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
The US Food and Drug Administration has agreed to review a supplemental New Drug Application (sNDA) for the use of Tagrisso (osimertinib) for a new indication. 18 December 2017
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended five new medicines for approval at its December 2017 meeting, including two orphan medicines, one of which is also an advanced therapy medicinal product (ATMP), and one biosimilar. 16 December 2017
The US Food and Drug Administration has lifted the hold on clinical studies with fitusiran, including the Phase II open-label extension (OLE) study and the ATLAS Phase III program. 15 December 2017
The management board of the European Medicines Agency has provided a statement with highlights from its December 2017 meeting, including a look ahead to the agency’s agenda for next year. 15 December 2017
Dr Nicola Davies discusses the US Food and Drug Administration’s (FDA) new framework on regenerative medicine that is aimed at spurring innovation in transformative products while ensuring safety and efficacy. 15 December 2017
The US Food and Drug Administration (FDA) has approved Pfizer’s (NYSE: PFE) biosimilar drug Ixifi (infliximab-qbtx), which references the big-selling inflammatory diseases drug Remicade. 14 December 2017
In a reversal of a previous guidance, the UK’s National Institute for Health and Care Excellence (NICE) has issued draft guidance recommending ibrutinib (or routine National Health Service (NHS) use to treat mantle cell lymphoma in people who have had only one prior line of therapy. 14 December 2017
The US Food and Drug Administration yesterday expanded the approved use of Nucala (mepolizumab) to treat adult patients with eosinophilic granulomatosis with polyangiitis (EGPA), a rare autoimmune disease that causes vasculitis, an inflammation in the wall of blood vessels of the body. 13 December 2017
The US Food and Drug Administration has extended the action date by three months for the supplemental New Drug Application (sNDA) for Xeljanz (tofacitinib), an oral treatment under investigation for adult patients with moderately to severely active ulcerative colitis (UC). 13 December 2017
German pharma major Bayer is among the four latest companies named and shamed for breaching the Code of Practice of the Association of the British Pharmaceutical Industry (ABPI). 12 December 2017
Privately-held drugmaker Consilient Health has revealed the UK’s health technology assessor NICE has rejected its appeal against July’s negative reimbursement decision for its obesity med Mysimba. 12 December 2017
Drugs that prove to be an effective treatment for migraines could find their way into the hands of as many as 13% of Americans, so it is no surprise that several of pharma’s biggest players are in the race to gain a share of the market. 12 December 2017
The US Food and Drug Administration has approved Admelog (insulin lispro injection), the first follow-on (ie, a similar) insulin lispro to help people living with diabetes manage blood sugar levels at mealtime. 12 December 2017
The news early Friday morning that Britain and the European Union had finally agreed that enough progress has been made in the Brexit talks for the UK to leave the EU, to move on to more detailed trade agreement discussions, was broadly welcomed by the pharma and biotech industry. 8 December 2017
In a reversal of its earlier draft decision, the UK’s health technology assessor has provided final draft guidance recommending Eisai’s Kisplyx (lenvatinib), in combination with everolimus, as an option for treating kidney cancer. 8 December 2017
The UK’s National Institute for Health and Care Excellence (NICE) has today published draft guidance on the following technology appraisals: 7 December 2017
Following a positive advisory committee vote in October, the US Food and Drug Administration has now given its formal approval to allow the marketing of Ozempic (semaglutide injection) in the USA. 6 December 2017
Three months after the US FDA put a partial hold on three clinical trials investigating Opdivo combinations in multiple myeloma, the agency has given Bristol-Myers Squibb and its collaborators the all clear to continue two of the studies. 6 December 2017
The British pharmaceutical industry’s leading trade group told a UK government committee this morning that it would favor “a pragmatic agreement” where parts of the European Medicines Agency would stay in London after Brexit. 5 December 2017
There was disappointing news today for Swiss pharma giants Novartis and Roche when the UK’s National Institute for Health and Care Excellence (NICE) published draft guidance on technology appraisals turning down drugs from the companies for regular use on the National Health Service (NHS). 5 December 2017