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 drugmaker AbbVie’s hopes that Skyrizi (risankizumab) will help to replace revenues lost when Humira (adalimumab) competition starts to bite, have been boosted further. 11 June 2019
Tecentriq (atezolizumab) has been added to the UK’s Early Access to Medicines Scheme (EAMS) for use in combination with the chemotherapy agents carboplatin and etoposide, for the first-line treatment of adults with extensive-stage small cell lung cancer (SCLC). 11 June 2019
The US Food and Drug Administration has approved top-selling immuno-oncology drug Keytruda (pembrolizumab), under priority review, for the first-line treatment of patients with metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC). 11 June 2019
Hopes for Novavax’s once highly-anticipated respiratory syncytial virus (RSV) shot, ResVax, were dealt a new blow on Monday, as the US regulator said an additional Phase III trial would be needed. 11 June 2019
A new biotech has been launched by GT Healthcare Capital Partners, a life science-focused private equity partnership specializing in capital investments and market scalability in the China region. 11 June 2019
US biotech major Celgene (Nasdaq: CELG) presented data from the first full readout of the APPRECIATE real-world evidence (RWE) study at the World Congress of Dermatology (WCD) in Milan. APPRECIATE is the largest RWE study of Otezla (apremilast), involving 480 patients across six European countries. 11 June 2019
Israeli microbiome company BiomX has licensed a new set of bacterial targets from JSR Corporation, for the development and commercialization of phage therapies for primary sclerosing cholangitis (PSC), an orphan liver disease. 11 June 2019
In the latest sign that the consumption of cannabis for medicinal purposes is being legitimized, the Church of England has reversed its previous policy of refusing to invest in schemes seeking to profit from the drug’s use. 11 June 2019
Shares in Roche were 2% higher by lunchtime on Tuesday following the US Food and Drug Administration (FDA) approval of the first chemo-immunotherapy regimen for patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). 11 June 2019
New York-headquartered charity TB Alliance has announced a positive decision from the US regulator’s scientific advisory body, in relation to an investigational multidrug-resistant (MDR) tuberculosis therapy. 11 June 2019
Evotec has entered into a five-year partnership with the Bill & Melinda Gates Foundation to discover new treatment regimens that better address tuberculosis (TB). 11 June 2019
Danish cancer specialist and Darzalex (daratumumab) discoverer Genmab has inked a deal with its long-time partner Johnson & Johnson, to develop and commercialize a novel CD38 monoclonal antibody, HexaBody-CD38. 11 June 2019
Merck & Co has entered into a definitive agreement to acquire Tilos Therapeutics, a privately held biopharmaceutical company developing therapeutics targeting the latent TGFβ complex for the treatment of cancer, fibrosis and autoimmune diseases. 10 June 2019
California-based rare diseases specialist Eiger BioPharmaceuticals today announced the appointment of Mark Mannebach, as vice president of global regulatory affairs. 10 June 2019
In yet a further delay to the transaction, Swiss pharma giant Roche and Spark Therapeutics today announced that they have each received a request for additional information and documentary material from the US Federal Trade Commission (FTC) in connection with the agency’s review of Roche’s pending $4.3 billion acquisition of Spark announced in February this year. 10 June 2019
Chinese biotech firm CStone Pharmaceuticals today announced that the company has entered into a global clinical collaboration with China focus with Bayer HealthCare LLC, a unit of Germany’s Bayer. 10 June 2019
Immune-mediated disease specialist Provention Bio has presented data from the At-Risk study, testing its type 1 diabetes candidate PRV-031 (teplizumab). 10 June 2019
US drugmaker Vertex Pharmaceuticals is enhancing its gene editing capabilities to develop novel therapies for Duchenne muscular dystrophy (DMD) and myotonic dystrophy Type 1 (DM1) by expanding its collaboration with CRISPR Therapeutics (Nasdaq: CRSP) and acquiring Exonics Therapeutics. 8 June 2019
Despite a perceived lack of innovation that has moved the needle in the last five years, rheumatology remains a massively lucrative sector in which many of the world’s biggest pharma companies continue to earn the largest slice of their revenue. 7 June 2019
As the dust settles on this year’s annual meeting of the American Society of Clinical Oncology (ASCO), analysts have a lot of promising data to digest. 7 June 2019