Ardelyx has released positive Phase III data from T3MPO-2, the firm’s second Phase III trial of tenapanor for irritable bowel syndrome with constipation (IBS-C). 12 October 2017
The UK’s National Institute for Health and Clinical Excellence (NICE) has today given a positive recommendation for Stivarga (regorafenib). 12 October 2017
Shares of Poland’s largest biotech firm Selvita plunged 17.2% to 45.12 zlotys on Monday, after the company revealed receipt of a clinical hold on the development of its acute myeloid leukemia (AML) drug by the US regulator. 10 October 2017
The US Food and Drug Administration has accepted for review the supplemental Biologics License Application (sBLA) for Prolia (denosumab) for the treatment of patients with glucocorticoid-induced osteoporosis (GIOP). 10 October 2017
The China Food and Drug Administration has announced far-reaching reforms to its regulatory system, that are expected to speed up approvals of medical technologies in the country. 9 October 2017
The European Medicines Agency and the European Commission have updated the annex to the EC guideline on excipients on the labelling and package leaflet of medicinal products for human use. 9 October 2017
Shares in AstraZeneca edged higher in early dealing today, on the news that US regulators have granted its Tagrisso (osimertinib) Breakthrough Therapy designation and its European peer has accepted the marketing application for its Imfinzi (durvalumab). 9 October 2017
The packaging of prescription-only medicinal products must have safety features from February 9, 2019 onwards, the Dutch Medicines Evaluation Board (CBG) has reminded players. 9 October 2017
By 2050, the world’s population aged 60 years and older is expected to reach 2 billion – a vast leap from the 900 million elderly citizens living across the globe today. 7 October 2017
Life sciences companies are facing familiar business risks, according to their most recent 10-K filings. But revolutionary forces - driven by innovations in technology, regulatory bodies, consumers, legislators and healthcare providers - will require new ways of thinking about risk mitigation. 6 October 2017
At present, two out of three people diagnosed with cancer survive at least five years. Between 1991 and 2011 deaths from cancer have fallen by 21% across the EU5 (UK, France, Germany, Spain and Italy). 6 October 2017
Two companies have been granted approval for the copycat versions of the Teva Pharmaceutical Industries (NYSE: TEVA) multiple sclerosis drug Copaxone (glatiramer acetate) 40mg/mL in Europe. 5 October 2017
Russia’s pharmaceutical market is one of the fastest growing in the world and is expected to reach $36.61 billion by 2021, says a leading business information and analytics provider. 5 October 2017
In what is something of a criticism of the European Medicines Agency, a research team has found most cancer drugs are approved by the EMA using only surrogate measures which, although indicators, are not strong predictors of survival – whether living longer or feeling better. 5 October 2017
After a number of media leaks regarding the European Medicines Agency’s view of the rival member states’ bids, the agency has published its assessment in full. 4 October 2017
Market activity on Wednesday underlined the importance of a US Food and Drug Administration (FDA) approval of a generic drug from Mylan. 4 October 2017
It has not been an uneventful reign for Guido Rasi as executive director of the European Medicines Agency (EMA) since he took over in November 2011, with first his appointment called into question in a saga that saw him stripped of the role and then reinstated, and now the agency facing a disruptive move from its London home due to Brexit. 4 October 2017
Trade group AusBiotech has released its annual report, showcasing the accomplishments of the Australian biopharmaceutical sector and lobbying for the preservation of tax incentives for research and development. 3 October 2017
The US Food and Drug Administration’s recent approval of the first gene therapy in the USA, Novartis’ (NOVN: VX) Kymriah1 (tisagenlecleucel), has understandably sparked much attention, writes Dr Nicola Davies in her monthly FDA Blog for The Pharma Letter. 3 October 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