The U.S. drug regulator declined to approve a combination of Merck & Co. Inc.’s blockbuster cancer drug Keytruda and Eisai Co. Ltd.’s Lenvima as the first line of treatment in patients with liver cancer.
IM Therapeutics is developing a personalized, orally available small molecule therapeutic for diabetes.
Cellectis announced that the U.S. Food and Drug Administration placed a clinical hold on the company’s MELANI-01 trial of UCARTCS1A for relapsed or refractory multiple myeloma (MM).
As the United States accelerates the search for a coronavirus vaccine, tensions have erupted between government scientists and Moderna Inc., one of the leading developers, Reuters has learned.
Immunomedics announced that the company’s Phase III study involving Trodelvy met the primary endpoint of progression-free survival, as well as secondary endpoints, in patients with metastatic triple-negative breast cancer who have previously received at least two prior therapies.
Companies Face Challenge of Enrolling Patients in COVID-19 Vaccine Studies
Business, Clinical Data, Clinical Trials, Coronavirus Disease 2019 (COVID-19), COVID-19 Vaccines, Manufacturing, Messenger RNA (mRNA) Vaccines, Oxford University, Patient Enrollment, R&D, The Wall Street Journal, World Health OrganizationCompanies Face Challenge of Enrolling Patients in COVID-19 Vaccine Studies Published: July 6, 2020 By Mark Terry BioSpace As of June 29, there were 13 vaccines against COVID-19 in […]
ObsEva announced topline data from the PRIMROSE 1 and 2 Phase III trials of Yselty (linzagolix) for uterine fibroids.
Regeneron Launches Phase III COVID-19 Prevention Trial with Antibody Cocktail
Antibodies, Brazil, Chile, Clinical Trials, Coronavirus Disease 2019 (COVID-19), Data Monitoring Committee (DMC), Drug Cocktails, Hospitalized COVID-19 Patients, Interleukin-6 (IL-6), Medical Journals, Mexico, National Institute of Allergy and Infectious Diseases (NIAID), R&D, Science, Secondary Endpoints, United StatesRegeneron Pharmaceuticals – with the U.S. National Institute of Allergy and Infectious Diseases (NIAID) – is launching Phase III trials of REGN-COV2, the company’s two-antibody cocktail for the treatment and prevention of COVID-19.
Emergent and J&J Ink COVID-19 Vaccine Deal
Adenovirus, Business, Clinical Data, Clinical Trials, Contract Development and Manufacturing (CDMO), Contract Development Manufacturing Organization (CDMO), COVID-19 Vaccines, Department of Health and Human Services (HHS), Manufacturing, National Institute of Allergy and Infectious Diseases (NIAID), R&D, Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)Emergent BioSolutions entered a five-year manufacturing services deal with Janssen Pharmaceutical to manufacture Johnson & Johnson’s Ad26.COV2-S COVID-19 vaccine.
China’s SinoVac is starting Phase III trials of a potential coronavirus vaccine, becoming one of three companies to move into the late stages in the race to develop an inoculation against the disease.