April 30th 2025
A seminar shares key observations and learnings from the first round of direct price negotiations.
April 29th 2025
IQVIA’s Doug Long offers a lay of the land, including trends and developing issues that are shaping the current market.
A session dives into the trends surrounding specialty drugs and therapies, along with providing an overview of the drug development landscape.
April 17th 2025
The interchangeability designation for Yuflyma, a biosimilar to Humira, may help to improve patient access and reduce costs.
April 9th 2025
Respective industry and government agendas could significantly reshape the US prescription drug market.
The Voyage to Beantown
Pharma Commerce team attends DIA's Annual Meeting for the first time.
Citing Suspected Vaccine Patent Infringement, GSK Files Lawsuit Against Pfizer
Company is seeking monetary damages from the alleged violation.
Breaking the Pharma Industry’s Bundled Pricing Arrangements
How the ‘fight-for-the-dollar’ is coming and likely will impact the bundled pricing of industry stakeholders.
FTC Files Lawsuit to Prevent IQVIA Propel Media Purchase
Agency claims union would threaten a monopoly on programmatic advertising space.
Addressing Revenue Leakage
Micah Litow, Kalderos’ president and COO, discusses the importance of identifying and resolving noncompliant discount requests, along with addressing the gross-to-net gap for drug manufacturers.
DSCSA: A Fast-Approaching Deadline
The legislation’s deadline for compliance is knocking on the door. Pharma Commerce offers a synopsis of how the Drug Supply Chain Security Act has progressed over the past decade.
Texas AG Files Subpoena Against Pfizer
Forces pharma giant to hand over marketing communications with Meta.
Merck Files Lawsuit Against Federal Government
Pharma company claims that the IRA’s drug pricing clauses violate the First and Fifth Amendments.
Channel Fragmentation and Diversifying Product Archetypes
New PC column explores commercialization trends and how pharma can adjust to the new squeeze of market, regulatory, pricing, and gross-to-net pressures.
DSCSA Compliance Readiness Inches Along, Says HDA Survey
Latest Q4 2022 results show some progress, but 100% readiness by November looks doubtful.
The Consolidated Appropriations Act and PBM Transparency
New federal law introduces significant changes in the design of pharmacy benefit plans with aims to level the playing field between PBMs and their employee healthcare benefit plan clients.
IQVIA Study: Illegal Online Pharmacies Cost Pharma $34B in Diverted 2022 US Sales
“Deep learning” IT tools were used to calculate sales volumes and drug class.
Pediatric Medicine: Challenges Abound
Innovation and investment in advancing lifesaving therapies for pediatric patients to the commercial stage remains a daunting task, but rapid advances today in modeling and simulation are reducing the hurdles for drugmakers.
Ramping Up DSCSA Readiness Efforts
As a November deadline looms for industry compliance with an interoperable system for product tracing, there is more urgency in the US pharma supply chain.
Rising Drug Shortages Are Garnering Increased Federal Attention
Senate committee report highlights a lack of visibility in API suppliers.
FDA Finalizes the Definitions of 'Suspect and Illegitimate' Pharma Products
Industry is still scrambling to handle clerical errors of DSCSA transactions.
HDA’s 2023 Distribution Management Conference Dives into DSCSA Specifics and More
Event—taking place in Indianapolis—places supply chain education at the forefront.
NABP Hopes to Fill a Key Gap in DSCSA Compliance: Local Pharmacies
The Pulse online service will provide free resources to enable pharmacy to meet drug traceability rules.
Introducing GDP-UCI: A New Medicines and Vaccines Reform Program
Initiative intends to facilitate regulatory compliance within the pharma distribution space.
HDA Seeks to Limit FDA Enforcement Discretion of DSCSA Come November, Raising the Burden on Some Manufacturers
Meanwhile, PDG issues more DSCSA guidance on data interoperability.
Pharmacists Push for Delaying DSCSA implementation
Citing FDA’s slow guidance, the American Pharmacists Association is requesting delay in November 2023 DSCSA enforcement.
Benefits of Structured Content in Preparing Data for Regulatory Submissions
How taking steps to incorporate data into all regulatory and labeling operations helps firms avoid retroactively planning to recapture information
Drug Shortages: A Chronic Problem, but New Opportunities Present Themselves
While this concern is causing ripples in the global supply chain, technological and regulatory advances can help address the issue
HDA Annual DSCSA Readiness Survey Shows Progress but Gaps Remain
Wholesalers continue to worry about manufacturer commitment to timely compliance
After a Decade of Regulatory Transformation, What’s Next?
Following a decade of solid groundwork to modernize regulatory information management in life sciences, leading companies have now shifted their focus to how they might exploit this new digital landscape
Pace Life Sciences Purchases Biopharma Global
Allows CDMO’s regulatory, consulting services to further expand into the pharma market
Barnes & Thornburg Expands East Coast Presence
Law firm to feature life sciences practice in New Jersey and Philadelphia
Achieving Efficient, Optimized, and Compliant Production at Scale
Innovation in pharma manufacturing as paradigms shift and biotech and personalized therapies move through clinical trials at pace
PharmaLex Opens New Office in Beijing
Location expands company’s pharmacovigilance, regulatory affairs services
PharmaLex Expands Nordic Presence, Merges with DRA Consulting
Partnership adds technological offerings to PharmaLex’s repertoire