27 September 2024 Antibody-drug conjugates (ADCs) represent a significant advancement in cancer treatment, particularly within China's burgeoning oncology sector.
Shares of German pharma major Bayer were up 4.6% at 30.45 euros after it released positive early trial results for its Parkinson’s disease candidate. 27 September 2024
Shionogi said today that it has submitted a New Drug Application (NDA) in Japan for zuranolone, a treatment in development for major depressive disorder (MDD). 27 September 2024
CNS specialist Lundbeck has announced data from the TALISMAN natural history study, as well as additional data from the AMULET trial, of amlenetug, in multiple system atrophy (MSA) at the International Congress of Parkinson's Disease and Movement disorders in Philadelphia, USA. 27 September 2024
Repair Biotechnologies, a company developing therapies to reverse atherosclerotic plaque, has entered into a collaboration with Genevant Sciences, a specialist in nucleic acid delivery technology. 27 September 2024
China’s National Medical Products Administration (NMPA) has approved Dupixent (dupilumab) as an add-on maintenance treatment for adults with uncontrolled chronic obstructive pulmonary disease (COPD). 27 September 2024
Chicago, USA-based ARCH Venture Partners revealed it has closed the ARCH Venture Fund XIII, a venture capital fund with more than $3 billion to support the founding and growth of early-stage biotechnology companies. 27 September 2024
US virology and immunology company Enanta Pharmaceuticals has given further weight to its claims to have the leading portfolio of potent respiratory syncytial virus (RSV) replication inhibitors 27 September 2024
Sage Therapeutics has announced that Biogen has terminated its partnership on the SAGE-324 program, following the recent failure of the drug in a Phase II study for the treatment of essential tremor. 27 September 2024
A US Food and Drug Administration advisory committee meeting has recommended restricting the use of PD-1 inhibitors, in a move which could affect blockbuster products such as Bristol Myers Squibb's Opdivo (nivolumab) and Merck & Co's Keytruda (pembrolizumab). 27 September 2024
The US Food and Drug Administration yesterday approved pharma major Bristol Myers Squibb’s Cobenfy (xanomeline and trospium chloride) capsules for oral use for the treatment of schizophrenia in adults. 27 September 2024
USA-based biotech funder and incubator Flagship Pioneering yesterday unveiled Mirai Bio, a company pioneering the first open end-to-end platform for the biotech industry to enable the co-creation of fully optimized genetic medicines. 27 September 2024
Antibody-drug conjugates (ADCs) represent a significant advancement in cancer treatment, particularly within China's burgeoning oncology sector. 27 September 2024
US drugmaker AbbVie has announced positive topline results from its pivotal Phase III TEMPO-1 trial for tavapadon as a monotherapy in early Parkinson's disease. 26 September 2024
Evaxion Biotech has entered into an option and license agreement with MSD (tradename of Merck & Co outside of the USA and Canada), for two pre-clinical vaccine candidates. 26 September 2024
Danish CNS specialist Lundbeck and US privately-held biotech Iambic Therapeutics today announced a strategic research collaboration to focus on discovery of a small molecule therapeutic for the treatment of migraine. 26 September 2024
The generics and biosimilars trade group, Medicines for Europe, has put out a strong message amid ongoing discussions on a European Union (EU) Critical Medicines Act. 26 September 2024
Pfizer (NYSE: PFE) has announced the withdrawal of Oxbryta (voxelotor), a treatment for sickle cell disease (SCD), from all global markets. 26 September 2024
US biotech Biogen and Japanese partner Eisai today announced that the First Committee on New Drugs (NDC) of the Pharmaceutical Affairs and Food Sanitation Council, which advises the Japanese Ministry of Health, Labor and Welfare (MHLW), has decided to continue deliberations on the application for the manufacturing and marketing approval of Aduhelm (aducanumab) for the treatment of Alzheimer’s disease. 23 December 2021
As the heavily-mutated Omicron strain of coronavirus continues to spread globally, vaccine developers are racing to assess the effectiveness of their options against the variant. 23 December 2021
German pharmaceutical firm Boehringer Ingelheim has published new data from the pivotal Phase II Effisayil trial in the New England Journal of Medicine. 23 December 2021
