthcare advertising’s annual chance to shine. For the past eight years, pharma agencies and clients stood side by side with consumer companies and agency hotshots on the biggest advertising award stage in the world at the Palais in Cannes, France.