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
The VIALE-C (M16-043) trial of Venclexta (venetoclax) in combination with low-dose cytarabine (LDAC) versus LDAC in combination with placebo did not meet its primary endpoint of statistically-significant improvement of overall survival (OS) for patients with acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy at the time of the planned analysis. 29 February 2020
Biohaven Pharmaceutical Holding late Thursday gained regulatory approval for its migraine treatment drug to join the already competitive market sector, with the news sending its shares up 5.3% to $40.82 in after-hours trading, after falling 8.5% in the regular session. 28 February 2020
After the bell on Thursday US biotech major Biogen and genomic medicines company Sangamo Therapeutics announced that they have executed a global licensing collaboration agreement, that could be worth over $2.5 billion, with the news sending the latter’s shares almost 40% higher to $9.31 in after-hours trading. 28 February 2020
Data on Vitrakvi (larotrectinib) in adult and pediatric patients with TRK fusion cancer shows the need to identify suitable patients through genomic testing, says German pharma major Bayer. 27 February 2020
Germany’s Boehringer Ingelheim and privately-held US firm Trutino Biosciences have entered into a research collaboration and worldwide licensing agreement based on Trutino’s innovative On-Demand-Cytokine (ODC) platform. 27 February 2020
Singapore-based Tessa Therapeutics, a Temasek-backed clinical stage biotech company, has been granted Regenerative Medicine Advanced Therapy (RMAT) designation for its experimental CD30-directed autologous Car-T cell candidate. 27 February 2020
A vote of the US Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) on Eli Lilly’s Cymramza (ramucirumab) has narrowly come out in favor of using the drug in combination with erlotinib in a lung cancer indication. 27 February 2020
The Brazilian Health Regulatory Agency (ANVISA) has approved Onpattro (patisiran) for the treatment of hereditary transthyretin-mediated (hATTR) amyloidosis in adults with stage 1 or stage 2 polyneuropathy. 27 February 2020
The US Food and Drug Administration has approved a supplemental New Drug Application (sNDA) for Nerlynx (neratinib) in combination with capecitabine for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. 27 February 2020
The Institute for Clinical and Economic Review (ICER) today released a Final Evidence Report and Report-at-a-Glance assessing the comparative clinical effectiveness and economic value of three acute treatments for migraine. 26 February 2020
Under a January 2017 agreement, Japanese drug major Takeda Pharmaceutical has now taken up its option to acquire PvP Biologics, following the conclusion of a Phase I proof-of-mechanism study of investigational medicine TAK-062 (Kuma062) for the treatment of uncontrolled celiac disease. 26 February 2020
With stocks reeling over safety concerns for blindness medicine Beovu (brolucizumab), Swiss pharma giant Novartis has begun an external review into the product. 26 February 2020
US biotech Vertex Pharmaceuticals (Nasdaq: VRTX) today announced that Kalydeco (ivacaftor) will be available to eligible patients with cystic fibrosis (CF) in New Zealand from March 1. 26 February 2020
A randomized, controlled clinical trial to evaluate the safety and efficacy of the investigational antiviral remdesivir in hospitalized adults diagnosed with coronavirus disease 2019 (COVID-19) has begun at the University of Nebraska Medical Center (UNMC) in Omaha. 26 February 2020
UK-based biotech Bicycle Therapeutics has entered into a strategic collaboration agreement with Swiss pharma giant Roche’s Genentech subsidiary, a to discover, develop and commercialize novel Bicycle-based immuno-oncology (I-O) therapies. 25 February 2020
US biotech NGM Biopharmaceuticals yesterday announced positive preliminary top-line results for its liver disease candidate aldafermin, sending the firm’s shares rocketing 23.5% to $20.00 in heavy volume by Monday mid-morning, having jumped as much as 41%. 25 February 2020
The US Food and Drug Administration has granted priority review for the supplemental New Drug Application (sNDA) to expand the use of Alunbrig (brigatinib) as a first-line treatment for patients with anaplastic lymphoma kinase-positive (ALK+) metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test. 25 February 2020
The US Food and Drug Administration (FDA) and European Medicines Agency (EMA) have accepted the supplemental Biologics License Application (sBLA) and Marketing Authorization Application (MAA), respectively, for ofatumumab (OMB157) for the treatment of relapsing forms of multiple sclerosis (RMS) in adults. 24 February 2020