Generic and biosimilar medicines significantly lower healthcare treatment costs and are essential for enabling competition and vastly improved access to medicines, says a leading European trade group. 13 June 2023
Spanish drugmaker PharmaMar and China-based Luye Pharma have revealed that the New Drug Application (NDA) submission of lurbinectedin has been accepted by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA). 12 June 2023
The US regulator is to review a submission from British drugmaker AstraZeneca for capivasertib, in combination with Faslodex (fulvestrant), under the Priority Review scheme. 12 June 2023
Shares of US gene and cell therapy company Abeona Therapeutics closed down 6.5% at $4.01 on Friday, when it announced receipt of feedback from the US Food and Drug Administration (FDA) regarding EB-101. 12 June 2023
Having won accelerated approval in January this year, Alzheimer’s drug Leqembi (lecanemab) now looks set to get full approval from the US Food and Drug Administration (FDA) as early as next month. 10 June 2023
The Windsor Framework sets out a long-term solution for the supply of medicines into Northern Ireland as part of the revized agreement relating to the UK’s Brexit. 9 June 2023
The US Food and Drug Administration (FDA) has accepted the Biologics License Applications (BLAs) for the investigational treatment exagamglogene autotemcel (exa-cel) for severe sickle cell disease (SCD) and transfusion-dependent beta thalassemia (TDT) that has been submitted by US biotech Vertex Pharmaceutical. 9 June 2023
Sandoz, the generics and biosimilars unit of Novartis, has outlined an ambitious plan for its newly-independent future once the spin-out from its parent is complete. 9 June 2023
The US Food and Drug Administration (FDA) has published guidance entitled Clinical Drug Interactions Studies with Combined Oral Contraceptives. 9 June 2023
The US Food and Drug Administration (FDA) Antimicrobial Drugs Advisory Committee (AMDAC) yesterday voted unanimously 21 to 0 that nirsevimab has a favorable benefit risk profile for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) in new-borns and infants born during or entering their first RSV season. 9 June 2023
The number of medicines recalled by manufacturers due to defects has increased 153% in the UK since 2017, according to new figures from the Medicines and Healthcare products Regulatory Agency (MHRA), with relaxed regulations during Covid one possible factor behind the increase. 8 June 2023
Ahead of a key meeting from the US Food and Drug Administration’s scientific advisory panel, briefing notes reveal a broadly positive view of Eisai and Biogen’s new Alzheimer’s med. 8 June 2023
Legend Biotech and Janssen have announced the submission of a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration (FDA) relating to their partnered asset Carvykti (ciltacabtagene autoleucel). 8 June 2023
The European Commission has authorized Arexvy (respiratory syncytial virus vaccine, adjuvanted), developed by UK pharma major GSK, for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in adults 60 years of age and older. 8 June 2023
The US Food and Drug Administration (FDA) has announced the availability of a draft guidance with updated recommendations for good clinical practices (GCPs) aimed at modernizing the design and conduct of clinical trials. 7 June 2023
The US Food and Drug Administration (FDA) has approved a new indication for Prevymis (letermovir) for prophylaxis of cytomegalovirus (CMV) disease in adult kidney transplant recipients at high risk (Donor CMV-seropositive/Recipient CMV-seronegative [D+/R-]) following a priority review. 7 June 2023
The US Food and Drug Administration (FDA) has published briefing papers on AstraZeneca and Sanofi's Beyfortus (nirsevimab) ahead of Thursday’s meeting of the agency’s Antimicrobial Drugs Advisory Committee Meeting. 7 June 2023
The European Commission (EC) has granted marketing authorization for Bimzelx (bimekizumab) for the treatment of adults with active psoriatic arthritis (PsA) and adults with active axial spondyloarthritis (axSpA) including non-radiographic axSpA (nr-axSpA) and ankylosing spondylitis (AS), also known as radiographic axSpA. 7 June 2023
The US Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) for Jemperli (dostarlimab) alongside chemotherapy for mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) primary advanced or recurrent endometrial cancer. 6 June 2023
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
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for Sanofi’s mega blockbuster drug Dupixent (dupilumab) as an add-on maintenance treatment for adults with uncontrolled chronic obstructive pulmonary disease (COPD) characterized by raised blood eosinophils. 12 September 2024
Intercept Pharmaceuticals’ Ocaliva (obeticholic acid) will come under the microscope when the US Food and Drug Administration’s (FDA) Gastrointestinal Drugs Advisory Committee meets on Friday. 12 September 2024
The US Food and Drug Administration (FDA) yesterday announced revised final guidance for industry entitled, “ANDA Submissions – Amendments to Abbreviated New Drug Applications under GDUFA.” 12 September 2024
The research based pharmaceutical industry has welcomed Mario Draghi’s report, published by the European Commission, outlining proposals on how Europe can regain its competitive edge and the critical role of innovative industries in achieving this. 11 September 2024
Several pharma companies that had moved the Delhi High Court against the government’s recent notification banning 156 fixed-dose combination (FDC) drugs have got a breather. 10 September 2024