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
US AAV-based gene therapies developer Taysha Gene Therapies today announced that it has received both rare pediatric disease and orphan drug designations from the US Food and Drug Administration for TSHA-105, an AAV9-based gene therapy in development for SLC13A5-related epilepsy. 19 January 2021
From today National Health Service (NHS) clinicians in England will be able to consider the treatment for some patients with a form of lymphoma, a cancer that attacks the immune system, according to UK health technology assessor the National Institute for Health and Care Access (NICE). 19 January 2021
US cancer metabolism specialist Agios Pharmaceuticals has reported a full analysis of the final data, including mature overall survival (OS) results, from its global Phase III ClarIDHy trial of Tibsovo (ivosidenib tablets) in patients with previously treated isocitrate dehydrogenase 1 (IDH1) mutated cholangiocarcinoma, a rare cancer of the bile ducts. 19 January 2021
The British medicines regulator has granted a Promising Innovative Medicine (PIM) designation to nirsevimab, a monoclonal antibody designed to immunize unborn babies via maternal administration. 19 January 2021
Investors will continue to chase after Chinese biotechs despite obvious bubbles, said speakers from several venture capitals and biotechs at China Biomed innovation and investment conference held online on January 12, reports The Pharma Letter’s correspondent Wang Fangqing. 18 January 2021
Incoming US President Joe Biden - due to be sworn in on Wednesday - has outlined several new appointments to the team in charge of tackling the coronavirus pandemic in the USA. 18 January 2021
China’s Fosun Pharma’s biotech arm Henlius has agreed to acquire rights for development and commercialization of the anti-TPOR-2 antibodies, LIV-2008/2008b, generated by Chiome Bioscience. 18 January 2021
US trade group the Pharmaceutical Research and Manufacturers of America (PhRMA) has pointed out the savings that gene therapies can deliver for patients that otherwise require lifelong treatment. 18 January 2021
US pharma giant Pfizer and German partner BioNTech have developed a plan that will allow the scale-up of manufacturing capacities for its COVID-19 vaccine, dubbed BNT162b2 and Comirnaty, in Europe and deliver significantly more doses in the second quarter. 18 January 2021
Shares of USA-based VBI Vaccines gained as much as 14% to $3.88 in early trading on Friday, after it announced that results from a Phase IV study of its prophylactic 3-antigen hepatitis B virus (HBV) vaccine in younger adults were published in the journal Vaccine. 18 January 2021
On January 15, the Food and Drug Administration approved Enhertu (fam-trastuzumab deruxtecan-nxki) for adult patients with locally-advanced or metastatic HER2-positive gastric or gastroesophageal (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen. 16 January 2021
Late Friday, Janssen announced that the US Food and Drug Administration has granted accelerated approval for Darzalex Faspro (the subcutaneous formulation of daratumumab), in combination with bortezomib, cyclophosphamide and dexamethasone (VCd or CyBorD for short), for the treatment of newly-diagnosed light chain (AL) amyloidosis. 16 January 2021
US biotech Five Prime Therapeutics has updated Phase II FIGHT data in gastric cancer - including subgroup data, safety data, and immediate next steps – which were presented as an oral late-breaker at ASCO Gastrointestinal Cancers Virtual Annual Symposium (ASCO: GI) on Friday. 16 January 2021
US biotech Novavax today announced the appointment of Henrietta Ukwu to the position of senior vice president, chief regulatory and quality officer. 15 January 2021
Sharing results at the TOXINS 2021 conference, organized by the International Neurotoxin Association, French drugmaker Ipsen has announced new Phase III analyses for Dysport (abobotulinumtoxinA). 15 January 2021
Shares of French biopharma company DBV Technologies (Euronext: DBV) leapt more than 17% to 7.78 euros in early trading, after it revealed receipt of written responses from the US Food and Drug Administration to questions provided in the Type A meeting request the company submitted in October 2020. 15 January 2021
Late December last year, there were Russian media reports suggesting that Swiss pharma giant Novartis was expected to face delays in the regulatory approval for its gene therapy Zolgensma (onasemnogene abeparvovec) in Russia, notably the Kommersant journal, on the basis of which were also reported by The Pharma Letter. 14 January 2021
Sino-America biotech firm BeiGene’s says that its anti-PD-1 antibody tislelizumab has received approval from the China National Medical Products Administration (NMPA) for use in combination with two chemotherapy regimens as a first-line treatment for patients with advanced squamous non-small cell lung cancer (NSCLC). 14 January 2021