Discussions about climate change often revolve around temperature changes and more turbulent weather-related conditions. However, there’s an under-discussed related effect on human health. AstraZeneca wants to emphasize that issue and spur more conversations with a corporate campaign now rolling out around sustainability and science.
At the heart of the new “Science Can” effort is a two-minute short film that lays out the connection between climate change and public health.
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Key takeaways:
The data supporting regulatory approval alone are often insufficient for demonstrating the added benefit of a new therapy
Planning in advance to continuously deliver data that illustrate value and post-launch, to not only the regulator, but payers, healthcare professionals, and patients results in more clinically meaningful benefits
By working cross-functionally, biopharmaceutical teams can uncover evidence gaps and better shape registration trials to ensure the needs of as many stakeholders as possible are met
Attempting to push forward an ALS drug despite a failed Phase III study, Biogen saw its FDA review date delayed Monday.
The big biotech announced that the agency pushed back its decision deadline by three months to April 25, 2023 for tofersen, an antisense drug designed to treat a genetic subset of ALS. Biogen had previously received priority review for the application, which will fall under the accelerated approval pathway.
On a continual search for more baskets to put its oncology eggs in, Gilead has landed on a hot target: CD123.
Specifically, Gilead is grabbing a bispecific antibody from MacroGenics, a seasoned biotech player that’s seen its share of setbacks. For $60 million upfront, Gilead buys an exclusive option to license MGD024 after MacroGenics wraps up the ongoing Phase I study and calls dibs on two other early-stage bispecific research programs.
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SpringWorks Therapeutics is tackling the little-known and misunderstood rare desmoid tumor condition — and connecting with patients.
Striking images on the “Rethink Desmoid Tumors” campaign website show the unpredictable and tendril-like desmoid tumors growth. The landing page shows a woman sitting on the floor holding her right bicep while a long wiry root-like growth winds out and across the floor in front of her.
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NGM Bio just found itself on the bad end of a clinical trial readout, and investors are responding harshly.
The San Francisco biotech and long-standing Merck partner reported that a sham-controlled Phase II trial investigating a monoclonal antibody for geographic atrophy, a late stage version of dry age-related macular degeneration, did not meet the primary endpoint.
Over 52 weeks, the biotech injected its candidate, NGM621, into the back of the eye once every four weeks in 108 patients and once every eight weeks in 104 patients — adding four weeks in the end for additional monitoring. While the injections showed a reduction in the rate of change in GA lesion size by 6.3% and 6.5% compared to the 106 patients on placebo, neither arm reached statistical significance.
The writing was on the wall.
The FDA spelled out its qualms with Minerva Neurosciences’ schizophrenia drug candidate roluperidone in 2020. Nevertheless, the biotech pushed forward and had meetings with the regulator to attempt to assuage concerns and get its drug to market.
So the biotech went ahead and, in August, asked the drug regulator to approve the treatment for negative symptoms in people with schizophrenia.
Moderna is calling it quits on its current agreement with Gavi, the Vaccine Alliance, meaning an original deal for up to 500 million doses of the mRNA vaccine is now out the door.
On Monday, Moderna said it had mutually canceled the supply agreement, with all pending orders axed for the remainder of the year. Through its COVAX work, Gavi said it had delivered nearly 186 million doses of the Moderna vaccine via the advance purchase agreement and donations.
More than two years after Milestone Pharmaceuticals’ stock got hammered after their lead heart drug flopped in a crucial Phase III study, the biotech is looking for some redemption now that its redesigned Phase III pivotal has come through with positive results.
Milestone went public $MIST back in 2019 on the back of a plan to create a self-administered nasal spray version of a calcium channel blocker to treat cases of paroxysmal supraventricular tachycardia (PSVT) — nonfatal bursts of heart rate that often send patients running to the ER.
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An $8 billion exit from Eli Lilly and a short-lived stint heading up oncology work at the Big Pharma post-Loxo sale have persuaded Josh Bilenker to be hush-hush about his new venture, which ever-so-slightly broke cover last year and remains almost 100% under wraps, save for investor names.
Bilenker, who was a life sciences VC investor prior to Loxo and before that, a medical officer at the FDA, is working on a 130-employee startup with co-founder Jeffrey Engelman, the former head of oncology at Novartis Institutes for BioMedical Research. The CEO and CSO duo put out word Monday morning that KKR led an expansion to its existing pool of backers for Treeline Biosciences, which they claim is focused on the “outer edge of scientific possibility.”
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Bioscience & Technology Business Center
The University of Kansas
Lawrence, Kansas
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