The Foundation for Economic and Industrial Research and Greek pharma trade group the Hellenic Association of Pharmaceutical Companies have presented two studies reflecting the industry’s importance. 23 September 2024
The Japanese Ministry of Health, Labor, and Welfare (MHLW) has approved Otsuka’s (TYO: 4578) Lupkynis (voclosporin) for the treatment of lupus nephritis (LN), an inflammation of the kidneys caused by systemic lupus erythematosus (SLE), an autoimmune disease 24 September 2024
CSL Vifor today announced that Japan’s Ministry of Health and Labor Welfare (MHLW) has granted its partner, Zeria Pharmaceutical marketing authorization approval for Veltassa (patiromer). 24 September 2024
The Pharmaceutical Research and Manufacturers of America (PhRMA) is continuing its legal challenge against the US government’s drug pricing reforms. 24 September 2024
Takeda has announced the Japanese approval of Fruzaqla (fruquintinib) capsules 1mg/5mg, a selective oral inhibitor of vascular endothelial growth factor receptor (VEGFR) -1, -2 and -3, to treat advanced or recurrent colorectal cancer (CRC) that is neither curable nor resectable and that has progressed after chemotherapy. 24 September 2024
Japan’s Ministry of Health, Labor and Welfare of Japan (MHLW) has approved New Drug Application (NDA) for Quviviq (daridorexant; ACT-541468) 25mg and 50mg for the treatment of adult patients with insomnia, submitted by Nxera Pharma. 24 September 2024
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 Foundation for Economic and Industrial Research and Greek pharma trade group the Hellenic Association of Pharmaceutical Companies have presented two studies reflecting the industry’s importance. 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
On Friday, the USA’s Federal Trade Commission (FTC) brought action against the three largest prescription drug benefit managers (PBMs) - Caremark Rx, Express Scripts (ESI), and OptumRx 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
Shares of US clinical-stage drug developer Unum Therapeutics tumbled as much as 23% after the company revealed that the Food and Drug Administration had placed a "clinical hold" on the Phase I trial of its cancer treatment ACTR087. 4 July 2019
Alexion Pharmaceuticals’ shares edged up almost 1% to $134.66 in after-hours trading on Wednesday, following the US drugmaker’s announcement that the European Commission had approved its rare blood disease drug Ultomiris (ravulizumab). 4 July 2019
Shares of US drugmaker Karyopharm Therapeutics leapt more than 36% to $8.90 by close of trading on Wednesday, after it announced that the US Food and Drug Administration had granted accelerated for its blood cancer drug Xpovio (selinexor). 4 July 2019
Sponsors of clinical trials run in the European Union have been reminded of their obligation to publish summaries of results in the EU Clinical Trials Database (EudraCT). 3 July 2019
US biotech Gilead Sciences and Belgium-based partner Galapagos both saw their shares go up by close of trading yesterday, after Gilead provided an update about the investigational oral, selective JAK1 inhibitor, filgotinib. 3 July 2019
The European Commission’s approval of Dovato (dolutegravir/lamivudine) has been hailed as an important milestone for HIV patients because this therapy offers a different option to three-drug regimens. 3 July 2019
In a business update, cardiovascular specialist Amarin said the market opportunity for its heart med Vascepa (icosapent ethyl) is larger than previously thought. 3 July 2019
The European Medicines Agency (EMA) is seeking to ensure that its regulatory processes keep pace with the innovation and change going on in the drug development industry. 2 July 2019
The US Food and Drug Administration has issued new draft guidance providing recommendations for drugmakers on how to create an Instructions for Use (IFU) document. 2 July 2019
National Health Service patients in the UK will be the first to gain access in Europe to new skin cancer treatment, Libtayo (cemiplimab), through the Cancer Drugs Fund (CDF), it was revealed today, just a day after the drug won conditional regulatory approval from the European Commission. 2 July 2019
Libtayo (cemiplimab) has been granted conditional approval for the treatment of certain adults with metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC), one of the most commonly diagnosed skin cancers worldwide. 1 July 2019
The Russian government has put forward an initiative for the compulsory licensing of patented drugs produced for exports, so that Russian companies can manufacture and sell drugs protected by a patent, according to recent statements by the press service of the Russian federal government, reports The Pharma Letter’s local correspondent. 1 July 2019
Close on the heels of an alert raised by the US Food and Drug Administration and Health Canada regarding the safety of sodium glucose cotransporter-2 (SGLT-2) inhibitors from Johnson & Johnson (NUSE: JNJ) and Germany-based Boehringer Ingelheim, the Drug Controller General of India (DCGI) has asked drug manufacturers to carry a warning label on all new diabetes drugs, reports The Pharma Letter’s India correspondent. 1 July 2019
The new biotechnology report describing the situation of medical biotechnology in Germany is now available on the website of the German trade group the VFA. 1 July 2019
Gross domestic product (GDP) in Japan is about $5 trillion, and the country’s pharmaceutical market is one of the largest in the world, with figures from the Ministry of Health, Labour and Welfare (MHLW) indicating a market value of about $95 billion, including non-prescription medications. 28 June 2019
Another biosimilar of one of the world’s best-selling oncology drugs, Avastin (bevacizumab), has been approved by the US Food and Drug Administration (FDA). 28 June 2019
Privately-held Danish vaccines specialist AJ Vaccines has won approval in Denmark for its adjuvanted IPV vaccine, after positive results from clinical trials involving almost 3,000 infants. 28 June 2019
Danish drugmaker Genmab has won US approval for Darzalex (daratumumab), in combination with lenalidomide and dexamethasone (Rd) to treat people with multiple myeloma who are ineligible for autologous stem cell transplant (ASCT). 28 June 2019
"IDEAYA is an oncology-focused precision medicine company committed to the discovery and development of targeted therapeutics for patient populations selected using molecular diagnostics."
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