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Respiratory

Cipla CEO On Tariff Threat: ‘We Have One Of The Most Well Diversified Models’

Cipla's leadership fields shareholder queries on the specter of US tariffs and also outlines how the firm is nurturing the business for the future in areas like mRNA and point-of-care diagnostics, while building on its strength in the respiratory space.

PureTech Ponders Way Forward As CEO Exits

Bharatt Chowrira departs days after firm’s chair stepped down.

England Leads Europe In Reimbursing Vertex’s Next-In-Class CF Drug Alyftrek

Vertex said it reached “a broad reimbursement agreement” with the National Health Service for its once-daily, triple combination treatment for cystic fibrosis. As for reimbursement in the rest of Europe, the company is targeting Ireland, Denmark and Germany next.

‘I Saw An Unpolished Diamond’: Iconovo CEO Wäborg On Breaking Even In 2027 And Beyond

In an exclusive interview, Iconovo CEO Johan Wäborg outlines the company’s strategy to become a leader in dry powder inhalation by focusing on platform development, reformulated therapies, and B2B licensing, with a plan to break even by 2027.

How Ethris Cracked mRNA’s “Do Not Shake” Problem To Unlock Respiratory Therapeutics

A German biotech has solved a fundamental physics problem that has limited mRNA therapeutics to injectable vaccines. Its breakthrough stabilizer technology allows mRNA particles to survive the mechanical stress of inhalation delivery, opening the door to treating chronic respiratory diseases.

‘Unprecedented’ Data Lift AstraZeneca’s Ambitions For Airsupra

The company hopes the drug will become the standard of care rescue treatment in asthma.

PharmaMar Seeks EU Fast-Track Status For ‘Practice-Changing’ ES-SCLC Therapy

PharmaMar, which wants to use the Jazz Pharmaceuticals-partnered drug, lurbinectedin, in combination with Roche’s Tecentriq for treating extensive-stage small cell lung cancer, is one of two companies that this month sought an accelerated assessment of their planned EU marketing applications.

Iconovo Slims Down As It Focuses On Commercialization

As its need for development resources declines, Iconovo is cutting staff to save money as it moves to the commercialization stage for its portfolio of off-patent inhaled products.

Supreme Court May Be Next After Federal Circuit Refuses To Rehear Teva Inhaler Patents Case

Teva was forced to delist its ProAir HFA inhaler patents from the FDA’s Orange Book by mid-March after the Federal Circuit denied its petition for en banc rehearing. Will the Supreme Court listen?

Federal Circuit Refuses To Rehear Teva On Inhaler Patents – Next Stop, Supreme Court?

Teva will have to delist its ProAir HFA inhaler patents from the FDA’s Orange Book by mid-March, as the Federal Circuit denied its petition for en banc rehearing. Will the Supreme Court listen?

EMA Revises Acute Respiratory Distress Syndrome Expectations: Impact On Trial Patient Selection

The European Medicines Agency is consulting on new requirements in its guideline on clinical trials for acute respiratory distress syndrome. The updates cover the selection of target population, choice of endpoints, use of biomarkers and pandemic preparedness.

Major Public Health Interest? Scholar, Insmed & Soleno Ask EMA To Fast-Track Their Products

The European Medicines Agency is considering whether apitegromab, brensocatib and diazoxide choline, from Scholar, Insmed and Soleno respectively, are drugs that are of potential major public health interest, particularly from the point of view of therapeutic innovation.