Japanese drugmaker Chugai Pharmaceutical has obtained approval from the Ministry of Health, Labor and Welfare (MHLW) for the anticancer agent Polivy (polatuzumab vedotin [genetical recombination]) intravenous infusion 30mg and 140mg [generic combination with bendamustine and rituximab (BR therapy) for the treatment of relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL). 23 March 2021
Taisho Pharmaceutical has submitted an application for approval to manufacture and market the anti-TNFα Nanobody therapeutic ozoralizumab to the Ministry of Health, Labor and Welfare (MHLW) for the planned indication of rheumatoid arthritis (RA), which is to-date inadequately managed by the current available treatments. 23 March 2021
Novo Nordisk late Monday announced that the US Food and Drug Administration has issued a Refusal to File letter covering the label expansion application for once-weekly semaglutide 2.0mg for the treatment of type 2 diabetes, which was filed on 20 January 2021. 23 March 2021
The US Food and Drug Administration has approved a label update for Merck & Co’s blockbuster checkpoint blocker, targeting advanced esophageal or gastroesophageal (GEJ) cancer. 23 March 2021
Russian Deputy Prime Minister Tatyana Golikova – a state official also responsible for the development of pharmaceutical and healthcare sector in the Russian government - has instructed the national government to speed the procedure for registration of new drugs in Russia and to provide additional preferences to domestic drugmakers during public procurements, according to recent statements by the state press-service and some local media, reports The Pharma Letter’s local correspondent. 23 March 2021
The European Medicines Agency says it has reviewed the latest evidence on the use of ivermectin for the prevention and treatment of COVID-19 and concluded that the available data do not support its use for COVID-19 outside well-designed clinical trials. 22 March 2021
US Senators on Thursday approved California Attorney General Xavier Becerra as Health and Human Services (HHS) Secretary on a razor-thin vote that broke almost entirely along party lines and followed searing debate over the lawyer's qualifications and support for abortion rights. 19 March 2021
The US Food and Drug Administration (FDA) has approved Ponvory (ponesimod), a once-daily oral selective sphingosine-1-phosphate receptor 1 (S1P1) modulator, to treat adults with relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease. 19 March 2021
The US Food and Drug Administration has approved Arcalyst (rilonacept) injection to treat recurrent pericarditis and reduce the risk of recurrence in adults and children 12 years and older. 19 March 2021
The Russian Direct Investment Fund (RDIF, Russia’s sovereign wealth fund), and Stelis Biopharma, the biopharmaceutical division of Indian drugmaker Strides Pharma Science, have partnered to produce and supply a minimum of 200 million doses of the Russian Sputnik V vaccine against coronavirus sufficient to vaccinate 100 million people. 19 March 2021
The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has concluded a hurried preliminary review of a signal of blood clots in people vaccinated with COVID-19 Vaccine AstraZeneca. 18 March 2021
The US Food and Drug Administration has extended the review period for the supplemental New Drug Application (sNDA) for Rinvoq (upadacitinib) in the treatment of adult patients with active psoriatic arthritis. 17 March 2021
The European Commission (EC) has approved an expanded label for Keytruda (pembrolizumab) as monotherapy for adults and children aged three years and older with relapsed or refractory classical Hodgkin lymphoma (cHL) who have failed autologous stem cell transplant (ASCT) or following at least two prior therapies when ASCT is not a treatment option. 17 March 2021
In a filing with the US Securities and Exchange Commission (SEC), bluebird bio has announced the departure of its chief medical officer, David Davidson. 17 March 2021
The US Federal Trade Commission (FTC) and its counterpart competition enforcement agencies in the USA, European Union, the UK and Canada, are launching a working group to update their approach to analyzing the effects of pharmaceutical mergers. 17 March 2021
The regenerative medicine and advanced therapies sector raised a record $19.9 billion in funding in 2020, fueling the broader biotech sector and driving a rapidly advancing pipeline of potentially transformative therapies, according to the Alliance for Regenerative Medicine’s (ARM) 2020 Annual Report released today. 16 March 2021
As of lunchtime on Tuesday, 11 European countries had halted the rollout of COVID-19 Vaccine AstraZeneca after a number of cases of blood clots. 16 March 2021
Since the start of the fight against the COVID-19 pandemic, the Russian Direct Investment Fund has been in favor of active coordination with all partners, including from Europe, and open to negotiations, said the organization’s chief executive Kirill Dmitriev today. 15 March 2021
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
Applied Therapeutics saw its stock price climb by over two-thirds after an encouraging update on the US Food and Drug Administration review of govorestat. 19 September 2024
Pharma giant Merck & Co has announced that the US Food and Drug Administration (FDA) has approved Keytruda (pembrolizumab), alongside pemetrexed and platinum chemotherapy, for the first-line treatment of adults with unresectable advanced or metastatic malignant pleural mesothelioma (MPM). 18 September 2024
AstraZeneca’s Fasenra (benralizumab) has been approved in the USA for the treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA, the UK pharma major announced today. 18 September 2024
Yesterday, the US Food and Drug Administration (FDA) issued a draft guidance, “Integrating Randomized Controlled Trials for Drug and Biological Products into Routine Clinical Practice” 18 September 2024
Bayer has submitted a Marketing Authorization Application (MAA) to the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for the investigational compound elinzanetant. 17 September 2024
The US Food and Drug Administration (FDA) has approved Ocrevus Zunovo (ocrelizumab and hyaluronidase-ocsq) for the treatment of relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS), from Swiss pharma giant Roche. 16 September 2024
The Gastrointestinal Drugs Advisory Committee (GIDAC) of the US Food and Drug Administration (FDA) met on Friday to discuss Intercept Pharmaceuticals’ supplemental New Drug Application (sNDA) for Ocaliva (obeticholic acid, OCA). 16 September 2024
Oligonucleotide therapeutics are rapidly emerging as a promising class of drugs capable of addressing a variety of genetic and complex diseases by targeting RNA sequences.1 16 September 2024
On Thursday, the US Food and Drug Administration released a Drug Safety Communication warning that Veozah (fezolinetant), which is used to treat hot flashes due to menopause, can cause rare but serious liver injury. 13 September 2024
The US Food and Drug Administration (FDA) has approved Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs), the first and only PD-(L)1 inhibitor for subcutaneous (SC) injection for patients in the USA, Swiss pharma giant Roche subsidiary Genentech announced yesterday. 13 September 2024