Roche company Genentech has won US approval for its intravenous Actemra (tocilizumab) product, for adults that have been hospitalized with COVID-19. 22 December 2022
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has authorized Sanofi’s SARS-CoV-2 spike protein (B.1.351 strain) vaccine for the prevention of COVID-19 disease in adults in Great Britain. 21 December 2022
UK pharma major AstraZeneca today announced two approvals from the European Commission for expanded indications for its blockbuster cancer drugs, one for Imfinzi (durvalumab) and the other for Lynparza (olaparib). 21 December 2022
The European Commission (EC) has granted conditional marketing authorization for the use of Zynlonta (loncastuximab tesirine) for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL), Swedish Orphan Biovitrum, also known as Sobi, and Switzerland’s ADC Therapeutics announced today. 21 December 2022
The US Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Applications (sBLAs) for Seagen and Astellas’ Padcev (enfortumab vedotin-ejfv) and Merck & Co’s Keytruda (pembrolizumab). 20 December 2022
Switzerland-based Idorsia today announced that it has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) seeking approval for aprocitentan, the firm’s investigational, novel dual endothelin receptor antagonist, for the treatment of patients with difficult-to-control hypertension. 20 December 2022
The European Commission (EC), the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) have published recommendations that aim to facilitate the conduct of decentralized clinical trials (DCTs). 20 December 2022
Chinese biopharma Hutchmed has started the filing of a rolling submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for fruquintinib. 19 December 2022
The European Commission (EC) has granted marketing authorization for Ebvallo (tabelecleucel)vas a monotherapy for treatment of adult and pediatric patients two years of age and older with relapsed or refractory Epstein Barr virus positive post transplant lymphoproliferative disease (EBV+ PTLD) who have received at least one prior therapy. 19 December 2022
The US Food and Drug Administration has approved Adstiladrin (nadofaragene firadenovec-vncg), a non-replicating (cannot multiply in human cells) adenoviral vector-based gene therapy indicated for the treatment of adult patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. 19 December 2022
The European Medicines Agency’s human medicines committee (CHMP) recommended four novel medicines for approval at its December 2022 meeting. A final approval decision from the European Commission can be expected within the next two or three months. 16 December 2022
Big pharma pairing AstraZeneca and Merck & Co announced a rare setback with their blockbuster PARP inhibitor Lynparza (olaparib) in prostate cancer on Thursday. 16 December 2022
Of the 20 drugs currently being developed for primary progressive multiple sclerosis (PPMS), three are now in Phase III development, offering hope to the patients, who have very few treatment options in comparison to patients affected by relapsing remitting multiple sclerosis (RRMS). 16 December 2022
The European Commission has granted marketing authorization for Livmarli (maralixibat) oral solution for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS) aged two months and older. 15 December 2022
Adding to a string of approved indications for the interleukin (IL) and IL-4 blocking antibody, the European Commission (EC) has expanded the marketing authorization for Dupixent (dupilumab) in the European Union to treat adults with moderate-to-severe prurigo nodularis who are candidates for systemic therapy. 15 December 2022
As the year draws to a close, this article presents some of the wins of the orphan drug community in terms of US FDA approvals, while highlighting challenges faced by the sector and looking ahead to the expectations of the next year. 15 December 2022
As anticipated, following a positive decision from its scientific committee, the European Medicines Agency has granted marketing authorization for Pluvicto (vipivotide tetraxetan). 14 December 2022
The US Food and Drug Administration’s (FDA) Cardiovascular and Renal Drugs Advisory Committee (CRDAC) voted eight to three that the benefits of omecamtiv mecarbil do not outweigh its risks for the treatment of heart failure with reduced ejection fraction (HFrEF). 14 December 2022
Drugmakers Novo Nordisk, Daiichi-Sankyo, Lundbeck, AstraZeneca, UCB and Biogen have been named and shamed by the UK pharma trade group. 12 December 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