GigaGen has been awarded a contract by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) within the US Department of Health and Human Services (HHS). 4 October 2024
Oxford, UK-based Enara Bio today announces the closing of a $32.5 million Series B financing supported by a strong syndicate of new and existing biotech investors. 3 October 2024
Zenas BioPharma announced the pricing of its upsized initial public offering of 13,235,294 shares of its common stock at an initial public offering price of $17.00 per share. 13 September 2024
US pharma major Eli Lilly and Egyptian firm EVA Pharma have entered into an agreement to expand access to Olumiant (baricitinib) to an estimated 20,000 people in 49 low- to middle-income countries in Africa by 2030. 6 September 2024
Japan’s Eisai and US biotech Biogen today revealed that the Ministry of Health and Prevention in the United Arab Emirates (UAE) has approved Leqembi (lecanemab) for the treatment of Alzheimer’s disease (AD). 14 August 2024
US clinical stage caner drug developer Theriva Biologics revealed that the US Food and Drug Administration (FDA) has granted Rare Pediatric Drug designation (RPDD) for VCN-01 for the treatment of retinoblastoma. 1 August 2024
Eisai and Biogen have announced that Israel has approved their Alzheimer's treatment, Leqembi (lecanemab), adding to nods in the USA, Japan, China, South Korea, and Hong Kong. 12 July 2024
Contract research and development organization (CDMO) Emergent BioSolutions has announced that Johnson & Johnson will pay $50 million to resolve claims linked to a terminated manufacturing deal for the latter’s COVID-19 vaccine. 11 July 2024
Japan’s Eisai and US biotech Biogen have announced that the Department of Health in Hong Kong has approved humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody Leqembi (lecanemab) for treatment of Alzheimer’s disease (AD). 11 July 2024
PolTREG, a Polish biotech developing cell therapies for autoimmune diseases, has announced that its polyclonal Treg cell therapy PTG-007 demonstrated significant insulin secretion restoration in early-onset type-1 diabetes (T1D) patients, as well as a longer period of disease remission compared to a control group receiving standard-of-care. 24 June 2024
Indian drugmaker Cipla announced that its wholly-owned subsidiary in the UK, Cipla (EU) Limited, will invest an additional 3 million euros ($3.2 million) in Ethris GmbH, a German firm delivering mRNAs directly to the respiratory system. 19 June 2024
Dutch autoimmune diseases specialist Argenx announced that results from the Phase II ALPHA study of efgartigimod in post-COVID-19-mediated postural orthostatic tachycardia syndrome (PC-POTS) show that treated patients had no clinically meaningful improvement compared to placebo on the total Malmö POTS symptom (MaPS) score and COMPASS31. 17 June 2024
The US Food and Drug Administration (FDA) has accepted Eisai’s supplemental Biologics License Application (sBLA) for monthly Leqembi (lecanemab-irmb) intravenous (IV) maintenance dosing. 10 June 2024
The European Medicines Agency (EMA) has approved a Type II variation to the Summary of Product Characteristics (SmPC) for its approved Chimeric Antigen Receptor (CAR) T-cell therapies, Yescarta (axicabtagene ciloleucel) and Tecartus (brexucabtagene autoleucel) from Gilead Sciences’ Kite subsidiary. 6 June 2024
Boehringer Ingelheim has elected to exercise an option with US biotech Eureka Therapeutics for the exclusive license of novel human TCR-mimicking (TCRm) antibodies against an undisclosed target to be used for the potential development and commercialization of therapies for cancer patients. 18 July 2018
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