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 timing of the release of statistics showing that 2016 was a record year for the US Food and Drug Administration’s (FDA) generic drug program “couldn’t be better amid concerns about rising drug prices,” according to a senior figure at the agency. 28 February 2017
The US Food and Drug Administration has approved once-daily Qtern (10mg dapagliflozin and 5mg saxagliptin) for the treatment of type-2 diabetes. 28 February 2017
Bausch + Lomb and French biotech firm NicOx have re-submitted a New Drug Application to the US Food and Drug Administration seeking approval for latanoprostene bunod ophthalmic solution, 0.024%. 28 February 2017
In what is believed to be the first move of its kind ever, healthcare professionals in the UK have resorted to crowdfunding to provide cancer patients access to treatment. 28 February 2017
US healthcare giant Johnson & Johnson has released a 2016 US Transparency Report that includes information on pricing and other business practices, covering everything from discovery to the commercialization of pharmaceuticals. 27 February 2017
At a press conference held last week, the Hellenic Association of Pharmaceutical Companies (SFEE) issued an ultimate distress call and a strong warning against the irreparable detrimental consequences for Greek patients from the imminent Ministry of Health measures. 27 February 2017
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended four new medicines for approval at its February meeting. 25 February 2017
As well as four new drug approvals, at its February meeting the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended broader use of three already marketed products. 25 February 2017
The mixed messages on drug pricing policy coming from new US President Donald Trump’s administration are starting to harm healthcare stocks, according to an analyst at the independent broker finnCap. 24 February 2017
US biotech firm Celgene has been approved to market Revlimid (lenalidomide) in the EU as a monotherapy for the maintenance treatment of certain adult patients with newly diagnosed multiple myeloma. 24 February 2017
The US Food and Drug Administration has accepted a supplementary New Drug Application for Zykadia (ceritinib) from Swiss giant Novartis. 24 February 2017
Pharmaceutical firm Zydus Cadila has received approval from Indian regulators to market its tetravalent inactivated influenza vaccine for seasonal flu, VaxiFlu 4. 24 February 2017
The US Food and Drug Administration has granted Toca 511 & Toca FC Breakthrough Therapy designation for the treatment of patients with recurrent high grade glioma (HGG). 23 February 2017
The chief executive of German pharma major Bayer (BAYN: DE) did not hold back in expressing his views on the year’s politics developments as he presented his company’s annual results for the first time. 23 February 2017
Australian biotech companies might not have Brexit or an unpredictable new President to worry about, but they are being caused uncertainty by a troubling tax issue. 23 February 2017
Swiss pharmaceutical firm Dipharma has announced that the European Medicines Agency has validated its Marketing Authorization application for Disanit. 23 February 2017
Truxima (biosimilar rituximab) has been approved by the European Medicines Agency for use in all indications of the reference product Mabthera, the blockbuster monoclonal antibody developed by Roche. 22 February 2017
China's Food and Drug Administration has announced that two five-year plans (2016-2020) on food and drug safety were issued by the State Council on February 21. 22 February 2017
Amphastar Pharmaceuticals revealed it had received a complete response letter (CRL) from the US Food and Drug Administration regarding its opioid overdose drug. 22 February 2017