Tergus ribbon cutting ceremony

CD­MO Ter­gus cuts the rib­bon on Durham plant, lat­est in a line of com­pa­nies pack­ing in­to the emerg­ing NC hub

Among the fastest-grow­ing biotech hubs in the US, North Car­oli­na has seen a flur­ry of in­vest­ments from drug­mak­ers, par­tic­u­lar­ly con­tract man­u­fac­tur­ers. Now, an­oth­er CD­MO is plant­i­ng its flag near the Raleigh-Durham cor­ri­dor, lever­ag­ing the grow­ing brain trust in the area.

This week, Ter­gus Phar­ma cut the rib­bon on a 100,000-square-foot head­quar­ters and CD­MO fa­cil­i­ty in Durham, NC. The new fa­cil­i­ty will house four R&D labs, six man­u­fac­tur­ing suites and six fill-fin­ish and pack­ag­ing suites. The com­pa­ny’s goal is lofty: be­come the largest top­i­cal drug CD­MO in the US.

The Tar Heel State has turned in­to a re­cruit­ment ma­chine for the biotech in­dus­try — and that’s not an ac­ci­dent, Gov. Ray Coop­er said at the rib­bon cut­ting cer­e­mo­ny.

“When you look at the syn­er­gy that we have in biotech­nol­o­gy here in North Car­oli­na, you know that we are the place to be. When you look at the qual­i­ty of life, when you look at the amaz­ing work­force, when you see our great uni­ver­si­ties both pub­lic and pri­vate, along with our com­mu­ni­ty col­leges, you know that this is the place to be,” he said.

Ear­li­er this week, Chi­nese on­col­o­gy play­er CARs­gen Ther­a­peu­tics threw its hat in­to the North Car­oli­na ring, with the an­nounce­ment of two new sites in Raleigh-Durham, and the cre­ation of its first man­u­fac­tur­ing hub in the US. In April, In­vi­tae chose North Car­oli­na over Wash­ing­ton, DC; Boston; and Austin, Texas, drawn by the life sci­ences com­mu­ni­ty that In­vi­tae COO Ken Knight said will be easy to tap in­to for em­ploy­ees, and a need for a lo­ca­tion on the east coast of the US.

Be­fore that, CD­MO Abzena an­nounced the ad­di­tion of a new fa­cil­i­ty, and Fu­ji­film Diosynth and Bio­gen too. Those are just the deals that have been an­nounced with­in the last two months.

“We’re on a hot streak, folks,” Coop­er said at the Ter­gus cer­e­mo­ny. “And it’s go­ing to keep go­ing as long as we can keep the tal­ent­ed work­force avail­able for com­pa­nies like this that are grow­ing and thriv­ing in North Car­oli­na.”

Un­lock­ing ESG strate­gies for growth with Gilead Sci­ences

RBC Capital Markets explores what is material in ESG for biopharma companies with the ESG leads at Gilead Sciences. Gilead has long focused on sustainability but recognized a more robust framework was needed. Based on a materiality assessment, Gilead’s ESG strategy today focuses first on drug access and pricing, while also addressing D&I and climate change. Find out why Gilead’s board is “acutely aware” of the contribution that ESG makes to firm’s overall success.

On the hunt for the next Mod­er­na, in­vestors have pumped 'plat­form plays' with cash. Can any­thing slow the run­away train?

It didn’t take an expert to see that mRNA platforms could be huge.

Julie Sunderland partnered with both Moderna and BioNTech about a decade ago while she was running program-related investments for the Bill & Melinda Gates Foundation — and even then the potential for their platforms was obvious despite some well-founded concerns about whether the next-gen tech would ever cross the finish line.

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Sen. Ron Wyden (D-OR) with reporters in the Senate Subway (Graeme Sloan/Sipa via AP Images)

Top Wyden pri­or­i­ty for drug price re­forms: Medicare ne­go­ti­a­tions

As the Biden administration tries to wrangle the details of its infrastructure bill, Senate Finance Committee Chair Ron Wyden (D-OR) took a concrete step forward on drug pricing reforms on Tuesday and unveiled five principles for such reforms, including providing Medicare with the ability to negotiate prices.

