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
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
Basilea Pharmaceutica announced that the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) has awarded Basilea an Other Transaction Agreement (OTA), under OTA number 75A50124C00033. 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
Daiichi Sankyo’s today revealed that its Vanflyta (quizartinib) has been recommended by the National Institute for Health and Care Excellence (NICE) for routine National Health Service (NHS) commissioning in England and Wales. 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
Novo Nordisk is under increasing pressure over the cost of its blockbuster drugs in the USA, as chief executive Lars Fruergaard Jørgensen prepares to testify before a powerful Senate committee. 18 September 2024
In a lawsuit filed in federal court in Missouri, USA, Health insurer Cigna (NYSE: CI) and its pharmacy benefit manager (PBM) Express Scripts demanded that the Federal Trade Commission (FTC) retract its July 2024 report. 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
To the surprise of many, the US government has backed a World Trade Organization (WTO) proposal to disclaim certain intellectual property (IP) rights to coronavirus vaccines, after previously opposing it. 6 May 2021
The US Food and Drug Administration has approved Keytruda (pembrolizumab), Merck & Co’s blockbuster anti-PD-1 therapy, in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma. 6 May 2021
European authorities have granted marketing authorization for a new indication for Tecentriq (atezolizumab), the checkpoint blocker developed by Roche. 5 May 2021
The European Commission (EC) has granted marketing authorization to ADV7103 (potassium citrate/potassium hydrogen carbonate), proposed trade name Sibnayal, for the treatment of distal renal tubular acidosis (dRTA), says French biotech Advicenne. 4 May 2021
Chiesi Global Rare Diseases, a business unit of Chiesi Farmaceutici, announced that the US Food and Drug Administration has approved Ferriprox (deferiprone) for the treatment of patients with transfusional iron overload due to sickle cell disease (or other anemias) in adults and children (age three and older). 4 May 2021
Indian drugmaker Glenmark Pharmaceuticals has announced the launch of Ryaltris-AZ Nasal Spray for the treatment of moderate to severe allergic rhinitis, in India. 4 May 2021
Legend Biotech, a clinical stage CAR-T immuno-oncology biotech being spun out of Hong Kong-listed GenScript Biotech, revealed on Friday that a Marketing Authorization Application (MAA) has been submitted to the European Medicines Agency (EMA) seeking approval of ciltacabtagene autoleucel (cilta-cel) for the treatment of patients with relapsed and/or refractory multiple myeloma. 1 May 2021
The US Food and Drug Administration on Friday approved Farxiga (dapagliflozin) oral tablets to reduce the risk of kidney function decline, kidney failure, cardiovascular death and hospitalization for heart failure in adults with chronic kidney disease who are at risk of disease progression. 1 May 2021
A UK Innovation Passport has been granted for a proposed new indication in the treatment of adult patients with anaplastic lymphoma kinase (ALK) positive advanced non-small-cell lung carcinoma (NSCLC), previously not treated with an ALK inhibitor for Lorviqua (lorlatinib). 1 May 2021
The first coronavirus vaccine for children could soon be available in Europe, after Pfizer and BioNTech submitted to broaden the Conditional Marketing Authorization for their Comirnaty jab. 30 April 2021
After two days of discussions yielding reaffirmed support for Tecentriq’s (atezolizumab) Accelerated Approvals, the US regulator’s scientific panel changed tack on Thursday, voting to rescind decisions for both Keytruda (pembrolizumab) and Opdivo (nivolumab). 30 April 2021
The European Federation of Pharmaceutical Industries and Associations (EFPIA) has filed its response to the European Union (EU) roadmap/IIA on the Evaluation and revision of the general pharmaceutical legislation. 30 April 2021
London-listed Hikma Pharmaceuticals saw its share gain more than 2% to 2,415 pence by late morning, as the company, announces the approval of Kloxxado (naloxone hydrochloride) nasal spray 8mg, by the US Food and Drug Administration for the emergency treatment of known or suspected opioid overdose. 30 April 2021
The UK’s Medicines and Healthcare Regulatory Agency (MHRA) has approved Ogluo (glucagon) injection for the treatment of severe hypoglycemia in adults, adolescents, and children aged two years and over with diabetes mellitus, said the drug’s developer, Xeris Pharmaceuticals. 30 April 2021
Vifor Fresenius Medical Care Renal Pharma (VFMCRP) today announced positive results from a Phase-III study in China (PA-CL-CHINA-01), evaluating the efficacy of Velphoro (PA21: sucroferric oxyhydroxide) compared to sevelamer carbonate in lowering and maintaining serum phosphorus in adult Chinese patients with chronic kidney disease (CKD) on dialysis after 12 weeks of treatment. 30 April 2021
Complete response letters (CRLs) seem to be coming thick and fast from the US Food and Drug Administration, the latest victim being Denmark’s dermatology specialist LEO Pharma. 29 April 2021
Shares in Protalix BioTherapeutics closed 44% lower on Wednesday after the firm and its partner Chiesi Farmaceutici announced receipt of a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) regarding the Biologics License Application (BLA) seeking accelerated approval of pegunigalsidase alfa (PRX–102) for Fabry disease. 29 April 2021
There was more good news for Swiss company Roche on Wednesday, as the US regulator’s scientific panel voted to maintain another Accelerated Approval for Tecentriq (atezolizumab). 29 April 2021