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 clinical development of medical cannabis has moved forward with completion of Phase IIa trial of Israel-based Therapix Biosciences’ THX-110, a cannabinoid-based treatment for Tourette syndrome. 23 April 2018
France’s AB Science has received another blow to its hopes for amyotrophic lateral sclerosis (ALS) candidate masitinib, with a negative opinion from the EU regulator’s medical panel. 23 April 2018
In the wake f the ongoing opioid crisis in the USA, the Food and Drug Administration on Friday announced the latest action to encourage and support the development of treatment options for people with opioid use disorder (OUD). 23 April 2018
A predicted blockbuster has moved closer to market with the news that a US Food and Drug Administration (FDA) advisory committee has recommended GW Pharmaceuticals’ Epidiolex (plant-derived cannabidiol) for approval as an adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) and Dravet syndrome. 20 April 2018
Mindful that integrating model-informed drug development (MIDD) into more drug applications and advancing its use are US Food and Drug Administration’s (FDA) goals under the Prescription Drug User Fee Amendments of 2017, the agency has stepped up its publicizing of the potential benefits to drugmakers. 20 April 2018
The US Food and Drug Administration has approved Tagrisso (osimertinib) for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) mutations, (exon 19 deletions or exon 21 L858R mutations), as detected by an FDA-approved test. 19 April 2018
A day after news broke that it was to sell its oncology business for $2.4 billion, Ireland-incorporated drugmaker Shire has shown the strength of its hematology portfolio. 18 April 2018
US Food and Drug Administration Commissioner Scott Gottlieb has welcomed the White House budget request of $5.8 billion for the agency in 2019, an increase of 13% from this year. 18 April 2018
Shares in Californian biotech Rigel Pharmaceuticals (Nasdaq:RIGL) leapt a tenth yesterday on news that the US regulator had approved Tavalisse (fostamatinib disodium hexahydrate) to treat adult patients with chronic immune thrombocytopenia (ITP). 18 April 2018
The US Food and Drug Administration has approved Crysvita (burosumab), the first drug cleared to treat adults and children ages 1 year and older with x-linked hypophosphatemia (XLH), a rare, inherited form of rickets. 18 April 2018
UK-based cannabinoid specialist GW Pharmaceuticals was up by a double-digit percentage by Tuesday afternoon as investors looked at the latest news on its New Drug Application for Epidiolex (cannabidiol or CBD). 17 April 2018
Analysts at Jeffries have predicted that Roche’s Hemlibra (emicizumab) could generate $5 billion in annual sales – provided its use for hemophilia A is widened to the larger, non-inhibitor population. 17 April 2018
The combination of Opdivo (nivolumab) 3mg/kg plus Yervoy (ipilimumab) 1mg/kg (injections for intravenous use) has received priority approval from the US Food and Drug Administration as the first immuno-oncology combination therapy for previously untreated patients with intermediate- and poor-risk advanced renal cell carcinoma (RCC). 17 April 2018
A report from market analyst GlobalData finds that the Chinese pharmaceutical market is expected to grow at an annual rate of 30% up to 2022, pushing the size of the market up to $573 billion. 16 April 2018
Massachusetts, USA-based messenger RNA (mRNA) specialist Translate Bio says the US Food and Drug Administration has cleared the company to begin a first-in-human clinical trial of MRT5005 in patients with cystic fibrosis. 13 April 2018
The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has released highlights from its meeting that took place April 9-12. 13 April 2018
More drug approvals, a busy US Food and Drug Administration (FDA) and the growing success of small and medium sized pharma companies are some of the major findings of a comparison published on Thursday. 12 April 2018
The US Food and Drug Administration has said that it requires extended time to review additional information regarding the results of liver function tests provided in connection with its New Drug Application (NDA) for elagolix in endometriosis-associated pain. 12 April 2018