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
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
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
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
Daiichi Sankyo’s today revealed that its Vanflyta (quizartinib) has been recommended by the National Institute for Health and Care Excellence (NICE) for routine National Health Service (NHS) commissioning in England and Wales. 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
Novo Nordisk is under increasing pressure over the cost of its blockbuster drugs in the USA, as chief executive Lars Fruergaard Jørgensen prepares to testify before a powerful Senate committee. 18 September 2024
In a lawsuit filed in federal court in Missouri, USA, Health insurer Cigna (NYSE: CI) and its pharmacy benefit manager (PBM) Express Scripts demanded that the Federal Trade Commission (FTC) retract its July 2024 report. 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
Lynparza (olaparib) has been approved in Japan for the treatment of advanced ovarian, prostate and pancreatic cancers, the drug’s developers announced on Monday. 29 December 2020
Representatives of the Association of Cancer Patients, Zdravstvy, one of Russia’s leading public associations representing the interests of patients, has called on the national government to resume procurements of some high-priced original drugs, which are used to treat cancer and for which purchases are not planned for 2021. 29 December 2020
China's National Health Security Administration (NHSA) has announced the annual results from the National Reimbursement Drug List (NRDL) negotiations in 2020, according to a client noted from SVB Leerink Research analyst Andrew Berens. 28 December 2020
UK government officials confirmed on Sunday that the Medicines and Healthcare products Regulatory Agency (MHRA) would imminently approve the Oxford COVID-19 vaccine, adding that the announcement could come as soon as Tuesday, according to the Financial Times. 28 December 2020
This afternoon, Christmas Eve, we finally heard that the UK had reached a trade agreement with the European Commission on the terms of its departure from the European Union, that will come into effect on January 1, 2021. 24 December 2020
US biotech Moderna says that medicines regulator Health Canada has authorized its vaccine against COVID-19, mRNA-1273, for the immunization of people 18 years of age and older under an Interim Order. 24 December 2020
The US Food and Drug Administration has approved the New Drug Application (NDA) for once-daily Gemtesa (vibegron), a beta-3 adrenergic receptor (β3) agonist, for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence (UUI), urgency, and urinary frequency in adults, from Urovant Sciences. 24 December 2020
US pharma giant Pfizer and German partner BioNTech have signed a second deal with the US government to supply an additional 100 million doses of BNT162b2, their COVID-19 vaccine, from production facilities in the USA. 23 December 2020
The European Commission has approved Phesgo, a fixed-dose combination of Perjeta (pertuzumab) and Herceptin (trastuzumab) with hyaluronidase, administered by subcutaneous injection for the treatment of early and metastatic HER2-positive breast cancer. 23 December 2020
The demand for foreign drugs designed for cancer treatment in Russia remains stable, despite the ever-growing number of generics in the local market, according to recent statements by some leading Russian pharma analysts and local media, reports The Pharma Letter’s local correspondent. 22 December 2020
Netherlands-based gene therapy company uniQure saw its shares down 15.7% at $38.75 around midday in New York trading today, after it announced that its hemophilia B gene therapy program, including the pivotal, Phase III HOPE-B study, has been placed on clinical hold by the US Food and Drug Administration. 21 December 2020
The European Medicines Agency’s advisory committee today recommended granting a conditional marketing authorization for Pfizer and BioNTech’s vaccine Comirnaty (previously known as BNT162b2), to prevent COVID-19 in people from 16 years of age. 21 December 2020
HIV specialist company ViiV Healthcare, which is majority owned by GlaxoSmithKline, today announced the authorization of Vocabria (cabotegravir injection and tablets) in combination with Janssen’s Rekambys (rilpivirine injection) and Edurant (rilpivirine tablets), in the European Union, for the treatment of HIV-1 infection in adults who are virologically suppressed. 21 December 2020
Shionogi has been included in an innovative pilot program in the UK, designed to support the production of novel antibiotics and boost defences against antimicrobial resistance (AMR). 21 December 2020
The US Food and Drug Administration on Friday issued a complete response letter (CRL) regarding the new drug application (NDA) for inclisiran, a potential treatment for hyperlipidemia in adults who have elevated low-density lipoprotein cholesterol (LDL-C) while being on a maximum tolerated dose of a statin therapy. 21 December 2020
Any doubts that Moderna’s (Nasdaq: MRNA) COVID-19 vaccine is moving swiftly closer to patients in the USA and European Union (EU) have all but vanished this week. 18 December 2020