GSK Bio

NEWS
Targeting the red hot antibody-drug conjugate market, OnCusp Therapeutics is coming out of the gate with $100 million from investors such as Novo Holdings and OrbiMed.
FDA
The regulator greenlit 55 new drugs last year, seven of which belonged to Pfizer, including an ulcerative colitis treatment and a migraine nasal spray—both acquired in multibillion-dollar buys.
The antibody-drug conjugate market remains hot so far in 2024 with Tuesday’s collaboration and license agreement between Roche and MediLink Therapeutics to develop a next-generation ADC in oncology.
GSK withdrew three patents related to its asthma inhalers while Impax delisted both of its patents for Adrenaclick and Kaléo delisted eight patents covering Auvi-Q—the companies’ respective epinephrine auto-injectors.
The regulator’s Complete Response Letter on Wednesday said Merck’s data package for gefapixant “did not meet substantial evidence of effectiveness.” The FDA also rejected the drug in 2022 due to a lack of efficacy evidence.
A court in Germany on Tuesday nullified one of CureVac’s intellectual property rights in a patent case against BioNTech. However, court proceedings involving seven other patent rights will continue.
With an upfront payment of $185 million, GSK on Wednesday added another exclusive antibody-drug conjugate license agreement with China-based Hansoh Pharma.
The combination of Jemperli and chemotherapy followed by Zejula improved progression-free survival in a late-stage study of patients with advanced or recurrent endometrial cancer.
A European Medicine Agency panel on Friday reaffirmed its decision not to renew the conditional marketing authorization for GSK’s multiple myeloma drug Blenrep.
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