Jefferies analyst Stephen Barker said in a note the data was “worse-than-expected”, citing that treatment with the drug only improved the time patients with non-small cell lung cancer live without their disease worsening by 0.7 months compared to chemotherapy.
Without consumer health and with its orthopedics business undergoing restructuring, pressure on J&J’s large pharmaceutical unit is likely to intensify as the company aims to reach its goal of $57 billion in drug sales by 2025.
Maxigesic IV, a combination of paracetamol with ibuprofen solution for infusion, helps reduce pain and inflammation without the risk of opioid addiction that resulted in more than half a million deaths in the U.S. during 1999 to 2020.
The U.S. medical equipment maker is looking to boost its life sciences portfolio that helps in drug discovery.
The blockbuster PD-1 inhibitor’s label expanded further on Monday when the FDA greenlit Keytruda as a perioperative treatment for certain patients with earlier stages of non-small cell lung cancer.
In a follow-up readout, data from the head-to-head SEQUENCE study showed that AbbVie’s Skyrizi induced better rates of steroid-free remission in Crohn’s disease than Johnson & Johnson’s Stelara.
This follows a late-cycle review meeting in which the regulator flagged “substantive review issues” with the New Drug Application (NDA). The FDA pointed out to Aldeyra that it does not appear to “have data to support the clinical relevance of the ocular signs to support your dry eye indication,” according to the company’s SEC filing.
Regulators on both sides of the Atlantic have stepped up their scrutiny into the pharmaceutical industry to ensure that smaller innovative companies can compete with bigger rivals and that prices for drugs and products remain affordable.
Stelara, J&J’s top-selling anti-inflammatory drug, brought in sales of $2.86 billion in the quarter, above LSEG estimates of $2.61 billion.
The company stated that the European Union medicines regulator recommended a marketing authorization for the company’s drug Prevymis to treat a type of infection in adult kidney transplant recipients at high risk.
Reuters