It’s game time for Abbott Laboratories’ 15-minute concussion test now that FDA clearance is in hand. The I-Stat traumatic brain injury cartridge uses whole blood, allowing bedside assessment of patients without lab processing.
The notion of using vacuum pressure on the anterior portion of the human eye as a treatment for open-angle glaucoma might be a clinical novelty, but Balance Ophthalmics Inc. is poised to change that. The company recently won a favorable outcome at a U.S. FDA advisory panel for its Fsyx negative pressure pump for ocular use, although the company is likely to have to drum up a large body of data in post-approval studies, assuming the FDA gives the Fsyx the nod.
Voydeya (danicopan), from Alexion, Astrazeneca Rare Disease, racked up its second global approval as the U.S. FDA greenlit it as an add-on therapy for treating extravascular hemolysis in adults with paroxysmal nocturnal hemoglobinuria (PNH), a crowded market with several already approved treatments and more in development.
Novo Nordisk A/S is the latest drug company to be challenged by U.S. Sen. Bernie Sanders (I-Vt.), who has made tilting at prescription drug prices one of the hallmarks of his tenure as chair of the Senate Health, Education, Labor and Pensions (HELP) Committee.
Xilio Therapeutics Inc. retreated with its lead oncology IL-2 drug, XTX-202, after phase II data indicated stable disease was the best response, prompting the company to reprioritize its pipeline and cut its workforce by 21% – but investors focused more on a $647.5 million IL-12 program deal the company signed with Gilead Sciences Inc., as well as an $11.3 million private placement financing.
Boundless Bio Inc. got a lukewarm welcome on Nasdaq after pricing its IPO of 6.25 million shares at the midpoint price of $16 per share, raking in about $100 million in gross proceeds to advance its pipeline of ecDNA-driven drugs targeting oncogene-amplified tumors.
After a complete response letter (CRL) from the U.S. FDA in 2022 and approvals in Europe, Japan and Australia, Akebia Therapeutics Inc.’s Vafseo (vadadustat) has finally been approved by the FDA. But the uphill climb still isn’t over for Akebia, as it has more hurdles to clear for the drug.
Exact Sciences Corp. reported on data showing high sensitivity and specificity for the non-endoscopic Oncoguard Esophagus test that is currently in development for the detection of esophageal adenocarcinoma (EAC) and its precursors, including Barrett’s esophagus.
Endostart s.r.l. received U.S. FDA 510(k) clearance for Endorail, a magnetic balloon system which helps resolve intestinal looping and facilitates the efficiency and safety of colonoscopy procedures. The approval is an “important milestone” for the company as it will allow Endostart to bring its technology to the U.S. market to empower physicians, Alessandro Tozzi, co-founder and CEO of the company, told BioWorld.
Thanks to technological advances, the U.S. FDA is reducing the quantity of reserve drug samples that must be retained from bioavailability and bioequivalence studies.
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