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
Germany-based Medigene has announced an update and prioritization of its pipeline and resource allocation in support of its long-term corporate strategy. 22 November 2023
InDex Pharmaceuticals Pharmaceuticals plunged 60% to 0.26 kronor this morning, as it reported a failed clinical trial for its ulcerative colitis candidate cobitolimod. 22 November 2023
Japanese drugmaker Sumitomo Pharma has received approval from China’s National Medical Products Administration (NMPA) for the use of Xenleta (lefamulin acetate) to treat adults with community-acquired pneumonia in injection and tablet formulation. 22 November 2023
Complex regional pain syndrome (CRPS) is a chronic and potentially debilitating neuropathic pain condition that typically affects an extremity, such as an arm or leg.1 22 November 2023
Signalling a strategic shift towards research, artificial intelligence (AI), blockchain, and patent laws, the Indian government has released a draft of the National Pharmaceutical Policy, inviting crucial inputs from industry stakeholders. 22 November 2023
Russian pharmaceutical companies are eyeing expanding in the United Arab Emirates (UAE) by launching production of their drugs and establishing their manufacturing facilities in the local market. 22 November 2023
In 1984, Congress passed and the President signed into law the Drug Price Competition and Patent Term Restoration Act, better known as the Hatch-Waxman Act. 21 November 2023
A new multi-year collaboration between Swiss pharma giant Roche subsidiary Genentech and US tech firm NVIDIA aims to transform the discovery and development of new medicines by bringing together experts from each company to optimize and accelerate Genentech’s proprietary algorithms. 21 November 2023
In the rush to develop effective vaccines against the novel coronavirus, several companies have sued, and counter-sued, for patent infringement, with potentially billions on the line. 21 November 2023
Just six months after raising $150 million in an upsized series E financing, cardiometabolic specialist Carmot Therapeutics has filed for an initial public offering (IPO). 21 November 2023
Indian pharmaceutical company Jodas Expoim is experiencing serious problems with the construction of its first enterprise in the Russian Federation. 21 November 2023
US pharma giant Merck & Co as entered into a definitive agreement, through a subsidiary, to acquire Caraway Therapeutics, a privately-held US pre-clinical biopharmaceutical company. 21 November 2023
Shares of US pharma major Bristol Myers Squibb fell more than 4% pre-market and partner 2seventy bio was down 17.6% at $1.76 on Monday, after the companies said the US Food and Drug Administration would miss its target date for potential approval of earlier use of a cancer therapy Abecma (idecabtagene vicleucel). 21 November 2023
Contract manufacturing organization (CMO) and sterile injectable specialist Torbay Pharmaceuticals has received an investment from private equity firm NorthEdge. 21 November 2023
The USA’s Federal Trade Commission (FTC) says it has filed an amicus brief to address the anticompetitive harm that stems from improperly listed patents in the Food and Drug Administration’s (FDA) publication of “Approved Drug Products with Therapeutic Equivalence Evaluations,” commonly known as the “Orange Book.” 21 November 2023