Drug repurposing involves the use of existing drugs for new indications.1 Repurposed drugs include not only previously approved drugs but also clinically failed and investigational drugs.2 24 June 2022
The European Medicines Agency (EMA) has recommended granting a marketing authorization for COVID-19 Vaccine (inactivated, adjuvanted) Valneva, developed by developed by French company Valneva, for use in the primary vaccination of people from 18 to 50 years of age. 23 June 2022
Swiss pharma giant Novartis has received an Accelerated Approval in the USA for its combination BRAF/MEK inhibitor therapy, for certain biomarker-defined tumors. 23 June 2022
Swiss pharma giant Novartis today announced that the European Commission (EC) approved Tabrecta (capmatinib) as a monotherapy for the treatment of adults with advanced non-small cell lung cancer (NSCLC) harboring alterations leading to mesenchymal-epithelial-transition factor gene (MET) exon 14 (METex14) skipping who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy. 23 June 2022
Despite tremendous political-economic challenges that Egypt faced in last two decades, Egypt still remains the largest producer and consumer of pharmaceuticals in the entire Middle East and Africa region with a market value of EGP 56.6billion (US$2.9 billion) in 2022 for pharmaceutical sales. 23 June 2022
The US Centers for Disease Control and Prevention’s (CDC’s) Advisory Committee on Immunization Practices (ACIP) unanimously voted to include Vaxneuvance (pneumococcal 15-valent conjugate vaccine) as a recommended option for vaccination in infants and children, including routine use in children under two years of age, US pharma giant Merck & Co announced yesterday. 23 June 2022
After repeated failures to register its Duchenne muscular dystrophy (DMD) drug in the USA, new data suggest PTC Therapeutics might be about ready to try again. 22 June 2022
Biotech firm BeiGene said today that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has accepted a supplemental biologics license application (sBLA) for the company’s anti-PD-1 inhibitor, tislelizumab, in combination with chemotherapy as a first-line treatment for patients with advanced or metastatic gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1. 22 June 2022
Japanese drug major Chugai Pharmaceutical has obtained regulatory approval from the Ministry of Health, Labor and Welfare (MHLW) for the anti-coagulation factor IXa/X humanized bispecific monoclonal antibody/coagulation factor VIII substitute Hemlibra (emicizumab [genetical recombination]) for an additional indication of routine prophylaxis to prevent or reduce the frequency of bleeding episodes in patients with acquired hemophilia A. 22 June 2022
The Drugs Controller General of India (DCGI) recently approved Biological E’s Corbevax vaccine as the first heterogeneous COVID-19 booster vaccine in India for adults above 18 years who have received two shots of Covaxin or Covishield. 22 June 2022
The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for ACER-001 (sodium phenylbutyrate) for oral suspension for the treatment of patients with urea cycle disorders (UCDs). 21 June 2022
The European Medicines Agency (EMA) has validated the type II variation application for extension of the indication for Breyanzi (lisocabtagene maraleucel) to treat adult patients with diffuse large B-cell lymphoma (DLBCL), high grade B-cell lymphoma (HGBCL), primary mediastinal large B-cell lymphoma (PMBCL) and follicular lymphoma grade 3B (FL3B), who are refractory or have relapsed within 12 months of initial therapy and are candidates for hematopoietic stem cell transplant (HSCT). 21 June 2022
The National Medical Products Administration (NMPA) of China has recently approved Chinese biotech firm CStone Pharmaceuticals’ sugemalimab (trade name Cejemly) to treat patients with stage III non-small cell lung cancer (NSCLC), whose disease has not progressed following concurrent or sequential or platinum-based chemoradiotherapy. 21 June 2022
Stelis Biopharma, a contract development and manufacturing organization (CDMO) and the biologics arm of India's Strides Pharma Science, has received the European Union Goods Manufacturing Practices (EU-GMP) compliance certificate from the National Institute of Pharmacy and Nutrition, Hungary, for two of its manufacturing facilities. 21 June 2022
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved Scemblix (asciminib) for Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP), previously-treated with two or more tyrosine kinase inhibitors (TKIs), and without a known T315I mutation. 20 June 2022
Japanese drugmaker Taiho Pharmaceutical today announced it has obtained manufacturing and marketing approval from Japan’s Ministry of Health, Labor and Welfare (MHLW) for the oral heat shock protein (HSP) 90 inhibitor Jeselhy (pimitespib; development code: TAS-116), 40mg tablets for the indication of gastrointestinal stromal tumor (GIST) that has progressed after chemotherapy. 20 June 2022
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
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
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
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
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
The Russian Ministry of Health wants to speed registration of drugs that are not localized in the Russian Federation at the time of the application submitted by domestic pharmaceutical companies, explaining such changes by "unpredictable geopolitical situation," reports The Pharma Letter’s local correspondent. 12 September 2024
The US Food and Drug Administration (FDA) has approved Tremfya (guselkumab) for the treatment of adults with moderately to severely active ulcerative colitis (UC). 12 September 2024