27 September 2024 Antibody-drug conjugates (ADCs) represent a significant advancement in cancer treatment, particularly within China's burgeoning oncology sector.
Acadia Pharmaceuticals has appointed Catherine Owen Adams to succeed Steve Davis as chief executive (CEO) and a member of its board of directors. 28 September 2024
The US Food and Drug Administration (FDA) on Friday approved Dupixent (dupilumab) as an add-on maintenance treatment of adults with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype. 28 September 2024
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
Seeking to assess the rationality and status of fixed-dose combination (FDCs) drugs licensed prior to 1988, India's Central Drugs Standard Control Organization (CDSCO) has asked stakeholders to submit information on the safety and efficacy of 19 FDCs that bagged the green signal pre-1988. Asking pharmaceutical companies to justify their cocktail of medicines, the CDSCO has opened old wounds, reports The Pharma Letter’s India correspondent. 12 August 2021
Central nervous system (CNS) specialist Axsome Therapeutics will hope a positive report from GlobalData could take the sting out of a recent run of bad news. 12 August 2021
German CNS specialist atai Life Sciences has announced the launch of Revixia Life Sciences, a wholly-owned subsidiary developing Salvinorin A (SalA) to treat a variety of mental health disorders. 12 August 2021
Specialty UK pharma company Shield Therapeutics has entered into an exclusive licence agreement for Accrufer/Feraccru (ferric maltol) with Korea Pharma in the South Korea. 12 August 2021
The US Food and Drug Administration (FDA) has issued a new approval for the combination of Merck & Co’s anti-PD-1 therapy, Keytruda (pembrolizumab) and Lenvima (lenvatinib), the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai. 12 August 2021
Japanese drugmaker Chugai says it has launched Evrysdi (risdiplam) Dry Syrup 60mg for the treatment of spinal muscular atrophy (SMA). Evrysdi had been approved by Japan’s Ministry of Health, Labor and Welfare (MHLW) on June 23, 2021, and was listed on the national health insurance (NIH) reimbursement price list this week. 12 August 2021
The World Health Organization (WHO) has announced the next phase in its Solidarity trial: Solidarity PLUS will enroll hospitalized patients to test three new drugs in hospitalized COVID-19 patients. 12 August 2021
Eli Lilly has won a positive reimbursement decision in the UK for Verzenios (abemaciclib) as an option for people with advanced HR+ HER2-breast cancer. 12 August 2021
The US Food and Drug Administration (FDA) has recently lifted a clinical hold on the spinal muscular atrophy (SMA) drug OAV-101, an intrathecal (IT) formulation of Zolgensma (onasemnogene abeparvovec). 11 August 2021
UK clinical-stage biotech PureTech Health today announced that Imbrium Therapeutics, a subsidiary of Purdue Pharma, has exercised a license option under the companies’ R&A collaboration agreement to develop PureTech’s LYT-503/IMB-150 (formerly designated as ALV-107), a non-opioid therapeutic candidate being developed for interstitial cystitis/bladder pain syndrome (IC/BPS). 11 August 2021
Yet another public listing via special purpose acquisition company (SPAC) demonstrates the growing popularity of the approach, as an alternative to the traditional initial public offering. 11 August 2021
The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) regarding the New Drug Application (NDA) for roxadustat for the treatment of anemia of chronic kidney disease (CKD), in both non-dialysis dependent (NDD) and dialysis-dependent (DD) adult patients. 11 August 2021
The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has granted Marketing Authorization in Great Britain for Ponvory (ponesimod) for the treatment of adult patients with relapsing multiple sclerosis (RMS) with active disease defined by clinical or imaging features. 11 August 2021
Australia’s Therapeutic Goods Administration (TGA) granted provisional determination for Merck & Co’s molnupiravir, which will be processed by the US pharma major’s Merck Sharp & Dohme (Australia) Pty Ltd (MSD) unit. 11 August 2021
Japan’s Otsuka Pharmaceuticals has been handed a grant for up to $17.8 million from the Bill & Melinda Gates Foundation to support the clinical trial of a treatment-shortening regimen in drug-sensitive tuberculosis (TB). 11 August 2021
In a further move to increase its COVID-19 and other vaccines production capacity, US messenger RNA (mRNA) therapeutics and vaccines company Moderna on Tuesday announced a Memorandum of Understanding (MoU) with the government of Canada to build a state-of-the-art messenger RNA (mRNA) vaccine manufacturing facility in Canada including access to Moderna’s mRNA development engine. 11 August 2021
In the latest twist in the battle to acquire Vectura, the board of the UK inhaled therapies maker today acknowledged that Carlyle, one of the two bidders, has announced it will not improve its 155 pence per share offer for the company, as declared on August 6, through its Murano Bidco vehicle. 11 August 2021