In today's Pharmaceutical Executive Daily, FDA approves Otsuka's Simtriyo as the first NDSRI treatment for ADHD, argenx agrees to acquire Forte Biosciences for approximately $2.2 billion, and an AbbVie neuroscience researcher discusses the shift from symptom management to disease modification in Parkinson's research.
FDA has approved Otsuka's Simtriyo as the first norepinephrine, dopamine, and serotonin reuptake inhibitor for ADHD.
Argenx has agreed to acquire Forte Biosciences for approximately $2.2 billion, adding a first-in-class anti-CD122 antibody with clinical proof-of-concept in vitiligo and celiac disease.
TruTechnologies’ Dr. Richard Graham explains where he sees the actual issues that need to be addressed at FDA.
Susan Thomas, chief commercial officer at LucyRx, discusses how women in a certain age range are disproportionately impacted by cardiovascular risk.
Dr. Stoehr, neuroscience researcher at AbbVie discusses how biomarkers are opening a new window into Parkinson’s disease.
Mike Faddoul, Partner, Audit & Assurance, Crowe, makes the case that gross-to-net accounting deserves the same pre-launch rigor as commercial strategy.
In today's Pharmaceutical Executive Daily, an FDA advisory panel narrowly votes to recommend easing restrictions on four unapproved peptides, a supply chain expert discusses how China's export controls are exposing vulnerabilities in the U.S. pharmaceutical supply chain, and a pharmacy benefits executive lays out a business case for more targeted employer-based GLP-1 coverage.
An FDA advisory panel voted narrowly to recommend four unapproved peptides, BPC-157, KPV, TB-500, and MOTS-c.
Chief commercial officer Susan Thomas from LucyRx explains why coverage isn’t a one-size-fits all problem.
Gerren McHam, vice president of Government and External Affairs, API Innovation Center, discusses what is compounding U.S. pharmaceutical supply chain vulnerabilities.
Dr. Richard Graham, chairman and co-founder of TruTechnologies, discusses the importance of global clinical trials while also being a center for these trials.
In today's Pharmaceutical Executive Daily, Eli Lilly's Retatrutide delivers up to 22.6% weight loss in two new Phase III trials, a clinical trial expert discusses why the U.S. is losing trial volume to Australia and China, and a pharmacy benefits executive weighs in on why short-term cost thinking is complicating GLP-1 coverage decisions.
TruTechnologies’ chairman and co-founder Dr. Richard Graham explains why Australia and China are the main competitors for clinical trials.
Eli Lilly's Retatrutide met primary endpoints in two Phase III trials, delivering up to 22.6% body weight loss in adults with severe obesity and cardiovascular disease.
LucyRx’s chief commercial officer Susan Thomas discusses the impact that only looking at immediate cost impact has on certain indications.
Gerren McHam, vice president of Government and External Affairs, API Innovation Center,argues that closing the gap between federal reshoring policy and manufacturer investment requires more than incentives.
In today's Pharmaceutical Executive Daily, Novo Nordisk sues Eli Lilly over GLP-1 advertising it calls misleading, President Trump announces a phased tariff plan for imported generic drugs, and a new commentary argues pharma's AI investment is missing the areas of drug discovery where it matters most.
President Trump announces a zero tariff on imported generic drugs through August 2026 before a phased escalation to 200% by 2029.
Dr. Richard Graham from TruTechnologies details the likelihood that Project Trialblazer reduces trial times by 6-to-12 months.
Gerren McHam, vice president of Government and External Affairs, API Innovation Center, explains how geopolitical disruptions like the Strait of Hormuz situation have accelerated the organization's push to develop a national fragility index.
Susan Thomas, chief commercial officer at LucyRx, explains the areas where GLP-1 coverage still lacks.
AI adoption in pharma drops sharply in the domains that matter most for discovery.
Novo's lawsuit claims that Eli Lilly's marketing campaigns for Mounjaro and Zepbound misrepresented the efficacy of Wegovy in comparison.
In today's Pharmaceutical Executive Daily, FDA grants emergency use authorization for Seegene's multiplex PCR assay, a Pfizer medical lead makes the case for continued antiviral use among Covid-19 high-risk patients, and Nuvation Bio's CEO discusses the company's oncology pipeline and philosophy of developing better drugs rather than more of them.
FDA has granted Emergency Use Authorization to Seegene USA's Allplex multiplex PCR assay, making it the first U.S.-authorized test to simultaneously detect and differentiate HSV-1, HSV-2, VZV, and monkeypox virus in a single reaction.
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.
Nuvation Bio’s president, CEO, and founder discusses the company’s mission, approach to developing a global strategy, and how it manages its increasing pipeline.
The catalyst for this renewed interest is the USPTO Appeals Review Panel's Ex parte Chamberlain decision and the Federal Circuit decision on appeal.
Gerren McHam, vice president of Government and External Affairs, API Innovation Center, outlines why reshoring API manufacturing requires more than investment incentives.
