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
Chinese biopharmaceutical company Hutchison China MediTech (AIM: HCM), also known as Chi-Med, says that the China Food and Drug Administration (CFDA) has acknowledged acceptance of the New Drug Application for fruquintinib for the treatment of patients with advanced colorectal cancer. 13 June 2017
Just as the US Senate Committee on Health, Education, Labor and Pensions begins hearings examining the drug delivery system, the Pharmaceutical Care Management Association (PCMA) is releasing a new analysis, "Increasing Prices Set by Drugmakers Not Correlated With Rebates." 13 June 2017
The Institute of Clinical and Economic Review (ICER) has issued a Final Evidence Report and summary of a public meeting of the Midwest Comparative Effectiveness Public Advisory Council (Midwest CEPAC) that concludes Dupixent (dupilumab) offers good long-term value for patients with moderate-to-severe atopic dermatitis. 12 June 2017
A New Drug Application has been submitted to the US Food and Drug Administration for an investigational, once-daily single tablet regimen containing bictegravir (50mg) (BIC), a novel investigational integrase strand transfer inhibitor, and emtricitabine/tenofovir alafenamide (200/25 mg) (FTC/TAF) for the treatment of HIV-1 infection in adults. 12 June 2017
Dutch quango the Medicines Evaluation Board (MEB) has released its annual report, focusing on its role in ensuring the availability of medicines and reducing the use of animal testing in clinical development. 12 June 2017
Lartruvo (olaratumab), in combination with doxorubicin, has been recommended by the medicines cost-effectiveness watchdog for England and Wales for use as an option for advanced soft tissue sarcoma in adults who have not had any previous systemic chemotherapy for advanced soft tissue sarcoma and cannot have curative treatment with surgery or their disease does not respond to radiotherapy. 12 June 2017
Europe's first oral medication for the treatment of bladder pain syndrome (BPS) characterized by glomerulations or Hunner's lesions has been approved. 12 June 2017
At its June meeting, the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) started a review of Zinbryta (daclizumab) used to treat adults with relapsing forms of multiple sclerosis. 10 June 2017
The National Institute for Health and Care Excellence (NICE) has stuck by its recommendation, made last year, that pirfenidone should be reserved for people with moderate idiopathic pulmonary fibrosis (IPF) only and not prescribed on the NHS for people in the early stages of this fatal lung condition. 9 June 2017
In October 2016, the US Food and Drug Administration placed a clinical hold on a proposed Phase III clinical program for VGX-3100, its investigation therapeutic vaccine for cervical dysplasia caused by the human papillomavirus (HPV). 9 June 2017
The PDUFA renewal bill has cleared its penultimate hurdle in the House of Representatives, as the Energy and Commerce Committee this week cleared a final version to be voted on. 9 June 2017
Biotech industry trade group EuropaBio has developed recommendations for changes to the Summary of Product Characteristics (SmPC) of biosimilars that would result in an enhanced level of transparency in the label. 9 June 2017
When setting the price not only of the first drug of its kind to reach the market, but also one that is manufactured for each individual patient, a drugmaker might feel justified in asking for a good return to cover the significant development and manufacturing costs. 9 June 2017
With concern among much of UK life sciences sector at the hard-Brexit rhetoric of Theresa May but Labour Leader Jeremy Corbyn having risked the wrath of pharma by calling for greater nationalization of medical research, it is hard to know what industry executives must be making of the latest surprise result in a UK political vote. 9 June 2017
The US Food and Drug Administration on Thursday called on Endo Pharmaceuticals to voluntarily remove its opioid pain medication, reformulated Opana ER (oxymorphone hydrochloride), from the market. 9 June 2017
New York, USA-based pharmaceutical giant Pfizer has defended its decision to raise the price of around 100 drugs in the US market by up to 20% in 2017. 8 June 2017
The US Food and Drug Administration (FDA) has accepted for filing Synergy Pharmaceuticals’ supplemental New Drug Application (sNDA) for Trulance (plecanatide) for the treatment of adults with irritable bowel syndrome with constipation (IBS-C). 8 June 2017
As governments, patients and the pharmaceutical industry take ever more seriously the threat of antimicrobial resistance, German researchers have published a new study that points the finger at globalized drug manufacturing. 8 June 2017
The Biologics License Application (BLA) for the first biosimilar candidate to the Roche blockbuster cancer drug Avastin (bevacizumab) to be submitted in the USA, is to be reviewed by a Food and Drug Administration (FDA) committee next month. 8 June 2017