Switzerland-based Novartis has won European approval for the one-time gene therapy Luxturna (voretigene neparvovec). The treatment was approved in the USA in late December 2017. 23 November 2018
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended fexinidazole, the first all-oral treatment for sleeping sickness. 22 November 2018
R-Pharm plans to dominate in public procurements of anti-HIV and hepatitis drugs in Russia, the overall annual value of which is estimated at 20 billion roubles (~$300 million), according to recent statements of some senior officials of the Russian Ministry of Health and sources of the company, The Pharma Letter’s local correspondent reports. 22 November 2018
Swedish drugmaker Camurus (STO: CAMX) today said that the European Commission has granted marketing authorization for Buvidal (CAM2038), with news of the approval sending the firm’s shares soaring 9.38% to 89.80 Swedish kronor. 22 November 2018
The US Food and Drug Administration Wednesday approved Daurismo (glasdegib) tablets to be used in combination with low-dose cytarabine (LDAC), a type of chemotherapy, for the treatment of newly-diagnosed acute myeloid leukemia (AML). 22 November 2018
Shares in Novartis ticked downwards on Tuesday after the US Food and Drug Administration revealed it was adding a new warning to the label for the firm’s multiple sclerosis (MS) medicine Gilenya (fingolimod). 21 November 2018
Weeks after a US Food and Drug Administration (FDA) panel overwhelmingly voted in support of the benefit-risk profile of Sage Therapeutics’ Zulresso (brexanolone) in postpartum depression (PPD), the agency has delayed a decision on whether to approve it. 21 November 2018
The US Food and Drug Administration has granted the Biological Product Designation for Israel-based biotech BioLineRx’ novel immunotherapy compound AGI-134. 21 November 2018
The US Food and Drug Administration (FDA) has approved Gamifant (emapalumab-lzsg), an interferon gamma (IFNγ) blocking antibody, in an ultra-rare syndrome of hyperinflammation with high morbidity and mortality and for which there was previously no drug on the market. 20 November 2018
As expected, following a positive recommendation from its advisory panel in September, the European Medicines Agency has granted approval for Emgality (galcanezumab), in the treatment of migraines. 19 November 2018
The China National Medical Products Administration (NMPA) has approved Vemlidy (tenofovir alafenamide, TAF) 25mg, a once-daily treatment for chronic hepatitis B in adults and adolescents (aged 12 years and older with body weight at least 35kg). 19 November 2018
Admitting that its trial results are not strong enough, Roche has told the European Medicines Agency (EMA) not to consider a type II variation to extend the use of Tecentriq (atezolizumab) in combination with Avastin (bevacizumab). 19 November 2018
Promacta (eltrombopag), a drug from Swiss pharma giant Novartis that is marketed as Revolade in most countries outside the USA, has had its label expanded by the US Food and Drug Administration (FDA). 19 November 2018
Earlier this month, the leading Russian professional associations in the pharmaceutical industry and communication services market, in the presence of Federal Antimonopoly Service (FAS) Russia, signed the “Recommendations on compliance with legislation on advertising of non-prescription medicines” in Moscow. It was developed in close cooperation with FAS Russia. 19 November 2018
The US Food and Drug Administration today approved Aemcolo (rifamycin), an antibacterial drug indicated for the treatment of adult patients with travelers’ diarrhea caused by non-invasive strains of Escherichia coli (E. coli), not complicated by fever or blood in the stool. 17 November 2018
Shares in Seattle Genetics are up nearly 5% and climbing today after the firm announced a new approval for Adcetris (brentuximab vedotin), shortly after revealing the US regulator had granted the therapy Breakthrough Designation in the same indication. 16 November 2018
The European Medicines Agency’s Committee for Products for Human Use (CHMP) recommended four medicines for approval, including one for use in countries outside the European Union, at its November 2018 meeting, as well as two re-examinations and four indication extensions. 16 November 2018
Seattle Genetics has been given Breakthrough Designation from the US Food and Drug Administration for Adcetris (brentuximab vedotin) for certain peripheral T-cell lymphomas (PTCL). 16 November 2018
The European Commission yesterday released the results of a new Eurobarometer study on the public knowledge on antibiotics and overall trends in their use ahead of the 11th European Antibiotic Awareness Day. 16 November 2018
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of Hetronifly (serplulimab). 23 September 2024
The US Food and Drug Administration (FDA) has approved Bimzelx (bimekizumab-bkzx) for the treatment of adults with active psoriatic arthritis (PsA), adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation, and adults with active ankylosing spondylitis (AS). 23 September 2024
Ocumension Therapeutics, has received approval of the New Drug Application (NDA) to commercialize Zerviate (cetirizine ophthalmic solution), 0.24% in China for ocular itching associated with allergic conjunctivitis. 23 September 2024
The US Food and Drug Administration (FDA) has approved Sarclisa (isatuximab) in combination with bortezomib, lenalidomide, and dexamethasone (VRd) as a first line treatment option for adult patients with newly diagnosed multiple myeloma (NDMM). 23 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
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