USA-based biotech Aimmune Therapeutics, which is now fully owned by Swiss foods giant Nestle, today announced that the UK’s National Institute for Health and Care Excellence (NICE) has recommended Palforzia [defatted powder of Arachis hypogaea L, semen (peanuts)] or use within the National Health Service (NHS) for the treatment of peanut allergy in patients aged four to 17. 23 December 2021
Wednesday saw Swiss pharma giant Novartis gain approval from the US Food and Drug Administration for Leqvio (inclisiran) and an added indication for Cosentyx (secukinumab). 23 December 2021
On Wednesday, the US Food and Drug Administration issued an emergency use authorization (EUA) for pharma giant Pfizer’s Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) for the treatment of mild-to-moderate coronavirus disease (COVID-19). 23 December 2021
New data from East Coast, USA-based vaccine developer Novavax provide a window into the potential effectiveness of its COVID-19 vaccine, NVX-CoV2373, against the Omicron variant. 23 December 2021
Bipolar disorder is a mental disorder characterized by periods of mania and depression. While there are a high number of treatments that can effectively manage the acute mania, there is a striking lack of treatments for bipolar depression, with this unmet need set to be only partially met over the next decade. 23 December 2021
With the recent launch of the Avastin (bevacizumab) biosimilar in China, Henlius, the biotech arm of Fosun Pharma, now has four biosimilars under its belt. However, the Shanghai-based firm is eager to shake off the image of a biosimilars supplier. 22 December 2021
US healthcare giant Johnson & Johnson subsidiary Janssen today welcomed the decision from the UK’s National Institute for Health and Care Excellence (NICE) recommending the use of Darzalex (daratumumab) in combination with Velcade (bortezomib), thalidomide and dexamethasone (DVTd) as induction and consolidation treatment for untreated multiple myeloma in adults, when an autologous stem cell transplant (ASCT) is suitable. 22 December 2021
Japan’s largest drugmaker Takeda Pharmaceutical yesterday announced that it has received a Complete Response Letter (CRL) from the US Food and Drug Administration in response to its New Drug Application (NDA) for TAK-721 (budesonide oral suspension) for the treatment of eosinophilic esophagitis (EoE), a chronic inflammatory disease of the esophagus. 22 December 2021
Industry analyst GlobalData says that the Chinese approval of Brii Biosciences’ monoclonal antibody combo amubarvimab/romlusevimab will raise the country’s status as an R&D hub. 22 December 2021
Novartis announced today that it entered into a definitive agreement to acquire all of the outstanding share capital of the UK-based ocular gene therapy company Gyroscope Therapeutics, which was formed in 2016 and co-funded by Syncona. 22 December 2021
The US regulator has placed a clinical trial hold on research into a Duchenne muscular dystrophy (DMD) candidate under development by New York-based pharma giant Pfizer. 22 December 2021
Research from British online pharmacy Chemist4U has revealed some insights on the current state of prescriptions in England, including the most prescribed medicines in the country. 22 December 2021
French vaccines developer Valneva has announced positive top-line results from the lot-to-lot Phase III trial of its single-shot chikungunya vaccine candidate, VLA1553. 22 December 2021
US biotech Intra-Cellular Therapies saw its shares gain 6.3% to $48.20, after it revealed that the US Food and Drug Administration has approved Caplyta (lumateperone tosylate) for the treatment of depressive episodes associated with bipolar I or II disorder in adults, as monotherapy and as adjunctive therapy with lithium or valproate. 22 December 2021
The Russian Ministry of Health has approved the use of Zolgensma (onasemnogene abeparvovec), the world’s most expensive drug against spinal muscular atrophy (SMA) in the domestic market, reports The Pharma Letter’s local correspondent. 22 December 2021
Russia is faced with a significant delay of drug supplies to the domestic market, as producers delay signing of contracts with the local state in an attempt to make a deal with higher prices for them, according to a recent report published by the Institute of State and Municipal Administration of the Higher School of Economics (ISMU), one of Russia’s leading research institutions in the field of finance, reports The Pharma Letter’s local correspondent. 22 December 2021
ViiV Healthcare, the global specialist HIV company majority owned by GlaxoSmithKline, has announced that Apretude (cabotegravir), the first and only long-acting injectable pre-exposure prophylaxis (PrEP) option to reduce the risk of sexually-acquired HIV-1, has been approved in the USA. 21 December 2021