Respiratory

Back-to-back FDA nods for generic Restasis and ProAir highlight Amneal’s growing strength in complex sterile and inhalation manufacturing.

NRTX-1001, taladegib and AZD0292 are the latest investigational products to make it onto PRIME, the European Medicines Agency’s priority medicines scheme for drugs for unmet medical needs.

Teva has agreed to pay $35m and delist six patents tied to its QVAR asthma inhalers to resolve claims it illegally blocked cheaper generics.

Beximco said it will manufacture a generic rival to Vertex’s Trikafta, offering cystic fibrosis patients a much-needed cheaper alternative. However, people will be subject to domestic personal use importation laws to access the drug.

The recall of various Respironics sleep and respiratory care devices in 2021 plunged Philips into static growth and market share loss. Careful remediation is the group’s top priority, but S&RC head Dan Leonard is determined that the manner of its achievement will be the envy of the industry.

Lupin has become the latest company to announce plans to build a manufacturing facility in the US, as confusion over tariffs and incentives to pursue “Made in America” drugs persists.

The recall of various Respironics sleep and respiratory care devices in 2021 plunged Philips into static growth and market share loss. Careful remediation is the group’s top priority, but S&RC head Dan Leonard is determined that the manner of its achievement will be the envy of the industry.

Transpire Bio says it has become the first firm to file a paragraph IV ANDA challenging GSK’s Breo Ellipta in the US, making it eligible for 180-day market exclusivity.

The sponsors of seven new medicines nearing the end of their EU regulatory review are due – or possibly due – to appear before the European Medicines Agency’s human medicines committee, the CHMP, to address remaining concerns about their marketing applications.

The European Medicines Agency is this week expected to recommend whether EU marketing approval should be granted to myriad new products, including therapies for bronchiectasis, RSV, menopause-related symptoms and type 2 diabetes.

Amphastar confident Primate Mist asthma spray will lose little market share to eventual generic competitors because it’s developing a propellant with a lower ozone-depleting impact. Also looks for US OTC market revenues from proposed naloxone nasal spray.

Cessatech and Proveca’s investigational, sufentanil/ketamine fixed-dose combination analgesic nasal spray is among the latest drugs that the European Medicines Agency has started to review for potential pan-EU marketing authorization.