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
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
Novo Nordisk is under increasing pressure over the cost of its blockbuster drugs in the USA, as chief executive Lars Fruergaard Jørgensen prepares to testify before a powerful Senate committee. 18 September 2024
In a lawsuit filed in federal court in Missouri, USA, Health insurer Cigna (NYSE: CI) and its pharmacy benefit manager (PBM) Express Scripts demanded that the Federal Trade Commission (FTC) retract its July 2024 report. 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Yesterday, the US Food and Drug Administration (FDA) issued a draft guidance, “Integrating Randomized Controlled Trials for Drug and Biological Products into Routine Clinical Practice” 18 September 2024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
The National Institute for Health and Care Excellence (NICE) has recommended access Vabysmo (faricimab) for the treatment of adults with visual impairment due to macular oedema secondary to branched and central retinal vein occlusion. 13 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
Even as emerging signs of a thaw in the broader Indian start-up funding landscape were evident, the Competition Commission of India (CCI) has tightened its exemption list under new combination rules. 11 September 2024
Italy’s Philogen and Indian drugmaker Sun Pharmaceutical Industries have submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for the approval of Nidlegy (daromun). 5 June 2024
Lykos Therapeutics’ hopes of being the first to market with a hallucinogenic medicine suffered a major blow Tuesday during a meeting of the US Food and Drug Administration's (FDA) Psychopharmacologic Drugs Advisory Committee (PDAC). 5 June 2024
Privately-held neurology company Tris Pharma has received approval from the US Food and Drug Administration for Onyda XR (clonidine hydrochloride). 3 June 2024
CSL Seqirus is set to complete the fill and finish process for pre-pandemic vaccine to support the US government’s outbreak and preparedness response. 3 June 2024
Last week, the US Court of Appeals for the District of Columbia (DC) ruled that Section 340B of the Public Health Service Act does not prohibit pharmaceutical manufacturers from imposing conditions on the distribution of discounted drugs to covered entities in the program, noted Sophia Gaulkin and Alan Kirschenbaum of law firm Hyman Phelps & McNamara. 1 June 2024
Biotech firm Moderna has won US Food and Drug Administration (FDA) approval for mRESVIA (mRNA-1345), an mRNA respiratory syncytial virus (RSV) vaccine, to protect adults aged 60 years and older from lower respiratory tract disease caused by RSV infection. 31 May 2024
The US Food and Drug Administration yesterday approved Bristol Myers Squibb’s Breyanzi (lisocabtagene maraleucel) for adult patients with relapsed or refractory mantle cell lymphoma (MCL). 31 May 2024
The US Food and Drug Administration (FDA) has extended by three months the target action date of its priority review of the supplemental Biologics License Application (sBLA) for Dupixent (dupilumab) as an add-on maintenance treatment in certain adult patients with uncontrolled chronic obstructive pulmonary disease (COPD). 31 May 2024
Biogen has announced European approval for Qalsody (tofersen), for certain amyotrophic lateral sclerosis (ALS) patients, under exceptional circumstances. 31 May 2024
Danish allergy immunotherapy specialist ALK Abell today revealed that its European regulatory filing for Itulazax (tree sublingual allergy immunotherapy [SLIT] tablet) in young children has been accepted for review by the relevant health authorities. 30 May 2024
The US Food and Drug Administration granted accelerated approval to Retevmo (selpercatinib) from US pharma major Eli Lilly for pediatric patients two years of age and older. 30 May 2024
The US Food and Drug Administration has approved US biotech major Amgen’s Bkemv (eculizumab-aeeb) as the first interchangeable biosimilar to Soliris (eculizumab) to treat certain rare diseases. 30 May 2024
The US Food and Drug Administration (FDA) has accepted and granted Priority Review of the Biologics License Application (BLA) submitted by Jazz Pharmaceuticals for zanidatamab, the human epidermal growth factor receptor 2 (HER2)-targeted bispecific antibody. 30 May 2024
The US Food and Drug Administration (FDA) has accepted the New Drug Application and granted Priority Review to inavolisib, an investigational, oral therapy, in combination with palbociclib (Ibrance) and fulvestrant, under development by Swiss pharma giant Roche. 29 May 2024
US biotech Insmed (Nasdaq: INSM) yesterday released positive top-line results from the ASPEN study, a global, randomized, double-blind, placebo-controlled Phase III trial to assess the efficacy, safety, and tolerability of brensocatib in patients with non-cystic fibrosis bronchiectasis. 29 May 2024
Russia has suspended state purchases of a number of original anti-cancer drugs due to problems associated with sanctions and the ever-growing isolation of the country in the international arena, The Pharma Letter’s local correspondent reports. 29 May 2024
Chief Executive Officers of the world’s largest generic and biosimilar medicines companies recently met in Vienna, Austria, to provide strategic advice to the International Generic and Biosimilar Medicines Association (IGBA). 29 May 2024
The US Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Sarclisa (isatuximab) alongside bortezomib, lenalidomide and dexamethasone (VRd) for transplant-ineligible newly diagnosed multiple myeloma (NDMM). 28 May 2024
Russia has registered a new domestic drug, fluorothiazinone, which is intended for the treatment of bacterial infections caused by microorganisms resistant to antibiotics, reports The Pharma Letter’s local correspondent. 28 May 2024
Capricor Therapeutics is a clinical-stage biotechnology company focused on the discovery, development, and commercialization of first-in-class biological therapeutics for the treatment of rare disorders.
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