Type 2 diabetes drugs and weight loss: Calibrate's model starts with pharma and builds out – Endpoints News

Calibrate is looking to upend the weight loss industry. And thanks to the drug industry, it’s got a secret weapon – GLP-1 meds.
Over the past few years, next-generation Type 2 diabetes treatments have often chatted up the weight-loss side benefit in TV commercials. Actors and patients in ads have often said things like, “And I may even lose a little weight,” across campaigns for the glucagon-like peptide-1 brands such as Eli Lilly’s Trulicity and Novo Nordisk’s Victoza, Ozempic and Rybelsus.
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Last month, Septerna, Inc., became the latest in a recent string of new biotechs to launch by building on cryo-electron microscopy (cryo-EM) and other transformative platform technologies, to deliver novel therapeutics for new and well-validated drug targets alike. With financing led by Third Rock Ventures, Septerna, Inc., closed a $100M Series A financing round to leverage its proprietary Native Complex Platform for cryo-EM enabled structure-based drug design, to target native G protein-coupled receptors (GPCRs) with novel small molecule medicines, covering a wide range of therapeutic areas.
Eli Lilly’s latest Verzenio ad campaign aims to reach newly diagnosed women with breast cancer — four months after the brand got its first nod in early-stage disease.
A “Make Your Way” campaign TV ad opens with a woman walking on a beach who specifically mentions node-positive breast cancer. Lilly’s narrow approval for Verzenio in early stage is for relapse in patients with high-risk HR-positive, HER2-negative breast cancer. Still, the CDK4/6 inhibitor is the first in class approved for early stage, one of only a few current-generation drugs with an early treatment green light.
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Sanofi is calling on the FDA to change the labels for CSL Limited subsidiary Seqirus’ flu vaccines, which won accelerated approvals but have failed to confirm clinical benefit.
In a crowded flu vaccine market, in which Sanofi’s flu business pulled in more than $2.8 billion in 2021, two of Seqirus’ flu vaccines include Fluad, which is an adjuvanted seasonal aTIV vaccine that won accelerated approval in Nov. 2015, and Fluad Quadrivalent, which is a formulation of the original that won accelerated approval via an sBLA in Feb. 2020.
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A new patent challenge to Aurinia Pharmaceuticals’ lupus nephritis drug Lupkynis is adding to the biopharma’s woes this week. Sun Pharmaceutical is challenging Aurinia’s “treatment protocol” patent, the company revealed in a 10-K filing this week first reported by STAT.
Aurinia pushed back on the news report, pointing out, in a statement to Endpoints News, that the patent has already been through “significant review” with the US Patent and Trademark Office before Lupkynis was approved by the FDA in January 2021.
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As millions of insulin-dependent Americans have seen their out-of-pocket costs soar over the last few years, the market controlled by the three big insulin manufacturers — Sanofi, Eli Lilly and Novo Nordisk — is ripe for disruption.
And that’s just what nonprofit generic drugmaker Civica is looking to do, with plans to manufacture and market three of the most common forms of insulin: glargine, lispro and aspart. Perhaps most importantly, the company says it plans to set the price of each insulin to the consumer at no more than $30 per vial and no more than $55 for a box of five pen cartridges.
The layoffs at Biogen have begun.
In the wake of a controversial approval for its Alzheimer’s drug Aduhelm, Biogen started informing employees Wednesday that their roles were being eliminated, the big biotech said in a statement, as part of a cost-cutting plan implemented in December. Biogen is giving no details on the exact number of layoffs, a practice that falls outside the standard procedure of publicly traded companies even though they are not legally required to do so.
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Last year, Pfizer stopped distribution of megablockbuster smoking cessation drug Chantix over an increased level of carcinogenic nitrosamines.
Now, two of the Big Pharma’s blood pressure drugs have been recalled in Canada this week after Canada’s health authority found levels of a type of nitrosamine too high to be allowed in the drugs.
Pfizer Canada recalled all 8 lots of blood pressure drug Accuretic yesterday after higher-than-approved levels of N-nitroso-quinapril were found. That recall was just two days after the pharma subsidiary recalled 15 lots of Inderal-LA, another blood pressure drug, over similar concerns over nitrosamines.
As experimental treatments for Huntington’s disease continue to suffer setbacks, Novartis is outlining a plan for a repurposed SMA drug it hopes can break pharma’s losing streak.
In a new paper published to Nature Communications, Novartis scientists detailed how a small molecule called branaplam lowers the overall level of mutant gene expressed in Huntington’s mouse brains and in neurons taken from Huntington’s patients, potentially helping curb disease progression. On top of that, researchers say the therapeutic effects appear short-lasting and reversible, suggesting the drug may eventually prove safe too.
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Bayer has signed a deal to pump $1.53 billion into expanding the manufacturing operations in Bergkamen, Berlin, Leverkusen, Weimar and Wuppertal.
The deal will help establish hubs for innovative research methods and digital technology, as well as the modernization of facilities and more intensive collaboration with universities and startups.
“We are thus giving the employees in Germany much-needed orientation and creating the basis for competitive, sustainable and growing employment in Germany,” Oliver Zühlke, the chairman of the Bayer Geneal Works Council, said in a translated statement. “At the same time, we want to strengthen Bayer’s global competitiveness and innovative strength from Germany and support the group in achieving its growth targets.”
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