US pharma major Bristol Myers Squibb’s recent approval from the US Food and Drug Administration (FDA) for Cobenfy (xanomeline and trospium chloride) for the treatment of adults with schizophrenia is a win for the company. 9 October 2024
The US Food and Drug Administration on Friday approved Zinbryta (daclizumab) for the treatment of adults with relapsing forms of multiple sclerosis (MS). 31 May 2016
The Drugs Controller General India (DCGI) has granted limited approval for manufacturing and marketing of stem cell based biological product Stempeucel for the treatment of Buerger's disease. 31 May 2016
The US Food and Drug Administration has granted accelerated approval to liver disease drug Ocaliva (obeticholic acid), the lead product of US biopharma Intercept. 31 May 2016
The European Commission has approved Strimvelis, the first ex-vivo stem cell gene therapy to treat patients with a very rare disease called ADA-SCID (severe combined immunodeficiency due to adenosine deaminase deficiency). 31 May 2016
The cost of medicines in Ukraine is the lowest in Europe, but still Ukrainians cannot afford them due to low income, according to experts of Spanish non-governmental organization CivioFoundation. 31 May 2016
At its Annual Assembly last week, Spanish trade group Farmaindustria gave the green light to the amendment of the Code of Practice by which all companies adhered to it will inform healthcare professionals that transfers of value made from January 1, 2017 (to be disclosed in 2018) derived from their collaboration as far as education, scientific-professional meetings and services provision will be disclosed in an individual manner. 31 May 2016
Minerva Neurosciences saw its shares make massive gains on Thursday following the release of positive results from a couple of mid-stage clinical trials. 31 May 2016
The European Medicines Agency started a review of the guidelines that describe first-in-human clinical trials and the data needed to enable their appropriate design and allow initiation. This is being done in cooperation with the European Commission and the Member States of the European Union. 27 May 2016
The European Medicines Agency has recommended the granting of marketing authorizations in the European Union for two new combination therapies against chronic (long-term) hepatitis C virus (HCV) infection, Epclusa (sofosbuvir/velpatasvir) and Zepatier (grazoprevir/elbasvir). 27 May 2016
AstraZeneca today announced that the US Food and Drug Administration has issued a Complete Response Letter (CRL) regarding the New Drug Application for sodium zirconium cyclosilicate (ZS-9). 27 May 2016
The US Food and Drug Administration has approved Afstyla (antihemophilic Factor [recombinant], single chain), a novel long-lasting recombinant factor VIII single-chain therapy for adults and children with hemophilia A from CSL Behring. 27 May 2016
The pharmaceutical industry in Italy is set to decline from $21.3 billion in 2016 to $18.6 billion by 2020, at a negative compound annual growth rate of 3.3%, primarily due to the country's struggling economy. 27 May 2016
Adoption of the European Parliament’s report on the Single Market Strategy in Plenary has been applauded by Medicines for Europe, which represents generic and biosimilar medicines producers in Europe. 26 May 2016
The National Institute for Health and Care Excellence (NICE) has today published draft guidance that does not recommend approval for use in the National Health Service of US pharma major Eli Lilly’s Portrazza (necitumumab) for treating lung cancer. 26 May 2016
The US Food and Drug Administration’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) yesterday recommended the approval of the New Drug Application (for the investigational fixed-ratio combination of basal insulin glargine 100 Units/mL and GLP-1 receptor agonist lixisenatide for the treatment of adults with type 2 diabetes. 26 May 2016
US biopharma Intercept Pharmaceuticals is due to find out on Friday whether its liver disease drug Ocaliva (obeticholic acid) receives approval from the Food and Drug Administration (FDA). 25 May 2016
Sarepta Therapeutics today announced that the US Food and Drug Administration has notified the company that it is continuing its review and internal discussions related to the pending New Drug Application for eteplirsen. 25 May 2016
The Transatlantic Trade and Investment Partnership (TTIP) could increase the annual value of European Union (EU) pharma exports by 9 billion euros ($10.03 billion) by slashing trade barriers, a study suggests. 25 May 2016
Two US units of Israel’s Teva Pharmaceutical Industries have agreed to pay $450 million to resolve two matters that allege Teva violated the Anti-Kickback Statute (AKS) and the False Claims Act (FCA), the US Department of Justice (DoJ) announced yesterday. 11 October 2024
South Korea’s Samsung Bioepis has released its Fourth Quarter 2024 Biosimilar Market Report, marking the seventh-edition of the Quarterly Biosimilar Market Report in the United States. 11 October 2024
The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has approved Pfizer and BioNTech's latest COVID-19 vaccine, Comirnaty (KP.2). 11 October 2024
In what Astella Pharma calls “a landmark decision for advanced bladder cancer patients,” the Japanese drugmaker gained approval in the UK for its treatment regimen. 10 October 2024
Nanoscope Therapeutics says that, following a productive FDA meeting with the US Food and Drug Administration (FDA) for its clinical program evaluating MCO-010 for the treatment of retinitis pigmentosa (RP), the company will commence with submission of a Biologics License Application (BLA) in the first quarter of 2025. 10 October 2024
US healthcare giant Johnson & Johnson’s Tecvayli (teclistamab) has been recommended by the National Institute for Health and Care Excellence (NICE) as a first-line option to treat myeloma in England and Wales. 10 October 2024
The European Medicines Agency (EMA) has accepted for review the Marketing Authorization Applications for AVT03, a proposed biosimilar candidate to the Prolia and Xgeva (denosumab), submitted by Germany’s STADA Arzneimittel. 10 October 2024
The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for Part 1 of the New Drug Application (NDA) for dasiglucagon. 10 October 2024
CMS released a Request for Information (RFI) and a sample list of prescription drugs that the agency preliminarily intends to include under the proposed Medicare $2 Drug List Model. 10 October 2024
The UK has launched a new Regulatory Innovation Office (RIO), with the goal of accelerating new technologies, particularly in sectors like biotech and healthcare, by reducing regulatory barriers. 9 October 2024
US pharma major Bristol Myers Squibb’s recent approval from the US Food and Drug Administration (FDA) for Cobenfy (xanomeline and trospium chloride) for the treatment of adults with schizophrenia is a win for the company. 9 October 2024
Israel-based Teva Pharmaceutical Industries today announced that the US Food and Drug Administration (FDA) has accepted, and the European Medicines Agency (EMA) has validated, applications for TVB-009P, a biosimilar candidate to Prolia (denosumab). 8 October 2024
UK-based ViiV Healthcare, the specialist HIV company majority-owned by GSK (LSE: GSK), with Pfizer and Shionogi as shareholders, has announced a milestone in its efforts to achieve widespread international access to its therapies. 7 October 2024
Texas Attorney General Ken Paxton has filed a lawsuit against major pharmaceutical companies, including Eli Lilly (NYSE: LLY), alleging a conspiracy to artificially inflate the prices of insulin by up to 1,000%. 7 October 2024