China-based Hangzhou Just Biotherapeutics (HJB), an organization dedicated to expanding global access to important protein therapeutics, yesterday held the grand opening ceremony for its R&D center and manufacturing facility. 23 January 2018
The European Commission (EC) has expanded the indication of Yervoy (ipilimumab) to include treatment of advanced (unresectable or metastatic) melanoma in pediatric patients 12 years of age and older. 22 January 2018
Japan’s Ministry of Health, Labor and Welfare (MHLW) has granted marketing and manufacturing authorization for Dupixent (dupilumab) for the treatment of atopic dermatitis in adults not adequately controlled with existing therapies. 22 January 2018
Denmark’s Genmab will receive a $50 million compensation payment from Novartis after the Swiss firm announced it would stop selling Arzerra outside the USA for certain chronic lymphocytic leukemia (CLL) indications. 22 January 2018
East Coast, USA-based Pandion Therapeutics has raised $58 million in a series A funding round, co-led by Polaris Partners, Versant Ventures and Roche Venture Fund. 18 January 2018
BeiGene today announced the pricing of its follow-on public offering of 7,425,750 American Depositary Shares (ADSs), each representing 13 of its ordinary shares, par value $0.0001 per share, at a price to the public of $101.00 per ADS. 18 January 2018
The UK’s National Institute for Health and Clinical Excellence (NICE) has recommended daratumumab (Darzalex, Janssen) for some adults with previously treated multiple myeloma within the Cancer Drugs Fund (CDF). 17 January 2018
Hong Kong-listed WuXi Biologics has appointed former US FDA associate country manager Chiang Syin as chief quality officer, responsible for quality assurance, quality control laboratories and regulatory affairs. 16 January 2018
Switzerland’s Novartis has released results from its CLARITY study, in which its IL-17A inhibitor Cosentyx compares favorably with Janssen’s IL-12 and IL-23 inhibitor Stelara. 16 January 2018
Opdivo discoverer Ono Pharmaceutical and licensee Bristol-Myers Squibb have filed in Japan to add new information to the label for combination Opdivo/Yervoy in renal cell carcinoma. 15 January 2018
The European Medicines Agency has given the green light to London-listed Shire to market its hemophilia A therapy Adynovi (antihemophilic factor, recombinant, PEGylated), marketed since 2015 in the USA as Adynovate. 15 January 2018
Rare disease specialist GeneDx, part of Nasdaq-listed OPKO Health, has entered into a research collaboration with the Radboud University Medical Center, Netherlands. 12 January 2018
The USA-based Institute for Clinical and Economic Review (ICER) has posted a Draft Scoping Document outlining a planned review of AbbVie and Neurocrine Biosciences’ elagolix for the treatment of endometriosis and associated pain. 12 January 2018
Dutch I-O specialist Merus and China’s Simcere Pharmaceutical have agreed a deal related to Merus’ proprietary Biclonics technology platform. 11 January 2018
Fasenra (benralizumab), the first respiratory biologic from Anglo-Swedish pharma major AstraZeneca, has been approved in Europe as an add-on maintenance treatment in adults with severe eosinophilic asthma inadequately controlled despite high-dose inhaled corticosteroids plus long-acting beta-agonists. 10 January 2018
Belgo-Dutch biotech Galapagos has teamed up with a research institute and Belgium’s Centre for Drug Design and Discovery (CD3) over the development of new MALT1 inhibitors as therapeutics in inflammatory and oncological diseases. 10 January 2018
Italian pharma major Recordati saw its shares rise more than 5% to 52.00 euros in early trading, as it announced a deal to expand its portfolio of marketed rare disease medicines. 4 October 2024
Paris-based asset manager Kurma Partners has raised 140 million euros ($154 million), successfully completing the first closing of Biofund IV 4 October 2024
Bristol Myers Squibb has received a new approval from the US Food and Drug Administration for its blockbuster checkpoint blocker, Opdivo (nivolumab). 4 October 2024
Singapore’s Agency for Science, Technology and Research (A*STAR) and US biotech incubator Flagship Pioneering have agree to collaborate on advancing health and sustainability outcomes in Singapore and the broader Asia Pacific region. 4 October 2024
The US Food and Drug Administration (FDA) has removed the partial clinical hold on delpacibart etedesiran (del-desiran/AOC 1001), an investigational treatment designed to address the root cause of myotonic dystrophy type 1 (DM1), under development by US biotech Avidity Biosciences . 4 October 2024
The US Food and Drug Administration (FDA) has granted the Gilead Sciences subsidiary Kite a Regenerative Medicine Advanced Therapy Designation (RMAT) for Yescarta (axicabtagene ciloleucel) for adults with newly-diagnosed, high-risk large B-cell lymphoma (LBCL). 3 October 2024
Kedrion Biopharma has finalized an agreement with Germany-based Biotest for the long-term commercialization and distribution of Yimmugo (immune globulin) in the USA. 3 October 2024
US clinical-stage biotech Arcus Biosciences has entered into a clinical trial collaboration with AstraZeneca on renal cancer treatments. 3 October 2024
PeptiDream says that its wholly-owned PDRadiopharma subsidiary has entered into a strategic partnership with French nuclear medicines firm Curium. 3 October 2024
Privately-held Ferring Pharmaceuticals has announced the opening of a global manufacturing hub in Finland for the drug substance of its intravesical non-replicating gene therapy Adstiladrin (nadofaragene firadenovec-vncg). 3 October 2024
Shares of UK drug developer Hemogenyx Pharmaceuticals rose as much as 9% and closed up 5.9% at 1.70 pence yesterday on the news of a further investment from Prevail Partners. 3 October 2024
UK-based biotech Resolution Therapeutics has announced the completion of a £63.5 million ($76.8 million) series B financing round led by Syncona. 3 October 2024
The BioIndustry Association (BIA), in collaboration with the Centre for Process Innovation (CPI), has published a new report on the UK’s mRNA sector. 2 October 2024
Aspen Neuroscience, a private biotechnology company specializing in autologous cell therapies, has announced the opening of a major new facility near its headquarters in San Diego. 2 October 2024
Privately-held UK biotech Curve Therapeutics today announced the further strengthening of its leadership team with the appointments of Andre Hoekema as chairman of the board and Cora Griffin as head of business development. 2 October 2024