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
In a filing with the US Securities and Exchange Commission, Clovis Oncology has revealed it will voluntarily withdraw part of the label for its PARP blocker Rubraca (rucaparib). 20 June 2022
The continuous depreciation of the forint, the pandemic, and then the war in Ukraine has seriously endangered safe access to modern medicinal treatments, which is now exacerbated by the disproportionate and high special tax increase that may lead to unforeseen consequences, says the Hungarian pharma trade group Association of Innovative Pharmaceutical Manufacturers (AIPM). 20 June 2022
At its June 16, 2022, meeting in Amsterdam, the European Medicines Agency's (EMA) management board, among other items, heard an update about the implementation of the new EU regulation that reinforces EMA’s role in crisis preparedness and management for medicinal products and medical devices. 20 June 2022
Among significant news last week, US biotech Alnylam Pharmaceutical on Monday revealed that the Food and Drug Administration has approved its rare disease drug Amvuttra (vutrisiran). Japan’s Shionogi entered into a landmark collaboration to expand global access to its antibiotic cefiderocol. Swiss pharma giant Roche last Wednesday released new data on its Alzheimer’s disease candidate crenezumab that once again proved a failure. Also, rumors surfaced on Friday that US biotech Seagen is in talks with US pharma giant Merck & Co about a possible acquisition of the company with which it already has research collaborations. 19 June 2022
The US Food and Drug Administration (FDA) Psychopharmacologic Drugs Advisory Committee (PDAC) meeting to discuss the case for approval of pimavanserin for the treatment of hallucinations and delusions associated with Alzheimer’s disease psychosis (ADP) resulted in a decisive negative vote of 9 to 3, noting that the evidence presented does not support a conclusion that pimavanserin is effective for the treatment of hallucinations and delusions in the ADP population. 18 June 2022
As the COVID-19 pandemic has prompted multinational pharma corporations to adopt a ‘China Plus One’ strategy, Indian government officials are urging domestic players to take advantage of the opportunity to become a viable alternative to China. 18 June 2022
The US Food and Drug Administration (FDA) has approved a supplemental indication for Imcivree (setmelanotide) injection for chronic weight management in adult and pediatric patients aged six years and older with obesity due to Bardet-Biedl Syndrome (BBS). 17 June 2022
The UK’s National Institute for Health and Care Excellence (NICE) has recommended abemaciclib in combination with endocrine therapy, within its marketing authorization, as an option for adjuvant treatment of hormone receptor-positive, HER2-negative, node-positive early breast cancer in adults whose disease is at high risk of recurrence, defined as pathological tumor involvement in: 17 June 2022
The Swiss parliament has failed to finance the government's plan to buy COVID-19 vaccines in 2023, forcing the cabinet to try to renegotiate contracts with Moderna and Pfizer/BioNTech’s for millions of doses of their vaccines, according to a report from Reuters. 17 June 2022
UK drugmaker GSK has welcomed the decision from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) to grant Innovation Passport designation to two of its oncology medicines. 16 June 2022
Nuplazid (pimavanserin), which is approved for the treatment of Parkinson’s disease psychosis, could struggle to gain a new nod in Alzheimer’s after agency briefing notes revealed doubts over the developer’s submission. 16 June 2022
Following Tuesday’s scientific recommendation to approve Moderna’s coronavirus vaccine for older children, a panel of experts yesterday endorsed the jab for children as young as six months old. 16 June 2022
India's Central Drugs Standard Control Organization's (CDSCO) oncology/hematology Subject Expert Committee, which advises the drug regulator, has asked the local subsidiary of Swiss pharma giant Roche to submit the efficacy results of its Phase III trial on Tecentriq (atezolizumab), an anti-cancer drug. 16 June 2022
Japanese drugmaker Shionogi has signed an agreement with the National Health Service (NHS) to begin an innovative subscription payment model reimbursement of cefiderocol in England. 15 June 2022
Shares of Japanese drug major Shionogi closed down 5.6% at 6,493 yen today, despite revealing what it described as a “landmark” collaboration for access to its antibiotic cefiderocol, which is marketed under the trade name Fetroja. 15 June 2022
A key scientific panel of the US Food and Drug Administration has unanimously voted to recommend approval for Moderna’s COVID-19 vaccine in the age group six to 17. 15 June 2022
The first CAR-T cell therapy to treat cancers of the blood and lymphatic system is to be available in India early next year, offering hope to patients who can’t afford to travel abroad for the expensive treatment. 14 June 2022