The European Union and Japan have agreed to broaden the range of medicines for which they will recognize each other’s inspections of manufacturing sites. 18 July 2018
The US Food and Drug Administration has approved Janssen’s four-in-one HIV-1 therapy Symtuza (cobicistat/darunavir ethanolate/emtricitabine/tenofovir alafenamide fumarate), following on from European approval, granted in September 2017. 18 July 2018
Indian pharma major Lupin saw its shares fall 3.75% to 833.15 rupees this morning despite announcing that it has received approval from the UK health regulator for its Goa manufacturing facility. 16 July 2018
Sweden’s Camurus says the US Food and Drug Administration has provided an action date of December 26, 2018 for the firm’s regulatory filing for CAM2038, an investigational opioid use disorder (OUD) treatment. 16 July 2018
On Friday, the US Food and Drug Administration alerted health care professionals and patients of a voluntary recall of several drug products containing the active ingredient valsartan, used to treat high blood pressure and heart failure. 16 July 2018
US biotech company Advaxis saw its shares surge 68% in premarket trading on Friday after the Food and Drug Administration lifted a clinical hold on the company's Phase I/II trial for an immuno-oncology drug combination. 16 July 2018
As was largely expected, Tegsedi (inotersen) has received marketing authorization approval from the European Commission for the treatment of stage 1 or stage 2 polyneuropathy in adult patients with hereditary transthyretin amyloidosis (hATTR). 13 July 2018
Following a review of data showing a possible risk of earlier death and an increase in fractures with Xofigo (radium-223 dichloride), the European Medicines Agency's (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has recommended restricting the use of this cancer medicine to patients who have had two previous treatments for metastatic prostate cancer or who cannot receive other treatments. 13 July 2018
Be they about boosting generics, advancing gene therapies or other aspects of the drug development and manufacturing industry that it is trying to improve, announcements have been coming thick and fast from the US Food and Drug Administration (FDA). 13 July 2018
The US Food and Drug Administration’s Antimicrobial Drugs Advisory Committee (AMDAC) at its meeting on Thursday voted that there is substantial evidence of the effectiveness (13 for; 0 against) and adequate evidence of the safety (12 for; 1 against) of single-dose tafenoquine for the radical cure (prevention of relapse) of Plasmodium vivax (P. vivax) malaria in patients aged 16 years and older. 13 July 2018
Following the UK’s publication of its proposed Brexit deal, the country’s biotech industry has issued a statement interpreting the likely impact for the sector, noting a range of effects from the UK’s relationship with the EMA, to IP protection and other legal issues. 13 July 2018
US biotech major Amgen and Belgian pharma company UCB have resubmitted their Biologics License Application (BLA) to the US Food and Drug Administration for Evenity (romosozumab), 13 July 2018
A new draft guidance document, published by the UK’s National Institute for Health and Care Excellence (NICE), warns physicians to take antimicrobial resistance (AMR) into account when prescribing antibiotics for COPD. 12 July 2018
Switzerland’s Roche and Chicago, USA-based AbbVie have submitted to extend the US label for Venclexta (venetoclax) as a first-line acute myeloid leukaemia (AML) therapy. 12 July 2018
Having last year announced its comprehensive policy framework for regenerative medicine, the US Food and Drug Administration (FDA) has this week unveiling complementary measures for the development, review and approval of gene therapies. 12 July 2018
Hemel Hempstead, UK-based EUSA Pharma has received a positive reimbursement decision from the UK’s health technology assessor for its targeted cancer immunotherapy, Qarziba (dinutuximab beta). 12 July 2018
At the annual meeting of 340B Health, a trade body representing hospitals participating in the 340B scheme, Health Secretary Alex Azar promised greater oversight in an effort to reign in costs. 11 July 2018
After its European Medicines Agency (EMA) approval in this indication in April, Sobi's Kineret (anakinra) has launched in the UK for the treatment of adult onset stills disease (AOSD) and systemic-onset juvenile idiopathic arthritis (SOJIA). 11 July 2018
US pharma major Bristol-Myers Squibb has scored an approval in a third tumor type with the combination of its two immuno-oncology drugs, Opdivo (nivolumab) and Yervoy (ipilimumab). 11 July 2018
With safety reviews underway in Europe and warnings for the Canadian regulator, the Food and Drug Administration is strengthening the current warnings in the prescribing information that fluoroquinolone antibiotics may cause significant decreases in blood sugar and certain mental health side effects. 11 July 2018
The Association of the British Pharmaceutical Industry (ABPI) and the Prescription Medicines Code of Practice Authority (PMCPA) have published an updated Code of Practice for drugmakers. 23 September 2024
Shares of California, USA-based precision medicines IDEAYA Biosciences were down 6.3% at $32.5 mid-morning after it revealed what is described as “positive” developments for its darovasertib. 23 September 2024
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