Armed with positive results in two phase 3 trials, Takeda intends to file for approval of its oral psoriasis therapy zasocitinib in the US and other countries next year, with Bristol Myers Squibb’s Sotyktu in its sights. Once-daily zasocitinib, described as a second-generation TYK2 inhibitor, met all its safety and efficacy objectives in patients with…
There has been a flurry of new licensing deals in the last few days, with Bristol Myers Squibb, Sanofi, Pfizer, Roche, and little Yarrow Bioscience all adding to their R&D pipelines. BMS’ antibody alliance BMS signed a multiyear agreement with antibody specialist Harbour BioMed, which has operations in the US, the Netherlands, and China, that…
Privately-held drug developer LIB Therapeutics has claimed FDA approval for a new once-monthly PCSK9 inhibitor – Lerochol – that can be used to reduce cholesterol levels. The injectable product has been approved alongside diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, including those with heterozygous familial hypercholesterolemia (HeFH). According to…
Regulators in the UK and US are the first to approve GSK’s Exdensur, a long-acting, twice-yearly IL-5 inhibitor for severe asthma that has been billed as a major new product for the drugmaker. In the UK – the first market for the drug – the MHRA has cleared Exdensur (depemokimab) for the treatment of asthma…
Overturning decades of advice, the CDC has said it no longer recommends that all US newborns receive a hepatitis B vaccine, a change that experts say will harm children. The new recommendations will replace the universal birth dose of the shot with “individual decision-making” that will require parents and healthcare providers to “consider vaccine benefits,…
Among seven new medicines recommended for approval by the EMA’s human medicine advisory committee at its latest meeting is GSK’s depemokimab, a long-acting anti-IL-5 antibody for severe asthma and an inflammatory condition that causes nasal polyps. GSK hopes that depemokimab – which has the proposed trade name of Exdensur in the EU – will become…
Sobi has hit the acquisition trail with a deal to buy Arthrosi Therapeutics for up to $1.5 billion, adding a drug in late-stage clinical testing for gout. The deal, which includes a sizeable $950 million in upfront cash and $550 million tied to potential clinical, regulatory, and sales milestones, revolves around once-daily URAT1 inhibitor pozdeutinurad…
A first-of-its-kind partnership between medicines regulators in the UK and Singapore could allow patients in both countries to access new medical advances more quickly. The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) and Singaporean Health Sciences Authority (HSA) say the ‘regulatory innovation corridor’ aims to speed up patient access to breakthrough therapies in high-impact…
Eli Lilly has ramped up the competition in weight-loss therapies by reporting the first pivotal data with its triple therapy retatrutide, showing average weight losses of up to 28.7% in its first phase 3 readout. Top-line results from the TRIUMPH-4 trial, carried out in patients overweight or with obesity and knee osteoarthritis, raise expectations for…
Swiss biotech AC Immune has said that its vaccine-like alpha-synuclein-targeted immunotherapy has shown promise in slowing down the progression of Parkinson’s disease. The results of the phase 2 VacSYn trial of ACI-7104.056 in patients with early-stage Parkinson’s have shown that the immunotherapy can reduce disease-related biomarkers – namely alpha-synuclein levels in the cerebrospinal fluids (CSF)…