A supplemental New Drug Application (sNDA) has been submitted to the US Food and Drug Administration for Zejula (niraparib) by GlaxoSmithKline. 24 June 2019
Erytech Pharma has opened a new GMP manufacturing facility in New Jersey, USA, to support production capacity needs for its lead candidate Graspa (eryaspase), which is in Phase III testing for pancreatic cancer as a second-line option. 24 June 2019
Recursion Pharmaceuticals, an industry leader in artificial intelligence for drug discovery and development, today announced the appointment of Sharath Hegde as its chief scientific officer. 20 June 2019
Japan’s Ricoh has inked a strategic partnership with cell and gene therapy specialist Elixirgen Scientific to develop innovative biomedical products and services supporting drug discovery. 20 June 2019
US pharma major Bristol-Myers Squibb (B-MS) will maintain a presence in Italy through its medicines alone after agreeing to sell its Anagni manufacturing facility to Catalent. 19 June 2019
US immuno-oncology company Kleo Pharmaceutical announced today that CD38-ARM, a CD38 targeting antibody recruiting molecule (ARM™) to treat multiple myeloma, will be its first product candidate to move into the clinic with anticipated human studies to commence in 2020, under its collaboration with Japan’s PeptiDream. 18 June 2019
Amgen Astellas BioPharma (AABP), a joint venture between US biotech Amgen and Japanese drug major Astellas Pharma, have expanded the label in Japan for Repatha (evolocumab). 18 June 2019
Rare disease specialist Eiger BioPharmaceuticals has been granted Breakthrough Therapy Designation for avexitide for the treatment of post-bariatric hypoglycemia (PBH), a serious condition occurring in post-bariatric surgical patients. 18 June 2019
Calithera Biosciences has announced positive results from the Phase II ENTRATA study of telaglenastat (CB-839), in combination with everolimus, in patients with advanced renal cell carcinoma (RCC). 17 June 2019
Novo Nordisk has revealed new analyses from the SUSTAIN 6 and LEADER trials, comparing Ozempic (semaglutide) and Victoza (liraglutide) with placebo on renal outcomes, in people with type 2 diabetes at high CV risk. 17 June 2019
Netherlands-based biotechnology firm UniQure is exploring options including a potential sale amid interest from pharmaceutical companies looking to expand in gene therapy, news service Bloomberg reported on Sunday, citing people with knowledge of the matter. 17 June 2019
bluebird bio on Friday announced pricing plans for its gene therapy Zynteglo in Europe, but that also came with suggestions that the beta-thalassemia treatment’s launch will likely be delayed. 15 June 2019
USA-based biotech Evofem Biosciences and PDL BioPharma today announced the closing of the second tranche for $50 million of an aggregate $80 million strategic financing from PDL and existing Evofem investors, Invesco Asset Management, and Woodford Investment Management. 11 June 2019
BioMarin has won Chinese approval for Vimizim (elosulfase alfa) to treat people with the rare disease mucopolysaccharidosis type IVA (MPS IVA), also known as Morquio A syndrome. 11 June 2019
Calliditas Therapeutics has agreed to sell rights to Everest Medicines to develop and commercialize the kidney disease therapy Nefecon (budesonide) in China, Hong Kong, Macau, Taiwan and Singapore. 10 June 2019
The US Food and Drug Administration has issued guidance making recommendations regarding the components of a drug development program for nonalcoholic steatohepatitis (NASH) with compensated cirrhosis. 7 June 2019
Celgene has filed for the investigational immunotherapy ozanimod, to treat relapsing forms of multiple sclerosis (RMS) in the USA, and relapsing-remitting forms of the disease (RRMS) in Europe. 7 June 2019
US trade group the Biotechnology Innovation Organization (BIO) released “Transforming Ideas into Advances: Best Practices in State and Regional Bioscience Economic Development Initiatives” yesterday at the 2019 BIO International Convention. 5 June 2019
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