Good news on the regulatory progress of its terlipressin pushed shares of Mallinckrodt up 12.7% by close of trading on Wednesday, plus a further 5.8% to $3.28 in after-hours trading. 16 July 2020
A US Food and Drug Administration (FDA) advisory committee has voted in favor of the demonstrated benefit of treatment with belantamab mafodotin outweighing the risks for relapsed or refractory multiple myeloma patients, who have received at least four prior therapies including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody. 15 July 2020
On Tuesday, the European Council adopted, by written procedure, a regulation which aims to speed up the development and the deployment of a vaccine against COVID-19 in the European Union. 15 July 2020
In the USA, Senate Minority Leader Charles Schumer (Democrat: New York) and Senator Patty Murray (Democrat: Washington), the top Democrat on the Senate Health Committee, released a white paper on Monday saying the Trump Administration needs to do more to ensure safe and effective vaccines for the fight against the novel coronavirus pandemic sweeping the country. 15 July 2020
Johnson & Johnson’s Janssen unit has announced that the US Food and Drug Administration (FDA) has approved Tremfya (guselkumab) for adult patients with active psoriatic arthritis (PsA). 14 July 2020
US tumor drug resistance specialist Deciphera Pharmaceuticals today announced that the Australian Therapeutics Goods Administration (TGA) has approved Qinlock (ripretinib) for the treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with three or more kinase inhibitors, including imatinib. 14 July 2020
Washington, USA-based biotech has received a Refusal to File letter for leronlimab, causing shares in the company to fall more than a fifth. 14 July 2020
US pharma giant Pfizer has announced the registration of Bisponsa (inotuzumab ozogamycin), which is an innovative drug, designed for the treatment of acute lymphoblastic leukemia (ALL), in Russia. 14 July 2020
Anglo-Swedish drugmaker AstraZeneca has announced that the US Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) and granted Priority Review for Brilinta (ticagrelor) for the reduction of subsequent stroke in patients who experienced an acute ischemic stroke or transient ischemic attack (TIA). 13 July 2020
The US Food and Drug Administration (FDA) has granted Fast Track designation to two vaccine candidates from the Pfizer and BioNTech BNT162 mRNA-based vaccine program. 13 July 2020
US RNAi therapy specialist Alnylam Pharmaceuticals says that the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has granted lumasiran, an investigational RNAi therapeutic in development for the treatment of primary hyperoxaluria type 1 (PH1), a positive scientific opinion through the Early Access to Medicines Scheme (EAMS). 13 July 2020
Clocking up another approval for the repurposed anti-viral, Australia’s Therapeutic Goods Administration (TGA) has granted provisional approval to US biotech major Gilead Sciences’ Veklury (remdesivir) as the first treatment option for COVID-19 in the country. 13 July 2020
Biocon has received the Drugs Controller General of India’s (DCGI) approval to market Alzumab (itolizumab) injection 25mg/5mL solution for emergency use in India for the treatment of cytokine release syndrome (CRS) in moderate to severe ARDS (acute respiratory distress syndrome) patients due to COVID-19. 13 July 2020
The US Food and Drug Administration said on Friday that has been thoughtfully and deliberately determining the safest and most appropriate time to resume prioritized domestic inspections of FDA-regulated facilities and other associated activities since we first announced postponement in March. 11 July 2020
Even though Russian drugmakers had expressed their worries about the proposed regulation in no uncertain terms, even writing to the country’s President Vladimir Putin, on July 1, compulsory labeling of medicines began in Russia. 10 July 2020
The US Food and Drug Administration approved a supplemental Biologics License Application (sBLA) that supports expanded use of Botox (onabotulinumtoxinA) for the treatment of spasticity in pediatric patients two years of age and older, including those with lower limb spasticity caused by cerebral palsy, says Allergan. 10 July 2020
Wisconsin, USA-based diagnostics company Promega is launching a new test for microsatellite instability (MSI) in the UK, which could help identify candidates for cancer immunotherapy. 9 July 2020
The US regulator has granted Priority Review status to Brilinta (ticagrelor), for the reduction of subsequent stroke in people who have had an acute ischemic stroke or transient ischemic attack (TIA). 9 July 2020
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
The US Food and Drug Administration (FDA) has approved Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs), the first and only PD-(L)1 inhibitor for subcutaneous (SC) injection for patients in the USA, Swiss pharma giant Roche subsidiary Genentech announced yesterday. 13 September 2024