Sections of Indian pharmaceutical companies and health groups have expressed concern over a move by the Department of Pharmaceuticals (DoP) for an information dissemination mechanism that could allegedly subvert efforts by Indian manufacturers to release generic drugs, reports The Pharma Letter’s local correspondent. 19 June 2019
The US Food and Drug Administration has said it will provide new data regarding the eligibility of products for the 180-day exclusivity period for generic drug products. 19 June 2019
US antibiotics specialist Melinta Therapeutics today announced that the US Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) for Baxdela (delafloxacin) for priority review. 19 June 2019
Onpattro (patisiran), the gene-silencing drug from US biotech Alnylam, has been approved for the treatment of hereditary transthyretin-mediated (hATTR) amyloidosis with polyneuropathy in Japan. 19 June 2019
In a boost for its medicines portfolio in Japan, AstraZeneca has gained regulatory approval for not one, but three products, the Anglo-Swedish pharma major announced today. 19 June 2019
Much of the dialogue surrounding Roche’s oncology drugs is currently about the big-selling products at the end of their patent life, but the company has provided a timely reminder that its new innovations are a big deal too. 18 June 2019
Merck & Co has been granted a new label update for its immuno-oncology blockbuster, Keytruda (pembrolizumab), in metastatic small cell lung cancer (SCLC). 18 June 2019
Shionogi has announced the approval for Intuniv (guanfacine hydrochloride) for the treatment of attention deficit hyperactivity disorder (ADHD) with an additional indication in adult patients in its domestic market. 18 June 2019
Shares in UK-based drugmaker AstraZeneca were up over 1% in early trading on Tuesday morning, after the firm announced European approval for Lynparza (olaparib) as a first-line maintenance treatment for women with BRCA-mutated advanced ovarian cancer. 18 June 2019
The US Food and Drug Administration on Monday approved Victoza (liraglutide) injection for the treatment of pediatric patients aged 10 years or older with type 2 diabetes, under a priority review evaluation. 18 June 2019
At the meeting of the European Medicines Agency’s (EMA) management board last week, the topic of the move to Amsterdam and its impact on business and staff, along with other Brexit-related business, dominated the agenda. 17 June 2019
A key milestone has been reached in the launch of the recently-approved postpartum depression (PPD) therapy Zulresso (brexanolone), as the Drug Enforcement Administration (DEA) has listed the product on “Schedule IV” of the Controlled Substances Act. 14 June 2019
The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) stated following its June 11-14 meeting that it has started a review of leuprorelin medicines. 14 June 2019
The US Food and Drug Administration on Thursday approved Kanjinti (trastuzumab-anns), a biosimilar to Swiss pharma giant Roche’s US-licensed Herceptin (trastuzumab). 14 June 2019
New legal action from Catalyst Pharmaceuticals signals the Florida, USA-based firm’s intention to strongly defend its market share in the rare disease Lambert-Eaton myasthenic syndrome (LEMS). 13 June 2019
Germany’s Merck KGaA has been building a multi-dimensional ecosystem with its two pharmaceutical sectors - healthcare (formerly known as Merck Serono) and life sciences - to propel its future advances in China. 13 June 2019
Luxembourg and the Netherlands were included into the mutual recognition agreement between the European Union (EU) and the US Food and Drug Administration, effective June 10. 12 June 2019
The US Food and Drug Administration has approved top-selling immuno-oncology drug Keytruda (pembrolizumab), under priority review, for the first-line treatment of patients with metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC). 11 June 2019
Hopes for Novavax’s once highly-anticipated respiratory syncytial virus (RSV) shot, ResVax, were dealt a new blow on Monday, as the US regulator said an additional Phase III trial would be needed. 11 June 2019
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