Respiratory

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.

2030 sales forecasts for Novo’s obesity hope are an order of magnitude larger than its closest rival among 2025’s expected debutantes.  

This week, a Delaware court awarded Auris Health shareholders $1bn in a lawsuit against Johnson & Johnson; Abbott recalled some FreeStyle Libre 3 sensors; and McKesson purchased a controlling interest in a Florida cancer care chain.

The European Medicines Agency has started reviewing new marketing applications for 10 products, including Blenrep, GSK’s previously approved multiple myeloma drug that was withdrawn from the market, and vimseltinib, which could become the EU’s first oral treatment approved for TGCT.

ARS will compete directly with EpiPen and other injectable products with inhaled neffy as the first needle-free epinephrine therapy for severe allergy attacks. EU approval is thought imminent.

Philips has filed a lawsuit against a Pennsylvania lab it hired to analyze sound abatement foam that prompted widespread recalls of its CPAP machines. Philips alleges PSN Labs grossly overestimated the risk to patients, which led Philips to initiate a larger recall than it otherwise would have.

In this episode of the In Vivo podcast, Billy Boyle, CEO of Owlstone Medical, discusses how his company is developing several breath biopsy products for use by clinicians, biopharma companies and researchers.   

Second quarter revenues are up but RSV jab woes drag on the company’s stock.    

An instagram post by Brittany Mahomes, wife of Kansas City Chiefs quarterback Patrick Mahomes, failed to contain any risk information for the epinephrine injector, the FDA’s Office of Prescription Drug Promotion said in an untitled letter.

The deal includes up to 10 medicines, with an initial focus on immunology and respiratory diseases, and is similar to one the VC firm made with Pfizer last year.

This week, Nipro Medical Corp. announced it will invest $397.8m to build a US-based production plant, generating 232 new jobs; both Baxter and Hamilton announced ventilator recalls; Imperative Care wins FDA clearance for its stroke catheter; Intelligent Ultrasound Group plc entered into a conditional sale and purchase deal to sell its Clinical AI business to GE HealthCare for £40.5m; RMI distributed 350m rapid test kits in the fight against HIV/AIDS; Jiangsu Shenli Medical Production Co., Ltd received a second FDA warning letter about quality and safety of plastic syringes.

With sales of its big sellers Jardiance and Ofev to start shrinking in the next few years, the German group is teeing up a suite of new drugs.    

This week, Roche filed suit against Foresight Diagnostics and Stanford University over patent infringement; the former head of a COVID-19 test company was convicted of securities fraud; and Baxter announced a recall of Life2000 ventilators.

Last month, the US FDA increased the number of injuries and deaths initially reported in a March recall from Philips, which the company disputed. The FDA now says its adjusted numbers were in error.

The US Federal Trade Commission wants to clean up the FDA’s Orange Book by purging medical device patents that the commission says should not be in the listing. The FTC argues improper patents in the Orange Book block lower-cost generic equivalents from coming to market. Medtech Insight spoke to attorney Sara Koblitz about the FTC’s delisting push.

The French drugmaker can now boast seven approvals for its huge-earning IL-4/IL-13 inhibitor.

The US FDA is reporting dozens more additional deaths associated with a May recall of Philips ventilators than initially reported. The company says it stands by its original number of seven and has reached out to the FDA.

The June meeting of the European Medicines Agency's human medicines committee brought mixed fortunes for companies. 10 new products were recommended for pan-EU approval, two drugs were rejected, while the conditional approval of one drug is set to be revoked. PTC Therapeutics again faced disappointment regarding its Duchenne muscular dystrophy drug Translarna, but has vowed to fight back.

The respiratory specialist is set to hit the ground running with Ohtuvayre, the first COPD inhaled product with a novel mechanism of action to be approved in over two decades.

Five years after a Phase III failure, Savara reports pivotal data supporting approval of molgramostim as the first drug for autoimmune pulmonary alveolar proteinosis.