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Yesterday, the US Food and Drug Administration (FDA) issued a draft guidance, “Integrating Randomized Controlled Trials for Drug and Biological Products into Routine Clinical Practice” 18 September 2024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
California, USA-based clinical-stage biopharmaceutical company 89bioe edged up 2% to $15.37 in morning trading, after it revealed that the US Food and Drug Administration (FDA) granted Breakthrough Therapy designation (BTD) to pegozafermin in patients with non-alcoholic steatohepatitis (NASH). 21 September 2023
Following a favorable recommendation form the European Medicines Agency’s advisory committee on July, the European Commission (EC) has now granted marketing authorization in the European Union (EU) for Indian drugmaker Biocon’s Yesafili, a biosimilar of Eylea (aflibercept). 21 September 2023
Italian drugmaker Menarini has secured European approval for Orserdu (elacestrant) as a monotherapy for the treatment of certain people with advanced or metastatic breast cancer. 21 September 2023
The US Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) regarding its New Drug Application (NDA) for Neffy (epinephrine nasal spray) in the treatment of allergic reactions (Type I), including anaphylaxis for adults and children ≥30 kg. 21 September 2023
According to a statement from China’s National Health Commission (NHC), mpox will now be treated under a higher level of threat protocol, after hundreds of new cases were detected in the country. 20 September 2023
Gene therapy company Orchard Therapeutics has announced that the US Food and Drug Administration (FDA) has accepted the filing of its Biologics License Application (BLA) for OTL-200 in metachromatic leukodystrophy (MLD) under Priority Review. 20 September 2023
Belgian drugmaker UCB is not expecting a decision from the US Food and Drug Administration (FDA) any time soon on its Biologics License Application (BLA) for Bimzelx (bimekizumab) for the treatment of adults with moderate to severe plaque psoriasis. 20 September 2023
The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has granted marketing authorization for Adtralza (tralokinumab) in a new pre-filled pen, developed by privately-held Danish dermatology specialist LEO Pharma. 20 September 2023
The European Commission has authorized Apretude (cabotegravir long-acting [LA] injectable and tablets) for HIV prevention, from ViiV Healthcare, the specialist HIV company majority-owned by UK Pharma major GSK. 19 September 2023
Sino-American biotech BeiGene today announced that it has entered into an agreement with Novartis to regain worldwide rights to develop, manufacture, and commercialize Tevimbra (tislelizumab). 19 September 2023
The European Commission (EC) has become the third medicines regulator to grant marketing authorization for Litfulo (ritlecitinib) to treat adults and adolescents 12 years of age and older with severe alopecia areata. 19 September 2023
The European Commission (EC) has approved Otsuka Pharmaceutical and its subsidiary Astex Pharmaceuticals’ Inaqovi (oral decitabine and cedazuridine) as monotherapy for the treatment of adults with newly-diagnosed acute myeloid leukemia (AML) who are ineligible for standard induction chemotherapy. 19 September 2023
Citing resource constraints for the decision, the US Food and Drug Administration (FDA) says requires additional time to complete the Priority Review of Iovance Biotherapies’ Biologics License Application (BLA) for lifileucel. 18 September 2023
Following scrutiny from Democratic senators in Congress, the US Federal Trade Commission has issued a policy statement on the proper listing of pharmaceutical patents. 18 September 2023
Just three months ago, the US Food and Drug Administration (FDA) extended the review period of the new drug application (NDA) for blood cancer drug momelotinib by three months to provide time to review recently submitted data. 18 September 2023
Significant changes to the way European health technology assessments (HTA) take place is underway, with a transitional period set to be in force for several years. 18 September 2023
While the US medicines regulator has been granting approvals for biosimilar version of branded medicine for some time, it is only in the last year or so that they have been coming onto the market due to originators’ strong patent positions. 18 September 2023