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
A completed rolling submission has been filed with the US Food and Drug Administration (FDA) of the Biologics License Application (BLA) for axicabtagene ciloleucel. 3 April 2017
Privately-held Swiss biotech AB2 Bio has received Breakthrough Therapy Designation from the US Food and Drug Administration for its autoinflammatory candidate IL-18BP (tadekinig alfa). 3 April 2017
The US Food and Drug Administration has approved a supplemental New Drug Application (sNDA) for a first-in-class cyclin dependent kinase 4/6 (CDK 4/6) inhibitor, Ibrance (palbociclib). 3 April 2017
Most of the headline grabbing news last week focussed on approvals of new medicines and some exciting clinical trial results. Among these were the approvals of Roche’s Ocrevus for multiple sclerosis, Tesaro’s Zejula for treatment of recurrent ovarian cancer and Sanofi’s Dupixent for atopic dermatitis. Also stirring interest was clinical data on Vertex’ combination of tezacaftor and ivacaftor. 2 April 2017
The chief executive for the UK and Ireland at German pharma major Bayer is spending 30% of his time working on issues related to Brexit, he said this week. 1 April 2017
In a new snapshot survey of leading pharmaceutical businesses in the UK, companies have said that changes to the way the National Institute for Health and Care Excellence (NICE) and NHS England (NHSE) assess new medicines coming in to effect today (April 1, 2017), will decrease access to the latest treatments, with new medicines for cancer set to be impacted the most. 1 April 2017
Jubilant Democrats may have to put the champagne cork back in the bottle - the Affordable Care Act (ACA) may not be out of the woods just yet. 31 March 2017
Ahead of its Advisory Committee meeting to discuss the Biologics License Application for nonacog beta pegol, a long-acting factor IX for the treatment of hemophilia B, the US Food and Drug Administration has published briefing documents. 31 March 2017
There's no doubt about it - last week's failure to pass the American Health Care Act was a painful setback in the fight to repeal and replace Obamacare, wrote Sally Pipes in the Washington Examiner’s Beltway Confidential blog. 31 March 2017
The US Food and Drug Administration (FDA) has fully approved AstraZeneca’s non-small cell lung cancer (NSCLC) treatment Tagrisso (osimertinib), the company announced today. 31 March 2017
Canada-based Aeterna Zentaris’ announced that, following its meeting with the US Food and Drug Administration on March 29, 2017, the company intends to file a New Drug Application (NDA) seeking approval of Macrilen (macimorelin) for the evaluation of growth hormone deficiency in adults (AGHD). 30 March 2017
President Trump's choice to head up the US Food and Drug Administration, Scott Gottlieb, is severing ties with industry in an attempt to put clear blue water between his previous life as a pharmaceutical insider and his new incarnation as FDA Commissioner. 30 March 2017
UK-based Mundipharma has received the green light from Japanese regulators to market Mundesine (forodesine hydrochloride), the first regulatory approval for the novel therapy. 30 March 2017
International expansion and bringing affordable biosimilars to patients are two of the stated aims of privately-held Russian biotech company Biocad, and the company has taken a step forward on both fronts with news on one of its products. 30 March 2017
The Food and Drug Administration’s Oncologic Drugs Advisory Committee (ODAC) voted unanimously (11 to 0) that the benefit-risk of rituximab/hyaluronidase for subcutaneous injection was favorable for the treatment of certain blood cancers. 30 March 2017
The US Food and Drug Administration has accepted the Biologics License Application (BLA) filing and granted priority review for CTL019 (tisagenlecleucel-T), an investigational chimeric antigen receptor T cell (CAR-T) therapy, in relapsed and refractory (r/r) pediatric and young adult patients with B-cell acute lymphoblastic leukemia (ALL). 30 March 2017
News that the company had received a complete response letter (CRL) from the US Food and Drug Administration (FDA) on its abbreviated new drug application (ANDA) for a generic version of a big-selling asthma medication caused a 3% drop in the share price of Mylan on Wednesday. 30 March 2017
Before Theresa May signed the decree absolute, Ireland began preparing its bid to become the new home of the European Medicines Agency (EMA). 29 March 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