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30 December 2024 Antibody-drug conjugates (ADCs) combine monoclonal antibody (MAb) specificity with cytotoxic drug potency via a linker, delivering targeted cancer therapy. ADCs concentrate treatment at tumor sites, enhancing efficacy while minimizing harm to healthy tissues.
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Pharmaceutical
Privately-held neurology company Tris Pharma has received approval from the US Food and Drug Administration for Onyda XR (clonidine hydrochloride). 3 June 2024
Pharmaceutical
CSL Seqirus is set to complete the fill and finish process for pre-pandemic vaccine to support the US government’s outbreak and preparedness response. 3 June 2024
Pharmaceutical
Eli Lilly has released updated data from its Phase I/II clinical trial evaluating olomorasib. 3 June 2024
Pharmaceutical
At the 2024 annual meeting of the American Society of Clinical Oncology (ASCO), Bristol Myers Squibb has announced promising results from the Phase III KRYSTAL-12 study. 3 June 2024
Interview
With a steady flow of oncology results emerging from the ongoing ASCO meeting, a company such as Pierre Fabre, which does not have major data to present, might not usually claim the spotlight. 3 June 2024
Pharmaceutical
US cancer-focussed firm Karyopharm Therapeutics presented updated exploratory subgroup analyses from the Phase III SIENDO study in patients with advanced or recurrent TP53 wild-type endometrial cancer at the American Society of Clinical Oncology (ASCO). 2 June 2024
Pharmaceutical
Last week, the US Court of Appeals for the District of Columbia (DC) ruled that Section 340B of the Public Health Service Act does not prohibit pharmaceutical manufacturers from imposing conditions on the distribution of discounted drugs to covered entities in the program, noted Sophia Gaulkin and Alan Kirschenbaum of law firm Hyman Phelps & McNamara. 1 June 2024
Pharmaceutical
Privately-held UK clinical-stage firm Soterios Pharma has announced positive multi-dose Phase II trial evaluating STS-01 as a treatment for mild/moderate alopecia areata (AA). 31 May 2024
Pharmaceutical
Biogen has announced European approval for Qalsody (tofersen), for certain amyotrophic lateral sclerosis (ALS) patients, under exceptional circumstances. 31 May 2024
Pharmaceutical
Danish allergy immunotherapy specialist ALK Abell today revealed that its European regulatory filing for Itulazax (tree sublingual allergy immunotherapy [SLIT] tablet) in young children has been accepted for review by the relevant health authorities. 30 May 2024
Pharmaceutical
US genetic diseases and cancer drug developer BridgeBio Pharma has announced positive results of five new analyses of clinical endpoint events from its Phase III ATTRibute-CM study of acoramidis in transthyretin amyloidosis cardiomyopathy (ATTR-CM). 30 May 2024
Pharmaceutical
Globally, the devastating and widespread impact of neurological disorders like Alzheimer's disease, epilepsy, Parkinson’s disease and depression is only getting worse. 30 May 2024
Pharmaceutical
Johnson & Johnson has announced positive results from the Phase III MDD3001 trial for seltorexant, a selective orexin-2 receptor antagonist. 30 May 2024
Pharmaceutical
New research published in Nature Communications shows another potential application for GLP-1 agonists, adding to established benefits in type 2 diabetes, obesity and heart disease. 30 May 2024
Pharmaceutical
Ikena Oncology has announced the discontinuation of its IK-930 program, as well as plans to slash its workforce by about 50%. 29 May 2024
Pharmaceutical
After more than 30 years with neuroscience-focused biopharma Neurocrine Biosciences, founder and chief executive Kevin Gorman is to retire in October - albeit staying on as a board member. 29 May 2024
Pharmaceutical
Russia has suspended state purchases of a number of original anti-cancer drugs due to problems associated with sanctions and the ever-growing isolation of the country in the international arena, The Pharma Letter’s local correspondent reports. 29 May 2024
Pharmaceutical
The Bill & Melinda Gates Medical Research Institute (Gates MRI) has appointed Patrice Matchaba, as chief executive (CEO), starting June 10, 2024. 29 May 2024
Pharmaceutical
Cambridge, USA-based Agios Pharmaceuticals closed up more than 23% at $38.81 yesterday, after it revealed it has agreed to sell its rights to its 15% royalty on potential US net sales of Servier’s vorasidenib to Royalty Pharma. 29 May 2024
Pharmaceutical
IDEAYA Biosciences, a precision oncology company, has recruited Daniel Simon to the role of chief business officer. 28 May 2024
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Pharmaceutical
