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
Shares of Futura Medical moved higher yesterday, as it announced that it has entered into a licensing agreement with m8 Pharmaceuticals, a specialty biopharmaceutical company focused on commercialization in Latin America, for the rights to exclusively develop and commercialize the company's topical, gel-based erectile dysfunction (ED) treatment MED3000, in Brazil and Mexico. 1 September 2021
Dutch drugmaker Centrient Pharmaceuticals, an antibiotics manufacturer wholly-owned by Bain Capital, has acquired Vadodara, India-based Astral SteriTech, a manufacturer in sterile antibiotic injectable finished dosage forms. 1 September 2021
Teva Pharmaceutical Industries and its partner MedinCell have announced that the New Drug Application (NDA) for TV-46000/mdc-IRM (risperidone extended-release injectable suspension for subcutaneous use) for schizophrenia has been accepted by the US Food and Drug Administration (FDA). 1 September 2021
Japanese pharma major Astellas Pharma has voluntarily paused screening and dosing of additional participants in its ASPIRO clinical trial evaluating AT132 in patients with X-linked myotubular myopathy (XLMTM). 1 September 2021
Swiss pharma giant Novartis has reached a commercial agreement with the National Health Service (NHS) in England as part of a collaboration to pioneer a first-of-its-kind population health management approach to address elevated "bad" low-density lipoprotein (LDL)-cholesterol in eligible patients with atherosclerotic cardiovascular disease (ASCVD) across England. 1 September 2021
The US Centers for Disease Control and Prevention (CDC) has officially endorsed the recommendation for use of tozinameran, the coronavirus vaccine produced by Pfizer and BioNTech. 31 August 2021
Johnson & Johnson’s pharmaceutical arm, Janssen, has announced results from a post-hoc pooled analysis of the Phase III GRIPHON and Phase IIIb TRITON studies. 31 August 2021
Shares in AC Immune were up on Tuesday, after the firm announced encouraging results from a Phase II trial of its Alzheimer’s disease (AD) candidate. 31 August 2021
Chinese biopharma firm Innovent Biologics and US biotech Bolt Biotherapeutics have announced a drug research and development collaboration to develop three new anti-cancer therapeutic immune-stimulating antibody conjugate (ISAC) candidates. 31 August 2021
Japanese pharma major Eisai has concluded a license agreement concerning dotinurad, a treatment for hyperuricemia and gout discovered by Fuji Yakuhin, for development and distribution in five ASEAN (Association of Southeast Asian Nations) member states: Indonesia, Malaysia, Myanmar, the Philippines, and Thailand. 31 August 2021
Russia again faces a shortage of foreign drugs for the treatment of serious diseases, this time for the treatment arthritis, according to recent statements by representatives of local patent associations and some local media, reports The Pharma Letter’s local correspondent. 31 August 2021
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has licensed Evrenzo (roxadustat) for the treatment of adult patients with symptomatic anemia associated with chronic kidney disease (CKD). 31 August 2021
Daiichi Sankyo has concluded an agreement on commercialization collaboration in Japan with the local subsidiary of US pharma major Eli Lilly for the 5-HT1F receptor agonist lasmiditan succinate, for which Eli Lilly Japan has submitted a new drug application for the treatment of migraines. 31 August 2021
These are billed as being exciting times for cell and gene therapies, but seasoned observers of the pharmaceutical industry would be forgiven for taking that billing with a pinch of salt. 31 August 2021
A raft of measures adopted by the US government to enhance the availability of drugs are impacting the margins of Indian companies. While several Indian drugmakers have witnessed a decline in their US generic business on a quarter-on-quarter (QoQ) and year-on-year (YoY) basis, few companies have taken inventory write-offs and also tried to liquidate the high inventory carried by them in the US market, reports The Pharma Letter’s India correspondent. 31 August 2021
A huge patent opportunity is supporting the Indian pharmaceutical sector, as several older and once lucrative drugs are losing their patent, presenting a $240 billion opportunity over the next five-six years until 2026. 31 August 2021
The protection of intellectual property (IP) rights currently remains one of the most pressing problems for global drugmakers operating in the Russian market, according to recent statements by Oksana Monzh, general director of French pharma major Sanofi in the Eurasian Region and representatives of other producers. 31 August 2021
Revelation Biosciences, a clinical-stage life sciences company focused on the development of immunologic based therapies for the prevention and treatment of disease, and Petra Acquisition, a special purpose acquisition company (SPAC), have entered into a definitive merger agreement for a business combination that will result in Revelation Biosciences becoming a publicly traded company. 30 August 2021