The novel type 2 oral polio vaccine (nOPV2), developed by a team including scientists from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), has now been quality-assured (prequalified) by the World Health Organization (WHO). 10 January 2024
The Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) seeking to convert the accelerated approval of Tivdak (tisotumab vedotin-tftv) to full approval. 9 January 2024
Japanese drugmaker Astellas has announced that the US Food and Drug Administration (FDA) has issued a complete response letter (CRL) regarding the Biologics License Application (BLA) for zolbetuximab. 9 January 2024
The European Commission (EC) has approved US pharma giant Pfizer’s Talzenna (talazoparib) in combination with Xtandi (enzalutamide), for the treatment of adult patients with metastatic castration-resistant 9 January 2024
Shares of UK blood disease drug developer Hemogenyx Pharmaceuticals were down 7.5% at 2.13 pence as trading drew to a closed today, despite announcing the successful completion of its Process Qualification (PQ) run of the end-to-end process for the manufacture of HEMO-CAR-T cells. 8 January 2024
Belgium’s UCB has won European Commission (EC) approval for Rystiggo (rozanolixizumab) as an add-on to standard therapy for generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive. 8 January 2024
The US Food and Drug Administration has authorized a drug importation program in Florida, as the state seeks to benefit from lower cost medicines across the border. 8 January 2024
French rare disease company Innate Pharma has received good news from the US Food and Drug Administration, with a partial clinical hold being lifted from its lacutamab program. 5 January 2024
Swiss pharma giant Novartis announced today that it has received approval from the US Food and Drug Administration (FDA) for commercial manufacturing of Pluvicto at new plant. 5 January 2024
Privately-held British drugmaker Mundipharma has secured European approval for Rezzayo (rezafungin), for the treatment of invasive candidiasis in adults. 3 January 2024
US clinical-stage immunotherapy specialist ImmunityBio yesterday announced an up to $320 million royalty financing and equity investment in the company by Oberland Capital. 3 January 2024
Shares of Denmark-based Zealand Pharma dipped 4.9% to 355.00 kroner by late afternoon, on negative news from the US medicines regulator. 2 January 2024
After decades without a breakthrough, scientists targeting the respiratory syncytial virus (RSV) have notched up three successes in a period of around a year. 2 January 2024
From January 1, 2024, developers of new medicines can now submit applications via the UK Medicines and Healthcare products Regulatory Agency’s (MHRA) new, International Recognition procedure (IRP). 2 January 2024
China’s National Medical Products Administration (NMPA) has approved Japanese pharma major Takeda’s antiviral drug Livtencity (maribavir). 29 December 2023
US biotech Iovance Biotherapeutics saw its shares drop more than 20% on Tuesday, after it revealed a setback with its clinical program for LN-145 TIL therapy in non-small lung cancer (NSCLC). 29 December 2023
Vertex Pharmaceuticals and CRISPR Therapeutics made history last month by gaining approval for the first CRISPR-based drug, Casgevy (exagamglogene autotemcel). 29 December 2023
Californian biotech Amgen has announced that the US Food and Drug Administration has rejected its bid for full approval of Lumakras (sotorasib). 28 December 2023
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved the advanced melanoma medicine Opdualag (nivolumab-relatlimab) for patients from the age of 12. 28 December 2023
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
The US House of Representatives has passed the BIOSECURE Act, gaining bipartisan support with a vote of 306–81. Nearly all of the votes against the bill came from Democrats. 10 September 2024