10 October 2024 Machine learning-enabled drug discovery and development company insitro has announced the execution of three strategic agreements with Eli Lilly.
Vertex Pharmaceuticals says it received a proposal from NHS England regarding its portfolio of cystic fibrosis medicines, notably Orkambi (lumacaftor/ivacaftor), the first drug directed at treating the cause of the disease. 18 July 2018
Chinese biopharma start-up Ascentage Pharma has announced the successful completion of approximately $150 million in a Series C financing, bringing the total capital raised since the Company's launch to around $240 million. 17 July 2018
New Zealand’s Pharmaceutical Management Agency PHARMAC said today that is progressing work aimed at improving funded access to medicines for rare disorders. 16 July 2018
OncoSec Medical, a company developing intratumoral cancer immunotherapies, today announced the appointment of Sara Bonstein as Chief Financial Officer and Chief Operating Officer. 16 July 2018
The UK’s health technology assessor has provided a draft guidance recommending reimbursement for AstraZeneca’s biologic asthma option Fasenra (benralizumab). 16 July 2018
USA-based biotech CytoDyn says it has signed a non-binding letter of intent regarding a proposed acquisition of intellectual property and other assets of ProstaGene. 16 July 2018
Greg Hunt, Australian MP for Flinders and Minister of Health, has announced the government's intention to invest A$250,000 ($186,000) to improve access to four immuno-oncology (I-O) therapies. 16 July 2018
US biotech company Advaxis saw its shares surge 68% in premarket trading on Friday after the Food and Drug Administration lifted a clinical hold on the company's Phase I/II trial for an immuno-oncology drug combination. 16 July 2018
As was largely expected, Tegsedi (inotersen) has received marketing authorization approval from the European Commission for the treatment of stage 1 or stage 2 polyneuropathy in adult patients with hereditary transthyretin amyloidosis (hATTR). 13 July 2018
East Coast, USA-based I-O startup Compass Therapeutics has finished raising $132 million to take its lead candidate into the clinic and identify two more clinical candidates. 13 July 2018
Roche’s immuno-oncology drug Tecentriq (atezolizumab) has largely been an outsider to the leaders in the first wave of I-O treatments, Bristol-Myers Squibb’s Opdivo (nivolumab) and Merck & Co’s Keytruda (pembrolizumab). 13 July 2018
Following the UK’s publication of its proposed Brexit deal, the country’s biotech industry has issued a statement interpreting the likely impact for the sector, noting a range of effects from the UK’s relationship with the EMA, to IP protection and other legal issues. 13 July 2018
US biotech major Amgen and Belgian pharma company UCB have resubmitted their Biologics License Application (BLA) to the US Food and Drug Administration for Evenity (romosozumab), 13 July 2018
Today, USA-based CNS-focused biotechZogenix announced positive top-line results from its second Phase III trial (Study 1504) for its investigational drug, ZX008 (low-dose fenfluramine hydrochloride), for the treatment of Dravet syndrome, a rare form of childhood epilepsy. 12 July 2018
Having last year announced its comprehensive policy framework for regenerative medicine, the US Food and Drug Administration (FDA) has this week unveiling complementary measures for the development, review and approval of gene therapies. 12 July 2018
Otsuka Pharmaceutical has signed an agreement to acquire privately-held US biotech Visterra, pushing the Japanese drug major’s share up 2.05% at 4,975 yen in Tokyo trading today. 12 July 2018
Privately-held German firm Immatics Biotechnologies has entered into a research collaboration and license agreement with Danish biotech firm Genmab to develop next-generation, T-cell engaging bispecific immunotherapies targeting multiple cancer indications. 12 July 2018
Hemel Hempstead, UK-based EUSA Pharma has received a positive reimbursement decision from the UK’s health technology assessor for its targeted cancer immunotherapy, Qarziba (dinutuximab beta). 12 July 2018
After its European Medicines Agency (EMA) approval in this indication in April, Sobi's Kineret (anakinra) has launched in the UK for the treatment of adult onset stills disease (AOSD) and systemic-onset juvenile idiopathic arthritis (SOJIA). 11 July 2018
On Wednesday, AbbVie reported results from its ongoing Phase III clinical trial, DBL3001, investigating the effectiveness of Imbruvica (ibrutinib) in diffuse large B-cell lymphoma, revealing that the study had failed to meet its primary endpoint. 11 July 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