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
Switzerland-based biotech ADC Therapeutics today announced the appointment of Dr Mohamed Zaki as chief medical officer, bringing over 20 years of experience in hematology and oncology drug development to his role. 4 January 2023
USA-based tumor drug resistance specialist Deciphera Pharmaceuticals saw its shares close down 2.7% at $15.94 yesterday, after it announced findings of a planned exploratory analysis of data from the INTRIGUE Phase III clinical study of Qinlock (ripretinib) using circulating tumor DNA (ctDNA) from a subgroup of patients with gastrointestinal stromal tumor (GIST) previously treated with imatinib who harbor mutations in KIT exon 11 and 17/18 only. 4 January 2023
Polish clinical-stage biotech Molecure has announced that Dr Samson Fung, currently chief medical officer, has been appointed to the company’s management board. 4 January 2023
CAR-T therapy company Allogene Therapeutics has swiftly named its replacement for executive vice president of research and development Rafael Amado, who has resigned to join Sino-American firm Zai Lab. 3 January 2023
Israel-based clinical-stage company Purple Biotech saw its shares edge up more than 4% to 53.10 shekels today, when it announced a research collaboration with Mor Research Applications (Mor), the technology transfer subsidiary of Clalit Healthcare Services (Clalit). 3 January 2023
USA-based Legend Biotech Corporation has announced that China’s National Medical Products Administration (NMPA) has formally accepted its New Drug Application (NDA) for ciltacabtagene autoleucel (cilta-cel). 3 January 2023
A marketing authorization submission for talquetamab - an immunotherapy with the potential to shake up the multiple myeloma market - is now sat on regulators’ desks at the European Medicines Agency. 3 January 2023
Slightly earlier than expected, US pharma giant Pfizer last week announced positive top-line results from the Phase III BENEGENE-2 study evaluating fidanacogene elaparvovec, an investigational gene therapy, for the treatment of adult males with moderately severe to severe hemophilia B. 3 January 2023
Swedish company Alligator Bioscience yesterday announced an expansion to its research collaboration and license agreement with Finland-based Orion Corporation, to discover and develop together new bispecific antibody cancer therapeutics. 3 January 2023
During the whole of 2022, merger and acquisition (M&A) activity in the pharma and biotech sector showed a slight improvement on 2021, when it fell to a decade low of just 92 deals, with a total number of 109 (See table below). 2 January 2023
The Food and Drug Administration (FDA) has now approved TG Therapeutics’ Briumvi (ublituximab-xiiy), for the treatment of relapsing forms of multiple sclerosis (RMS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. 31 December 2022
Faith in the transparency of the US regulatory process has been shaken, following an accusatory report from influential congressional committees into the approval of Aduhelm (aducanumab). 30 December 2022
The Indian pharma market is increasing at an annual growth rate of 15%, twice the world market growth rate, and has become one of the most expansive sectors in India. While the pharma industry is expected to grow to $130 billion by 2030, there are deep seated challenges posed at this industry when it comes to rare disease management. 30 December 2022
Indian drugmaker Cipla Limited , via its UK subsidiary, has signed definitive agreements for an equity investment of 15 million euros ($16 million) in German biotech Ethris GmbH. 30 December 2022
Paris, France-based neurodegenerative disease specialist Pharnext has attracted a strategic investment from fellow French firm Néovacs. 29 December 2022
US retinal diseases focussed start-up Opus Genetics has acquired the rights to two pre-clinical-stage AAV-based gene therapy product candidates for inherited retinal diseases (IRDs) from Iveric Bio. 29 December 2022
AstraZeneca’s Calquence (acalabrutinib) has secured a new approval in Japan, for the treatment of adults with chronic lymphocytic leukemia (CLL), in the first-line setting. 28 December 2022
Shares of Jounce Therapeutics were trading up a massive 72% at $1.27 pre-market, on the news that biotech major Gilead Sciences is amending an existing license agreement for GS-1811 (formerly JTX-1811), enabling Gilead to buy out remaining contingent payments potentially due under the license agreement executed in August 2020. 28 December 2022