Full mergers and acquisitions in the pharmaceutical and biotechnology in 2024 fluctuated throughout the year with hardly any in some months and a significant number in other. But one thing was clear – buyers were shying away from big bets on commercially ready medicines in favor of earlier stage drug developers. 3 January 2025
Pharmaceutical
Regeneron Pharmaceuticals has acquired UK-based biotech Oxular, enhancing its gene therapy development program with the firm’s specialized ocular delivery tech. 3 January 2025
Pharmaceutical
One of the most promising areas of medical innovation in the next five years is immuno-oncology (I-O)/cancer therapeutics represent, fundamentally transforming how cancer is treated. 3 January 2025
Pharmaceutical
Massachusetts, USA-based based brain disease biotech Neumora Therapeutics shares tumbled 81.4% to 1.97 after it revealed that its experimental depression treatment failed in the first of three studies planned by the biotech company. 3 January 2025
Pharmaceutical
Hutchmed has announced agreements to divest its 45% equity stake in Shanghai Hutchison Pharmaceuticals Limited (SHPL) for $608 million in cash. The buyers are GP Health Service Capital and Shanghai Pharmaceuticals. 2 January 2025
Pharmaceutical
Kazia Therapeutics, an oncology-focused Australian drug developer, has been advised by the US Food and Drug Administration (FDA) that accelerated approval for its brain cancer drug, paxalisib, is unlikely. 2 January 2025
Pharmaceutical
The type 1 diabetes (T1D) market across the seven major markets (7MM: USA, France, Germany, Italy, Spain, the UK, and Japan) is set to grow at a compound annual growth rate (CAGR) of 13.3% from $2.2 billion in 2023 to $9.9 billion in 2033. 2 January 2025
Pharmaceutical
The US Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) under the accelerated approval pathway for avutometinib, an oral RAF/MEK clamp, in combination with defactinib. 2 January 2025
Pharmaceutical
The new $2,000 cap on out-of-pocket costs for prescription drugs went into effect as of January 1, 2025, the US Department of Health and Human Services (HHS) Secretary Xavier Becerra has announced. 2 January 2025
Pharmaceutical
The market for artificial intelligence (AI) in cancer care is projected to grow from $2.2 billion in 2024 to $6.3 billion by 2029, reflecting a growth rate of 23.1%, according to a recent study by BCC Research. 31 December 2024
Pharmaceutical
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved Winrevair (sotatercept) to treat pulmonary arterial hypertension (PAH), from US pharma giant Merck & Co. 31 December 2024
Pharmaceutical
US CNS specialist Axsome Therapeutics yesterday announced the completion of its Phase III clinical program evaluating AXS-05 (dextromethorphan-bupropion). 31 December 2024
Pharmaceutical
It has been a year since the launch of Zepbound (tirzepatide) for obesity, and US pharma major Eli Lilly’s competition with Denmark’s Novo Nordisk continues. 31 December 2024
Pharmaceutical
The US Food and Drug Administration (FDA) is reopening the comment period for the Federal Register notice (FRN), “Evaluating the Immunogenicity Risk of Host Cell Proteins in Follow-on Recombinant Peptide Products: Establishment of a Public Docket: Request for Information and Comments” due to high interest from industry. 31 December 2024
Pharmaceutical
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has issued a warning urging the public to avoid purchasing weight-loss medicines without a prescription. 30 December 2024
Pharmaceutical
For many in the life sciences, the year gone by has been marked by volatility across a range of metrics, as political and economic disruptions threaten to upend the standard operating model. 30 December 2024
Pharmaceutical
China’s National Medical Products Administration (NMPA) has recently approved Zorifer (zorifertinib), an oral epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) specifically for the treatment of non-small cell lung cancer (NSCLC) with CNS metastases. 30 December 2024
Pharmaceutical
The Japanese Ministry of Health, Labor and Welfare (MHLW) has approved the use of Hyqvia (immune globulin infusion 10% [human] with recombinant human hyaluronidase) in patients with agammaglobulinemia or hypogammaglobulinemia disorders, from domestic drug giant Takeda Pharma 27 December 2024
Pharmaceutical
Japanese drugmaker Kaken Pharmaceutical has entered into a license agreement with US healthcare giant Johnson & Johnson for the global development, manufacturing and commercialization of a STAT6 program that Kaken is developing. 27 December 2024
Pharmaceutical
Akums, India’s largest contract development and manufacturing organization (CDMO), has signed a strategic agreement with an undisclosed global pharmaceutical company. 27 December 2024
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