9 October 2024 US pharma major Bristol Myers Squibb’s recent approval from the US Food and Drug Administration (FDA) for Cobenfy (xanomeline and trospium chloride) for the treatment of adults with schizophrenia is a win for the company.
US drugmaker AbbVie and I-Mab signed a broad, global agreement for the development and commercialization of lemzoparlimab, an innovative anti-CD47 monoclonal antibody internally discovered and developed by the Chinese biopharma for the treatment of multiple cancers. 4 September 2020
Kite today announced that it has submitted a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration for Yescarta (axicabtagene ciloleucel). 4 September 2020
US authorities have been urged to review whether Moderna Therapeutics has been upfront about public sources of funding for some of its work. 4 September 2020
RedHill Biopharma announced that opaganib (trade name Yeliva) has been selected for $300,000 grant funding from the Pennsylvania state COVID-19 Vaccines, Treatments and Therapies (CV-VTT) program, which will support the rapid further development of novel COVID-19 therapies. 4 September 2020
Californian monoclonal antibody (Mab) specialist Xencor has entered a strategic collaboration with the University of Texas MD Anderson Cancer Center to study investigational treatments for patients with a variety of cancer types. 4 September 2020
Chinese biotech InxMed (Nanjing) says that it has completed its Series A+ financing of 130 million renminbi (~$19 million), which was led by Ennovation Ventures and China Growth Capital and followed by InnoMed Capital and Grand Yangtze Capital 4 September 2020
Gilead Sciences’ CAR-T subsidiary Kite and HiFiBiO Therapeutics have entered into a two-year research collaboration and license agreement in acute myeloid leukemia (AML). 3 September 2020
Janssen says it is disappointed with the UK’s medicines cost-effectiveness body the National Institute for Health and Care Excellence (NICE) second draft guidance published today, that does not recommend Spravato (esketamine) nasal spray. 3 September 2020
Days after the US Food and Drug Administration issued an emergency use authorization (EUA) for the use of convalescent plasma in COVID-19, a key advisory panel has warned of a lack of evidence. 3 September 2020
A new analysis from professional services firm BDO shows that demands for innovation have caused research and development (R&D) spend to outpace revenue growth from 2016 to 2019. 3 September 2020
Shares of UK biotech Allergy Therapeutics jumped 7.8% to 19.40 pence in early trading after it revealed a further investment in virus-like particle (VLP) technology for applications beyond the allergy immunotherapy field. 3 September 2020
Shares of US drugmaker AbbVie closed down 3.4% at $92.24 yesterday, after it was revealed that US House Committee on Oversight and Government Reform chairwoman Carolyn Maloney intends to subpoena AbbVie for documents related to the committee's investigation into how big-name drugmakers price some of the world's best-selling drugs. 2 September 2020
A new agreement between Santhera Pharmaceuticals and fellow Swiss firm Idorsia, plus USA-based ReveraGen BioPharma, will make Santhera a direct license holder of vamorolone. 2 September 2020
Swedish rare disease specialist Hansa Biopharma has provided updated guidance regarding its ongoing and planned clinical trial program. 2 September 2020
The US Food and Drug Administration (FDA) has approved Onureg (azacitidine 300mg tablets, CC-486) for the continued treatment of adult patients with acute myeloid leukemia (AML). 2 September 2020
Bristol Myers Squibb has announced interim results from the Phase III open-label extension trial DAYBREAK, demonstrating the long-term efficacy and safety profile of Zeposia (ozanimod) in relapsing forms of multiple sclerosis. 1 September 2020
US clinical-stage biotech Jounce Therapeutics’ shares ratcheted up nearly 49% to $7.19 in mid-morning trading, having soared as much as 97% pre-market, after it announced a lucrative out-licensing deal for its JTX-1811 immunotherapy program. 1 September 2020
Anglo-Swedish pharma major AstraZeneca (LSE: AZN) says that development of its COVID-19 vaccine candidate ZD1222 has expanded into a Phase III clinical trial in the USA to assess its safety, efficacy and immunogenicity. 1 September 2020
Strasbourg-based G Protein-Coupled Receptors (GPCR) pioneer Domain Therapeutics has expanded a research collaboration with New York’s Pfizer. 1 September 2020
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
German family-owned pharma major Boehringer Ingelheim and USA-based Circle Pharma (have entered into a research collaboration and license agreement with the shared goal to develop a first-in-class cyclin inhibitor that can halt the growth of cancer cells potentially offering hope to those living with hard-to-treat cancers. 9 October 2024
Calluna Pharma, a biotech focused on treating inflammatory and fibrotic diseases, has appointed Mark Gaffney as its new chief executive. 9 October 2024
Cambridge, USA-based City Therapeutics has announced its launch with a vision to lead the future of RNA interference (RNAi)-based medicine. 9 October 2024
Zephyrm Bioscience, a Cayman Islands-based biotech, has filed for an initial public offering (IPO) in Hong Kong, seeking to raise additional capital to advance its cell therapy pipeline. 9 October 2024
Privately-held UK biotech Curve Therapeutics has announced the appointment of Rab Prinjha as chief research and development (R&D) officer. 9 October 2024