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 Hellenic Association of Pharmaceutical Companies (SFEE) is strongly against and rejects in principle the new method for calculating the claw-back in Greece, as it is an unfair measure. 10 July 2017
Events in the pharma sector hitting the headlines last week included a hitch for Merck & Co’s Keytruda, mixed results for Cara Therapeutics’ pain drug candidate CR848, Celgene’s deal with China’s BeiGene and an overview on the sluggish first-half 2017 M&A activity. 9 July 2017
US Health and Human Services Secretary Dr Tom Price has named Dr Brenda Fitzgerald, as the 17th Director of the Centers for Disease Control and Prevention (CDC) and Administrator of the Agency for Toxic Substances and Disease Registry (ATSDR). 8 July 2017
The US Food and Drug Administration (FDA) on Friday approved Endari (L-glutamine oral powder) for sickle cell disease to reduce severe complications associated with the blood disorder. 7 July 2017
Some of the most senior figures in UK pharma have applauded a commitment made by government ministers to seek a collaborative post-Brexit relationship between the UK and the European Union (EU). 7 July 2017
The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC),at its meetings over July 3-6, said it is provisionally restricting the use of the multiple sclerosis medicine Zinbryta (daclizumab)
. 7 July 2017
Japan, with an aging population and increasing healthcare costs, is looking to reform parts of its regulatory system and introduce a larger role for value-based medicine. 7 July 2017
Under pressure from the US Food and Drug Administration, Ireland-incorporated Endo International has agreed to voluntarily withdraw its opioid pain drug Opana ER (oxymorphone hydrochloride extended release) from the US market. 7 July 2017
Germany’s health technology assessor, the Federal Joint Committee, has determined that Cinqaero provides “minor additional benefit” in certain asthma cases. 7 July 2017
Bristol-Myers Squibb’s Orencia (abatacept) received US Food and Drug Administration (FDA) approval to treat adults with active psoriatic arthritis (PsA), the company announced on Thursday. 6 July 2017
Japan’s medicines regulator has ordered that the gastroenterological condition primary sclerosing cholangitis (PCS) be added as a potential side effect of Opdivo. 6 July 2017
National Health Service trusts in England reported a £791 million ($1 billion) deficit last year, despite receiving an additional £1.8 billion from government through a reform program. 5 July 2017
Colorado-based Array BioPharma has submitted two applications to the US Food and Drug Administration, for binimetinib and encorafenib as treatments for BRAF-mutant advanced, unresectable or metastatic melanoma. 5 July 2017
Members of the European Parliament (MEPs) today urged the Commission to address the increase in HIV/AIDS, tuberculosis and viral hepatitis cases in the EU and to develop long-term programs. 5 July 2017
The antiviral drug tenofovir alafenamide (TAF) has been used since 2015 in different combinations for the treatment of HIV and has already been subject to three early benefit assessments for this therapeutic indication by the German Institute for Quality and Efficiency in Health Care (IQWiG). 5 July 2017
The National Institute for Health and Care Excellence (NICE) today published final draft guidance recommending asfotase alpha for people with pediatric-onset hypophosphatasia – a very rare inherited condition affecting between one and seven babies each year in England. 5 July 2017
Biopharmaceutical research draws from a diffuse range of highly specialized technologies, and the traditional wisdom is that pharmaceutical firms, even very large companies, have little choice but to collaborate with others if they are to succeed. 4 July 2017
Although the Canadian regulatory agency has approved the use of three important new drugs for the treatment of multiple myeloma since the start of 2016, none of them is being funded by the government, bemoans the charity Myeloma Canada. 4 July 2017
Dr Nicola Davies looks at how real world evidence carries ever greater importance in an industry where often regulatory approval alone is no longer enough. 4 July 2017