When life-saving inhalers sell in Europe at 1.5% to about 8% of their list price in the U.S., they’re bound to attract scrutiny, especially in a time when inequities in prescription drug prices are fueling more and more legislation to reduce U.S. prices.
GSK plc is plunking down $1 billion cash to take over Aiolos Bio Inc., with the promise of as much as $400 million in regulatory milestone payments along with tiered royalties. The deal gives London-based GSK asthma candidate AIO-001, a phase II-ready, long-acting antibody that binds to the human thymic stromal lymphopoietin (TSLP) ligand to inhibit TSLP signaling and relieve inflammation. GSK said AIO-001 could redefine the standard of care in asthma via the prospect of dosing every six months.
Receiving a second complete response letter (CRL) from the U.S. FDA for gefapixant to treat refractory and unexplained chronic cough – an indication for which there are no approved treatments in the U.S., Merck & Co. Inc. said it is reviewing the agency’s feedback to determine the next steps, if any, for the oral selective P2X3 receptor antagonist.
Arriving on the gene therapy scene with an undisclosed seed funding sum, Alveogene is tackling respiratory diseases with high unmet need via a next-generation lentiviral delivery platform to advance into the clinic a candidate for rare inherited disorder alpha-1 antitrypsin deficiency.
Partners Regeneron Pharmaceuticals Inc. and Sanofi SA will file a supplemental BLA by year-end for Dupixent (dupilumab) in chronic obstructive pulmonary disease (COPD) after interim data from a second phase III trial confirmed – even bested – data from the first, demonstrating a reduction in exacerbations by 34% and improved lung function in patients with uncontrolled COPD and evidence of type 2 inflammation.
Low expectations on Wall Street for the Pulmonary-Allergy Drugs Advisory Committee (PADAC) sit-down on Merck & Co. Inc.’s P2X3 receptor antagonist gefapixant for chronic cough (CC) translated to negative balloting by panelists. PADAC members were polled on a single question: Does the evidence demonstrate that [Merck’s] gefapixant provides a clinically meaningful benefit to adults with refractory or unexplained CC? The results came out 12 no, 1 yes.
The U.S. FDA’s Pulmonary-Allergy Drugs Advisory Committee has a lot to discuss Nov. 17, but only one voting question: Does the evidence demonstrate that Merck & Co. Inc.’s gefapixant provides a clinically meaningful benefit to adults with refractory or unexplained chronic cough?
With one of the higher series A rounds for 2023, the newly launched Aiolos Bio Inc. pulled in $245 million to advance its lead product, AIO-001, an anti-thymic stromal lymphopoietin monoclonal antibody set to enter a phase II trial for moderate to severe asthma.
With a U.S. biotech identified as One Bio, Jiangsu Hengrui Pharmaceutical Co. Ltd. has inked an out-licensing deal potentially worth $1.05 billion for its asthma and chronic sinusitis-targeting drug, SHR-1905. The latest deal gives One Bio exclusive rights to develop, produce and commercialize SHR-1905 worldwide, excluding the greater China territory.
Shares in Galecto Inc. (NASDAQ:GLTO) plummeted by 71%, closing Aug. 15 at 67 cents, on news that its lead drug candidate, GB-0139, flamed out in a phase IIb trial in idiopathic pulmonary fibrosis (IPF). The inhaled galectin-3 inhibitor actually performed considerably worse than placebo in the 52-week placebo-controlled study, the endpoint of which was the annual rate of decline from baseline in forced vital capacity (FVC).
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