The Japanese Ministry of Health, Labor, and Welfare (MHLW) has approved Otsuka’s (TYO: 4578) Lupkynis (voclosporin) for the treatment of lupus nephritis (LN), an inflammation of the kidneys caused by systemic lupus erythematosus (SLE), an autoimmune disease 24 September 2024
CSL Vifor today announced that Japan’s Ministry of Health and Labor Welfare (MHLW) has granted its partner, Zeria Pharmaceutical marketing authorization approval for Veltassa (patiromer). 24 September 2024
Takeda has announced the Japanese approval of Fruzaqla (fruquintinib) capsules 1mg/5mg, a selective oral inhibitor of vascular endothelial growth factor receptor (VEGFR) -1, -2 and -3, to treat advanced or recurrent colorectal cancer (CRC) that is neither curable nor resectable and that has progressed after chemotherapy. 24 September 2024
Japan’s Ministry of Health, Labor and Welfare of Japan (MHLW) has approved New Drug Application (NDA) for Quviviq (daridorexant; ACT-541468) 25mg and 50mg for the treatment of adult patients with insomnia, submitted by Nxera Pharma. 24 September 2024
The Association of the British Pharmaceutical Industry (ABPI) and the Prescription Medicines Code of Practice Authority (PMCPA) have published an updated Code of Practice for drugmakers. 23 September 2024
Shares of California, USA-based precision medicines IDEAYA Biosciences were down 6.3% at $32.5 mid-morning after it revealed what is described as “positive” developments for its darovasertib. 23 September 2024
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of Hetronifly (serplulimab). 23 September 2024
The US Food and Drug Administration (FDA) has approved Bimzelx (bimekizumab-bkzx) for the treatment of adults with active psoriatic arthritis (PsA), adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation, and adults with active ankylosing spondylitis (AS). 23 September 2024
Ocumension Therapeutics, has received approval of the New Drug Application (NDA) to commercialize Zerviate (cetirizine ophthalmic solution), 0.24% in China for ocular itching associated with allergic conjunctivitis. 23 September 2024
The US Food and Drug Administration (FDA) has approved Sarclisa (isatuximab) in combination with bortezomib, lenalidomide, and dexamethasone (VRd) as a first line treatment option for adult patients with newly diagnosed multiple myeloma (NDMM). 23 September 2024
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
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
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
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
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
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. 19 September 2024
South Korea’s Celltrion Healthcare welcomes the publication of the latest position paper from the European Crohn’s and Colitis Organization (ECCO) on the use of biosimilars for inflammatory bowel disease (IBD). 12 December 2016
Rather like Kite’s registrational Zuma-1 trial of KTE-C19 in lymphoma, Novartis’ Eliana study has generated a fileable response rate. In the case of the Swiss firm’s rival CAR-T therapy, CTL019, this is in childhood leukemia patients, says EP Vantage, the editorial arm of the Evaluate group. 10 December 2016
The US Food and Drug Administration has accepted the first Biologics License Application (BLA) for durvalumab, a PD-L1 human monoclonal antibody (MAb), and granted priority review status with a Prescription Drug User Fee Act (PDUFA) set for the second quarter of 2017. 10 December 2016
The European Commission has granted an additional indication for Lucentis (ranibizumab) to treat patients with visual impairment due to choroidal neovascularization (CNV) associated with causes other than neovascular age-related macular degeneration (nAMD), or secondary to pathologic myopia (PM). 9 December 2016
A wide-ranging bill promising to fund biomedical research, establish a council to speed up the discovery, development, and delivery of innovative medicines and advance precision medicine, has been passed in the US Senate. 8 December 2016
Following a positive recommendation in October from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP), the European Commission (EC) has now granted conditional marketing authorization for Venclyxto (venetoclax) monotherapy. 8 December 2016
The European Medicines Agency has accepted for review the Marketing Authorization Application (MAA) for Dupixent (dupilumab) for the treatment of adults with moderate-to-severe atopic dermatitis (AD) who are candidates for systemic therapy. 8 December 2016
Breakthrough immunotherapy Opdivo (nivolumab) has been approved in the European Union for the treatment of classical Hodgkin lymphoma (cHL), a rare and often-aggressive blood cancer. 7 December 2016
US clinical-stage biotech Sage Therapeutics was trading 7% higher after Tuesday’s trading at $55.68 following news from its development plan for its SAGE-547 program in postpartum depression (PPD). 7 December 2016
The US Food and Drug Administration has approved Avastin (bevacizumab) for the treatment of patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer. 7 December 2016
Over the past half-century, the prescription medication industry has witnessed phenomenal growth. To combat sharp increments in drug costs during the 1970s, states deployed laws and developed guidance material with the help of the Food and Drug Administration, writes Dr Nicola Davies in her monthly exclusive FDA Blog for The Pharma Letter. 7 December 2016
Changes in the way that NHS England commissions specialized treatments have been called for by a charity working to improve the lives of patients and families affected by genetic conditions. 6 December 2016
Global drugmakers operating their plants in Russia have criticized the latest state initiative to introduce new restrictions on the participation of foreign drug manufacturers in tenders for the public procurement of drugs for state needs, reports The Pharma Letter’s local correspondent. 6 December 2016
A New Drug Application has been filed with the US Food and Drug Administration for semaglutide, a glucagon-like peptide-1 (GLP-1) analog administered once-weekly, for the treatment of adults with type 2 diabetes. 5 December 2016
New Zealand’s Pharmaceutical Management Agency PHARMAC has announce a major funding package following an agreement with the local subsidiary of Swiss pharma giant Roche for funding nine medicines covering 10 different medical conditions with changes implemented from January 1, 2017. 5 December 2016
A rolling submission with the US Food and Drug Administration of the Biologics License Application (BLA) for KTE-C19 as a treatment for patients with relapsed/refractory aggressive B-cell non-Hodgkin lymphoma (NHL) who are ineligible for autologous stem cell transplant (ASCT) has been initiated. 5 December 2016
Some 344 fixed dose combination (FDC) medications that have been off chemists' shelves in India for some time now, are to make a reappearance, with the Delhi High Court setting aside the Indian government’s decision to ban the FDC drugs. 5 December 2016
The US Food and Drug Administration on Friday approved a new indication for Jardiance (empagliflozin) to reduce the risk of cardiovascular death in adult patients with type 2 diabetes mellitus and cardiovascular disease. 5 December 2016
A Marketing Authorization Application (MAA) to the European Medicines Agency for ABP 215, a biosimilar candidate to Swiss pharma major Roche’s blockbuster cancer drug Avastin (bevacizumab). 3 December 2016
The Japanese Ministry of Health, Labor and Welfare (MHLW) has approved Relvar Ellipta (fluticasone furoate/vilanterol 100/25mcg) for the relief of various symptoms with chronic obstructive pulmonary disease. 2 December 2016