After the disappointing failures of highly anticipated anti-amyloid pipeline drugs, such as Pfizer/Johnson...
- Lanabecestat termination: another blow for BACE inhibitors
- EULAR 2018: Focus on infliximab biosimilars in rheumatoid arthritis
- Pfizer’s blockbuster drug Lyrica comes off-patent in 2018
- Report: Gene therapies may see success and regulatory oncology updates
- Deals and M&As this week: Alexion Pharmaceuticals, Recipharm, AstraZeneca
FDA approves Suboxone generic variant to treat opioid dependence
The US Food and Drug Administration (FDA) has granted Mylan Technologies and Dr. Reddy's Laboratories marketing approval for generic versions of Suboxone (buprenorphine and naloxone) sublingual film to treat opioid dependence.
Lanabecestat termination: another blow for BACE inhibitors
After the disappointing failures of highly anticipated anti-amyloid pipeline drugs, such as Pfizer/Johnson & Johnson’s bapineuzumab and Eli Lilly’s solanezumab, the focus of research in Alzheimer’s has increasingly turned to beta-secretase (BACE) inhibitors. Unlike the injectable monoclonal antibodies, the BACE inhibitors are oral small molecules.
EULAR 2018: Focus on infliximab biosimilars in rheumatoid arthritis
On June 14th, Biocad presented Week 14 results on the safety and efficacy of BCD-055 (infliximab biosimilar) from the ongoing Phase III LIRA clinical trial. The international, multicenter, double-blind, placebo-controlled trial randomised (2:1) 426 adult patients with active rheumatoid arthritis (RA) to receive BCD-055 or infliximab innovator for 54 weeks both at a dose of 3mg/kg. At Week 14, 71.6% of patients receiving BCD-055 compared with 67.9% of patients receiving Remicade achieved American College of Rheumatology 20% improvement criteria (ACR20) (p=0.587).
Pfizer’s blockbuster drug Lyrica comes off-patent in 2018
Lyrica, Pfizer’s blockbuster anticonvulsive treatment, is expected to come off-patent in December 2018, leading to a dramatic reduction in sales due to generic erosion.
Report: Gene therapies may see success and regulatory oncology updates
Immune-based gene therapy candidates have the potential to prevail in oncology space but this uncharted territory will require new regulatory guidelines and restructuring of current treatment algorithms, according to a report by GlobalData.
Deals and M&As this week: Alexion Pharmaceuticals, Recipharm, AstraZeneca
Alexion Pharmaceuticals has partnered with Complement Pharma for the co-development of pre-clinical complement inhibitor for neurodegenerative disorders.
Merck’s Keytruda gets US approval for PMBC lymphoma
Merck has received the US Food and Drug Administration (FDA) approval for the use of its Keytruda drug to treat refractory primary mediastinal large B-cell lymphoma (PMBCL).
The ten most promising cancer drugs being trialled
To meet rising demand, companies worldwide are striving to develop cost-effective and innovative therapies for a wide variety of cancer types. Pharmaceutical-technology.com lists some of the most promising oncology drugs that are currently undergoing late-stage clinical trials.
FDA fast-tracks Nordic Nanovector’s Betalutin for follicular lymphoma
Norwegian biotechnology firm Nordic Nanovector has secured fast-track status from the US Food and Drug Administration (FDA) for its Betalutin (177Lu-lilotomab satetraxetan) drug to treat follicular lymphoma (FL).
UK’s NICE issues positive guidance for Janssen’s Tremfya
The National Institute for Health and Care Excellence (NICE) of the UK has issued positive guidance for Janssen Pharmaceutical’s Tremfya (guselkumab) to treat adults suffering from moderate to severe plaque psoriasis.
Read our magazine
Pharma Technology Focus is the essential reading material for decision-makers in the pharmaceutical industry, bringing you the latest news and analysis in an exciting, interactive format.