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
Underlying M&A activity appeared to pick up in the second quarter after a slow start to the year, when tumbling equity markets put the frighteners on dealmakers. 17 July 2016
The US Food and Drug Administration, at a public meeting on Friday, issued a document that contains the performance goals and procedures for the Prescription Drug User Fee Act (PDUFA) reauthorization for fiscal years (FYs) 2018-2022, known as PDUFA VI. It is commonly referred to as the “goals letter” or “commitment letter.” 16 July 2016
Shares in Swiss drugmaker Santhera Pharmaceuticals were sent tumbling on Thursday as markets learnt that the US Food and Drug Administration had not accepted its request for accelerated review of Duchenne muscular dystrophy (DMD) treatment Raxone (idebenone). 15 July 2016
US biotech firm Celgene says it has obtained approval from the European Commission for the use of Revlimid (lenalidomide) for patients with relapsed/refractory mantle cell lymphoma (MCL). 15 July 2016
The head of Eisai in Europe has pledged to subsidize the cost of thyroid cancer drug Lenvima (lenvatinib) if health bosses agree to include it in the revamped Cancer Drugs Fund (CDF). 14 July 2016
There have been reported cases of life-threatening, sometimes fatal pancreatitis associated with the use of Blincyto (blinatumomab) in clinical trial and post-market settings. 14 July 2016
A US Food and Drug Administration advisory committee has unanimously recommended approval of a biosimilar version of the big-selling arthritis drug Enbrel (etanercept). 14 July 2016
The US Food and Drug Administration has removed the clinical hold on the Phase II clinical trial of JCAR015 in patients with relapsed or refractory B cell acute lymphoblastic leukemia (r/r ALL), the drug's developer Juno Therapeutics has announced. 13 July 2016
Loxo Oncology has been granted Breakthrough Therapy designation for its investigational drug candidate LOXO-101 by the Food and Drug Administration. 13 July 2016
The Arthritis Advisory Committee of the US Food and Drug Administration has unanimously recommended approval of ABP 501, a biosimilar being developed by US biotech Amgen, which references Humira (adalimumab), an arthritis drug marketed by US pharma major AbbVie. 13 July 2016
A wave of expiring biotech patents will lead to a surge in growth for manufacturers of biosimilars during the coming years, notes Bellevue Asset Management's healthcare team. 13 July 2016
The author of a new book believes that governments must employ the same approaches to intellectual property (IP) that were used to improve affordable access to anti-retroviral treatment for HIV/AIDS when it comes to new essential medicines. 13 July 2016
The uncertainty over the state of the pharmaceutical industry following Brexit will favor internationally focused professionals, according to NonStop Recruitment. 13 July 2016
Pfizer yesterday revealed that Prevnar 13 (pneumococcal 13-valent conjugate vaccine [diphtheria CRM197 protein]) received US Food and Drug Administration approval for an expanded age indication to include adults 18 through 49 years of age. 13 July 2016
Patient access to biosimilar medicines will hinge on critical policy decisions around extrapolation and biosimilar label content, asserts the Biosimilars Council, a division of the Generic Pharmaceutical Association (GPhA) in comments to the Food and Drug Administration’s Arthritis Advisory Committee. 13 July 2016
A biosimilar version of Pfizer and Amgen’s arthritis drug Enbrel is ‘highly similar’ to the reference product, according to US Food and Drug Administration (FDA) staff briefing documents. 12 July 2016
The National Institute for Health and Care Excellence (NICE) has today published draft guidance recommending Belgian drugmaker UCB’s Cimzia (certolizumab pegol). 12 July 2016
The Canadian subsidiary of Anglo-Swedish pharma major AstraZeneca has received approval for medicines regulator Health Canada for Tagrisso (osimertinib) once-daily tablets. 12 July 2016
The Russian government is considering introducing a three-stage procedure for the public procurement of drugs, according to recent statements of an official spokesman of Denis Manturov, Russia’s Minister of Industry and Trade. 12 July 2016