FDA

The drug, Zilbrysq is the first once-daily subcutaneous targeted C5 complement inhibitor approved for generalized myasthenia gravis (gMG) and is currently the only self-administered targeting option rare autoimmune disease.

lung tumor

The abstracts, made available Tuesday ahead of the European Society for Medical Oncology Congress 2023, show strong efficacy data from some promising non-small cell lung cancer treatments.

phosphorus tube

The company’s resubmission succeeded in getting the greenlight for tenapanor, now to be marketed as Xphozah, to lower serum phosphorus levels in chronic kidney disease patients.

AstraZeneca

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.

Johnson & Johnson, Brussels

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.

Thermo Fisher

The U.S. medical equipment maker is looking to boost its life sciences portfolio that helps in drug discovery.

Merck

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.

AbbVie office

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.