There was positive news from Swiss pharma giant Roche this morning with the announcement that the US Food and Drug Administration is providing accelerated approval for not one, but two, novel oncology candidates. 19 February 2019
Merck & Co’s abstract presentation regarding KEYNOTE-426 trial at 2019 Genitourinary Cancers Symposium (ASCO GU) has confirmed that its Keytruda (pembrolizumab), an anti-PD-1 therapy, in combination with fellow US pharma giant Pfizer’s Inlyta (axitinib), a tyrosine kinase inhibitor, can significantly improve clinical outcomes for renal cancer patients. 18 February 2019
Going back on a negative decision and after an improved price offer from the company, the UK’s medicines cost-effectiveness watchdog has now backed Perjeta (pertuzumab) for National Health Service use in England. 18 February 2019
Following its February 11-14 meetings, the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) on Friday recommended a European Union-wide suspension of fenspiride medicines, used in children and adults to relieve cough caused by lung diseases. 18 February 2019
In an interview with UK press, Ipsen (Euronext: IPN) chief executive David Meek has said that that the UK will likely fall behind other major economies in terms of access to medicines, post-Brexit. 15 February 2019
With a matter of weeks to go until the UK is due to leave the European Union, negotiations between warring factions in the British political establishment threaten to derail any prospect of a staged, sensibly managed exit process. 15 February 2019
As with most regulations, there are those who think they are a good idea and those that believe otherwise, as has happened with the latest European pronouncement on pharmaceuticals. 14 February 2019
Clinical-stage biotech firm Motif Bio today revealed that it has received a Complete Response Letter (CRL) from the US Food and Drug Administration regarding the New Drug Application (NDA) for iclaprim for the treatment of acute bacterial skin and skin structure infections (ABSSSI). 14 February 2019
French company DBV Technologies plans to re-submit its Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for Viaskin Peanut to treat peanut-allergic children in the third quarter of 2019. 14 February 2019
Talk of innovating in pharma normally centers on drug discovery and development, but what about innovation in manufacturing and its ability to improve product quality and drive down costs? 14 February 2019
The US Food and Drug Administration has approved Egaten (triclabendazole) for the treatment of fascioliasis in patients six years of age and older. 14 February 2019
Australian medicinal cannabis company Althea has announced it is launching a UK-based subsidiary aimed at leveraging its experience as a supplier of cannabis-based pharmaceutical products. 13 February 2019
Japanese drugmaker Eisai has submitted an application to the European Medicines Agency (EMA) for its antiepileptic drug Fycompa (perampanel) seeking approval for use in pediatric patients with epilepsy. 13 February 2019
US healthcare giant Johnson & Johnson has been buoyed by a positive decision from the advisory panel of the US regulator on the firm’s experimental depression therapy Spravato (esketamine). 13 February 2019
US Food and Drug Administration Commissioner Scott Gottlieb has issued a statement outlining his agency’s efforts to stop the illegal importation of drugs and control the drug supply chain. The agency will also seek more more focused New Drug Applications (NDA) for opioid products. 12 February 2019
The US Food and Drug Administration has approved a split-dosing regimen for Darzalex (daratumumab), providing healthcare professionals and patients with multiple myeloma an option to split the first infusion over two consecutive days. 12 February 2019
Missing out on an oncology licensing deal with Merck KGaA raised questions over Pfizer’s strategy last week as the German company announced a tie-up with GlaxoSmithKline. 12 February 2019
Leading immuno-oncology therapy Keytruda (pembrolizumab) will be reviewed for approval in head and neck cancer under the US regulator’s Priority Review scheme. 12 February 2019
The European Medicines Agency has granted Takeda Pharmaceutical a label extension for Adcetris (brentuximab vedotin) to include the treatment of certain people with Stage IV Hodgkin lymphoma, in combination with chemotherapy. 11 February 2019
Sprycel (dasatinib) will now become available in the European Union in combination with chemotherapy for the treatment of pediatric patients with newly-diagnosed Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL). 11 February 2019
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
Bayer has submitted a Marketing Authorization Application (MAA) to the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for the investigational compound elinzanetant. 17 September 2024
The US Food and Drug Administration (FDA) has approved Ocrevus Zunovo (ocrelizumab and hyaluronidase-ocsq) for the treatment of relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS), from Swiss pharma giant Roche. 16 September 2024
The Gastrointestinal Drugs Advisory Committee (GIDAC) of the US Food and Drug Administration (FDA) met on Friday to discuss Intercept Pharmaceuticals’ supplemental New Drug Application (sNDA) for Ocaliva (obeticholic acid, OCA). 16 September 2024
Oligonucleotide therapeutics are rapidly emerging as a promising class of drugs capable of addressing a variety of genetic and complex diseases by targeting RNA sequences.1 16 September 2024
On Thursday, the US Food and Drug Administration released a Drug Safety Communication warning that Veozah (fezolinetant), which is used to treat hot flashes due to menopause, can cause rare but serious liver injury. 13 September 2024