Novartis claims its Theraflu Multi-Symptom Severe Cold "starts to get to work in your body in 5 minutes" after taking it. But Pfizer, which sells its own range of cold-fighters, has an issue with that--and so does National Advertising Division.
Novartis claims its Theraflu Multi-Symptom Severe Cold "starts to get to work in your body in 5 minutes" after taking it. But competitor Pfizer isn't having it--and neither is the National Advertising Division.
Just weeks after Novartis and Atlas Venture announced the launch of an upstart player in the fast-emerging field of CRISPR-Cas9 gene editing, the pharma giant has stepped back up to formally hammer out a partnership development deal and throw its enormous resources behind the biotech.
Those looking for a window into the FDA's thoughts on biosimilars got their first direct peek Monday. The agency released briefing documents for an upcoming panel meeting on Novartis' biosimilar of Amgen's Neupogen. The takeaway? The FDA seems to be softpedaling on whether the biosim is "interchangeable" with Neupogen itself, allowing approval to be based on biosimilarity instead.
Novartis' copy of Amgen's top-selling Neupogen matched up well with the original, FDA reviewers said, recommending what would be the first U.S. approval of a biologic knock-off.
Vanda Pharmaceuticals has come out at the other end of its dispute with former partner Novartis, getting back the rights to its schizophrenia drug and banking an equity investment from the Swiss drugmaker.
Novartis has lashed out at India's Cipla in court for rolling out a deeply discounted generic of its COPD drug Onbrez without waiting for the courts to rule whether its patents are valid. It has sued Cipla for infringing its patents on Onbrez, known as Arcapta in the U.S.
It's been a good news, bad news week for Novartis and its oncology business. Monday, the Swiss drugmaker won FDA approval for a long-acting version of Signifor, to treat acromegaly, a rare endocrine disorder. But Friday, Novartis announced that Afinitor fell short in a HER2-positive breast cancer trial, dashing hopes for what could have been a lucrative new indication.
The FDA signed off on a once-a-month version of Novartis' Signifor designed to treat acromegaly, a rare growth hormone disorder that can lead to disfigurement and death.
J&J's Stelara has some psoriasis competition waiting in the wings: On Friday, Novartis announced its Phase III prospect, to be marketed as Cosentyx, had bested the drug in a head-to-head trial.