The Foundation for Economic and Industrial Research and Greek pharma trade group the Hellenic Association of Pharmaceutical Companies have presented two studies reflecting the industry’s importance. 23 September 2024
Amgen yesterday revealed that Tepezza (teprotumumab [genetical recombination]) has been approved for the treatment of active or high clinical activity score (CAS) thyroid eye disease (TED) in Japan. 25 September 2024
Eli Lilly's Kisunla has been approved in Japan for early symptomatic Alzheimer's disease, following its US approval in July 2024. Administered via IV infusion, it targets patients with mild cognitive impairment and dementia linked to amyloid pathology. Kisunla aims to slow cognitive and functional decline in AD patients 25 September 2024
Healthcare plan provider Centivo has raised $75 million in equity and debt financing to support its goal of offering affordable care to employees and their families. 25 September 2024
President Biden has said the USA will commit at least $500 million to support African countries in battling the ongoing mpox outbreak in Central and Eastern Africa. 25 September 2024
People affected Niemann-Pick disease, a rare and fatal genetic disorder, have waited a lifetime for an effective medicine. Now, in the space of a week, the US regulator has approved two. 25 September 2024
The Japanese Ministry of Health, Labor, and Welfare (MHLW) has approved Otsuka’s (TYO: 4578) Lupkynis (voclosporin) for the treatment of lupus nephritis (LN), an inflammation of the kidneys caused by systemic lupus erythematosus (SLE), an autoimmune disease 24 September 2024
CSL Vifor today announced that Japan’s Ministry of Health and Labor Welfare (MHLW) has granted its partner, Zeria Pharmaceutical marketing authorization approval for Veltassa (patiromer). 24 September 2024
The Pharmaceutical Research and Manufacturers of America (PhRMA) is continuing its legal challenge against the US government’s drug pricing reforms. 24 September 2024
Takeda has announced the Japanese approval of Fruzaqla (fruquintinib) capsules 1mg/5mg, a selective oral inhibitor of vascular endothelial growth factor receptor (VEGFR) -1, -2 and -3, to treat advanced or recurrent colorectal cancer (CRC) that is neither curable nor resectable and that has progressed after chemotherapy. 24 September 2024
Japan’s Ministry of Health, Labor and Welfare of Japan (MHLW) has approved New Drug Application (NDA) for Quviviq (daridorexant; ACT-541468) 25mg and 50mg for the treatment of adult patients with insomnia, submitted by Nxera Pharma. 24 September 2024
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 Foundation for Economic and Industrial Research and Greek pharma trade group the Hellenic Association of Pharmaceutical Companies have presented two studies reflecting the industry’s importance. 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
On Friday, the USA’s Federal Trade Commission (FTC) brought action against the three largest prescription drug benefit managers (PBMs) - Caremark Rx, Express Scripts (ESI), and OptumRx 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
A new antibiotic, the first of its class, has received a positive review from the US Food and Drug Administration's (FDA) Antimicrobial Drug Discovery Committee ahead of a full FDA decision in October. 9 August 2018
It’s been an important week for clinical research, with two important documents published which should go a long way in helping to support clinical research as the UK leaves the European Union, writes Dr Sheuli Porkess, deputy chief scientific officer at the Association of the British Pharmaceutical Industry (ABPI). 9 August 2018
In an Expert View piece, Mark Davison, head of operations in the European Union for software company RFXCEL, outlines everything marketing authorization holders need to know and what you need to do for a seamless serialization process – before regulators remove your right to trade. 8 August 2018
Glenmark Pharmaceuticals today announced that the US Food and Drug Administration has accepted for review the company's New Drug Application for its leading respiratory pipeline candidate Ryaltris. 8 August 2018
Yesterday, delivering on proposals in President Trump’s American Patients First blueprint, the USA’s Health and Human Services (HHS) Department announced that Medicare Advantage plans will be able to use tools employed by private-sector insurers to negotiate lower prescription drug prices for patients. 8 August 2018
The US Food and Drug Administration as approved Orkambi (lumacaftor/ivacaftor) to include use in children ages two through five years with cystic fibrosis (CF) who have two copies of the F508del-CFTR mutation. 8 August 2018
The UK's Department for Health has launched a consultation on its plans to begin applying price controls to biosimilars, proposals that have promptly been ridiculed. 7 August 2018
The industry-funded ARM Foundation for Cell and Gene Medicine has launched a new health economic analysis of regenerative medicine therapies, which includes a review of academic literature, health technology assessments, and value frameworks. 7 August 2018
The US Food and Drug Administration has granted Breakthrough Therapy designation for Braftovi (encorafenib), in combination with Mektovi (binimetinib) and cetuximab, intended to expedite development and review of drugs for serious conditions, where preliminary clinical evidence indicates that they may demonstrate substantial improvement over existing therapies. 7 August 2018
I-MAK, a pressure group composed of lawyers, health professionals and academics, has published a report excoriating pharma giants for allegedly exploiting patent laws in order to drive up prices. 7 August 2018
The China National Drug Administration (CNDA) has granted approval of Ibrance (palbociclib), the first cyclin-dependent Kinase 4/6 (CDK4/6) inhibitor, for the treatment of hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2) advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine-based therapy in postmenopausal women. 7 August 2018
No need for anxiety — that’s the line at the launch of a new white paper from contract research organization IQVIA, tackling the uncertainty facing UK biopharma ahead of the country’s departure from the European Union. 7 August 2018
Following on from a series of measures aimed at challenging the ongoing opioid addiction epidemic in the USA, the US Food and Drug Administration announced new action on Monday, with a set of revised scientific recommendations. 7 August 2018
Pain Therapeutics has received a Complete Response Letter from the US Food and Drug Administration for its New Drug Application (NDA) for the abuse-deterrent opioid drug Remoxy ER (oxycodone) extended-release capsules CII. 6 August 2018
The UK’s medicines regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), has released an update on clinical trials regulations following the UK’s exit from the European Union, so-called “Brexit”. 6 August 2018
The Institute for Clinical and Economic Review has issued a final report for AbbVie’s Orilissa (elagolix), raising serious questions over the affordability of the product. 6 August 2018
The China National Drug Administration (CNDA) has approved Genvoya (elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg or E/C/F/TAF) for the treatment of HIV-1 infection. 6 August 2018
The USA’s Institute for Clinical and Economic Review (ICER) on Friday released a Final Condition Update report and Report-at-a-Glance on targeted immunomodulators for the treatment of moderate-to-severe plaque psoriasis. 6 August 2018
Capricor Therapeutics is a clinical-stage biotechnology company focused on the discovery, development, and commercialization of first-in-class biological therapeutics for the treatment of rare disorders.
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