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
Just a couple of months after it won European approval, Venclyxto (venetoclax) has been recommended for routine use alongside rituximab on the National Health Service (NHS) in England for previously-treated chronic lymphocytic leukemia (CLL). 18 January 2019
US biotech Amgen and Belgian drugmaker UCB, which are co-developing the investigational bone-forming monoclonal antibody Evenity (romosozumab), have welcomed a major step forward towards US approval of the drug. 17 January 2019
UK-based GlaxoSmithKline and the Medicines for Malaria Venture (MMV) have published positive Phase III data from two studies of Krintafel (tafenoquine) for the radical cure of malaria. 17 January 2019
Germany’s Boehringer Ingelheim said today it has initiated a capacity expansion at its commercial manufacturing site for biologics in China. 17 January 2019
French biotech firm Valneva, a leading pure play vaccine company, today announced the signing of a new contract with the US government Department of Defense for the supply of its Japanese encephalitis (JE) vaccine Ixiaro. 16 January 2019
China may offer a dynamic market for drug companies, but the country’s changeable policies and unique healthcare insurance system are among the major challenges faced by companies seeking launch excellence, reports The Pharma Letter’s local correspondent, Wang Fangqing. 16 January 2019
US Food and Drug Administration Commissioner Scott Gottlieb has issued a statement regarding the new policies the agency is implementing to advance the development of cell and gene therapies. 16 January 2019
China’s National Medical Products Administration (NMPA) has approved the marketing application for Linzess (linaclotide) for adults with irritable bowel syndrome with constipation (IBS-C) in China. 16 January 2019
Hitting one out of three primary endpoints has been billed as a success for Keytruda (pembrolizumab) as results were presented from KEYNOTE-181, a trial investigating the anti-PD-1 therapy for the second-line treatment of advanced or metastatic esophageal or esophagogastric junction carcinoma. 15 January 2019
China's oncology drug market has grown rapidly in recent years. Revenue of the oncology drugs in China grew from 83.4 billion renminbi in 2013 to 139.4 billion renminbi ($20.65 billion) in 2017, representing a compound annual growth rate (CAGR) of 13.7%. 15 January 2019
The US Food and Drug Administration has approved Cabometyx (cabozantinib) tablets for patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. 15 January 2019
The combination of the Bristol-Myers Squibb drugs, Opdivo (nivolumab) and Yervoy (ipilimumab), have received European approval for first-line treatment of patients with intermediate- and poor-risk advanced renal cell carcinoma (RCC). 15 January 2019
A global placebo-controlled, double-blind Phase II clinical study of varlitinib as a first-line therapy in HER1/HER2 co-expressing advanced or metastatic gastric cancer patients, comparing varlitinib plus mFOLFOX6 to placebo plus mFOLFOX6 did not meet the primary endpoint of significant reductions in tumor size after 12 weeks of treatment. 15 January 2019
A start-up that was founded by a group of investors led by Pablo Legorreta, the chief executive of biopharma investor Royalty Pharma, has announced the $62 million acquisition of inRegen and its affiliate, Twin City Bio. 14 January 2019
UK-based Seqirus, a subsidiary of the Australian biotech firm CSL Limited (ASX: CSL), has won European approval for a new cell-based seasonal influenza vaccine, Flucelvax Tetra (influenza vaccine). 14 January 2019
Chinese companies Ascletis Pharma and Suzhou Alphamab have signed a strategic collaboration and exclusive licensing agreement for the anti-PD-L1 drug KN035, to treat hepatitis B and other viral diseases in China. 14 January 2019
A University of Wisconsin-Madison researcher and his collaborators at the University of California, San Francisco have repurposed the gene-editing tool CRISPR to study which genes are targeted by particular antibiotics, providing clues on how to improve existing antibiotics or develop new ones. 14 January 2019