The European Commission has approved the marketing authorization of lutetium (177Lu) oxodotreotide (Lutathera) for the treatment of unresectable or metastatic, progressive, well differentiated (G1 and G2), somatostatin receptor positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in adults. 2 October 2017
Last week saw AbbVie entering a patent settlement with Amgen relating to the latter’s biosimilar version of blockbuster drug Humira. US Food and Drug Administration acceptance for review of Eisai’s cancer drug Lenvima in a new indication, and FDA approval for Eli Lilly’s new breast cancer drug Verzenio also figured in the news. Also attracting attention was news on the failure of Axovant Sciences’ Alzheimer’s disease candidate intepirdine. 1 October 2017
US Health and Human Services Secretary Tom Price sent this letter to President Donald Trump as he resigned Friday in the midst of a scandal over his use of private planes, racking up bills estimated at nearly a million dollar in taxpayer-funded travel since taking office in February, according CNN. 30 September 2017
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has endorsed an update of the European Union label with immediate effect for Tresiba (insulin degludec) to include results from the DEVOTE trial on severe hypoglycemia. 29 September 2017
Before Bioverativ found a way to extend the half life of recombinant factor therapies, hemophilia patients required a transfusion as often as every other day, resulting in higher bleed frequency and associated morbidity. 29 September 2017
Shares of US pharma major Eli Lilly were barely moved yesterday even though the company received approval from the US Food and Drug Administration for Verzenio (abemaciclib), under the agency’s Breakthrough and Priority Review designation programs. 29 September 2017
Rare diseases had long been ignored in China until very recently. In May, China’s Food and Drug Administration (CFDA) drafted a policy to accelerate the approval process for innovative medical devices and drugs, including those for rare diseases, reports The Pharma Letter’s local correspondent Wang Fangqing. 29 September 2017
The UK’s National Institute for Health and Care Excellence (NICE) has recommended Imbruvica (ibrutinib), within its marketing authorization, for use on the Cancer Drugs Fund (CDF) as an option for treating Waldenström’s macroglobulinemia (WM) in adults who have had at least one prior therapy, only if the conditions in the managed access agreement for ibrutinib are followed. 28 September 2017
The US pharmaceutical industry has signaled its support for severe limitations on the length of opioid prescriptions, saying it would be happy if the current 30-day maximum was reduced to just seven days. 28 September 2017
European pharma/biotech groups today issued their views and aims to support European competitiveness in the biomedical sector, and to avoid unnecessary delays for patient access to such innovative medicines whilst ensuring patient and environmental safety. 27 September 2017
Markets reacted accordingly on Tuesday as PTC Therapeutics suffered the latest blow to its hopes to gain approval in the USA for Translarna (ataluren) as a treatment of nonsense mutation Duchenne muscular dystrophy (nmDMD). 27 September 2017
Danish diabetes care giant Novo Nordisk today announced that the China Food and Drug Administration (CFDA) has approved Tresiba (insulin degludec) for the treatment of diabetes in China, which it said has the world's highest number of adult diabetes patients. 27 September 2017
As part of the ongoing Ease of Doing Export Business - Rapid Results Initiative (RRI), the Medicines Control Authority of Zimbabwe (MCAZ), through the Ministry of Health and Child Care recently reduced the cost of two permits that are essential for exporting pharmaceutical products, reports local newspaper The Herald. 26 September 2017
The China Food and Drug Administration (CFDA) has approved Sovaldi (sofosbuvir 400mg), a once-daily oral nucleotide analog polymerase inhibitor for the treatment of chronic hepatitis C virus (HCV) infection. 25 September 2017
The Russian government has prepared a bill simplifying the introduction of new drugs into the domestic pharmaceutical market, a spokesman of state press-service has said recently, reports The Pharma Letter’s local correspondent. 25 September 2017
The European Commission has granted a marketing authorization for Tecentriq (atezolizumab) as a monotherapy for the treatment of people with locally advanced or metastatic non-small cell lung cancer (NSCLC) after they have been previously treated with chemotherapy regardless of PD-L1 status. 25 September 2017
News last week attracted a great deal of comment included Neos Therapeutics gaining US Food and Drug Administration for its attention deficit hyperactivity disorder (ADHD) drug Adzenys. Also garnering attention were: Ultragenyx’ rival bid to acquire Dimension Therapeutics; supplemental approval for Ipsen’s Somatuline Depot; an FDA safety alert on Intercept Pharmaceuticals’ Ocaliva; and a Phase III success for Nabriva’s lefamulin 23 September 2017
The US Food and Drug Administration has issued a complete response letter (CRL) for the Biologics License Application (BLA) seeking approval of sirukumab for the treatment of moderately to severely active rheumatoid arthritis (RA). 23 September 2017
American advocacy group Public Citizen is launching a legal bid to force a ruling on a petition it launched three years ago regarding the use of benzocaine in over-the-counter medicines. 22 September 2017
With the leading pair of immuno-oncology (I-O) agents Keytruda (pembrolizumab) and Opdivo (nivolumab) seemingly scoring new approvals by the month in major markets, it would be easy to ignore the importance of the latest nod for the latter drug in Japan. 22 September 2017
The Association of the British Pharmaceutical Industry (ABPI) and the Prescription Medicines Code of Practice Authority (PMCPA) have published an updated Code of Practice for drugmakers. 23 September 2024
Shares of California, USA-based precision medicines IDEAYA Biosciences were down 6.3% at $32.5 mid-morning after it revealed what is described as “positive” developments for its darovasertib. 23 September 2024
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of Hetronifly (serplulimab). 23 September 2024
The US Food and Drug Administration (FDA) has approved Bimzelx (bimekizumab-bkzx) for the treatment of adults with active psoriatic arthritis (PsA), adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation, and adults with active ankylosing spondylitis (AS). 23 September 2024
Ocumension Therapeutics, has received approval of the New Drug Application (NDA) to commercialize Zerviate (cetirizine ophthalmic solution), 0.24% in China for ocular itching associated with allergic conjunctivitis. 23 September 2024
The US Food and Drug Administration (FDA) has approved Sarclisa (isatuximab) in combination with bortezomib, lenalidomide, and dexamethasone (VRd) as a first line treatment option for adult patients with newly diagnosed multiple myeloma (NDMM). 23 September 2024
The European Commission has conditionally approved the marketing application submitted by Ipsen for Iqirvo (elafibranor) 80mg tablets for the treatment of primary biliary cholangitis (PBC) 21 September 2024
On Friday, the US Food and Drug Administration approved UK pharma major AstraZeneca’s (LSE: AZN) FluMist for self- or caregiver-administration by a parent/caregiver to individuals 2-17 years of age. 21 September 2024
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