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 European Commission (EC) has approved Opdivo (nivolumab) for the treatment of locally-advanced unresectable or metastatic urothelial carcinoma (mUC) in adults after failure of prior platinum-containing therapy. 3 June 2017
Maryland will become the first state in the USA to enact a law prohibiting “price gouging” by generic pharmaceutical manufacturers, according to a posting on law firm Hyman, Phelps & McNamara’s FDA Law Blog by David Gibbons and Alan Kirschenbaum. 2 June 2017
The reality of a ‘hard Brexit’ – the UK leaving the European Union (EU) without a trade deal in place between the two parties – could lead to UK medicines being treated as imports by the EU and force drugmakers to set up some operations within member states. 2 June 2017
ViiV Healthcare has submitted applications for regulatory approval in Europe and the USA for a single-tablet, two-drug regimen combining its own dolutegravir with Janssen’s rilpivirine. 2 June 2017
In a reversal of its draft guidance, following review of additional data, the National Institute for Health and Care Excellence (NICE) has issued a final appraisal determination recommending Opdivo (nivolumab) for the treatment of adult patients with classical Hodgkin lymphoma (cHL). 2 June 2017
A US government estimate suggests that Netherlands-incorporated drugmaker Mylan overcharged American taxpayers by as much as $1.27 billion for its EpiPen (epinephrine) auto-injectors. 1 June 2017
US biotech Biogen’s Spinraza (nusinersen) has been approved in the European Union (EU) for the treatment of 5q spinal muscular atrophy (SMA). 1 June 2017
The European Commission has granted marketing authorization for Brineura (cerliponase alfa), the first treatment approved in the European Union for the treatment of neuronal ceroid lipofuscinosis type 2 (CLN2), also known as tripeptidyl peptidase 1 (TPP1) deficiency. 1 June 2017
Joe Jimenez, the chief executive of Swiss pharma giant Novartis and chairman-elect of US trade group PhRMA, has said that he expects Donald Trump’s administration to come back with proposals on making prescription drugs more affordable for Americans within three months. 1 June 2017
Breakthrough Therapy designation has been granted by the US Food and Drug Administration for givosiran (ALN-AS1), an investigational RNAi therapeutic targeting aminolevulinic acid synthase 1 (ALAS1) for the prophylaxis of attacks in patients with acute hepatic porphyria (AHP). 1 June 2017
Ohio is to become the second US state to sue the pharmaceutical industry over its role in the opioid epidemic currently facing America, after Mississippi. 1 June 2017
The US Food and Drug Administration has approved the Biologics License Application for Rebinyn (nonacog beta pegol; N9-GP) for the treatment of adults and children with hemophilia B. 1 June 2017
French biotech firm Nicox saw its shares rise 18% to 12.55 euros by late-afternoon trading today, after the company announced it has received its first drug approval from the US Food and Drug Administration. 31 May 2017
The National Institute of Health and Care Excellence (NICE) has issued a positive Final Evaluation Determination (FED) recommending Cerdelga (eliglustat) as a first-line treatment for adult patients with type 1 Gaucher disease, a very rare and inherited genetic condition which can be life-threatening in severe cases. 31 May 2017
The Cystic Fibrosis Engagement Network, a project of the Alliance for Patient Access, today released a new white paper, “Making Treatment Accessible for Cystic Fibrosis Patients.” 31 May 2017
The European Commission has granted approval for Trumenba (meningococcal group B vaccine) for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroup B (MenB) in individuals 10 years of age and older. 31 May 2017
Sandoz, a division of Swiss pharma giant Novartis, has had its proposed adalimumab and infliximab biosimilars accepted for regulatory review by the European Medicines Agency (EMA). 31 May 2017
Several drugmakers have simultaneously received US Food and Drug Administration approval for copycat versions of Strattera (atomoxetine), a treatment for attention-deficit/hyperactivity disorder in pediatric and adult patients. 31 May 2017
In a report likely to please French and Scandinavian readers and have the opposite effect on Italians and Spaniards, the cities hoping to host the new headquarters of the European Medicines Agency (EMA) have been ranked by the financial services firm KPMG. 30 May 2017
Partnerships between UK and European Union medical researchers have increased the value of research, benefiting patients across Europe, according to a report published today (May 30). 30 May 2017
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
Kezar Life Sciences has paused its Phase IIb PALIZADE trial evaluating zetomipzomib in lupus nephritis (LN) following the deaths of four patients. 7 October 2024