'We strong­ly dis­sent': Women biotech ex­ecs pen let­ter to col­leagues and politi­cians in Roe v. Wade af­ter­math

In the days fol­low­ing the US Supreme Court’s roll­back of fed­er­al abor­tion rights, more than  100 women biotech ex­ec­u­tives came to­geth­er in an open let­ter to con­demn the rul­ing and tell their fel­low drug de­vel­op­ment lead­ers that they “will not stand by silent­ly.”

Ad­dressed to in­dus­try, friends, leg­is­la­tors and elect­ed of­fi­cials, the biotech ex­ec­u­tives said they were join­ing “the re­sound­ing mil­lions in cho­rus” by show­ing their “pro­found dis­may and dis­ap­point­ment” at the de­ci­sion hand­ed down by SCO­TUS last week, a re­ver­sal of Roe v. Wade that had been an­tic­i­pat­ed for weeks fol­low­ing a court leak.

The let­ter — signed by the CEOs of Blade, In­Car­da, Daré Bio­science and a host of oth­er biotechs —  called out the rul­ing’s im­pact on the med­ical prac­ti­tion­ers who are “best suit­ed to pro­vide care.”

Since its orig­i­nal post­ing on Fri­day, the let­ter has grown from about 70 sig­na­to­ries to more than 100, “with mul­ti­ple oth­ers want­i­ng to sign and many view­ing this as a ral­ly­ing point for fur­ther ac­tion,” Re­Code Ther­a­peu­tics CEO Shehnaaz Suli­man told End­points News in an email. The lead­ers said the rul­ing fo­cus­es on the “spe­cial in­ter­ests of the few rather than the in­ter­ests of the ma­jor­i­ty.”

“Abor­tion is re­pro­duc­tive health­care. As doc­tors, sci­en­tists, in­no­va­tors, care­givers, lead­ers and al­lies who are at the fore­front of in­no­va­tion in sci­ence and med­i­cine for the ben­e­fit of pa­tients and women around the world — we de­cry and de­nounce the de­ci­sion by the Court,” the let­ter reads in part.

The let­ter did not point to any de­fin­i­tive or di­rect steps the in­dus­try can take in re­sponse to the rul­ing. Some bio­phar­mas have joined with oth­er com­pa­nies in say­ing they’ll cov­er abor­tion-re­lat­ed trav­el ex­pens­es for em­ploy­ees.

“The mes­sage we have ar­tic­u­lat­ed is one so many women want to add their voice to. The notes I have re­ceived in­clude ex­pres­sions of anger and help­less­ness, but al­so a de­sire to do some­thing and be part of fur­ther ac­tion. I tru­ly hope this let­ter is just the start,” Ju­lia Owens, for­mer Mil­len­do Ther­a­peu­tics CEO, said in an email to End­points News. Mul­ti­ple ad­di­tion­al lead­ers have reached out to Owens ask­ing to add their names, she said.

With dozens of lead­ers from var­i­ous back­grounds join­ing to­geth­er, the let­ter calls for free­dom of choice over one’s own body for every­one, “but es­pe­cial­ly for women, un­der­rep­re­sent­ed mi­nori­ties, and LGBTQIA+ com­mu­ni­ties.”

Shehnaaz Suli­man

In post­ing the let­ter to LinkedIn, Suli­man asked oth­er lead­ers to “join a sea of voic­es to am­pli­fy the call for re­pro­duc­tive health rights for all women.”

A por­tion of the women who signed the let­ter had come to­geth­er for a week­end con­fer­ence in March aimed at form­ing a net­work, spon­sor­ing the next gen­er­a­tion of women lead­ers and map­ping out re­gion­al mee­tups, in­clud­ing one that took place dur­ing BIO last month in San Diego.

In­dus­try lead­ers pre­vi­ous­ly came to­geth­er in Feb­ru­ary to pen a let­ter urg­ing busi­ness lead­ers to “eco­nom­i­cal­ly dis­en­gage from Russ­ian In­dus­try” fol­low­ing the in­va­sion of Ukraine.

Ed­i­tor’s note: This sto­ry was up­dat­ed to in­clude ad­di­tion­al in­for­ma­tion from Ju­lia Owens and Shehnaaz Suli­man.

UP­DAT­ED: In a fresh dis­ap­point­ment, Am­gen spot­lights a ma­jor safe­ty is­sue with KRAS com­bo

Amgen had hoped that its latest study matching its landmark KRAS G12C drug Lumakras with checkpoint inhibitors would open up its treatment horizons and expand its commercial potential. Instead, the combo spurred safety issues that blunted efficacy and forced the pharma giant to alter course on its treatment strategy, once again disappointing analysts who have been tracking the drug’s faltering sales and limited therapeutic reach.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,200+ biopharma pros reading Endpoints daily — and it's free.

Ad­dress­ing the ‘Ca­pac­i­ty Crunch’ with a Scal­able Plat­form Process Ap­proach

The field of gene therapy has been diligently moving forward over the past several decades to bring potentially life-saving treatments to patients with genetic diseases. In addition to two approved adeno-associated viral (AAV) gene therapies, there are more than 250 AAV gene therapies in various clinical trial stages.1 AAV vectors remain the most frequently used vector for delivering therapeutic transgenes to target tissues due to their demonstrated and lasting clinical efficacy and extensive safety track record. As AAV therapies advance through clinical trials and into commercialization, many biotech companies are turning to contract development and manufacturing organizations (CDMOs) to prepare their programs for late-stage clinical and commercial scale manufacturing. Given the scope and scale of the manufacturing needs that will accompany regulatory approvals for these assets, CDMOs continue to expand their capacity to meet the needs of increasing prevalent patient populations. However, despite rapid growth, projected gene therapy manufacturing demands still outpace the collective capacity of the CDMO industry.

