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
In a filing with the US Securities and Exchange Commission, Clovis Oncology has revealed it will voluntarily withdraw part of the label for its PARP blocker Rubraca (rucaparib). 20 June 2022
UK clinical-stage Zura Bio Limited, founded in January this year, and JATT Acquisition Corp, a publicly-traded US special purpose acquisition company (SPAC) formed for the purpose of acquiring or merging with one or more businesses, have entered into a definitive business combination agreement. 20 June 2022
Over the years, cell therapy has become an essential treatment method for many incurable diseases, illnesses and injuries such as cancers, autoimmune diseases, spinal cord injuries, and neurological conditions. 20 June 2022
Among significant news last week, US biotech Alnylam Pharmaceutical on Monday revealed that the Food and Drug Administration has approved its rare disease drug Amvuttra (vutrisiran). Japan’s Shionogi entered into a landmark collaboration to expand global access to its antibiotic cefiderocol. Swiss pharma giant Roche last Wednesday released new data on its Alzheimer’s disease candidate crenezumab that once again proved a failure. Also, rumors surfaced on Friday that US biotech Seagen is in talks with US pharma giant Merck & Co about a possible acquisition of the company with which it already has research collaborations. 19 June 2022
Market research firm Graphical Research has released an analysis indicating that the global biodefense market size is set to grow significantly through to 2028. 17 June 2022
Cardio-renal diseases specialist Renibus Therapeutics has announced positive interim data from its lead clinical candidate, RBT-1, from its randomized, placebo-controlled Phase II trial. 17 June 2022
US clinical-stage biotech Scholar Rock today announced new data from the Phase II TOPAZ trial extension period evaluating patient outcomes after 24-months of treatment, which support sustained and continued improvement with apitegromab (SRK-015) for non-ambulatory patients with Types 2 and 3 SMA receiving a spinal muscular atrophy (SMN) therapy. 17 June 2022
Switzerland-headquartered biotech Addex Therapeutics today announced that it has terminated the Phase IIb/III study evaluating dipraglurant as a potential treatment for dyskinesia associated with Parkinson’s disease (PD-LID) due to the slow recruitment of patients. 17 June 2022
Shares in Akero Therapeutics ended the day up over a fifth on Thursday, after the firm announced a deal with Pfizer, including a $25 million equity investment. 17 June 2022
Pharma can boast a major role in improving the quality of life of patients with diseases such as breast cancer and rheumatoid arthritis in Latin America, writes The Pharma Letter’s local correspondent. 17 June 2022
The UK’s National Institute for Health and Care Excellence (NICE) has recommended abemaciclib in combination with endocrine therapy, within its marketing authorization, as an option for adjuvant treatment of hormone receptor-positive, HER2-negative, node-positive early breast cancer in adults whose disease is at high risk of recurrence, defined as pathological tumor involvement in: 17 June 2022
The Swiss parliament has failed to finance the government's plan to buy COVID-19 vaccines in 2023, forcing the cabinet to try to renegotiate contracts with Moderna and Pfizer/BioNTech’s for millions of doses of their vaccines, according to a report from Reuters. 17 June 2022
UK drugmaker GSK has welcomed the decision from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) to grant Innovation Passport designation to two of its oncology medicines. 16 June 2022
US biotech Checkpoint Therapeutics today announced positive interim efficacy results from its registration-enabling clinical trial evaluating its anti-PD-L1 antibody, cosibelimab, in patients with locally advanced cutaneous squamous cell carcinoma (cSCC) who are not candidates for curative surgery or radiation. 16 June 2022
Swiss drugmaker Roche has announced the results of a trial run in collaboration with Banner Alzheimer’s Institute, the University of Antioquia in Colombia and the National Institute on Aging. 16 June 2022
Following Tuesday’s scientific recommendation to approve Moderna’s coronavirus vaccine for older children, a panel of experts yesterday endorsed the jab for children as young as six months old. 16 June 2022
US biotech company Exelixis and Sweden’s BioInvent have entered into an option and license agreement focused on the identification and development of novel antibodies for use in immune-oncology (I-O) therapeutics. 16 June 2022
Danish CNS specialist Lundbeck announced that the results from the DELIVER study have been recognized for their importance for the scientific and medical community. The results from the clinical study with Vyepti (eptinezumab) were accepted for publication in the prestigious journal Lancet Neurology, one of the most cited medical journals within neurology. 16 June 2022
India's Central Drugs Standard Control Organization's (CDSCO) oncology/hematology Subject Expert Committee, which advises the drug regulator, has asked the local subsidiary of Swiss pharma giant Roche to submit the efficacy results of its Phase III trial on Tecentriq (atezolizumab), an anti-cancer drug. 16 June 2022
Germany’s MorphoSys has entered into an equity participation agreement and license agreements to allow US biotech Human Immunology Biosciences (HIBio) to develop and commercialize MorphoSys’ felzartamab, an anti-CD38 antibody, and MOR210, an anti-C5aR1 antibody. 15 June 2022