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
Cambridge, USA-based biotech Ribon Therapeutics has closed a $65 million financing, which the company says will be used to support the clinical development of its novel precision medicine candidates. 14 July 2021
British pharma major and coronavirus vaccine developer AstraZeneca has cleared the final regulatory hurdle in its acquisition of Alexion Pharmaceuticals. 14 July 2021
Cambridge, Massachusetts-based Prime Medicine, a company delivering on the promise of Prime Editing to provide lifelong cures to patients, has announced its launch with $315 million in financing. 14 July 2021
German contract development and manufacturing company ProBioGen yesterday announced that they have entered into a research license agreement with US biotech Heat Biologics for both ProBioGen's Transposase System DirectedLuck as well as for its proprietary suspension HEK293 cell line. 14 July 2021
US biotech major Biogen has entered into a license and collaboration agreement for orelabrutinib, an oral small molecule Bruton’s tyrosine kinase inhibitor (BTKi) for the potential treatment of multiple sclerosis (MS), with China’s InnoCare Pharma. 13 July 2021
The Russian government is considering allowing foreign vaccines against COVID-19 to enter the domestic market, according to recent statements by some senior state officials and some local media reports, reports The Pharma Letter’s local correspondent. 13 July 2021
Ionis Pharmaceuticals has exercised its option and entered into an exclusive worldwide license and collaboration agreement with Bicycle Therapeutics for tissue-targeted delivery of oligonucleotide therapeutics. 13 July 2021
The US Food and Drug Administration has approved Darzalex Faspro (daratumumab and hyaluronidase-fihj) in combination with pomalidomide and dexamethasone for adult patients with multiple myeloma who have received at least one prior line of therapy including lenalidomide and a proteasome inhibitor. 13 July 2021
Hutchmed says that the first commercial sale in China of Orpathys (savolitinib), the Chinese firm's oral, potent, and highly selective small molecule inhibitor of MET, a receptor tyrosine kinase, occurred on July 12, 2021. 13 July 2021
Shares in New Jersey, USA-based Celldex Therapeutics leapt by a quarter on Monday, after the firm announced positive results from an ongoing Phase Ib trial of CDX-0159. 13 July 2021
The US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for ASP3772 for the prevention of pneumonia and invasive disease caused by Streptococcus pneumoniae serotypes included in ASP3772 in adults aged 50 years and older. 13 July 2021
The University of Texas MD Anderson Cancer Center and Hummingbird Bioscience have announced the launch of a multi-year strategic research collaboration to investigate and evaluate HMBD-002, the Texas biotech’s VISTA antagonist antibody. 12 July 2021
England’s health technology assessor, the National Institute for Health and Care Excellence (NICE), has dealt a blow to Orchard Therapeutics’ reimbursement goals for atidarsagene autotemcel. 12 July 2021
Data from two Phase II studies investigating bemcentinib in hospitalized COVID-19 patients have been presented at the European Congress of Clinical Microbiology & Infectious Diseases (ECCMID) by Norwegian biotech BerGenBio. 12 July 2021
Prothena Corp shares were up nearly 6% at $62.70 in pre-market New York trading, as the Ireland-headquartered biotech announced a definitive purchase agreement with Danish diabetes care giant Novo Nordisk. 12 July 2021
French vaccines developer Valneva has been awarded Breakthrough Therapy designation for its single-shot chikungunya vaccine candidate, VLA1553, by the US Food and Drug Administration (FDA). 12 July 2021
Belgian cell therapy company Bone Therapeutics, which is addressing unmet medical needs in orthopedics and other diseases, has appointed Anne Leselbaum as chief medical officer (CMO), effective August 23, 2021. 12 July 2021
The controversy over the approval of Alzheimer’s med Aduhelm (aducanumab) has deepened, as the acting head of the US Food and Drug Administration called for an investigation into her agency’s own actions. 12 July 2021
The US Food and Drug Administration has granted Padcev (enfortumab vedotin-ejfv) regular approval, in addition to approving a new indication for adult patients with locally-advanced or metastatic urothelial cancer who are ineligible for cisplatin-containing chemotherapy and have previously received one or more prior lines of therapy. 10 July 2021
Japanese drug major Chugai Pharmaceuticals has entered into an option and license agreement with Chinese biotech Alebund Pharmaceuticals (Hong Kong), regarding Chugai’s EOS789, an investigational agent under development for hyperphosphatemia. 10 July 2021