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
Astellas Pharma has submitted a new drug application to the Ministry of Health, Labor and Welfare in Japan for extended-release tablets of quetiapine fumarate (FK949E) for the indication of improvement of depressive symptoms associated with bipolar disorder. 10 August 2016
The US Food and Drug Administration has given the nod for Japanese pharma major Eisai and US biotech Biogen to take their investigational oral beta-secretase cleaving enzyme (BACE) inhibitor E2609 into Phase III studies in Alzheimer’s. 10 August 2016
Japanese pharma major Takeda Pharmaceutical has expressed its disappointment at preliminary draft guidance from the National Institute for Health and Care Excellence (NICE) which does not recommend Adcetris (brentuximab vedotin) – a drug which is on the UK’s Cancer Drugs Fund (CDF) list. 10 August 2016
The US Food and Drug Administration granted accelerated approval to for pharma giant Merck & Co’s Keytruda (pembrolizumab) for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy. 9 August 2016
The UK's National Institute for Health and Care Excellence (NICE) has gone back on its initial view after publishing final draft guidance which recommends talimogene laherparepvec for advanced melanoma that has spread and cannot be surgically removed. 9 August 2016
The overwhelming majority of US patients’ groups opposing a Medicare Part B proposal to reduce drug expenditures got funding from the pharmaceutical industry, according to a new Public Citizen report. 9 August 2016
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
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