The UK government has released a position paper outlining its vision for Framework Programme 10 (FP10), a successor to Horizon Europe, the EU's flagship research collaboration program. 26 September 2024
Shionogi said today that it has submitted a New Drug Application (NDA) in Japan for zuranolone, a treatment in development for major depressive disorder (MDD). 27 September 2024
China’s National Medical Products Administration (NMPA) has approved Dupixent (dupilumab) as an add-on maintenance treatment for adults with uncontrolled chronic obstructive pulmonary disease (COPD). 27 September 2024
A US Food and Drug Administration advisory committee meeting has recommended restricting the use of PD-1 inhibitors, in a move which could affect blockbuster products such as Bristol Myers Squibb's Opdivo (nivolumab) and Merck & Co's Keytruda (pembrolizumab). 27 September 2024
The US Food and Drug Administration yesterday approved pharma major Bristol Myers Squibb’s Cobenfy (xanomeline and trospium chloride) capsules for oral use for the treatment of schizophrenia in adults. 27 September 2024
The generics and biosimilars trade group, Medicines for Europe, has put out a strong message amid ongoing discussions on a European Union (EU) Critical Medicines Act. 26 September 2024
US biotech Emergent BioSolutions revealed it has secured approximately $400 million in orders in 2024 and 2025 associated with its vaccinia, smallpox and mpox product portfolio. 26 September 2024
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for Joenja (leniolisib), from Netherlands-based Pharming. 26 September 2024
The UK government has released a position paper outlining its vision for Framework Programme 10 (FP10), a successor to Horizon Europe, the EU's flagship research collaboration program. 26 September 2024
Shanghai-based Junshi Biosciences has announced that the European Commission has approved Loqtorzi (toripalimab) for two cancer indications. 26 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
The European Medicines Agency has agreed to review London-listed Shire's application for approval to market Veyvondi as a treatment for von Willebrand Disease (VWD), the most common inherited bleeding disorder. 22 June 2017
The New York Times published an analysis of a draft Trump executive order on prescription pricing and innovation. US advocacy group consumer rights Public Citizen reviewed portions of the order text in cooperation with the Times. 22 June 2017
Anthem is pulling out of health insurance exchanges in Wisconsin and Indiana, a decision cheered by Republicans as another harbinger of doom for Obamacare. 22 June 2017
One interesting corollary of Amazon’s recent acquisition of Whole Foods was the effect on pharmacies, which shed about $10 billion in share price value, according to UBS. 22 June 2017
Citing the saving of $1.67 trillion that competition from generics has brought to the US health care system in the last decade, Food and Drug Administration (FDA) Commissioner Scott Gottlieb has voiced his support for more of these copycat drugs to reach market sooner. 21 June 2017
Shares in Ireland-headquartered Shire are up more than 2% in London, on news that the rare disease specialist has finally received US Food and Drug Administration approval for its long-acting attention deficit hyperactivity disorder (ADHD) therapy. 21 June 2017
A group of the three biggest state rheumatology organizations have joined a new coalition of provider and patient groups concerned about the role of pharmacy benefit managers (PBMs) in driving up drug costs. 21 June 2017
Ten leading pharmaceutical companies in Canada have agreed to disclose payments made in exchange for services or to fund charitable, educational and scientific activities. 21 June 2017
Brexit, political instability, economic uncertainty, an aging population increasingly suffering from chronic conditions, a cost-effectiveness watchdog looking to save every penny possible when paying for new medicines and a National Health Service (NHS) reportedly facing its worst crisis in generations – the challenges facing the UK health sector appear almost insurmountable. 21 June 2017
The US Food and Drug Administration’s Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee (ODAC) has invited PharmaMar (MC: PHM) to participate in this ODAC, giving a presentation to provide background information on Zepsyre. 20 June 2017
Increased scrutiny around the pricing of medicines is starting to have an impact on drug sales growth, according to Evaluate’s latest World Preview report. 20 June 2017
US biotech Amgen closed 1.6% up on Monday at $165.09 after news of further progress relating to its monoclonal antibody, Xgeva (denosumab). 20 June 2017
The US Food and Drug Administration on Monday approved Baxdela (delafloxacin), a new antibacterial drug to treat acute bacterial skin and skin structure infections (ABSSSI). 20 June 2017
Following the recent presidential election and before the Parliamentary elections in France, Marcel Lechanteur, president of Lilly France and Benelux, a unit of Eli Lilly discussed the main issues for the pharmaceutical sector. 20 June 2017
The US Food and Drug Administration (FDA) has approved Darzalex (daratumumab) in combination with pomalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor (PI). 19 June 2017
Sandoz, Novartis’ biosimilars and generics business, today revealed that the European Commission has approved Rixathon (biosimilar rituximab). 19 June 2017
The US Food and Drug Administration has filed the New Drug Application (NDA) for the use of Tavalisse (fostamatinib disodium) in patients with chronic or persistent immune thrombocytopenia (ITP). 19 June 2017
The Institute for Clinical and Economic Review (ICER) has released a new evidence report assessing the comparative effectiveness and value of Tymlos, from US-based Radius Health and Forteo, from Eli Lilly. 19 June 2017