Tag Archives: tirzepatide

FDA Removes Tirzepatide from Shortage List

FDA announced the tirzepatide shortage has been resolved and provided clarifications for compounding manufacturers. According to the announcement, FDA confirmed with Lilly that their stated product availability and manufacturing capacity can meet the present and projected national demand. However, patients and prescribers may still see intermittent localized supply disruptions as the products move through the supply chain from Lilly and distributors to local pharmacies. Below, FENIX provides brief insight into the impact of the FDA announcement.

This content is for Read Less members only.
Already a member? Log in here

Novo CB1 Ph2a Obesity Topline Results; Two Ph3 Tirzepatide Combo Psoriatic Studies Observed; Aligos Ph2a MASH Topline Results; AZ Initiates Ph2 LA Amylin Obesity Study; FTC Sues PBMs; Synjardy Receives Pediatric CHMP Positive Opinion

A series of cardiometabolic-related news items have been observed from Novo Nordisk, Lilly, Aligos Therapeutics, AstraZeneca, FTC, and CHMP. Below, FENIX provides highlights and insights for the respective news items.

This content is for Read Less members only.
Already a member? Log in here

Lilly Raises FY Guidance by $3B; Lilly Q2 ’24 Earnings; Novo Q2 ’24 London Event

Two cardiometabolic-related news items have been observed: Lilly hosted its Q2 ’24 earnings call (press release; slides) and raised its FY2024 revenue guidance by $3.0B; and Novo Nordisk hosted its post-Q2 ’24 earnings London analyst event (view webcast). Below, FENIX provides highlights and insights for the respective calls.

This content is for Read Less members only.
Already a member? Log in here

Tirzepatide SUMMIT HFpEF Topline Results; Regeneron, Alnylam, Ionis, Teladoc, Amarin, and Biomea Q2 ’24 Earnings; Antag Increases Series A Funding for GIP Antagonism; Sanofi Expands Insulin Manufacturing in Germany; Boston Pharmaceuticals MASH Updates

A series of cardiometabolic-related news items have been observed from Lilly, Regeneron, Alnylam, Antag Therapeutics, Sanofi, Boston Pharmaceuticals, Ionis, Teladoc, Amarin, and Biomea Fusion. Below, FENIX provides highlights and insights for the respective news items, including initial thoughts on Lilly’s tirzepatide HFpEF results in the context of Novo’s STEP HFpEF and apparent regulatory delay.

This content is for Read Less members only.
Already a member? Log in here

BioAge Initiates Ph2 POC Oral Azelaprag+Tirzepatide Combination Trial in Obesity; TIXiMED Receives IND Approval from FDA for Oral Non-Immunosuppresive T1DM Drug; Novo Buys Land in Denmark for Potential Production Plant

Three cardiometabolic-related news items have been observed: BioAge Labs initiated a Ph2 POC study evaluating co-administered oral azelaprag QD or BID with QW SC injection of tirzepatide in obesity (STRIDES; view CT.gov record); TIXiMED announced it obtained IND approval from FDA for its oral T1DM drug, TIX100 (view press release); and Novo Nordisk reportedly will begin construction for a potential new production plant in Denmark (view article). Below, FENIX provides highlights and insights for the respective news items.

This content is for Read Less members only.
Already a member? Log in here