Zachary Zubulake

BioPhorum launches a 20-member collaboration uniting pharma, CDMOs, and regulators to address manufacturing challenges in small molecule drug production.

The FDA again rejected Unicycive's oxylanthanum carbonate over third-party manufacturing compliance, not safety, spotlighting CMC risk in nanoparticle drug development.

AI is reshaping GMP documentation and quality workflows, but human accountability remains non-negotiable, and the regulatory consequences for over-relying on AI are real.

Kristin Ciriello Pothier, KPMG US, discusses deal discipline, manufacturing diligence, and why oncology and GLP-1s are driving biopharma M&A activity in 2026.

How the Lehigh Valley Economic Development Corporation is building a technical workforce pipeline to support Eli Lilly's 850-job pharmaceutical manufacturing expansion.

The FDA's revised draft guidance updates master protocol recommendations on randomization, control groups, blinding, and regulatory submissions for multi-drug trials.

AbbVie acquires Apogee Therapeutics for $10.9 billion, gaining zumilokibart, a long-acting injectable targeting atopic dermatitis and asthma with once-quarterly dosing potential.

Kristin Ciriello Pothier, KPMG US, discusses why pharma dealmaking slowed in early 2026, but how AI partnerships, manufacturing acquisitions, and oncology are driving a second-half rebound.

US opens Section 301 probe into Germany's drug pricing, threatening tariffs that could disrupt API supply chains and reshape pharma manufacturing investment.

First generic of single-dose flu drug baloxavir marboxil approved by FDA ahead of 2026–2027 season, expanding antiviral access and manufacturing competition.

Kristin Ciriello Pothier, KPMG US, explains why supply chain resilience and platform technology diligence are reshaping biopharma M&A valuations globally.

Duloxetine was recalled over excess nitrosamine impurity, renewing scrutiny of process controls across generic drug manufacturing.

Karianne Gelinas, LVEDC, outlines workforce strategies to fill 850 technical roles ahead of Eli Lilly's major Lehigh Valley manufacturing investment.

Kristin Ciriello Pothier, KPMG US, discusses biopharma dealmaking shifting toward strategic precision, with oncology, GLP-1s, and manufacturing complexity reshaping M&A valuations in 2026.

The FDA priority review granting of AstraZeneca’s ravulizumab reinforces the commercial and scientific rationale for sustained investment in complement biology platforms.

Lehigh Valley's deep manufacturing base, community college partnerships, and apprenticeship programs positioned the region to attract Eli Lilly's investment.

GSK's momelotinib receives US and EU orphan drug designations for VEXAS syndrome, a rare myeloid disorder with 30–40% five-year mortality and no approved treatments.

Tom Sellig, Adare, discusses 3D-printed tablets, US reshoring investment, FDA timeline pressures, and workforce development strategies driving CDMO growth.

Molly Klote, Klote Medical Research Advisors, discusses how pharma must move beyond tariff-driven reactions to build evidence-based, quality-led supply chain resilience that satisfies FDA scrutiny and protects patient access.

GSK boosts oncology pipeline with Nuvalent acquisition, advancing FDA-designated ROS1/ALK inhibitors for NSCLC and expanding kinase inhibitor drug development in lung cancer.

Pharmaceutical suppliers face growing pressure to calculate product carbon footprints as customer requirements and global regulations tighten.

J&J and Roche commit billions to protein degrader platforms, signaling a new era in oncology drug development with major manufacturing implications.

Tom Sellig, Adare Pharma Solutions, shares how the CDMO is positioning for growth amid US reshoring and oral dose innovation trends.

At CPHI Americas, Molly Klote, Klote Medical Research Advisors, spoke about how the pharma industry faces tariff volatility and reshoring pressure. She warned FDA wants actionable supply chain plans, not slogans, with quality built in.

At CPHI Americas, Delaware Gov. Matt Meyer argues domestic pharma manufacturing is a national security priority and positions Delaware as the ideal reshoring hub.

At CPHI Americas, Delaware governor Matt Meyer outlined the state's biopharma vision: fostering workforce talent, industry collaboration, and regulatory speed to market.

FDA instability, staff turnover, and evolving review standards are reshaping drug development. Richard Pazdur, formerly with the FDA, shares what sponsors need to know now.

FDA approves inhaled insulin Afrezza for children aged 6+, expanding pediatric diabetes care and highlighting inhaled biologics' manufacturing complexity.

Pfizer and Innovent's $10.5B oncology collaboration spans 12 cancer programs, signaling a new model for global pharmaceutical development and cross-border drug partnerships.

FDA extends AstraZeneca’s camizestrant's review deadline to assess additional data after its advisory committee failed to reach a majority vote in April.