A US Food and Drug Administration (FDA) Advisory Panel voted against approving PTC Therapeutics’ Translarna (ataluren) as a treatment of nonsense mutation Duchenne muscular dystrophy on Thursday. 2 October 2017
The Final Evidence Report issued by the Institute for Clinical and Economic Review (ICER) has recommended cutting the prices of PARP inhibitors if they are to provide value for money as maintenance therapy in ovarian cancer. 2 October 2017
Casebia Therapeutics, the joint venture founded by German pharma Bayer and gene-editing start-up CRISPR Therapeutics, has announced an exclusive license agreement and research collaboration to explore new methods to treat and prevent autoimmune disease using CRISPR/Cas9 gene-edited regulatory T cells with Seattle Children’s Research Institute. 28 September 2017
Roche has been granted marketing authorization by Switzerland’s medicines regulator, Swissmedic, for Ocrevus for both relapsing and primary progressive forms of multiple sclerosis. 28 September 2017
US biotech major Gilead Sciences has announced that Kevin Young CBE, chief operating officer, plans to retire, effective early 2018. Mr Young will remain with Gilead through the first quarter of next year and in an advisory capacity thereafter. 28 September 2017
Sanofi has been granted marketing authorisation for Dupixent for the treatment of moderate-to-severe atopic dermatitis in certain adult patients. 28 September 2017
Hamburg-based Evotec is to invest 15 million euros ($18 million) in the UK’s Exscientia, a company focused on artificial intelligence-driven drug discovery. 28 September 2017
AbbVie’s Maviret (glecaprevir/pibrentasvir) has been approved in Japan as a once-daily, ribavirin-free treatment for adults with chronic hepatitis C virus (HCV) infection across all major genotypes. 27 September 2017
KaNDy Therapeutics was launched on Wednesday to take forward NT-814, a potential breakthrough medicine for chronic debilitating women’s health conditions, with backing from investors including Advent Life Sciences, Fountain Healthcare Partners, Forbion Capital Partners and OrbiMed Advisors. 27 September 2017
Bavencio (avelumab) became the first and only treatment indicated for curatively unresectable Merkel cell carcinoma (MCC) in Japan on Wednesday in a regulatory decision that also makes it the first anti-PD-L1 to be available in the Asian country. 27 September 2017
A US Food and Drug Administration (FDA) advisory committee will meet on Thursday to discuss the New Drug Application for Translarna (ataluren), submitted by US drugmaker PTC Therapeutics, for the treatment of dystrophinopathies – most notably Duchenne muscular dystrophy – resulting from nonsense mutations in the dystrophin gene. 27 September 2017
Glythera has paid an undisclosed sum for exclusive access to Cancer Research UK’s novel CDK11 inhibitor program to develop antibody drug conjugates (ADCs) using the biotech company’s proprietary PermaLink conjugation platform. 26 September 2017
Danish CNS specialist Lundbeck is to pay an initial five million euros ($5.9 million) to use the technology of Belgian drug discovery company Confo Therapeutics to discover small molecule compounds acting upon two G-protein coupled receptors (GPCRs). 26 September 2017
Netherlands-based Pharming Group has entered a partnership allowing access to its Ruconest (recombinant human C1 inhibitor) product for hereditary angioedema (HAE) to patients in all countries where it is not currently commercially available. 26 September 2017
Venture capital firms and a funding agency have joined US pharma giant Pfizer by backing SpringWorks Therapeutics, a mission-driven medicines company dedicated to developing innovative potential new treatments for underserved patient communities. 25 September 2017
In a landmark study published in the journal Science recently, researchers produced genetically-engineered antibodies with the highest activity and breadth of coverage yet seen against human immunodeficiency virus (HIV-1). 25 September 2017
Endocrine-focused biopharma company Versartis has announced that its VELOCITY Phase III trial of somavaratan in pediatric growth hormone deficiency (GHD) did not meet its primary endpoint of non-inferiority. 25 September 2017
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