A $5B Pfiz­er buy­out? Am­gen, Gilead head­line M&A Thurs­day; Al­ny­lam's AT­TR sweep; An­drew Lo's rare dis­ease quest; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

One of the cool things about adding EndpointsPharma to the daily roster is that my colleagues can now dedicate time to tracking quarterly updates and tuning into calls with Big Pharma companies. Check out their dispatch from the Q2 earnings below.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,200+ biopharma pros reading Endpoints daily — and it's free.

Albert Bourla, Pfizer CEO (Laurent Gillieron/Keystone via AP)

Break­ing: Pfiz­er in hot pur­suit of a $5B buy­out of Glob­al Blood Ther­a­peu­tics — re­port

Pfizer CEO Albert Bourla has vowed to leave no stone unturned in the search for new biotech deals, and the BD team is not letting him down.

The Wall Street Journal reported today that Pfizer is in the final stages of acquiring Global Blood Therapeutics for $5 billion. According to the Journal report, though, Pfizer is not the only buyer at the deal table and while the pharma giant may be close to clinching it, there are no guarantees it will continue.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,200+ biopharma pros reading Endpoints daily — and it's free.

Bob Bradway, Amgen CEO (Justin Kase Conder/AP Images for Amgen)

UP­DAT­ED: Am­gen chief Brad­way nabs a rare dis­ease play­er in $4B buy­out as the M&A tem­po ac­cel­er­ates

Amgen CEO Bob Bradway is bellying up to the M&A table today, scooping up the newly anointed commercial biotech ChemoCentryx $CCXI and its recently approved rare disease drug for $3.7 billion out of the cash stockpile. The deal comes in at $52 a share — a hefty increase over the $24.11 close yesterday.

Bradway and the Amgen team get a drug called Tavneos (avacopan) in the deal, a complement factor C5a inhibitor OK’d to treat anti-neutrophil cytoplasmic autoantibody (ANCA)-vasculitis, an autoimmune disease which can be lethal.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,200+ biopharma pros reading Endpoints daily — and it's free.

George Yancopoulos, Regeneron president and CSO (Brendan McDermid/Reuters/Alamy)

George Yan­copou­los says he's on the trail of the holy grail: ‘This could rep­re­sent the next break­through for im­munother­a­py’

Two of the most outspoken — and successful — drug developers in biotech say they’ve collected early-stage clinical data that are pointing them down the trail to the holy grail in cancer immunotherapy R&D.

While analysts largely busied themselves today with chronicling the ongoing success of Regeneron’s two big cash cows — Dupixent and Eylea — chief scientist George Yancopoulos and CEO Len Schleifer used the Q2 call to spotlight their early success with a combination of the “homegrown” PSMAxCD28 costimulatory bispecific antibody REGN5678 in combination with their PD-1 checkpoint Libtayo. The presentation comes just weeks after Regeneron completed a deal to gather all rights to the PD-1 that had been in Sanofi’s hands. And the two top execs are unstinting in their praise of the potential of a whole set of costimulatory pipeline projects which they say may finally deliver the long-awaited next-level approach to broadening the immunotherapy field of drugs.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

David Hallal (L) and George Daley (Hallal photo: Bertrand Guay/AFP via Getty Images)

David Hal­lal's El­e­vate­Bio launch­es new com­pa­ny to 'dis­rup­t' off-the-shelf cell ther­a­py, but pro­vides few oth­er de­tails

David Hallal’s ElevateBio is launching a new company Thursday as it looks to continue making its mark in the cell and gene therapy spaces. But Hallal is also keeping his cards close to the vest, preferring to toe the line between bombast and mystique rather than going all-in in one direction.

The new company comes out of a partnership with Boston Children’s Hospital and research from George Daley, the dean of Harvard Medical School. The triumvirate claims to have found a way to design better off-the-shelf cell therapies using new methods discovered in Daley’s Boston Children’s Hospital lab (Harvard is not involved in the collaboration).

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,200+ biopharma pros reading Endpoints daily — and it's free.

(AP Photo/Richard Vogel, File)

US de­clares mon­key­pox a na­tion­al health emer­gency, as new drug­mak­ers con­sid­er en­ter­ing vac­cine race

Rising monkeypox cases have put the US on high alert as it announces a national health emergency, which grants the government more power in its response.

The news comes as Bavarian Nordic continues to fill orders for its Jynneos vaccine and other companies – including Moderna – consider jumping into the vaccine race. Meanwhile, the New York Times reports that the US has allowed around 20 million doses of smallpox vaccine in its stockpile to expire.

Vlad Coric, Biohaven CEO

Bio­haven touts surge in Nurtec sales ahead of Pfiz­er takeover

Forget buyer’s remorse, Pfizer is likely feeling pretty good about its $11.6 billion Biohaven takeover deal following reports of a 57% sales boost for migraine med Nurtec.

Biohaven reported in Q2 results on Friday that it’s cleared the necessary antitrust hurdles to move forward with the sale of its calcitonin gene-related peptide (CGRP) assets to Pfizer. However, because the company is “focused on workstreams related to the closing” of the deal, it did not host a call with analysts and investors.