10 October 2024 Machine learning-enabled drug discovery and development company insitro has announced the execution of three strategic agreements with Eli Lilly.
TG Therapeutics has announced the completion of the rolling submission of a New Drug Application (NDA) to the US Food and Drug Administration requesting accelerated approval for umbralisib as a treatment for patients with previously-treated marginal zone lymphoma (MZL) and follicular lymphoma (FL). 18 June 2020
Californian company Ideaya Biosciences has agreed a strategic partnership with UK pharma major GlaxoSmithKline in synthetic lethality, an emerging field in oncology. 17 June 2020
US clinical-stage immunotherapy firm PDS Biotechnology saw its shares soar 12% pre-market today, after announcing a co-development agreement with Brazil-based Farmacore Biotechnology for Versamune CoV-2FC, a Versamune -based vaccine aimed at preventing COVID-19 infection. 17 June 2020
Latest research findings show Emgality (galcanezumab-gnlm), which received regulatory approval in the USA and Europe in 2018, reduces total pain burden in a recent analysis of patients with episodic and chronic migraine. 17 June 2020
The US Food and Drug Administration granted accelerated approval for an additional indication for Keytruda (pembrolizumab), Merck & Co’s best-selling drug with 2019 sales of $11.08 billion, and already approved for a number of cancer indications. 17 June 2020
Cosentyx (secukinumab), the only fully-human biologic directly targeting IL-17A, has picked up a new approval for a fourth indication in the USA. 17 June 2020
Eli Lilly yesterday announced that Verzenio (abemaciclib) in combination with standard adjuvant endocrine therapy (ET) has met the primary endpoint of invasive disease-free survival (IDFS), significantly decreasing the risk of breast cancer recurrence or death compared to standard adjuvant ET alone. 17 June 2020
The first ever therapy for active and adult-onset Still’s disease (AOSD) has been approved in the USA, providing hope for people with the rare autoinflammatory condition. 17 June 2020
London-listed biotech firm PureTech Health’s founded entity, Akili Interactive, has gained US Food and Drug Administration clearance for EndeavorRx (AKL-T01) as a prescription treatment for children with attention-deficit/hyperactivity disorder (ADHD). 16 June 2020
US RNA (mRNA) therapeutics and vaccines specialist Moderna today announced that Ray Jordan has joined the firm as chief corporate affairs officer, effective Monday, June 15, 2020. 16 June 2020
Detailed data for bimekizumab show strong efficacy in psoriasis, raising the prospect that UCB’s dual IL-17 blocker could make a bigger splash in the market than had been expected. 16 June 2020
The US Food and Drug Administration (FDA) has approved Zepzelca (lurbinectedin) to treat metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy. 16 June 2020
Having risen a percentage point rise in earlier trading, Japanese drugmaker Kyowa Kirin’s shares closed down almost 2% at 2,725 yen, despite announcing the roll-out of its rare blood cancer diseases drug Poteligeo (mogamulizumab) in Europe. 15 June 2020
UK drugmaker AstraZeneca has announced progress lining up manufacturing capacity in Europe for its investigational COVID-19 vaccine, AZD1222. 15 June 2020
Janssen has announced new long-term plaque psoriasis data for Tremfya (guselkumab), a first-in-class treatment showing consistent, high levels of skin clearance at week 100 and week 204 (four years) in adult patients with moderate to severe plaque psoriasis. 15 June 2020
UK health technology assessor the National Institute for Health and Care Excellence (NICE) has granted a positive final appraisal document (FAD) for the use of Rozlytrek (entrectinib) in adults with ROS1-positive non-small cell lung cancer (NSCLC) not previously treated with ROS1 inhibitors. 15 June 2020
The US Food and Drug Administration on Thursday approved Uplizna (inebilizumab-cdon) injection for intravenous use for the treatment of neuromyelitis optica spectrum disorder (NMOSD), also called Sjögren’s syndrome, in adult patients with a particular antibody (patients who are anti-aquaporin-4 or AQP4 antibody positive). 12 June 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