The last several years has shown a particular focus on immuno-oncology therapies, probably as close to miracle cures as anything seen in recent years. Arpita Dutt, writing for Zacks, predicts what the three hot areas for approvals are likely to be in 2018.
Belgium-based reMYND’s pre-clinical diabetes therapy ReS39 will get a significant boost after the company entered a licensing agreement with noted European diabetes company Novo Nordisk.
U.S. researchers have used nanotechnology plus the powerful CRISPR-Cas9 gene editing tool to turn off a key cholesterol-related gene in mouse liver cells.
Boehringer Ingelheim struck a deal targeting liver disease with MiNA Therapeutics.
Staines-Upon-Thames, UK-based Mallinckrodt agreed to buy Redwood City, Calif.-based Ocera Therapeutics in a deal that could hit $117 million.
Gilead Sciences released results from a Phase II clinical trial of GS-0976 for nonalcoholic steatohepatitis (NASH).
TARGET PharmaSolutions Inc. – a real-world clinical data company – and Boehringer Ingelheim International GmbH entered into a multi-year strategic partnership for TARGET-NASH, a longitudinal observational study that evaluates patients with nonalcoholic fatty liver disease (NAFLD) or nonalcoholic steatohepatitis (NASH).
Takeda Pharmaceutical is jumping into the $40 billion market for nonalcoholic steatohepatitis (NASH) and other diseases of the liver with a $470+ million investment into Virginia-based HemoShear Therapeutics LLC.
The FDA warned health-care providers to stick to dosing recommendations for Intercept Pharma’s liver disease medicine Ocaliva after 19 patient deaths were reported.
Nestle is investing 20 million euros in a joint venture with Enterome SA to develop microbiome-based diagnostics for inflammatory bowel and liver diseases.
Novartis’ push into oncology and liver disease, two of its treatment priorities, advanced as the Swiss drugmaker won a second U.S. breakthrough tag for its cancer gene therapy while striking a separate pact with Allergan.
Drugmaker Allergan Plc said it would buy LifeCell – a regenerative medicine unit owned by privately held Acelity LP Inc. – for $2.9 billion in cash.
Intercept Pharmaceuticals Inc. said its liver drug received conditional approval from the European Commission to treat patients with primary biliary cholangitis (PBC).
Investors were not particularly happy with Gilead’s Q3 2016 report. In addition to sagging sales and revenue, it outlined a laundry list of failed clinical trials.
Drugmaker Intercept Pharmaceuticals Inc.’s drug to treat a rare liver condition was conditionally approved an advisory committee to the European Medicines Agency.
Following a disappointing review of interim data from a clinical study of GS-5745, an investigational anti-MMP9 antibody, Gilead said the company will halt the trial.
The new generation of hep C drugs has completely changed the conversation about launches.
The outlook remains bright due to a favorable regulatory arena, support for biopharma-friendly legislation and development incentives, expanding scientific opportunities in key therapeutic areas such as immuno-oncology, and big pharma’s continued push to obtain innovation.
FDA granted accelerated approval to Ocaliva, the first new medicine for primary biliary cholangitis in nearly 20 years.
Merck award may be in jeopardy after reports a former Merck scientist lied to a jury about claims he was responsible for developig hepatitis drugs Gilead was accused of infringing upon.