The FDA approved 7 new drugs in August 2026. These approvals introduced new treatment approaches across sleep disorders, Alzheimer's disease diagnostics, oncology, rare diseases, autoimmune conditions, and hematology. For pharma companies, each approval can signal future opportunities around market entry, exclusivity timelines, and filing strategies. These approvals may also create future requirements for comparator sourcing,…

Comparator sourcing is one of the most consequential decisions in trial design. Get it wrong, and the results become hard to interpret, regulators question the design, or the supply team cannot get the product in time. Comparator drug, active comparator, and placebo are often used as if they mean the same thing. They don't. Each…

Salim Shaikh, Founder and CEO of Spring Bio Solution, has authored a new article, "The Intelligence Gap in Comparator Sourcing: Why Clinical Trial Teams Are Still Flying Blind". This article examines one of the most costly yet overlooked problems in clinical research: the disconnect between comparator sourcing intelligence and trial design. Sponsors invest millions in…

6 new drugs were approved by the FDA in the month of July. These drugs created new opportunities across oncology, immunology, cardiovascular care, ophthalmology, and CNS therapies. They hint at new market opportunities, exclusivity timelines, and potential filing strategies for the decision-making teams. Each new approval also signals a future comparator & RLD sourcing requirement,…

A drug can look brilliant in a single-arm study and fail completely once placed head-to-head against an active control. That gap between apparent effect and real effect is the entire reason controlled clinical trials exist. Most participants improve for reasons that have nothing to do with the investigational product. Disease states fluctuate. Trial participants often…

High-value oncology drugs often come with equally complex clinical supply requirements. OGSIVEO® (nirogacestat) is one such example. Approved by the U.S. FDA on November 27, 2023, OGSIVEO became the first approved treatment to transform nearly 30 years of desmoid tumor management. Where surgery was once the primary treatment option despite recurrence rates approaching 77%, OGSIVEO…

Every few months, someone in a regulatory affairs forum asks a version of the same question: does rolling review actually save time, or does it just move the same amount of work earlier? It's a fair thing to wonder as the term gets used loosely. Some people confuse it with priority review. Others assume it…

In specialty and comparator sourcing, the working assumption is that the molecule is the hard part. For restricted-access products, that's often fair. To secure an authentic, compliant supply is genuinely difficult. But there's a quieter failure point that sits downstream of procurement: whether the product that arrives can actually be administered. Fintepla (fenfluramine) oral solution…

The clock on exclusivity doesn't start when a patent expires; it starts the moment a drug is approved. For clinical operations and strategic sourcing teams, a new FDA approval triggers two immediate operational needs: calculating future generic or biosimilar entry timelines and securing the newly approved asset as a comparator for ongoing clinical programs. In…

The NCE-1 date for 𝗢𝗥𝗦𝗘𝗥𝗗𝗨® (𝗘𝗹𝗮𝗰𝗲𝘀𝘁𝗿𝗮𝗻𝘁) is January 27, 2027. While patent protection may extend to 2038, the effective Paragraph IV window opens well before the end of the decade. For generic sponsors and bioequivalence (BE) teams eyeing this market, formulation planning has already started. But here is what nobody tells you about navigating modern…