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Financing Snapshot: Seattle biotech claims its targeted, inhalable versions of Esbriet and Ofev, both oral IPF drugs, may offer better tolerability and stronger efficacy than established products.
The Boston-based biotech is weighing up its options as the fall-out from its failed IPF candidate casts a shadow over Galecto’s future.
Getting on the best reimbursement pathway in the US will be vital for the UK company as it moves closer to approval and taking on the established players in the chronic obstructive pulmonary disease arena.
Slower COVID-19 vaccine sales will see Moderna’s revenues decline this year, but the company is investing heavily to speed a new wave of therapies to the market.
AstraZeneca's Fasenra has demonstrated non-inferiority compared with GSK's fellow interleukin-5 inhibitor Nucala for eosinophilic granulomatosis with polyangiitis and the company hopes its more convenient single monthly subcutaneous injection will win market share if approved for the rare, immune-mediated inflammatory disease.
Phase III trials of BMS-986278 are already being prepped.
Insmed’s ARISE trial validated a patient-reported outcome measure it plans to use as the new primary endpoint in the ongoing pivotal ENCORE study, but it will ask the US FDA about accelerated approval based on ARISE.
Elsewhere at the European Respiratory Society meeting, Bristol Myers Squibb will hope that its LPA1 antagonist can add a hit in progressive pulmonary fibrosis to the success it has already posted in the idiopathic form of the disease.
Moderna is suffering from a slump in sales of its COVID-19 vaccine, and investors remain skeptical about its chances of hitting anywhere near those blockbuster heights with its next wave of products.
Galecto’s decision to discontinue its idiopathic pulmonary fibrosis candidate after disappointing Phase IIb results represents the latest in a number of mid/late-stage failures to treat the disease.
Cipla’s chief Dr Yusuf Hamied talks about investments in new technologies that will shape the company’s future, terming reports of a stake sale as “speculative" but not going as far as an outright denial.
Cipla reports highest ever quarterly revenues in the US, a market that’s seeing lower “price compression” amid sell-offs, bankruptcies and a rebalancing of the supply chain. The firm’s portfolio has a “lot of steam” left to be unlocked and it’s also keeping an eye on the impact of the tornado-hit Pfizer site on supplies.
GSK is gearing up for its most important new product launch in years and hopes US payers will buy into Arexvy’s likely higher price than Pfizer’s rival RSV vaccine.
The US biotech is hoping to either partner off its wholly owned pipeline or become a target for an acquisition or merger after AstraZeneca’s asthma exit left it with dwindling cash, and a need to cut costs.
Emerging Company Profile: The US biotech acquired its sole asset from CDMO Vectura in 2020 and is now gearing up for a Phase II proof-of-concept trial in severe asthma to help address the unmet need in non-eosinophilic patients.
The French firm used a vaccines investor event to tout its respiratory syncytial virus prophylactic, Beyfortus, citing real-world data as well as a predictive model following recent questions about its utility in the face of advancing maternal vaccines.
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