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
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
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
In the USA, the Biden-Harris Administration has made expanding access to health insurance and lowering health care costs for America’s families a top priority, and, starting now, consumers can preview their health care coverage options and see the savings available to them in the most competitive Marketplace in history. 27 October 2022
A US regulatory submission from microbiome company Seres Therapeutics has been accepted, with an expected decision date of April 26, 2023. 26 October 2022
According to the Russian pharma trade body the ARPM, the 2nd Annual “Right to Health” Congress was held in Moscow, aimed to highlight the prospects of the domestic healthcare industry, which have become more acute in modern geopolitical conditions, in a wide format. 26 October 2022
The US Food and Drug Administration yesterday granted accelerated approval to Tecvayli (teclistamab-cqyv), the first bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager, for adult patients with relapsed or refractory multiple myeloma. 26 October 2022
Pharma trade body Medicines Australia has welcomed the Anthony Albanese’s government Budget announced by Treasurer Jim Chalmers today, which takes steps towards addressing economic pressures and introduces new funding for Prescription Benefit Scheme (PBS) listings. 25 October 2022
The UK's National Institute for Health and Care Excellence (NICE) has recommended the use of Ryeqo (relugolix/estradiol/norethisterone) for the treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age. 24 October 2022
It was more than five years ago that AstraZeneca announced disappointing Phase III progression-free survival results from its MYSTIC lung cancer trial of Imfinzi (durvalumab) monotherapy or in combination with tremelimumab. 24 October 2022
New Jersey, USA-based cancer giant Bristol Myers Squibb has had its bid to broaden the label for Camzyos (mavacamten) accepted by the US regulator. 24 October 2022
Global drugmakers continue their operations in Russia, despite its ongoing military conflict with Ukraine and the ever deteriorating economic situation in the country, according to recent statements by some Russian senior state officials and local media, reports The Pharma Letter’s local correspondent. 24 October 2022
Another approval for the JAK blocker Rinvoq (upadacitinib) will help Chicago’s AbbVie boost market share in an increasingly crowded immunology market. 24 October 2022
In August, the UK’s Medicines and Healthcare Regulatory Agency (MHRA) approved Sunlenca (lenacapavir) injection and tablets, alongside other antiretrovirals, in adults with multi-drug resistant HIV infection for whom it is otherwise not possible to construct a suppressive anti-viral regimen. 21 October 2022
Boston, Massachusetts-based non-profit The Institute for Clinical and Economic Review (ICER) has issued its final report into the cost-effectiveness of the latest generation of weight loss treatments. 21 October 2022
US clinical-stage biotech Minerva Neurosciences (Nasdaq: NERV) has recently received a refusal to file letter from the Food and Drug Administration (FDA) regarding its new drug application (NDA) for roluperidone, which was filed in August, for the treatment of negative symptoms in patients with schizophrenia, is yet another obstacle to the drug’s development. 21 October 2022
Shares in Parisian immuno-oncology specialist OSE Immunotherapeutics rose by around a third on Friday morning, after the firm provided an update on its neoepitope cancer vaccine Tedopi. 21 October 2022
The US Food and Drug Administration’s (FDA) Obstetrics, Reproduction and Urologic Advisory Committee yesterday voted to recommend that the FDA pursue withdrawal of approval of privately-held Swiss drugmaker Covis Pharma’s Makena (hydroxyprogesterone caproate injection), the only FDA-approved treatment to reduce the risk of preterm birth in pregnant women who have had a prior spontaneous preterm birth. 20 October 2022
An alternative to mRNA-based coronavirus vaccines has received an Emergency Use Authorization in the USA, providing a new option for a first booster dose. 20 October 2022
The European Medicines Agency’s (EMA) human medicines committee (CHMP) has recommended extending the use of Comirnaty and Spikevax targeting the original strain of SARS-CoV-2. 20 October 2022