The drug labeling experiment began in Russia at the beginning of 2017, the goal of which is to increase the transparency of the movement and accounting of medicines, to exclude counterfeit products from circulation 31 May 2019
Mitsubishi Tanabe Pharma announced today the withdrawal of the Marketing Authorization Application (MAA) of Radicava (edaravone) for the treatment of amyotrophic lateral sclerosis (ALS) in the European Union (EU). 30 May 2019
At its May 27-29 meeting, the European Medicines Agency’s Committee for Medical Products for Human Use (CHMP) recommended four medicines for approval, and gave two negative opinions. 30 May 2019
The share price of Canadian biopharma Zymeworks (TSX: ZYME) closed 4% up on Wednesday after the company received two separate validations of its approach. 30 May 2019
Following in the footsteps of Celltrion, Samsung Bioepis, Amgen and others, Prestige BioPharma is making headway with its Herceptin (trastuzumab) biosimilar. 29 May 2019
The US Food and Drug Administration has approved a supplemental New Drug Application (sNDA) for Vraylar (cariprazine) for expanded use to treat depressive episodes associated with bipolar I disorder (bipolar depression) in adults. 29 May 2019
The US Food and Drug Administration has approved Revlimid (lenalidomide) in combination with a rituximab product (R²) for the treatment of adult patients with previously treated follicular lymphoma (FL) or marginal zone lymphoma (MZL) following Priority Review designation. 29 May 2019
Italian biopharma Newron Pharmaceuticals looked set to close around 13% down on Tuesday after bad news was announced surrounding evenamide, a potential add-on therapy for the treatment of patients with positive symptoms of schizophrenia. 28 May 2019
The US Food and Drug Administration has approved Jakafi (ruxolitinib) for the treatment of steroid-refractory acute graft-versus-host disease (GVHD) in adult and pediatric patients 12 years and older 28 May 2019
Swiss specialty pharma Santhera on Monday submitted a marketing authorization application (MAA) to the European Medicines Agency, seeking conditional approval for its Puldysa (idebenone) for the treatment of respiratory dysfunction in patients with Duchenne muscular dystrophy (DMD). 28 May 2019
The US Food and Drug Administration on Friday approved Zolgensma (onasemnogene abeparvovec-xioi), the first gene therapy approved to treat children less than two years of age with spinal muscular atrophy (SMA), the most severe form of SMA and a leading genetic cause of infant mortality. 25 May 2019
China must take measures to largely improve its clinical data quality to be a competitive player in the global biotech market, said speakers at China’s recent clinical development summit held in Shanghai, reports The Pharma Letter’s local correspondent Wang Fangqing. 24 May 2019
Biotherapeutics revealed that the US Food and Drug Administration has granted Breakthrough Therapy designation for its TIL therapy candidate LN-145 in recurrent, metastatic, or persistent cervical cancer with disease progression on or after chemotherapy. 24 May 2019
GlaxoSmithKline today announced that China’s National Medical Products Administration (NMPA) has approved Shingrix for the prevention of shingles (herpes zoster) in adults aged 50 years or older. 23 May 2019
In a posting on the Pharmaceutical Research and Manufacturers of America website, Tom Wilbur, a director of public affairs at PhRMA, explains the intellectual property scene, taking a look at how Hatch-Waxman successfully streamlined the process for generic medicine approvals while preserving incentives for innovation. 23 May 2019
Less than a year after Japanese drugmaker Takeda’s Entyvio was approved in the company’s home country to treat ulcerative colitis, a further indication for the drug has been authorized. 22 May 2019
North Carolina, USA-based rare disease specialist BioCryst Pharmaceuticals has announced results from its Phase III APeX-2 trial of the investigational hereditary angioedema (HAE) therapy BCX7353. 22 May 2019
The US Supreme Court on Monday ruled that a lower court should consider dismissing the claims of more than 500 patients who blame pharma giant Merck & Co for not warning them about the risks of femoral fractures related to the company’s drug Fosamax (alendronate). 21 May 2019
Belgian biopharma UCB started the week by announcing that the US Food and Drug Administration (FDA) approval of Nayzilam (midazolam) for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity that are distinct from a patient’s usual seizure pattern in patients with epilepsy. 20 May 2019
A draft issued on March 29 by China’s National Health Commission (CNHC), which regulates hospitals in China, allows qualified 3 Jia ( meaning top-level) public hospitals to develop and commercialize somatic cell therapies within their own hospitals. 17 May 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