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
Sandoz, the generics and biosimilars business of Swiss pharma giant Novartis, has received approval from the European Commission (EC) for a type II variation for the addition of a subcutaneous (sc) route of administration in Binocrit’s (epoetin alfa) nephrology indication. 8 April 2016
A US Food and Drug Administration Advisory Committee has unanimously recommended accelerated approval of Ocaliva (obeticholic acid) for the treatment of the liver disease primary biliary cholangitis (PBC). 8 April 2016
The European Commission has approved Giotrif (afatinib) for the treatment of patients with advanced squamous cell carcinoma (SqCC) of the lung whose disease has progressed on or after treatment with platinum-based chemotherapy. 8 April 2016
Vectura Group and Hikma Pharmaceuticals have moved closer to US approval for a generic version of GlaxoSmithKline’s asthma drug Advair Diskus (fluticasone propionate and salmeterol inhalation powder). 8 April 2016
The European Commission adopted the Committee for Medicinal Products for Human Use (CHMP) recommendation to include the treatment of hereditary angioedema (HAE) attacks in adolescents with HAE and to remove the requirements for rabbit IgE testing that formed part of the EU label for Ruconest (recombinant human C1 inhibitor). 7 April 2016
A number of barriers are impeding access to insulin around the world, according to new research published today by Health Action International, Geneva University Hospitals/University of Geneva and Boston University School of Public Health. 7 April 2016
The trade group representing Australia’s biotech industry has moved to clear up confusion over the proposed Australian Innovation and Manufacturing’ (AIM) Incentive. 7 April 2016
The German Institute for Quality and Efficiency in Health Care (IQWiG) has completed its examination of Swedish Orphan Biovitrum’s Elocta (efmoroctocog alfa), assessing whether this new drug offers an added benefit over the appropriate comparator therapy both in prevention and in on-demand treatment for people with hemophilia A. 7 April 2016
A US Food and Drug Administration safety review has found that type 2 diabetes medicines containing saxagliptin and alogliptin may increase the risk of heart failure, particularly in patients who already have heart or kidney disease. 6 April 2016
The US Food and Drug Administration yesterday approved Inflectra (infliximab-dyyb) for multiple indications. This is the second biosimilar approved by the FDA and the first biosimilar monoclonal antibody (MAb) medication cleared in the USA. 6 April 2016
The planned $160 billion mega-merger of US pharma giant Pfizer and Ireland-domiciled Allergan will be called off, with an official announcement expected to be released today, according to media reports. 6 April 2016
The NDA Group, a leading global drug development consultancy, today released findings from its third annual comparison of drug approvals in the USA and Europe, in preparation for this year's DIA EuroMeeting in Hamburg. 5 April 2016
A critical response has been given to draft new guidance issued by the US Food and Drug Administration on the labeling of biosimilars by the Alliance for Patient Access (AfPA). 5 April 2016
The US Food and Drug Administration has approved Descovy (emtricitabine/tenofovir alafenamide), Gilead Science’s fixed-dose combination for the treatment of HIV. 5 April 2016
Russia has come one step closer to the establishment of production of foreign drugs at the facilities of domestic enterprises, as the Russian Federal Antimonopoly Service (FAS) has officially announced that it has completed the design of a scheme of compulsory licensing of imported vital drugs. 5 April 2016
The Indonesian government last week released the 11th economic stimulus package with the aim of boosting the domestic production of medicines' raw materials, particularly for five product categories: biotechnology, vaccines, herbal extracts, active pharmaceutical ingredients and medical devices. 4 April 2016
The Australian Minister for Health, Sussan Ley, has announced that patients will see the cost of their prescriptions for common medicines drop by as much as 60% as part of government reforms. 4 April 2016
Stronger enforcement is needed to deter pharmaceutical manufacturers from continuing to break the law and defraud federal and state health programs, according to a report from US consumer advocacy group Public Citizen released last week. 4 April 2016
The German Institute for Quality and Efficiency in Health Care (IQWiG) examination of Janssen’s HIV treatment Edurant (rilpivirine) finds no added benefit. 4 April 2016