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
Japan’s Ministry of Health, Labor and Welfare (MHLW) has approved Soliris (eculizumab) as a treatment for patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody-positive and whose symptoms are difficult to control with high-dose intravenous immunoglobulin (IVIG) therapy or plasmapheresis (PLEX). 27 December 2017
The Russian national Parliament (State Duma) plans to approve a bill that will ease imports of active pharmaceutical ingredients (APIs) to the country, according to press-service of the Russian Duma, reports The Pharma Letter’s local correspondent. 26 December 2017
The US Food and Drug Administration has approved Steglatro (ertugliflozin) tablets, an oral sodium-glucose co-transporter 2 (SGLT2) inhibitor, and the fixed-dose combination Steglujan (ertugliflozin and sitagliptin) tablets. 26 December 2017
The European Commission has granted a marketing authorization for Alecensa (alectinib) as a monotherapy for the first-line treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive, advanced non-small cell lung cancer (NSCLC). 23 December 2017
The US Food and Drug Administration today approved Giapreza (angiotensin II) injection for intravenous infusion to increase blood pressure in adults with septic or other distributive shock. 22 December 2017
The US Food and Drug Administration has granted Breakthrough Therapy designation for avelumab in combination with Inlyta (axitinib) for treatment-naïve patients with advanced renal cell carcinoma (RCC). 22 December 2017
The US Food and Drug Administration has issued a complete response letter (CRL) for the New Drug Application (NDA) for intravitreal (IVT) sirolimus (DE-109). 22 December 2017
After a long-running investigation, the US Food and Drug Administration has finally concluded that asthma can be treated with long-acting beta agonists (LABAs) in combination with inhaled corticosteroids (ICS) just as safely as with ICS alone. 21 December 2017
The US Food and Drug Administration’s (FDA) approval of an expanded label for Cabometyx (cabozantinib) has kept Exelixis climbing in the stock market throughout Wednesday morning. 20 December 2017
In what is seen as a historic move, the US Food and Drug Administration has approved Luxturna (voretigene neparvovec-rzyl), a new gene therapy, to treat children and adult patients with an inherited form of vision loss that may result in blindness. 20 December 2017
The UK’s health technology assessor NICE - the National Institute for Health and Care Excellence - has provided a draft recommendation against granting reimbursement for Scenesse (afamelanotide) for treating the rare disease erythropoietic protoporphyria (EPP). 20 December 2017
Pfizer has received US Food and Drug Administration approved of its supplemental New Drug Application (sNDA) to expand the indication for Bosulif (bosutinib) to include adult patients with newly-diagnosed chronic phase Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML). 20 December 2017
The UK’s National Institute for Health and Care Excellence has today published draft guidance recommending multiple sclerosis drug Extavia (beta 1b interferon), from Swiss pharma giant Novartis, for routine funding on the National Health Service (NHS). 20 December 2017
The National Institute for Health and Care Excellence (NICE) has published a Final Appraisal Determination (FAD) recommending Ninlaro (ixazomib) in combination with lenalidomide and dexamethasone (Rd) for the treatment of multiple myeloma patients who have received two or three prior lines of therapy. 20 December 2017
The US Food and Drug Administration has approved Rhopressa (netarsudil ophthalmic solution) 0.02% for the lowering of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. 19 December 2017
Two months after filing with the US FDA, embattled generics giant Teva Pharmaceutical Industries’ has been given priority review and fast track designation for fremanezumab, a novel biologic for the preventive treatment of migraine. 19 December 2017
The European Commission says that it has closed the infringement procedure taken against Swiss pharma giant Roche for failure to meet certain pharmacovigilance obligations. 19 December 2017
Australia’s Senate has determined that an inquiry is needed to consider the latest proposed legislation to improve public access to therapeutics. 19 December 2017
The UK government’s narrow defeat (Wednesday November 13) on amendment seven of the European Union withdrawal bill, demanding that Parliament have a binding vote on the final Brexit deal, has fuelled debate on whether the UK could now be heading for a softer Brexit and what impact this will have on leading industries like UK pharma. 19 December 2017
US drug giant Pfizer’s Xeljanz (tofacitinib) is already fighting a battle for market share in one of pharma’s most competitive indications – and now it is about to enter another crowded but potentially lucrative space. 18 December 2017