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
The British business of Japanese pharma major Takeda Pharmaceutical has secured conditional approval in the UK for its first-in-class oral tyrosine kinase inhibitor (TKI) Exkivity (mobocertinib). 18 March 2022
An Expert View from Jennifer Romanski, a principal of Porzio, Bromberg & Newman and a co-chair of its Life Sciences Compliance and Regulatory Counseling Department. She is also a senior vice president at Porzio Life Sciences, a wholly-owned subsidiary of the law firm. 18 March 2022
Rare diseases specialist Swedish Orphan Biovitrum, also known as Sobi, today announced that China’s National Medical Products Administration (NMPA) has approved Gamifant (emapalumab) for use in China. 18 March 2022
US mRNA specialist Moderna is the latest to request to the US Food and Drug Administration (FDA) for an amendment to the emergency use authorization (EUA) to allow for a fourth dose of its COVID-19 vaccine (mRNA-1273). 18 March 2022
The US Food and Drug Administration (FDA) has approved Rinvoq (upadacitinib) for the treatment of adults with moderately to severely active ulcerative colitis (UC) who have had an inadequate response or intolerance to one or more tumor necrosis factor (TNF) blockers. 18 March 2022
The Medicines Patent Pool (MPP) has signed agreements with 35 companies to manufacture the generic version of Pfizer’s oral COVID-19 treatment Paxlovid (nirmatrelvir/ritonavir) to be supplied in 95 low- and middle-income countries. 17 March 2022
Boston, USA-based pricing watchdog The Institute for Clinical and Economic Review (ICER) has published a revised assessment of the relative merits of two possible competitors in hematology. 17 March 2022
To help combat the nationwide insulin affordability crisis, Civica Rx, a non-profit generic pharmaceutical company, has launched its Insulin Initiative with the JDRF. The initiative aims to drive affordability and accessibility for all Americans, regardless of insurance status. 17 March 2022
Australian cancer patients will get improved access to local clinical trials through a new public-private partnership consortium, PrOSPECT, which today announced a funding agreement that is expected to enable a significant increase in local cancer clinical trial participation. 17 March 2022
The Indian government has extended the application date till March-end for the PLI (production linked incentive) scheme for bulk drugs. The government said that after two rounds of inviting applications, a total 49 projects have been approved for 33 critical APIs with a committed investment of $483 million. 16 March 2022
Yesterday, the US Food and Drug Administration approved the first generic of Symbicort (budesonide and formoterol fumarate dihydrate) Inhalation Aerosol for the treatment of two common pulmonary health conditions. 16 March 2022
UK health technology assessor the National Institute for Health and Care Excellence (NICE) has recommended the use of Darzalex (daratumumab) monotherapy for adult patients with relapsed and refractory multiple myeloma that has previously been treated with three therapies, including a proteasome inhibitor and an immunomodulator, and who have demonstrated disease progression on the last therapy. 15 March 2022
US biotech companies Exelixis yesterday announced results from the final analysis of the second primary endpoint of overall survival (OS) from the Phase III COSMIC-312 trial, which evaluated Cabometyx (cabozantinib) in combination with atezolizumab versus sorafenib in patients with previously untreated advanced hepatocellular carcinoma (HCC). 15 March 2022
Australia’s Therapeutic Goods Administration (TGA) has approved the use of single-dose Kozenis (tafenoquine) in children aged two years and above in combination with chloroquine for the radical cure (prevention of relapse) of Plasmodium vivax (P. vivax) malaria. 14 March 2022
Japanese firm Mitsubishi Tanabe has submitted to the Ministry of Health, Labor and Welfare in Japan an application for the manufacturing and marketing approval of an investigational oral formulation of edaravone (MT-1186) for the treatment of amyotrophic lateral sclerosis (ALS). 14 March 2022
Just as UK pharma major AstraZeneca received a positive US regulatory decision for its breast cancer Lynparza (olaparib), the company was also delivered a setback, as the US Food and Drug Administration (FDA) issued a complete response letter (CRL) regarding the supplemental Biologics License Application (sBLA) for Fasenra (benralizumab) for patients with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP). 14 March 2022
As the World Health Organization (WHO) considers amending guidelines for evaluating biosimilars so that Phase III clinical trials can be waived for biosimilar products, India may take a greater interest in developing biosimilars. 14 March 2022