“Allowing the Secretary of HHS to negotiate the price Medicare will pay creates a much needed mechanism to achieve fairer prices when the market has failed to do so,” Wyden wrote.

End­points News is now 5 years old. Here's how you can sup­port us for the next phase of growth

Endpoints News turned five years old over the weekend. I wanted to mark the happy occasion by extending our deepest gratitude to Endpoints’ premium subscribers while outlining several other ways to support us as we go broader and get bigger this year and beyond.

Same as any business, we’ve got to create value and get paid for delivering it. So if you depend on Endpoints to stay abreast on biopharma developments, we depend on you too.

Emma Walmsley, GlaxoSmithKline CEO (Credit: Fang Zhe/Xinhua/Alamy Live News)

Ac­tivist in­vestor El­liott in talks with oth­er Glax­o­SmithK­line in­vestors about re­plac­ing Em­ma Walm­s­ley, spin­ning off vac­cine busi­ness — re­port

As Emma Walmsley reveals details this Wednesday about the upcoming split of GlaxoSmithKline’s pharma and consumer units, some tough questions may be coming her way.

Elliott Management, the activist investor that’s previously threatened an attack on GSK (but eventually backed off), is floating more radical changes like replacing the CEO, further breaking up the company and spinning out the vaccine unit, or reviewing the focus on cancer drugs, the Financial Times reported.

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Fred Upton and Diana DeGette

New DARPA-like NIH agency preps for re­al­i­ty as E&C un­veils bi­par­ti­san Cures 2.0 draft bill

House Energy & Commerce leaders Fred Upton (R-MI) and Diana DeGette (D-CO) on Tuesday released new draft legislation with wide-ranging implications for public health, the FDA, NIH, and that would create a new, $6.5 billion federal advanced research agency under NIH, with an aim to cure cancer, Alzheimer’s and other difficult diseases.

Similar to DARPA, the new NIH division to be known as ARPA-H, would be run by a small group of program managers with more latitude to pursue high-risk, high-reward projects that other government agencies would likely shy away from.

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Ken Frazier, Merck CEO (Bess Adler/Bloomberg via Getty Images)

Mer­ck­'s Keytru­da blazes a path in first-line cer­vi­cal can­cer, mak­ing good on drug­mak­er's push for ear­li­er pa­tients

In the years since I/O wonder drug Keytruda’s initial approval, Merck has struck an aggressive clinical trial program, which is now firmly focused on earlier lines of therapy. The drugmaker has scored some success there so far, and now it’s earned one of its biggest wins yet.

Keytruda plus chemotherapy with or without background Avastin significantly extended patients’ lives over those dosed with a placebo control in first-line patients with persistent, recurrent or metastatic cervical cancer, according to top-line data from the Phase III KEYNOTE-826 study revealed Tuesday.

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Kimberly Smith, ViiV via Youtube

They went from dai­ly to once every two months. But how much longer act­ing can HIV meds be? Vi­iV en­lists Halozyme's tech to find out

It wasn’t easy navigating the manufacturing and controls issues that had led the FDA to reject ViiV Healthcare’s first pitch for the once-monthly HIV regimen cabotegravir and rilpivirine. But even as Kimberly Smith was knee-deep in sorting out those problems and putting together a new package that finally won the regulators over this January, her business development team kept looking for things that would take them to the next level.

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Roche's Alzheimer's drug spurred bio­mark­er changes but no cog­ni­tive im­pact — pa­per; vTv out-li­cens­es for­mer lead pro­gram

More than a year ago, Roche and Eli Lilly were forced to contend with a Phase II/III failure of their respective Alzheimer’s drugs. But while Eli Lilly essentially threw in the towels, Roche wasn’t ready to give up yet.

The Swiss drugmaker now has some biomarker data to spotlight as investigators continue monitoring patients in an open-label extension study.

Dubbed DIAN-TU, the study had been designed to see whether Roche’s gantenerumab and Lilly’s solanezumab could spur a cognitive benefit for a group of patients who had a rare, inherited form of Alzheimer’s that’d tied to early-onset. In short, they didn’t: Both failed the primary endpoint.