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
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
Daiichi Sankyo’s today revealed that its Vanflyta (quizartinib) has been recommended by the National Institute for Health and Care Excellence (NICE) for routine National Health Service (NHS) commissioning in England and Wales. 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
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Yesterday, the US Food and Drug Administration (FDA) issued a draft guidance, “Integrating Randomized Controlled Trials for Drug and Biological Products into Routine Clinical Practice” 18 September 2024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
In another win for Denmark’s Novo Nordisk, the US Food and Drug Administration approved a new indication for use for its Wegovy (semaglutide) injection to reduce the risk of cardiovascular death, heart attack and stroke in adults with cardiovascular disease and either obesity or overweight. 9 March 2024
With demand for GLP-1 agonists outstripping supply, Zepbound (tirzepatide) developer Eli Lilly has issued a warning against resorting to counterfeits. 8 March 2024
US drugmaker Eli Lilly had expected to hear whether its amyloid plaque-targeting therapy donanemab had been approved in the USA to treat early symptomatic Alzheimer's disease by the end of last year. 8 March 2024
The US Food and Drug Administration granted accelerated approval for Brukinsa (zanubrutinib) with obinutuzumab for relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. 8 March 2024
The US Food and Drug Administration (FDA) yesterday approved Opdivo (nivolumab), in combination with cisplatin and gemcitabine, for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma (UC), the most common type of bladder cancer. 8 March 2024
India's drug manufacturers are lobbying for a one-time exemption from a price control regulation linked to the Wholesale Price Index (WPI). 8 March 2024
A key committee of the US Senate has given its stamp of approval for the BIOSECURE Act, which aims to prevent contracts with Chinese biotech companies. 7 March 2024
French drugmaker Ipsen has secured a positive reimbursement decision from the UK’s National Institute for Health and Care Excellence (NICE). 7 March 2024
The US Food and Drug Administration (FDA) late yesterday approved Pfizer’s antibody drug conjugate Besponsa (inotuzumab ozogamicin) to include patients one year of age and older with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (B-ALL). 7 March 2024
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has today approved Rystiggo (rozanolixizumab), from Belgium’s largest drug maker UCB. 7 March 2024
The US subsidiary of Germany’s family-owned drug major Boehringer Ingelheim today said it will cap out-of-pocket costs at $35 per month for eligible patients for all the company’s inhaler products. 7 March 2024
President Joe Biden’s actions to cut prescription drug prices through the Inflation Reduction Act (IRA) and other means have been far from popular with big pharma and its lobbyists. 7 March 2024
UK-based Ellipses Pharma has received Fast Track designation from the US Food and Drug Administration (FDA) for its selective RET inhibitor EP0031/A400 for the potential treatment of RET-fusion positive non-small cell lung cancer (NSCLC). 7 March 2024
The UK’s leading pharmaceutical and biotechnology trade groups welcomed Chancellor Jeremy Hunt’s Spring Budget to unlock investment in medical research and manufacturing that was announced on Wednesday. 6 March 2024
A bold move to rip up intellectual property protections for COVID-19 vaccines appears to have been quietly dropped, after the World Trade Organization (WTO) opted not to extend the measure. 6 March 2024
US drugmaker Vanda Pharmaceuticals saw its shares close down 3% yesterday and fall a further 2.2% to $4.04 pre-market on news of a setback for its Hetlioz (tasimelteon) 6 March 2024
Sandoz has announced that the US Food and Drug Administration (FDA) approved Wyost (denosumab-bbdz) and Jubbonti (denosumab-bbdz), the first and only FDA-approved denosumab biosimilars, to treat all indications of the reference medicines. 6 March 2024
Shares of Sweden-headquartered Calliditas Therapeutics were up 6.8% at 116.60 kronor by mid-morning after revealing a patent extension on its lead product. 6 March 2024
A pair of big pharma companies have become the latest drugmakers to take aim at the National Institute for Health and Care Excellence (NICE), the cost-effectiveness watchdog for England and Wales. 5 March 2024