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
Shares in New Jersey, USA-based company Provention Bio rose by over a quarter on Tuesday, after the firm announced positive regulatory news related to its type 1 diabetes (T1D) candidate teplizumab. 26 May 2021
The European Commission (EC) should exempt advanced therapies from Genetically Modified Organism (GMO) legislation, which hurts Europe’s ability to attract clinical trials and delays patient access to transformative medicines. 26 May 2021
The USA’s Institute for Clinical and Economic Review (ICER) yesterday posted a Protocol outlining how it will conduct its first annual assessment into how well major insurers’ prescription drug coverage policies align with a set of fair access standards developed by ICER with expert input from patient advocates, clinician specialty societies, US payers, and life science companies. 26 May 2021
The US Food and Drug Administration has accepted the Biologics License Application (BLA) for ublituximab, an investigational glycoengineered anti-CD20 monoclonal antibody, in combination with Ukoniq (umbralisib), TG Therapeutics’ once-daily, oral, inhibitor of PI3K-delta and CK1-epsilon, as a treatment for patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). 26 May 2021
The European Commission has approved Venclyxto (venetoclax) in combination with hypomethylating agents, azacitidine and decitabine, for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy. 26 May 2021
Johnson & Johnson subsidiary Janssen has received approval from the European Commission for Ponvory (ponesimod) for the treatment of adult patients with relapsing multiple sclerosis (RMS) with active disease defined by clinical or imaging features. 25 May 2021
The US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for Verastem’s investigational RAF/MEK inhibitor VS-6766, combined with defactinib, its FAK inhibitor, in recurrent low-grade serous ovarian cancer (LGSOC) regardless of KRAS status after one or more prior lines of therapy, including platinum-based chemotherapy. 25 May 2021
New bipartisan legislation has been proposed by two US Representatives that would fund critical research on treatments and cures for diseases including Alzheimer’s, cancer, blindness, juvenile diabetes, and sickle-cell anemia amid research delays caused by the pandemic. 25 May 2021
The Russian government will use the mechanism of interventions in the domestic pharmaceutical market to tighten control of drug prices, according to recent statements by some senior state officials and local media, reports The Pharma Letter’s local correspondent. 25 May 2021
The US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation (BTD) for Boehringer Ingelheim’s BI 425809 for the treatment of cognitive impairment associated with schizophrenia (CIAS). 24 May 2021
The US Food and Drug Administration strictly prohibits the distribution of counterfeit, diverted, subpotent, substandard, adulterated, misbranded, and expired drugs that pose a serious threat to life. Nevertheless, such drugs continue to end up in circulation, compromising patient safety. 24 May 2021
Last Saturday, US biotech Moderna announced that the Ministry of Food and Drug Safety of South Korea (MFDS) has approved the company’s application for conditional marketing authorization for its mRNA vaccine against COVID-19. 24 May 2021
On Friday, the US Food and Drug Administration approved Rybrevant (amivantamab-vmjw) as the first treatment for adult patients with non-small cell lung cancer (NSCLC) whose tumors have specific types of genetic mutations: epidermal growth factor receptor (EGFR) exon 20 insertion mutations. 22 May 2021
The European Medicines Agency’s Committee for Human Medicinal Products (CHMP) has issued a positive scientific opinion following the referral of sotrovimab to the CHMP under Article 5(3) of Regulation 726/2004. 21 May 2021
Following its May 2021 meetings, the European Medicines Agency’s human medicines committee (CHMP) recommended eight even medicines, including one gene therapy and one generic, for approval. 21 May 2021
New storage conditions for the COVID-19 vaccine from Pfizer and Germany’s BioNTech have today been approved by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). 21 May 2021
With the Olympic Games just a couple of months away and coronavirus cases in the country at a dangerous point, Japan has approved two vaccines in a single day. 21 May 2021
The US Food and Drug Administration has approved another important indication for Opdivo (nivolumab, injection for intravenous use), this one for the adjuvant treatment of completely resected esophageal or gastroesophageal junction (GEJ) cancer with residual pathologic disease in patients who have received neoadjuvant chemoradiotherapy (CRT). 21 May 2021
US biotech Vertex Pharmaceuticals says that the European Medicines Agency (EMA) and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) have validated the post-marketing applications for an expanded indication of Kaftrio. 20 May 2021
A new rheumatoid arthritis (RA) drug, olokizumab, has been found to offer significant benefits to RA patients, following its completion of Phase III ‘CREDO’ trials. 20 May 2021