Remove Hospitals Remove Labelling Remove White Paper
article thumbnail

Exforge antitrust settlement caps Novartis’ year of legal disputes

Pharmaceutical Technology

Also mentioned in the same release, was Pharmaceutical biotech Alcon admitting to conspiring with Novartis AG to bribe employees of state-owned and state-controlled hospitals and clinics in Vietnam. Novartis argued that the early release of Entresto generics could cause labelling inconsistencies.

article thumbnail

Humira biosimilars set the stage for long-awaited 2023 US launches

Pharmaceutical Technology

Humira is indicated for 10 adult and pediatric conditions, including Crohn’s disease, rheumatoid arthritis, and ulcerative colitis, as per its label. Others are made by big pharma giants like Boehringer Ingelheim , Novartis , or Pfizer , which has raised the expectations for a competitive market. .

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

Trending Sources

article thumbnail

CMO Moves: Regulatory catalysts for drug manufacturing – March 2023

Pharmaceutical Technology

A few weeks later, the EC extended the approval label of AstraZeneca’s Forxiga (dapagliflozin) to include the treatment of symptomatic hearth failure. The study was conducted at Thomas Jefferson University Hospital in Philadelphia evaluated the therapy in 12 ambulatory patients. BioCentriq is contracted to manufacture the biologic API.

article thumbnail

Legal challenges put off label use of gender affirming care drugs in jeopardy

Pharmaceutical Technology

Most drugs used here are prescribed off-label, and experts say pharmaceutical companies remain hesitant to conduct clinical trials studying gender-affirming care. One of the reasons why organisations, including pharma companies, do not enter this debate is because these drugs are used off label, says Horowicz.

Labelling 144