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
As Mumbai-based Universal Medicare teams up with Private Equity firm Kedaara Capital to acquire Sanofi India's branded nutraceutical business, and Bayer officially sets up its consumer health division in India, pharmaceutical companies are readying for the long haul in India as vitamin and mineral supplements continue to fly off pharmacy shelves, reports The Pharma Letter’s India correspondent. 19 July 2021
New York, USA-based Regeneron is set to invest around $1.8 billion in its home state, with a major expansion of its research and development facilities. 19 July 2021
The European Medicines agency announced today that it has started evaluating an application to extend the use of Kineret (anakinra) to include treatment of coronavirus disease 2019 (COVID-19) in adult patients with pneumonia who are at risk of developing severe respiratory failure (inability of the lungs to work properly). 19 July 2021
Imfinzi (durvalumab) has been approved in China for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC), in combination with standard of care platinum chemotherapy (etoposide plus a choice of either carboplatin or cisplatin). 19 July 2021
The US Food and Drug Administration (FDA) approved Vaxneuvance (pneumococcal 15-valent conjugate vaccine) for active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F in adults 18 years of age and older. 19 July 2021
Licensing agreements featured heavily in last week’s news, starting with US biotech Biogen entering into an agreement that could cost it $1 billion to get rights to a BTK inhibitor – orelabrutinib for multiple sclerosis – from China’s InnoCare Pharma. Denmark’s Novo Nordisk in-licensed rights to Prothena’s ATTR amyloidosis program, and PRX004, in a deal worth up to $1.2 billion. Also, Ionis Pharmaceuticals last Tuesday exercised an option on fellow USA-based Bicycle Therapeutics’ oligonucleotide targeting the transferrin receptor 1. On the M&A front, Eli Lilly revealed on Wednesday it was acquiring privately-held US company Protomer Technologies for what could be a $1 billion transaction, getting rights to its glucose-sensing insulin project. Additionally, the US Food and Drug Administration took issue with Amgen’s promotion of its cancer drug Neulasta, which the agency said could undermine confidence in biosimilars. 18 July 2021
Shares of USA-based Kadmon Holdings shot up more than 20% to $4.28 on Friday, after the company revealed its pharma unit had received its first regulatory approval, for Rezurock (belumosudil). 17 July 2021
The US Food and Drug Administration on Friday approved a new use for Prograf (tacrolimus) based on a non-interventional (observational) study providing real-world evidence (RWE) of effectiveness. 17 July 2021
Melbourne, Australia-based stem cell company Mesoblast has presented more data from a trial of remestemcel-L in ventilator-dependent COVID-19 patients. 16 July 2021
Sandoz, the generic and biosimilar medicines unit of Swiss pharma giant Novartis, today announced the immediate US availability of generic ferumoxytol, an intravenous medicine used to treat iron deficiency anemia (IDA). 16 July 2021
The European Medicines Agency has validated and accepted the marketing authorization application (MAA) for surufatinib for the treatment of pancreatic and extra-pancreatic (non-pancreatic) neuroendocrine tumors (NETs), submitted by China’s Hutchmed. 16 July 2021
USA-based FibroGen's shares have dropped by more than a third after a scientific panel of the US Food and Drug Administration voted against approval of roxadustat. 16 July 2021
French drugmaker Ipsen has signed a licensing agreement with IRLAB, providing Ipsen exclusive worldwide development and commercial rights to mesdopetam, a novel dopamine D3-receptor antagonist, with the news sending the Swedish firm’s shares rocketing 42.5% to 69.60 kronor by late afternoon today. 16 July 2021
Looking to overturn a regulatory rebuff, New Jersey, USA’s Merck & Co has announced positive event-free survival (EFS) data from the pivotal neoadjuvant/adjuvant Phase III study KEYNOTE-522. 16 July 2021
Positive top-line results from a Phase III study evaluating the safety and efficacy of Ultomiris (ravulizumab-cwvz) in adults with generalized myasthenia gravis (gMG) were announced yesterday by Alexion Pharmaceuticals, whose shares nevertheless dipped 3.3% to $180.51 by close of trading. 16 July 2021
Belgian company Galapagos has released disappointing top-line results for GLPG3970, the first candidate from a range of SIK inhibitors, a novel class of therapy. 16 July 2021
Swiss biotech firm Polyphor saw its shares plunge more than 10% to 2.12 Swiss francs this morning, on revealing another setback for its breast candidate, compounding a 70% decimation last month after it reported the failure of its leading investigational asset, balixafortide, to meet its late-stage trial goal. 16 July 2021
XOMA Corp has acquired the royalty interest position Swiss biotech Kuros Biosciences holds in Checkmate Pharmaceuticals’ vidutolimod (CMP-001), an advanced-generation Toll-like receptor 9 agonist packaged in a virus-like particle, for $7.0 million upfront plus sales milestones. 16 July 2021
Italian drugmaker Recordati’s board of directors has approved the appointment of Rob Koremans as chief executive effective December 1, 2021. 16 July 2021
Shares of US drugmaker AcelRx Pharmaceuticals shot up 23.8% to $1.51 yesterday, after the company announced agreements with French family-owned company Laboratoire Aguettant, providing the later with a license to commercialize Dzuveo (sufentanil) sublingual tablet in Europe, and providing AcelRx with two innovative pre-filled syringe product candidates for the USA. 15 July 2021