Press Releases

RedHill Biopharma Ltd. , a specialty biopharmaceutical company, announced today that preliminary data first-line studies from their US phase 2 study of orally administered opaganib (Yeliva®, ABC294640) [1] in hospitalized patients with COVID-19 pneumonia demonstrated positive signs of safety and efficacy. The US Phase 2, randomized, double-blind, placebo-controlled, proof-of-concept study with opaganib ( NCT04414618 ) enrolled 40 patients requiring oxygen support. The study was

The Celltrion Group filed a formal application for conditional manufacturing and marketing approval (CMA) with the Ministry of Food and Drug Safety (MFDS) of Korea. This application is based on the results of a global Phase 2/3 clinical trial of CT-P59 that achieved the objectives of the clinical endpoint. Sertorion enrolled 327 patients with mild to moderate COVID-19 symptoms and assigned them to 3 groups (placebo, low and high), and CT in SARS-CoV-2 infected patients with standard

Moderna, Inc., biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, and Recipharm, a leading contract development and manufacturing organization (CDMO), announced that they have reached an agreement to support formulation and fill-finish a part of the Moderna COVID-19 Vaccine supply outside of the U.S. The activity will be performed in Recipharm’s drug product manufacturing facility located in France. Subject to regulatory approval of the vaccine in

Alkermes plc announced that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of the company's New Drug Application (NDA) resubmission for ALKS 3831 (olanzapine/samidorphan) for the treatment of adults with schizophrenia and adults with bipolar I disorder, and has assigned the application a new Prescription Drug User Fee Act (PDUFA) target action date of June 1, 2021. The FDA classified the resubmission as a complete, Class 2 response to the Complete Response

Pfizer Inc. and BioNTech SE  announced they will supply an additional 100 million doses of COMIRNATY®, the companies’ COVID-19 Vaccine, to the 27 European Union (EU) member states in 2021. This announcement is a result of the European Commission’s decision to exercise its option to purchase an additional 100 million doses under its Advanced Purchase Agreement signed on November 11, 2020. This agreement brings the total number of doses to be delivered to the EU to 300 mill

Cara Therapeutics, Inc., a biopharmaceutical company focused on developing and commercializing new chemical entities designed to alleviate pruritus by selectively targeting peripheral kappa opioid receptors, or KORs, announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for KORSUVA™ Injection (difelikefalin) for the treatment of moderate-to-severe pruritus in hemodialysis patients. KORSUVA Injection received Breakthrough Therapy Desi

WuXi Biologics, a global company with leading open-access biologics technology platforms, today announced that it has received the Good Manufacturing Practice (GMP) certification from Brazil's Agência Nacional de Vigilancia Sanitária (ANVISA). The positive assessment from ANVISA reaffirms WuXi Biologics' strong commitment to offering partners a global manufacturing network of the highest standard. This is WuXi Biologics' third GMP certification from drug reg

MODAG, a German biotechnology company focused on the development of disease-modifying small molecule therapeutics for neurodegenerative diseases, announced the clinical trial initiation of a first-in-patient Phase 1b study for anle138b in patients with mild to moderate Parkinson´s Disease (PD). Anle138b is a disease-modifying treatment option for synucleinopathies, such as Multiple System Atrophy (MSA) and PD. The short-term Phase 1b study with PD patients will be conducted by

Merck, known as MSD outside the United States and Canada, announced it has entered into an agreement with the United States Government to support the development, manufacture and initial distribution of an investigational biological therapeutic (CD24Fc, to be named MK-7110) upon approval or Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). Merck acquired MK-7110 through the acquisition of OncoImmune, a privately held, clinical-stage biopharmaceutical company.

Janssen Pharmaceutical Companies of Johnson & Johnson announce authorization for REKAMBYS ® (rilpivirine injection) in combination with VOCABRIA ® ( cabotegravir injection and tablets) from ViiV Healthcare in the European Union for the treatment of HIV-1 infection in virally-inhibited adults. 2 The approval marks the first time that people living in Europe with HIV will be able to receive prolonged injectable therapy eliminating the need for daily oral tablets. “Gr