Shares in Akebia Therapeutics finished the day around 6% up on Tuesday, after the firm announced the first ever filing for vadadustat, an investigational oral treatment for anemia due to chronic kidney disease (CKD). 24 July 2019
Massachusetts, USA-based rare and chronic disease specialist Chiasma has revealed positive top-line data from the Phase III CHIASMA OPTIMAL trial of Mycapssa (octreotide). 23 July 2019
Shares of Myovant Sciences, a clinical-stage healthcare firm that is part of the Roivant family of companies, leapt 17.8% at $9.61 in pre-market trading after releasing positive results for its uterine fibroids treatment. 23 July 2019
Germany’s Bayer is voluntarily recalling two lots of Kogenate FS antihemophilic factor (recombinant) 2000 IU vials in the USA to the patient level. Certain vials from these two lots that were labeled as Kogenate FS actually contain the FVIII hemophilia A treatment, Jivi, antihemophilic factor (recombinant) PEGylated-aucl 3000 IU. 23 July 2019
A new combination therapy for liver cancer has been granted Breakthrough Therapy Designation (BTD) by the US Food and Drug Administration, unlocking expedited development and review by the US regulator. 23 July 2019
The US Food and Drug Administration today announced that, on July 19, it approved multiple applications for first generics of Lyrica (pregabalin), thus opening the flood gates for competition to Pfizer’s blockbuster treatment. 22 July 2019
Indian drugmaker Cipla closed 1% down on Monday after disclosing that the US Food and Drug Administration (FDA) had issued seven observations following an inspection. 22 July 2019
For our latest Special Report, Adriaan Fruijtier from CATS Consultants, gives an account of major talking points at one of the year’s major events in the calendar of the Regulatory Affairs Professionals Society (RAPS), which took place in Brussels earlier in the summer. 22 July 2019
Tthe European Commission (EC) and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) have granted the marketing authorization transfer to Netherlands-headquartered drugmaker Mylan for TOBI Podhaler and TOBI Solution in the UK for patients with cystic fibrosis. 22 July 2019
Biohaven Pharmaceutical revealed that it has received a Complete Response Letter (CRL) from the Food and Drug Administration for the 505(b)2 application seeking approval for Nurtec (riluzole) for amyotrophic lateral sclerosis (ALS), or Lou Gehrig's disease. 22 July 2019
Belgium’s UCB has won approval from China’s National Medical Product Administration (NMPA) for Cimzia (certolizumab pegol), to treat moderate-to-severe rheumatoid arthritis. 22 July 2019
Japan’s Sumitomo Dainippon Pharma has announced positive top-line results from a Phase III Japanese study of the antipsychotic Lonasen (blonanserin), in adolescents. 22 July 2019
The US Food and Drug Administration (FDA) has approved Otezla (apremilast) 30mg twice daily (BID) for the treatment of adult patients with oral ulcers associated with Behçet’s disease. 20 July 2019
Johnson & Johnson’s pharma business Janssen has submitted to broaden the European label for Darzalex (daratumumab), for subcutaneous treatment of multiple myeloma. 19 July 2019
The US Food and Drug Administration has granted rare pediatric disease designation to LM-030, an investigational therapy licensed from Novartis last year and ready to enter into pivotal clinical trials for the treatment of Netherton syndrome by privately-held rare diseases specialist LifeMax Laboratories. 19 July 2019
Nearly 10 years after garnering approval in the USA, multiple sclerosis (MS) therapy Gilenya (fingolimod) has finally been given the green light for marketing in China, where the condition is classed as a rare disease. 19 July 2019
The trade group for the Russian pharmaceutical industry has argued for clarification to the procedure for issuing a compulsory license, to ensure that market participants can "clearly and unequivocally" understand the rules. 19 July 2019
As some of the world’s best-known biologics continue to face patent expiration, the biosimilars market faces a major haul of opportunities. However, though Indian firms have launched around 50 such products in the domestic market, a new report suggests certain regulatory framework concerns for biopharmaceuticals need to be addressed, reports The Pharma Letter’s India correspondent. 18 July 2019
India-based drugmaker Strides Pharma has received a warning from the US Food and Drug Administration, after being caught shredding documents related to quality control. 18 July 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