7 October 2024 India's new Biotechnology Research Innovation and Entrepreneurship Development (Bio-RIDE) scheme is a significant step towards consolidating and advancing the country's biotechnology initiative.
The US Food and Drug Administration (FDA) on Friday approved Epkinly (epcoritamab-bysp), which is being is co-developed by US pharma major AbbVie and Denmark’s Genmab. 20 May 2023
South Korea’s HanAll Biopharma dipped more than 3% to 21,850 won yesterday, after it announced mixed results from the Phase III VELOS-3 trial evaluating the safety and efficacy of tanfanercept. 20 May 2023
Neurocrine Biosciences has announced that the complete study results from its Phase III KINECT-HD study of valbenazine in chorea associated with Huntington's disease (HD) has been published in The Lancet Neurology online edition and will appear in the June 2023 print issue. 19 May 2023
Canada-based cell and gene therapy contract development and manufacturing organization (CDMO) uBriGene is expanding into the US market with the acquisition of a state-of-the-art GMP manufacturing facility from US cell and gene therapy specialist Mustang Bio. 19 May 2023
German pharma major Bayer has filed a lawsuit against the Russian manufacturer of generic drugs Medisorb, The Pharma Letter’s local correspondent reports. 19 May 2023
Stockholm-based biotech firm Swedish Orphan Biovitrum has announced that the European Medicines Agency (EMA) has accepted and validated a marketing authorization application for efanesoctocog alfa. 19 May 2023
Shares of Canada-based Bausch Health Companies were up 14.6% at $8.56 on Wednesday, after it said that a US district court stuck with an earlier judgment that prevented an application for a rival generic version of its Xifaxan (rifaximin) irritable bowel syndrome drug from getting US Food and Drug Administration (FDA) approval until 2029. 19 May 2023
The US Food and Drug Administration (FDA) yesterday approved Rinvoq (upadacitinib) for adults with moderately to severely active Crohn’s disease who have had an inadequate response or intolerance to one or more tumor necrosis factor blockers. 19 May 2023
Following positive briefing documents from the agency’s staff, the US Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted that the available data support the efficacy and safety of US pharma giant Pfizer unadjuvanted bivalent respiratory syncytial virus (RSV) prefusion F vaccine candidate RSVpreF or PF-06928316. 19 May 2023
German pharma major Bayer has secured a positive reimbursement decision from the UK’s health technology assessor for Nubeqa (darolutamide). 19 May 2023
The US Food and Drug Administration has published product-specific guidance for generics drugmakers with the goal of facilitating pipeline development and promoting access. 19 May 2023
French pharma major Sanofi has successfully completed the Phase I trial for its von Willebrand disease (vWD) therapy, efanesoctocog alfa (BIV001), a novel antihemophilic factor recombinant fusion protein that acts as a coagulation factor VIII therapy. 19 May 2023
Famed as a great success story of the generics sector in previous decades, Israel’s Teva Pharmaceutical Industries has seen its growth and share price tail off since the mid-2010s. 18 May 2023
As part of its ongoing inquiry into pharmacy benefit managers (PBMs) and their impact on the accessibility and affordability of prescription drugs, the USA’s Federal Trade Commission (FTC) has issued compulsory orders to two group purchasing organizations (GPOs) that negotiate drug rebates on behalf of other PBMs. 18 May 2023
The US Food and Drug Administration (FDA) has eased the partial clinical hold on AOC 1001, allowing Avidity Biosciences, the drug’s developer, to double the number of participants in the MARINA Open-Label Extension (MARINA-OLE) study receiving 4 mg/kg of AOC 1001. 18 May 2023
New guidance has been developed by the European Medicines Agency to help the pharmaceutical industry maintain continuity of supply and prevent shortages. 18 May 2023
Today’s announcement that the UK’s National Institute for Health and Care Excellence (NICE) has published Final Draft Guidance (FDG) recommending dapagliflozin for adult patients with symptomatic chronic heart failure (HF) with preserved or mildly reduced ejection fraction (LVEF of more than 40%) in England and Wales is a significant day for patients and the wider cardiology community. 18 May 2023
Genor Biopharma has announced plans for a significant merger with Edding Group, marking one of the first reverse takeovers involving a Hong Kong-listed biopharma company. 8 October 2024
UK-based AviadoBio, a LifeArc Ventures portfolio company, and Astellas Pharma today announced an exclusive option and license agreement for AVB-101. 8 October 2024
China-headquartered clinical-stage biotech MediLink Therapeutics has announced a global clinical trial collaboration and supply agreement with US major Amgen. 8 October 2024
Israel-based Teva Pharmaceutical Industries today announced that the US Food and Drug Administration (FDA) has accepted, and the European Medicines Agency (EMA) has validated, applications for TVB-009P, a biosimilar candidate to Prolia (denosumab). 8 October 2024
UK-based Mestag Therapeutics has entered into a license and collaboration agreement with Merck & Co to explore new therapeutic options for inflammatory diseases. 8 October 2024
With its recent US Food and Drug Administration (FDA) approval, Eli Lilly’s Ebglyss (lebrikizumab) adds a new competitor to the atopic dermatitis (AD) market. 8 October 2024
US antivirals specialist Gilead Sciences has released additional data from its pivotal Phase III PURPOSE 2 trial providing an overview of the efficacy and safety of twice-yearly lenacapavir. 8 October 2024
Germany’s Eckert & Ziegler, a specialist in radioisotopes for medical, scientific and industrial applications, has announced a global clinical supply agreement with GlyTherix, an Australian targeted radiotherapy firm specializing in developing antibody radiopharmaceuticals for solid tumors. 8 October 2024
US clinical-stage biotech OnKure Therapeutics has announced the completion of its previously announced merger with Reneo Pharmaceuticals. 8 October 2024
Novo Nordisk has reached a settlement with Mylan Pharmaceuticals, now part of Viatris, putting an end to a US patent lawsuit over blockbuster diabetes treatment Ozempic (semaglutide). 8 October 2024
UK-based ViiV Healthcare, the specialist HIV company majority-owned by GSK (LSE: GSK), with Pfizer and Shionogi as shareholders, has announced a milestone in its efforts to achieve widespread international access to its therapies. 7 October 2024
Texas Attorney General Ken Paxton has filed a lawsuit against major pharmaceutical companies, including Eli Lilly (NYSE: LLY), alleging a conspiracy to artificially inflate the prices of insulin by up to 1,000%. 7 October 2024
Daejeon-based Orum Therapeutics, a specialist in degrader-antibody conjugates (DAC), has filed for an initial public offering (IPO) on South Korea's Kosdaq market. 7 October 2024
Orchard Therapeutics has signed an exclusive distribution agreement with Turkish drugmaker Er-Kim, for the gene therapy Libmeldy (atidarsagene autotemcel). 7 October 2024
Cambridge, USA-based biotech Judo Bio has announced the company’s launch and $100 million in initial financing, including seed financing and Series A. 7 October 2024