Genmab A/S (GMAB.KO, GMAB) Friday said the European Medicines
Agency’s Committee for Medicinal Products for Human Use recommended
expanded approval of Darzalex in a form of multiple myeloma.
The Copenhagen biotechnology company said the recommendation covers
Darzalex in combination with lenalidomide and dexamethasone for newly
diagnosed adults with multiple myeloma who are ineligible for autologous
stem-cell transplant.
Genmab’s licensing partner, Johnson & Johnson’s (JNJ) Janssen
Biotech Inc. unit, had filed for approval of the new indication in
March. Janssen has an exclusive license to develop, manufacture and
commercialize Darzalex under an August 2012 agreement with Genmab.
The European Commission, which generally follows the CHMP’s
recommendations, is expected to make a final decision in the coming
months, Genmab said.
Darzalex is already approved in the European Union for several
indications in multiple myeloma, a cancer that forms in a type of white
blood cells called plasma cells and causes cancer cells to accumulate in
the bone marrow.
https://www.marketscreener.com/JOHNSON-JOHNSON-4832/news/Johnson-Johnson-Genmab-Janssen-Get-CHMP-Positive-Option-for-Expanded-Darzalex-Use-29416115/
Friday, October 18, 2019
J&J’s Janssen Gets CHMP Positive Option for Spravato
Johnson & Johnson’s (JNJ) Janssen Pharmaceutical Cos. unit on
Friday said the European Medicines Agency’s Committee for Medicinal
Products for Human Use recommended approval of its Spravato nasal spray
for adults with treatment-resistant major depressive disorder.
The drug maker said the recommendation covers Spravato in combination with a selective serotonin reuptake inhibitor or serotonin and norepinephrine reuptake inhibitor for adults with treatment-resistant depression, meaning they haven’t responded to at least two different treatments.
The European Commission, which generally follows the CHMP’s recommendations, is expected to make a final decision by the end of the year, Janssen said.
The U.S. Food and Drug Administration in March approved Spravato for patients with treatment-resistant depression. The nasal spray is a close chemical relation to ketamine, an anesthetic that is often abused as a party drug but has been shown to have a fast-acting impact on depression symptoms.
https://www.marketscreener.com/JOHNSON-JOHNSON-4832/news/Johnson-Johnson-J-J-s-Janssen-Gets-CHMP-Positive-Option-for-Spravato-29416188/
The drug maker said the recommendation covers Spravato in combination with a selective serotonin reuptake inhibitor or serotonin and norepinephrine reuptake inhibitor for adults with treatment-resistant depression, meaning they haven’t responded to at least two different treatments.
The European Commission, which generally follows the CHMP’s recommendations, is expected to make a final decision by the end of the year, Janssen said.
The U.S. Food and Drug Administration in March approved Spravato for patients with treatment-resistant depression. The nasal spray is a close chemical relation to ketamine, an anesthetic that is often abused as a party drug but has been shown to have a fast-acting impact on depression symptoms.
https://www.marketscreener.com/JOHNSON-JOHNSON-4832/news/Johnson-Johnson-J-J-s-Janssen-Gets-CHMP-Positive-Option-for-Spravato-29416188/
AbbVie Gets CHMP Positive Opinion for Rinvoq in Rheumatoid Arthritis
AbbVie Inc. (ABBV) said the European Medicines Agency’s Committee for
Medicinal Products for Human Use adopted a positive opinion for Rinvoq
for the treatment of adult patients with moderate to severe active
rheumatoid arthritis.
The CHMP positive opinion is supported by data from the pivotal Phase 3 SELECT rheumatoid arthritis program evaluating more than 4,400 patients, AbbVie said. The opinion will now be referred to the European Commission for final approval, the company said.
In Phase 3 trials, upadacitinib improved signs and symptoms of rheumatoid arthritis, inhibited radiographic progression and improved physical function, AbbVie said.
https://www.marketscreener.com/ABBVIE-12136589/news/AbbVie-Gets-CHMP-Positive-Opinion-for-Rinvoq-in-Rheumatoid-Arthritis-29416286/
The CHMP positive opinion is supported by data from the pivotal Phase 3 SELECT rheumatoid arthritis program evaluating more than 4,400 patients, AbbVie said. The opinion will now be referred to the European Commission for final approval, the company said.
In Phase 3 trials, upadacitinib improved signs and symptoms of rheumatoid arthritis, inhibited radiographic progression and improved physical function, AbbVie said.
https://www.marketscreener.com/ABBVIE-12136589/news/AbbVie-Gets-CHMP-Positive-Opinion-for-Rinvoq-in-Rheumatoid-Arthritis-29416286/
Subscribe to:
Posts (Atom)