pharma&

Hillhurst Bio doses first subject in Phase 2a HBI-002 Parkinson's trial

FDA · Parkinson's disease · 5 min

Hillhurst Bio doses first subject in a Phase 2a clinical trial of HBI-002 for Parkinson's disease. The study is recruiting and is listed on ClinicalTrials.gov as a randomized, double-blind, placebo-controlled multiple-dose trial.

Alembic Wins Tentative FDA Nod for First Generic Larotrectinib Capsules

FDA · NTRK fusion–positive solid tumors · 7 min

Alembic Pharmaceuticals received tentative FDA approval for generic larotrectinib capsules in 25 mg and 100 mg strengths. The move marks a key catalyst for Vitrakvi competition, with final launch timing still dependent on remaining patent or exclusivity issues.

Alnylam pipeline update: AMVUTTRA catalysts, outlook and profitability

U.S. FDA · ATTR-CM · 5 min

Alnylam pipeline momentum is anchored by AMVUTTRA’s FDA-approved ATTR-CM and hATTR-PN uses, plus two active Phase 3 catalysts. The update focuses on what changed, what it means for investors, and what to watch next.

Tillomed Laboratories update: pipeline, melphalan and next catalysts

oncology · 6 min

Tillomed Laboratories Ltd is owned by Emcure and operates across a broad portfolio spanning oncology, anti-infectives, women’s health, and more. This update focuses on the company’s melphalan link, competitive set, and what BD teams and investors should watch next.

FDA approves Dupixent for COPD with eosinophilic phenotype

FDA · chronic obstructive pulmonary disease · 6 min

The FDA has approved Dupixent as an add-on maintenance treatment for adults with inadequately controlled COPD and an eosinophilic phenotype. The decision gives Regeneron and Sanofi a new regulatory catalyst to track for commercial and investor implications.

Merck’s Harpoon acquisition deepens oncology pipeline ahead of Keytruda risk

oncology · 5 min

Merck has completed its acquisition of Harpoon Therapeutics, adding an immuno-oncology company to its pipeline as it keeps building beyond Keytruda. For analysts and BD teams, the deal is a signal to watch for follow-on M&A and pipeline diversification.

Fosun Pharma and AriBio Forge Alzheimer's Option Agreement: Deal Intelligence

FDA · Alzheimer's · 8 min

Fosun Pharma has entered into a strategic option agreement with AriBio, securing rights to the Alzheimer's drug candidate AR1001. This deal, involving a $60 million option fee, offers significant insights into current Alzheimer's drug development partnerships and their financial structures.

Rx Rundown: Pfizer, Hikma Pharmaceuticals, NewLimit — Drug Approvals & Catalyst Tracker

5 min

Pfizer, Hikma Pharmaceuticals, and NewLimit are at the center of recent FDA actions. This rundown covers approvals, withdrawals, and upcoming catalysts for pharma BD and investors.

MIRA Pharma Consolidates Global Rights to MIRA-55 and SKNY-1

5 min

MIRA Pharmaceuticals amends its MIRALOGX license to secure worldwide exclusive development and commercialization rights for MIRA-55 and SKNY-1, without altering core economics. The move strengthens IP control and follows peer-reviewed data on SKNY-1's obesity and nicotine addiction potential.

Aurobindo Pharma OAI Classification: Implications for Drug Approvals

FDA · 5 min

The FDA has classified a subsidiary unit of Aurobindo Pharma as Official Action Indicated (OAI), signaling significant regulatory non-compliance. This status threatens pending drug approvals and reshapes the competitive landscape for generic and specialty pharmaceuticals.