19 September 2024 Vanda Pharmaceuticals’ shares were down more than 10% at $4.45 pre-market today, as the) company provided an unfavorable update on its tradipitant development program.
The European Commission has conditionally approved the marketing application submitted by Ipsen for Iqirvo (elafibranor) 80mg tablets for the treatment of primary biliary cholangitis (PBC) 21 September 2024
On Friday, the US Food and Drug Administration approved UK pharma major AstraZeneca’s (LSE: AZN) FluMist for self- or caregiver-administration by a parent/caregiver to individuals 2-17 years of age. 21 September 2024
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved Fruzaqla (fruquintinib) to treat adults with metastatic colorectal cancer (CRC)—to be used when other treatments have not worked. 20 September 2024
Today, the US Food and Drug Administration approved Miplyffa (arimoclomol), an oral medication for the treatment of Neimann-Pick disease, type C (NPC). 20 September 2024
Danish drugmaker Novo Nordisk—a frontrunner in the obesity space with the GLP-1 receptor agonist Wegovy (semaglutide)—is now making swift progress in the field with monlunabant, a small molecule oral cannabinoid receptor 1 (CB1) inverse agonist. 20 September 2024
The European Medicines Agency’s (EMA) Committee for Human Medicinal Products (CHMP) recommended approval of five novel medicines at its September meeting 20 September 2024
Aligos Therapeutics (Nasdaq: ALGS) has announced positive top-line results from the Phase IIa HERALD study of ALG-055009, a thyroid hormone receptor beta (THR-β) agonist, in metabolic-dysfunction associated steatohepatitis (MASH) subjects. 20 September 2024
US neuroscience company BioXcel Therapeutics has announced a new clinical prioritization and an update on its late-stage development programs for the treatment of agitation with BXCL501. 20 September 2024
Sanofi has announced encouraging results from its Phase III HERCULES trial of tolebrutinib in people with non-relapsing secondary progressive multiple sclerosis (nrSPMS). 20 September 2024
The Israeli Ministry of Health (IL MOH) has approved Tevimbra (tislelizumab) as monotherapy for the treatment of adult patients with unresectable or metastatic oesophageal squamous cell carcinoma (OESCC). 20 September 2024
Basilea Pharmaceutica announced that the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) has awarded Basilea an Other Transaction Agreement (OTA), under OTA number 75A50124C00033. 20 September 2024
Edgewise Therapeutics has announced promising top-line results for its candidate EDG-7500, aimed at treating hypertrophic cardiomyopathy (HCM). 20 September 2024
Achilles Therapeutics has announced it will discontinue its tumor-infiltrating lymphocyte (TIL)-based clonal neoantigen T cell (cNeT) program and shut down its Phase I/IIa CHIRON and THETIS trials. 20 September 2024
The European Medicines Agency’s (EMA) advisory committee the CHMP has adopted a positive opinion for a label update of Danish drugmaker Novo Nordisk’s Wegovy (semaglutide 2.4mg). 20 September 2024
US companies Incyte and Syndax Pharmaceuticals today announced results from the pivotal Phase II AGAVE-201 trial of Niktimvo (axatilimab-csfr), 19 September 2024
Swedish drugmaker Calliditas Therapeutics has received full US Food and Drug Administration approval for Tarpeyo (budesonide), upgrading a previous nod under the Accelerated Approval scheme. 21 December 2023
For a second time, the US Food and Drug Administration has rejected a submission from Merck & Co for approval to market a chronic cough medication. 21 December 2023
India’s JB Chemicals & Pharmaceuticals saw its shares edge up 2% to 1,488.60 rupees, after it revealed it has acquired around 15 ophthalmology drugs from the Swiss pharma giant Novartis for rupees 964 crore or $116 million. 21 December 2023
Tonix Pharmaceuticals Holding Corp has announced highly statistically significant and clinically meaningful topline results in a second positive Phase III trial of TNX-102 SL for the management of fibromyalgia. 21 December 2023
The Indian pharmaceutical industry is firing on all cylinders, with exports showing a remarkable 8% increase year-to-date and a notable 29% surge in October alone, according to the chairman of Pharmexcil, the apex body for Indian pharma exports. 21 December 2023
Japanese drugmaker Shionogi has launched of siderophore cephalosporin antibiotic Fetroja (cefiderocol) intravenous infusion 1g vial in Japan. 21 December 2023
The US Food and Drug Administration (FDA) yesterday issued the final guidance Development of Monoclonal Antibody Products Targeting SARS-CoV-2 for Emergency Use Authorization. 21 December 2023
Privately-held Swiss firm LimmaTech Biologics has announced a license agreement that grants the company exclusive rights to further develop AbVacc’s multivalent toxoid vaccine candidate, LBT-SA7 (formerly IBT-V02). 20 December 2023
As The World Health Organization (WHO) draws to a close COVAX, its pioneering global effort to distribute coronavirus vaccines, the agency said a new strain of the virus, JN.1, would be classed as a "variant of interest." 20 December 2023
UK pharma major GSK and China’s Hansoh Pharma have entered into an exclusive license agreement for HS-20093, a B7-H3 targeted antibody-drug conjugate (ADC) utilizing a clinically validated topoisomerase inhibitor (TOPOi) payload. 20 December 2023
Shares of Dutch immunology specialist argenx slumped as much as 30% to 290.60 euros this morning, after it announced disappointing top-line results from the ADDRESS study 20 December 2023
The US Food and Drug Administration (FDA) published an update to the “List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic” (OPOE list). 20 December 2023
The rare disease unit of Italian drugmaker Chiesi has secured US approval for Filsuvez (birch triterpenes), a new treatment for people with junctional epidermolysis bullosa (JEB) and dystrophic epidermolysis bullosa (DEB). 20 December 2023
The contraceptives market across the seven major markets (7MM: the USA, France, Germany, Italy, Spain, UK and Japan) is forecast to slightly increase at a compound annual growth rate (CAGR) of 0.5% from $7.8 billion in 2022 to $8.2 billion in 2032. 20 December 2023
Foreign contract research companies (CROs) are suspending participating in clinical trials in Russia after the exodus of global drugmakers from the clinical research market in the country earlier this year, reports The Pharma Letter’s local correspondent. 20 December 2023