10 October 2024 Machine learning-enabled drug discovery and development company insitro has announced the execution of three strategic agreements with Eli Lilly.
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended nine medicines for approval, including six orphan medicines, and two CAR-T therapies, at its June 2018 meeting. 29 June 2018
Results from a Phase III, randomized, double-blind, multi-center clinical study (MEDALIST) showed that luspatercept achieved a highly statistically-significant improvement in the primary endpoint of red blood cell (RBC) transfusion independence of at least 8 consecutive weeks during the first 24 weeks compared to placebo. 29 June 2018
Clinical stage biotech Arsanis lost 78% of its market value on Thursday amid news that it is to halt a Phase II trial of its pneumonia candidate, ASN100. 29 June 2018
The US Food and Drug Administration has awarded New York-based Pfizer Priority Review designation for glasdegib, an oral smoothened (SMO) inhibitor. 28 June 2018
US biotech Global Blood Therapeutics is pretty confident that it will have important regulatory news on its sickle cell disease (SCD) candidate voxelotor by Christmas. 28 June 2018
Development and commercialization partners AstraZeneca and Merck & Co have clocked up a potentially important milestone with Lynparza (olaparib) that could expand its reach considerably. 27 June 2018
Tilos Therapeutics, a biotech firm developing anti-LAP antibodies for the treatment of cancer, fibrosis and autoimmune diseases, today announced the appointment of Jessie English as chief scientific officer. 27 June 2018
Illinois-based pharma major AbbVie has renewed its partnership with Calico, the Alphabet subsidiary dedicated to combating the effects of aging. 27 June 2018
Privately-held UK biotech Plasticell is to lead a consortium seeking to develop advanced technologies for the manufacturing of ex vivo gene therapies. 26 June 2018
Cambridge, Massachusetts-based Skyhawk Therapeutics has entered into a global strategic collaboration with an affiliate of US biotech major Celgene to discover, develop and commercialize innovative small molecule treatment options for patients with neurological diseases based on Skyhawk's innovative STAR* technology platform. 26 June 2018
The death of a patient in a Phase IIb trial of topsalysin in localized prostate cancer caused shares in Sophiris Bio to close more than 40% down on Monday. 26 June 2018
US drugmaker AbbVie has announced a collaboration with Calibr, a non-profit drug discovery division of Scripps Research, focusing on switchable CAR-T therapies aimed primarily at solid tumors. 25 June 2018
Generally speaking, Roche’s immuno-oncology asset Tecentriq (atezolizumab) has struggled to keep up with the front-runners in the space in terms of trial results and approvals. 25 June 2018
The European Commission has granted marketing authorization for Biktarvy (bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg; BIC/FTC/TAF), a once-daily single tablet regimen (STR) for the treatment of HIV-1 infection. 25 June 2018
Amgen has announced new data that show Repatha (evolocumab) significantly reduced low-density lipoprotein cholesterol (LDL-C) and non-high density lipoprotein cholesterol (non-HDL-C) in patients with type 2 diabetes and hypercholesterolemia or mixed dyslipidemia, taking the maximum tolerated dose of moderate/high-intensity statin therapy. 25 June 2018
Claims by ViiV Healthcare’s chief executive Deborah Waterhouse that her company is doing more than just playing second fiddle to US biotech Gilead Science in the HIV space have been backed up by an analyst at GlobalData. 22 June 2018
Privately-held German pharma major Boehringer Ingelheim has announced its intention to invest 230 million euros into a new Biologics Development Center (BDC) at its existing research site in Biberach, Germany. 22 June 2018
Ireland-headquartered rare diseases specialist Shire today revealed results from a retrospective review of more than 2,500 patient records with metastatic adenocarcinoma of the pancreas (mPAC) from nine countries. 22 June 2018
Ireland-incorporated rare diseases giant Shire announced on Friday that it had receieved approval from the US Food and Drug Administration on its first submission for a new plasma manufacturing center in the state of Georgia. 22 June 2018
Danish dermatology specialist Leo Pharma has revealed plans to cut 200 jobs, marking the company’s fourth workforce reduction since 2022. 11 October 2024
Booster Therapeutics, a biotechnology company pioneering a new class of proteasome activator medicines to treat neurodegenerative and other diseases, has launched with the support of a $15 million financing. 11 October 2024
German cancer specialist Immatics has announced the pricing of its $150 million public offering, with Jefferies, BofA Securities, and Leerink acting as joint book runners. 11 October 2024
The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has approved Pfizer and BioNTech's latest COVID-19 vaccine, Comirnaty (KP.2). 11 October 2024
In what Astella Pharma calls “a landmark decision for advanced bladder cancer patients,” the Japanese drugmaker gained approval in the UK for its treatment regimen. 10 October 2024
Nanoscope Therapeutics says that, following a productive FDA meeting with the US Food and Drug Administration (FDA) for its clinical program evaluating MCO-010 for the treatment of retinitis pigmentosa (RP), the company will commence with submission of a Biologics License Application (BLA) in the first quarter of 2025. 10 October 2024
US healthcare giant Johnson & Johnson’s Tecvayli (teclistamab) has been recommended by the National Institute for Health and Care Excellence (NICE) as a first-line option to treat myeloma in England and Wales. 10 October 2024
China’s Quantum Pharmaceuticals has announced a significant licensing agreement between its biologics-focused subsidiary, Ailux Biologics, and Johnson & Johnson. 10 October 2024
USA-based Kezar Life Sciences announced this week that it was pausing its Phase IIb PALIZADE trial evaluating zetomipzomib in lupus nephritis (LN) following the deaths of four patients. 10 October 2024
Advances in gene editing, such as the FDA approval of Vertex Pharmaceuticals’ Casgevy (exagamglogene autotemcel) in December 2023 for the treatment of beta thalassemia and sickle cell disease, have fueled significant interest in innovative epigenetic drugs. 10 October 2024
Gene therapy start-up GEMMA Biotherapeutics (GEMMABio) has announced a significant partnership with Brazil's Fiocruz, a key supplier for the Brazilian Ministry of Health. 10 October 2024
California’s Arda Therapeutics, a biotech focused on targeted cell depletion therapies for chronic diseases, has announced the successful completion of a $43 million Series A financing round. 9 October 2024
Purespring Therapeutics, a gene therapy company focused on transforming the treatment of kidney diseases, has raised £80 million ($105 million) in a Series B financing. 9 October 2024