FarmaKology Newsletter - Issue #16
Bridge Therapeutics Inc.
Bridge Therapeutics®, based in Birmingham, is an innovative development-stage specialty pharmaceutical company pursuing U.S. (FDA) and (EMA) approvals of a patented (U.S. Patent #8410092) drug combination, BT-205, for the treatment of chronic pain in opioid-experienced patients. Bridge Therapeutics' goal is to make the BT-205 compound and other investigational new drug candidates available to millions of patients in which addictive and potentially dangerous full-agonist opioids such as oxycodone and morphine are ineffective and/or unsatisfactory.
Novartis provides update on Phase III PARAGON-HF trial in heart failure patients with preserved ejection fraction (HFpEF)
Novartis today announced topline results from the global Phase III PARAGON-HF study, investigating the safety and efficacy of sacubitril/valsartan versus the active comparator valsartan in HFpEF patients. The trial narrowly missed statistical significance for its composite primary endpoint of reducing cardiovascular death and total heart failure hospitalizations. Safety and tolerability were consistent with previously reported sacubitril/valsartan data.
Pfizer is spinning off its off-patent and generics business UpJohn, and combining it with generic drugmaker Mylan to create a giant off-patent group with global annual revenues worth about $20 billion.
Indian pharma firms are seeking partners that can make tangible business contributions, safeguard IP, ensure operational control and manage talent .Dr Reddy’s, Aurobindo Pharma, Cipla, Sun Pharmaceuticals Industries are looking at China as a big opportunity.
The EMA has announced its approval for marketing authorisation in the EU for Vitrakvi (larotrectinib), used to treat solid tumours with a specific gene mutation.