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BioWorld - Saturday, June 20, 2026
Home » Topics » U.S., BioWorld

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Skin irritation

Market roomy, phase II zumi to reach dosing upside Apogee in AD?

March 23, 2026
By Randy Osborne
No Comments
In a competitive and still-needy space where Apogee Therapeutics Inc. CEO Michael Henderson noted that “even modestly differentiated products are quickly becoming blockbusters,” his firm’s IL-13 antibody zumilokibart (zumi, APG-777) has turned up satisfying phase II data in part A of the phase II atopic dermatitis (AD) experiment called Apex in moderate to severe disease. “We’re still digesting the data,” Henderson added, pointing out that the results proved better than Apogee expected at both time intervals tested.
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Syringe-and-tick.png

Pfizer, Valneva post mixed results for Lyme disease vaccine

March 23, 2026
By Jennifer Boggs
No Comments
Overall, results from the phase III Valor trial testing Lyme disease vaccine PF-07307405 “strengthen confidence” in the candidate, according to partners Pfizer Inc. and Valneva SE, with the big pharma now looking toward regulatory submissions. Investors, however, focused on the fact that the study, which demonstrated more than 70% efficacy in preventing Lyme disease in individuals, ages 5 and older, failed to hit the statistical criterion for the first prespecified analysis.
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FDA approved metal stamp
Biopharma approvals February 2026

US FDA clears four NMEs, including those for dermatitis, achondroplasia

March 20, 2026
By Amanda Lanier
No Comments
Drug approvals by the U.S. FDA totaled 26 in the first two months of 2026, with eight approvals in January and 18 in February. Compared with 2025, when approvals reached 12 in January and 16 in February (28 total), early 2026 activity is consistent with historical ranges.
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Paradromicx Connexus BCI

Paradromics partners with academics to accelerate BCI development

March 20, 2026
By Shani Alexander
No Comments
As the development of brain-computer interface (BCI) technologies gain momentum, Paradromics Inc. is building an ecosystem to enable collaboration between the company and academic researchers.
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NIH Director Jay Bhattacharya

US lawmakers to Bhattacharya: Explain your answers

March 20, 2026
By Mari Serebrov
No Comments
NIH Director Jay Bhattacharya is being fact-checked on his off-the cuff responses at a Senate Health, Education, Labor and Pensions Committee hearing in February. The fact-checkers are nine Democratic lawmakers from Massachusetts, only one of whom (Sen. Ed Markey) is on the committee and attended the hearing. In fact, seven of those signing the March 17 letter that questioned Bhattacharya’s veracity aren’t senators. They serve in the House.
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Tangled lines above silhouette

Azstarys (re-)born with Collegium’s ADHD buy

March 20, 2026
By Randy Osborne
No Comments
Attacking attention deficit hyperactivity disorder (ADHD) from two different angles, thanks to a new asset just brought aboard, should help Collegium Pharmaceutical Inc. protect its revenue stream in the pesky and widespread condition. Stoughton, Mass.-based Collegium disclosed its pact March 19 with Corium Therapeutics Holdings LLC for the former to buy the latter’s Azstarys (serdexmethylphenidate and dexmethylphenidate).
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Novartis campus in Basel, Switzerland

Synnovation’s PI3Kα inhibitor portfolio draws Novartis in $3B deal

March 20, 2026
By Jennifer Boggs
No Comments
Facing increasing competition to PI3Kα inhibitor Piqray (alpelisib) in breast cancer, Novartis AG looks to bolster its pipeline with next-generation programs, including phase I/II-stage candidate SNV-4818, by way of a potential $3 billion deal with Synnovation Therapeutics LLC.
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Antibodies illustration

Crossbow raises $77M series B for T-cell mimicking antibodies

March 19, 2026
By Marian (YoonJee) Chu
No Comments
Crossbow Therapeutics Inc. closed a $77 million series B round to support an ongoing phase I Crosscheck-001 trial of lead program, CBX-250, and additional T-Bolt immunotherapies targeting a broad range of cancers.
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Minimed Flex system

Minimed secures FDA nod for next-gen insulin pump

March 19, 2026
By Shani Alexander
No Comments
Minimed Group Inc. secured U.S. FDA approval for Minimed Flex, its next-generation discreet, smartphone-controlled insulin pump. The nod from the FDA follows the company’s debut on Nasdaq March 6. About half the size of the Minimed 780G pump and roughly the size of two stacked insulin vials, the screenless pump was designed in collaboration with people living with diabetes to offer a more intuitive, lifestyle‑friendly way to manage the condition.
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Red wooden approved stamp

GSK’s IBAT inhibitor wins US FDA nod for cholestatic pruritus

March 19, 2026
By Karen Carey
No Comments
With the U.S. FDA’s approval of GSK plc’s ileal bile acid transporter (IBAT) inhibitor, Lynavoy (linerixibat), patients with primary biliary cholangitis no longer need off-label treatments for a debilitating internal itch symptom called cholestatic pruritus.
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