Swiss biopharma company Relief Therapeutics today announced that its collaboration partner, Acer Therapeutics for ACER-001 (sodium phenylbutyrate) for oral suspension for the treatment of patients with urea cycle disorders (UCDs), has resubmitted its New Drug Application (NDA) for ACER-001 to the US Food and Drug Administration (FDA). 18 July 2022
Life science companies look to technology solution to increase efficiencies and reduce errors, whether these are related to data entry or other reasons. 18 July 2022
The European Commission (EC) has granted conditional marketing authorization for Kinpeygo (budesonide) for the treatment of primary immunoglobulin A (IgA) nephropathy (IgAN) in adults at risk of rapid disease progression with a urine protein-to-creatinine ratio (UPCR) ≥1.5 g/gram. 16 July 2022
Responding to the urgent public health needs of the most vulnerable and ensuring its ‘experiment in innovation’ bears fruit depend entirely on the dedication, commitment, and resolve of its partners, supporters, and staff, said Drugs for Neglected Diseases initiative (DNDi). 15 July 2022
In the USA, a new approval for Xalkori (crizotinib) will extend the first-generation ALK inhibitor’s use to include certain people with myofibroblastic tumors. 15 July 2022
Poland-based drugmaker Polpharma Biologics today announced that the European Medicines Agency (EMA) has accepted the first-ever Marketing Authorization Application (MAA) for biosimilar natalizumab, a proposed biosimilar to branded multiple sclerosis treatment Tysabri. 15 July 2022
Following a public comment period, the USA’s Federal Trade Commission (FTC) has approved a final order settling charges that London-listed Jordanian drugmaker Hikma Pharmaceuticals’ $375 million acquisition of Custopharm likely would have harmed competition in the market for the corticosteroid drug triamcinolone acetonide, or TCA. 15 July 2022
Chinese vaccine developer Sinovac Biotech announced that its COVID-19 vaccine (CoronaVac) has been approved by the Brazilian Health Regulatory Agency (Anvisa) for emergency use in children from three to five years old on July 13. 15 July 2022
The US Food and Drug Administration yesterday issued a final guidance, “Instructions for Use – Patient Labeling for Human Prescription Drug and Biological Products – Content and Format.” 15 July 2022
Sino-American biotech firm BeiGene today announced that the US Food and Drug Administration (FDA) has deferred action on the Biologics License Application (BLA) for tislelizumab as a second-line (2L) treatment for patients with unresectable or metastatic esophageal squamous cell carcinoma (ESCC). 14 July 2022
Despite a very tardy authorization in the USA, the Novavax jab has the potential to be much more than just an also-ran in the COVID-19 vaccine market. 14 July 2022
South Korean firm SK bioscience has announced that SKYCovione, the Asian country’s first COVID-19 vaccine candidate adjuvanted with GSK’s pandemic adjuvant, has been authorized by the Korean Ministry of Food and Drug Safety. 13 July 2022
US biopharma company Greenwich LifeSciences , which is focused on the development of GLSI-100, announced that the Food and Drug Administration (FDA) has removed the clinical hold permitting the Flamingo-01 Phase III clinical trial to proceed. 13 July 2022
As part of its efforts to keep up with changing technologies and to eliminate obsolete laws and regulations, the Indian government has unveiled a draft of the New Drugs, Medical Devices, and Cosmetics Bill 2022. 12 July 2022
The European Medicines Agency (EMA) has launched a pilot project to assess whether the analysis of ‘raw data’ from clinical trials by regulatory authorities improves the evaluation of marketing authorization applications (MAAs) for new medicines as well as post-authorization applications and to explore the practical aspects of the submission and analysis of such data. 12 July 2022
Shares of Dublin, Ireland-incorporated Perrigo Company were up 2.2% at $42.00 pre-market today, after it announced that its subsidiary HRA Pharma has submitted its application to the US Food and Drug Administration (FDA) for the first-ever over-the-counter (OTC) birth control pill in the USA. 11 July 2022
Horizon Therapeutics has announced that the US Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) expanding the labeling to include Krystexxa (pegloticase) injection co-administered with methotrexate, which will help more people with uncontrolled gout achieve a complete response to therapy. 11 July 2022
Russia plans to speed registration of Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor), an expensive drug from the USA’s Vertex Pharmaceuticals, which is indicated for the treatment of cystic fibrosis. 9 July 2022
The US Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for Pfizer and BioNTech’s COVID-19 vaccine, known as Comirnaty (COVID-19 Vaccine, mRNA), to include individuals 12 through 15 years of age. 9 July 2022
The European Medicines Agency has identified measures to address medicine shortages during public health emergencies, following a meeting of a steering group devoted to this task. 8 July 2022
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
The Russian Ministry of Health wants to speed registration of drugs that are not localized in the Russian Federation at the time of the application submitted by domestic pharmaceutical companies, explaining such changes by "unpredictable geopolitical situation," reports The Pharma Letter’s local correspondent. 12 September 2024
The US Food and Drug Administration (FDA) has approved Tremfya (guselkumab) for the treatment of adults with moderately to severely active ulcerative colitis (UC). 12 September 2024