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
Ohio, USA-based contract development and manufacturing organization (CDMO) Andelyn Biosciences has partnered with Purespring Therapeutics in the area of nephrology. 20 October 2023
Californian antiviral specialist Gilead Sciences has presented new data today supporting Sunlenca (lenacapavir) as an important treatment option for adults with multi-drug resistant (MDR) HIV who have extensive treatment history. 20 October 2023
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has today authorized a new medicine called, Tepkinly (epcoritamab), as a treatment for diffuse large B-cell lymphoma (a type of blood cancer) in adults. 20 October 2023
Even as India's National Pharmaceutical Pricing Authority (NPPA) is currently deliberating a threshold price for 10 formulations, including a significant 70% price reduction for a brain cancer drug, poor patients at the AIIMS hospital in Delhi are to get 63 more drugs, including 45 cancer drugs for free. 20 October 2023
US pharma giant Pfizer has revealed the cost of its oral antiviral treatment for COVID-19, Paxlovid (nirmatrelvir/ritonavir), once the company starts selling the drug commercially. 20 October 2023
New Jersey, USA-based PTC Therapeutics has announced an agreement with Royalty Pharma to acquire additional royalties on Evrysdi (risdiplam) for $1 billion upfront. 20 October 2023
Swiss drugmaker Basilea Pharmaceutica has entered into an asset purchase agreement with privately owned US firm Gravitas Therapeutics for GR-2397, a clinical-stage antifungal compound with a novel mechanism of action, targeting invasive mold infections caused by Aspergillus species. 20 October 2023
Shares of Japanese pharma major Daiichi Sankyo soared 14.4% to 4,095 yen by close of Tokyo trading today, after it announced what, if all goes according to plan, could be the biggest pharma licensing deal ever seen. 20 October 2023
In September, USA-based Ionis Pharmaceuticals (Nasdaq: IONS) unveiled positive Phase III clinical data for olezarsen, a ligand-conjugated antisense (LICA) designed to inhibit apolipoprotein C-III (apoC-III). 20 October 2023
Nearly five months have passed since the Annual Meeting of the American Society of Clinical Oncology (ASCO) took place, and cancer-focused drugmakers are ready once again to dump their data to the world’s oncologists, media and more. 19 October 2023
Osaka, Japan-based biotech RegCell today announced the appointment of experienced life science exec Michael McCullar, as its new president, chief executive and representative director. 19 October 2023
Singapore-based biotech Hummingbird Bioscience today announced that San Diego, USA-based Endeavor BioMedicines has acquired exclusive worldwide rights to Hummingbird’s antibody-drug conjugate (ADC), HMBD-501. 19 October 2023
US biotech major Gilead Sciences has presented new long-term real-world data on its flagship medication Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF). 19 October 2023
French pre-clinical biotech Mablink Biosciences has confirmed earlier rumors that it has agreed to a takeover bid from acquisition-hungry US pharma major Eli Lilly. 19 October 2023
Japanese drugmaker Daiichi Sankyo revealed that it has been ordered by a Texas district court to pay royalties on its antibody-drug conjugate (ADC) to US biotech Seagen. 19 October 2023
Californian advanced therapy company Nkarta moving forward with plans to leverage the potential of natural killer (NK) cell-based treatments outside of oncology. 19 October 2023
The GSK majority-owned company ViiV Healthcare is presenting 12-month efficacy, safety and patient-reported outcomes for European participants in the SOLAR study at the Annual European AIDS Conference (EACS) 2023 in Warsaw, Poland. 19 October 2023
German active pharmaceutical ingredient (API) manufacturer Axplora has appointed Stephan Haitz as president of the Novasep business unit. 19 October 2023
The European Commission (EC) has now approved Adcetris (brentuximab vedotin) in combination with doxorubicin, vinblastine and dacarbazine (AVD) to treat adult patients with previously untreated CD30+ Stage III Hodgkin lymphoma. 19 October 2023
After scientific advisors recommended that the US regulator not approve a new amyotrophic lateral sclerosis (ALS) therapy, developer BrainStorm Cell Therapeutics has opted to withdraw its submission. 19 October 2023