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This year has seen the approval of several first-in-class therapies for HAE, but in a fragmented space, experts question whether they will be enough to net their developers a significant share of the entrenched market.
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A new generation of companies is eyeing the existing, sizeable hair loss market, hoping that better formulations and new scientific targets will finally produce treatments that are safer and more effective, as well as commercially successful.
The nausea and other gastrointestinal side effects of weight loss drugs like Novo Nordisk’s Wegovy or Eli Lilly’s Zepbound will limit how much these drugs can help patients and stunt the overall obesity market unless we approach the problem head on.
While investment has slowed in radiopharmaceuticals, analysts predict increased interest to come as Novartis shows just how successful radiopharmaceuticals can be.
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About a year after cutting staff by 29%, Sana Biotechnology will trim its workforce as it increases investment in its type 1 diabetes program and looks to extend its cash runway.
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With five CDER leaders in one year and regulatory proposals coming “by fiat,” the FDA is only making it more difficult to bring therapies to patients.
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Sarepta must also run a post-marketing study for Elevidys to better assess the risk of serious liver injury in patients dosed with the gene therapy.
Artios Pharma is working on a pipeline of oncology assets, led by alnodesertib, currently being tested for second-line pancreatic cancer and third-line colorectal cancer.
Aside from announcing layoffs, Sensei has decided to terminate its R&D work. The biotech has $25 million on hand, and continues to evaluate its strategic alternatives.
Top Trump administration officials have taken issue with Marty Makary’s management style, pointing to infighting between his appointees and the difficulty to get a hold of the FDA commissioner.
Priority voucher awardees and regulators could feel pressure to “meet the moment” as FDA watchers question the intent and feasibility of the Commissioner’s National Priority Voucher program.
Bristol Myers Squibb and Johnson & Johnson will continue to test the asset in stroke and atrial fibrillation.
Bayer has let go of about 13,500 employees, including around 5,000 managers, since implementing a new operating model in early 2024. CEO Bill Anderson said in a recent earnings call that he expects a slower rate of headcount reduction moving forward.
“As the future chair I will attend to the interests of not only the Novo Nordisk Foundation but all shareholders of the company,” incoming chair and former Novo Nordisk CEO Lars Rebien Sørensen said at the meeting held Friday.
A day after Pfizer closed its hotly contested Metsera deal, Lundbeck has made an unsolicited offer to steal Avadel Pharmaceuticals away from Alkermes.
At $9.2 billion, the Cidara acquisition lands among the top 5 largest deals of the year.