Press Releases

AbbVie announced that the U.S. Food and Drug Administration (FDA) has provided full approval to VENCLEXTA® (venetoclax) in combination with azacitidine, or decitabine, or low-dose cytarabine (LDAC) for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adults who are age 75 years or older, or who have comorbidities that preclude the use of intensive induction chemotherapy. The approval is supported by data from the Phase 3 VIALE-A (M15-656) and VIALE-C (M16-043) studies and

Eisai Co., Ltd. announced today that the supplementary new drug applications for its in-house discovered and developed anti-epileptic drug (AED) Fycompa (generic name: perampanel) as monotherapy for partial-onset seizures and pediatric indication for partial onset seizures in patients with epilepsy 4 years or older have been accepted in China by the National Medical Products Administration. The submission covering monotherapy for partial-onset seizures was based on subgroup analysis

Boehringer Ingelheim has entered a collaboration with the Yale Clinical and Translational Research Accelerator to launch a study exploring digital health technologies for adults with heart failure. The goal of the study is to determine the impact of three digital health technologies on patient outcomes, clinical efficiencies and the improvement in patient quality of life.  Technology partners were selected for evaluation in the study based on their ability to increase engagemen

Iksuda Therapeutics (Iksuda), which develops a new generation of enhanced antibody-drug conjugates (ADCs), is now activated in the tumor environment. Announced that it has exercised the option to obtain a worldwide exclusive right to develop class prodrug payloads from the University of Göttingen. This option exercise is a result of a partnership that has successfully demonstrated a set of payloads in ADC format. This highly powerful and selective set of payloads represents a powerful ne

The third part of the 2020 CPhI Annual Report – released during the second week of the CPhI Festival of Pharma (5-16 October, 2020) – predicts, that if approved, COVID vaccines and therapeutics will cause an impending biomanufacturing capacity challenge, particularly for large scale reactors. CPhI Annual Report expert, Dawn M. Ecker – Managing Director of bioTRAK Database Services at BDO – explores the medium- to long-term implications of supply and demand fo

Sirio Europe – the leading European nutraceutical and pharmaceutical contract development and manufacturing organisation (CDMO), part of the Sirio group – announces the completion of a major overhaul of its Brandenburg site with advanced manufacturing and green technologies. The company has installed new HVAC systems, individual drying chambers, vegetarian softgel manufacturing equipment and a block heat & power plant. The improvements were implemented as part of Sirio Europe&

PierianDx, the leading clinical genomics informatics company, and Pillar Biosciences, a leading next-generation clinical oncology sequencing company, today announced a partnership that will allow Pillar Biosciences to directly sell clinical genomics reports of PierianDx in combination with its cancer profiling tests. Under the terms of the agreement, PierianDx will integrate the PiVAT® bioinformatics pipeline from Pillar Biosciences into the PierianDx environment to provide users with fas

Tevogen Bio,  announced that its Investigational New Drug (IND) application to develop a COVID-19 treatment using proprietary antigen specific T cell technology has been submitted to the US Food and Drug Administration (FDA). Tevogen is partnering with renowned bone marrow transplant expert, Dr. Neal Flomenberg, chair of the Department of Medical Oncology at Thomas Jefferson University, with the intent to evaluate Tevogen's T cell technology to treat hospitalized COVID-19 patients.

The winners of the 17th annual CPhI Pharma Awards, Powered by Informa Pharma Intelligence, were announced at its first-ever virtual ceremony on 13 October 2020. Since 2003, the CPhI Pharma Awards have recognised outstanding achievement in the pharmaceutical and biopharmaceutical industry, and this year’s digital event was no exception. Each category at the prestigious Awards ceremony celebrated the individuals, teams, and organizations committed to driving the industry forward.

As gene-based diagnostics are shortening the path to an accurate diagnosis, the risk of disparities in service and support have increased. To reduce those disparities, Global Genes, a leading rare disease patient advocacy organization, is pleased to announce a new partnership with Rady Children’s Institute for Genomic Medicine (RCIGM) to develop a next-generation support network for families with gene-based diagnosed rare diseases. Approximately 80 percent of rare diseases hav