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
The US Food and Drug Administration (FDA) on Friday approved Dupixent (dupilumab) as an add-on maintenance treatment of adults with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype. 28 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
Alkermes has submitted a supplemental New Drug Application (sNDA) to the US Food and Drug Administration for a two-month dosing interval of Aristada (aripiprazole lauroxil) extended-release injectable suspension for the treatment of schizophrenia. 9 August 2016
In our weekly expert view piece, Victoria Hordern, privacy and cybersecurity lawyer at Hogan Lovells, examines the UK government's proposals on data security and data sharing in the health sector. 9 August 2016
Russian President Vladimir Putin has instructed the national Federal Anti-Monopoly Service (FAS) and the federal government to continue regular monitoring of drug prices in the domestic market, as well as their compliance with the current market realities. 8 August 2016
New Zealand’s Pharmaceutical Management Agency PHARMAC today announced the approval of an agreement with Boehringer Ingelheim for the listing of Praxbind (idarucizumab) for use in District Health Board (DHB) hospitals, along with price reductions for anticoagulant Pradaxa (dabigatran). 8 August 2016
In a joint article published last week by Drug Discovery Today, the European Medicines Agency (EMA) and the Therapeutic Goods Administration (TGA) in Australia describe their positive experiences with the publication of assessment reports for medicines – known as European public assessment reports (EPARs) in Europe and Australian Public Assessment Reports (AusPARs) in Australia. 5 August 2016
The European Commission has approved under the EU Merger Regulation the proposed acquisition of the consumer health business of Germany's Boehringer Ingelheim by French pharma major Sanofi, subject to conditions. 5 August 2016
USA-based Bellicum Pharmaceuticals has received orphan drug designations from the European Commission for both its lead T-cell therapy product candidate BPX-501 for hematopoietic stem cell transplantation (HSCT), and for activator agent rimiducid for the treatment of Graft versus Host Disease (GvHD). 5 August 2016
Indian generics firm Natco Pharma says it has received final approval of its Abbreviated New Drug Application filed with the US Food and Drug Administration for oseltamivir phosphate oral capsules. 5 August 2016
As the trade ministers of the 16 countries negotiating the Regional Comprehensive Economic Partnership (RCEP) meet in Laos on August 5 to resolve differences that are holding back negotiations, international medical humanitarian organization Médecins Sans Frontières (MSF) is calling for the removal of damaging intellectual property provisions – known as TRIPS-plus provisions – that would lock in high drug prices and endanger the health of millions of people across the globe. 5 August 2016
In draft guidance published today, the National Institute for Health and Care Excellence (NICE), the drug cost-effectiveness watchdog for England and Wales, has recommended innovative new drug Cosentyx (secukinumab) from Swiss pharma giant Novartis for treating ankylosing spondylitis. 4 August 2016
A European pilot project which aims to give faster access to promising medicines in areas of unmet medical need has been hailed a success by the European Medicines Agency (EMA). 4 August 2016
Patents are granted to stimulate creativity and innovation among competing drug manufacturers. They are not easy to come by and so innovators who target new areas of health are rewarded with enough time to recoup the typically high costs incurred during the research and development phase, writes Dr Nicola Davies in her exclusive monthly FDA Blog for The Pharma Letter. 3 August 2016
US rare and orphan disease focussed biotech firm Amicus Therapeutics plans to submit a Japanese New Drug Application (J-NDA) to request marketing authorization for migalastat, an oral precision medicine for Fabry disease, in the first half of 2017. 3 August 2016
The drug cost-effectiveness watchdog for England and Wales, the National Institute for Health and Care Excellence (NICE), has published draft guidance recommending apremilast, a drug marketed by US biotech firm Celgene as Otezla, for psoriasis patients. 3 August 2016
Swiss pharma giant Novartis has received US Food and Drug Administration Breakthrough Therapy designation for LEE011 (ribociclib), in combination with letrozole, for hormone receptor positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced or metastatic breast cancer. 3 August 2016
The European Commission has approved US pharma giant Merck & Co’s Keytruda (pembrolizumab), the company’s anti-PD-1 therapy, at a dose of 2mg/kg every three weeks, for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) in patients whose tumors express PD-L1 and who have received at least one prior chemotherapy regimen. 3 August 2016
The High Court in Britain has overturned a decision by NHS England to remove Pre-Exposure Prophylaxix (PrEP) for HIV from its commissioning process. 2 August 2016
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is inviting interested parties to provide feedback on Clinical Trial Regulation guidance documents. 2 August 2016