Operations

An FDA advisory panel voted narrowly to recommend four unapproved peptides, BPC-157, KPV, TB-500, and MOTS-c.

Gerren McHam, vice president of Government and External Affairs, API Innovation Center, discusses what is compounding U.S. pharmaceutical supply chain vulnerabilities.

Dr. Gurinder S. Sidhu, senior medical director and U.S. Antiviral Medical Lead, Pfizer, discusses how Covid-19 remains a serious threat to the roughly 75% of American adults who qualify as high-risk, and pushes back against clinician complacency.

Gerren McHam, vice president of Government and External Affairs, API Innovation Center, outlines why reshoring API manufacturing requires more than investment incentives.

Bristol Myers Squibb is deploying Nvidia's DGX SuperPOD with Vera Rubin NVL72 systems to build what it claims is the most powerful AI computing infrastructure in life sciences.

Robert Allen, Ph.D., Chief Scientific Officer, outlines how the company's Invymab platform uses viral surveillance and predictive modeling to design monoclonal antibodies against likely future variants rather than current strains.

Jasper Therapeutics has closed its all-stock acquisition of Kira Pharmaceuticals and raised $132 million in concurrent financing, combining a three-asset immunology pipeline.

Ken Banta and Craig Tooman on why the best leaders win by asking better questions — not just chasing more data — and what that means for drug development, funding and AI in the years ahead.

Eli Lilly has agreed to acquire AtaiBeckley for up to $3.8 billion, adding a pipeline of neuroplastogen-based treatments.

Insilico Medicine and Bora Pharmaceuticals entered a strategic alliance to pair Insilico's AI drug discovery platform with Bora's development and manufacturing infrastructure.

AstraZeneca acquires global rights to approved EGFR exon 20 inhibitor Zegfrovy, Chai Discovery strikes an undisclosed AI antibody collaboration with Novartis, and Innovent Biologics licenses its CD40L antibody IBI355 to Spero Therapeutics.

FDA has paused public release of complete response letters while reviewing a citizen petition challenging the legal basis of the practice, stalling a transparency initiative the agency launched less than a year ago.

Sanofi Chief Digital Officer Emmanuel Frenehard on scaling AI across a Big Pharma global enterprise and why a strategy of concentrated AI bets — not scattered pilots — can better drive real transformation without losing sight of governance, culture or patients.

As advanced therapies scale, manufacturers are rethinking how they bring products to market and who they rely on to get there.

FDA selected seven companies to participate in its new PreCheck Pilot Program, offering earlier regulatory engagement and expedited facility review to incentivize domestic drug manufacturing.

Protillion Biosciences and AbCellera each secured platform-based drug discovery deals this week, with Protillion partnering with Merck on multi-target protein engineering in a deal worth up to $510 million and Jazz Pharmaceuticals committing up to $84 million upfront to AbCellera for T-cell engaging multispecific antibodies in gastrointestinal cancers.

Elicio Therapeutics' KRAS-targeting immunotherapy ELI-002 7P missed its primary endpoint in a Phase II adjuvant pancreatic cancer trial, sending shares down 47%.

With clinical trial data exploding to nearly 6 million datapoints, eClinical Solutions' CEO and Co-founder, Raj Indupuri makes the case for price transparency and a measurable ROI in clinical data technology.

Kardigan has filed to raise approximately $350 million in an IPO that would value the cardiovascular biotech at roughly $1.3 billion, expecting that its three late-stage programs can attract investors in a market still riding a biotech IPO wave.

The driving force behind Lilly’s Medicine Foundry on transforming the discovery-to-production handoff.

Parabilis Medicines surged 58% on its first trading day, pushing its market cap to roughly $3.7 billion and cementing its $670 million raise as the largest biotech IPO on record.

Special Guest Op-Ed: The time is now to elevate manufacturing and supply to a defining pillar of life sciences innovation.

AlzeCure Pharma has licensed Alzheimer's candidate ACD680 to Eli Lilly in a deal worth potentially more than $1 billion, adding an oral gamma-secretase modulator that targets amyloid production upstream to Lilly's Alzheimer's portfolio.

In this episode, Ron Lanton draws on insights from the JP Morgan Healthcare Conference to explain how healthcare investment is shifting from backing novel ideas to funding organizations that can scale, survive regulatory and reimbursement pressure, and embed technology into the operational infrastructure of care delivery.

City Therapeutics closed a $99.5 million Series B to push two RNAi programs into the clinic this year while Eloxx Pharmaceuticals raised $66 million alongside a Nasdaq uplisting to advance its nonsense mutation readthrough platform.