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By PharmaCompass
2025-05-08
Impressions: 984 (Article) || 3 (Video)
US President Donald Trump’s tariff threats appear to be working, as Bristol Myers Squibb became the latest drugmaker to announce a massive US investment — of US$ 40 billion — while Gilead increased its investments in the US by another US$ 11 billion.
Trump has signed an executive order aimed at revitalizing domestic drug manufacturing by instructing the US Food and Drug Administration (FDA) to streamline facility approvals and eliminate unnecessary requirements.
In a significant legal challenge, 19 Democratic-led states and the District of Columbia (DC) have sued the Trump administration for gutting health agencies and leaving them to pick up the bill for mounting health crises. The US Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. (RFK Jr.) has announced a US$ 500 million ‘Generation Gold Standard’ initiative to develop universal vaccines targeting multiple virus strains.
The FDA has reportedly asked several previously dismissed staff members to return to their critical roles in negotiating user fee agreements with pharmaceutical companies, marking the second such instance this year where the agency has rehired laid-off employees.
In clinical developments, AstraZeneca’s triple-combination inhaler Breztri Aerosphere has met all primary endpoints in two late-stage trials for uncontrolled asthma, demonstrating significant improvements in lung function compared to standard therapies.
Novo Nordisk is moving closer to a potential groundbreaking approval as the FDA has accepted its application for an oral version of its weight-loss drug Wegovy, which could become the first FDA-approved oral glucagon-like peptide-1 (GLP-1) therapy for chronic weight management. A decision is expected in the fourth quarter of 2025.
The field of gene therapy saw more adverse developments, with multiple personalized medicine players pivoting away from adeno-associated virus (AAV) vectors. While Vertex is restructuring its gene therapy initiatives, Johnson & Johnson’s botaretigene sparoparvovec failed to meet the primary endpoint in a late-stage, rare eye disease trial.
BMS invests US$ 40 bn to boost US manufacturing; Gilead enhances investment by US$ 11 bn
Bristol Myers Squibb (BMS) has announced an investment of US$ 40 billion in the US over the next five years, aiming to bolster its research, development, and manufacturing capabilities. This strategic move comes in response to potential threats of tariffs on pharmaceutical imports by Trump. The investment will support advancements in radiopharmaceutical manufacturing and the integration of artificial intelligence and machine learning to accelerate innovation.
Similarly, Gilead Sciences has announced US investments to the tune of US$ 11 billion. This investment will enhance its US manufacturing and research capabilities, and supplement an already planned spending of US$ 21 billion to boost US manufacturing and R&D.
Trump signs order to revitalize US drug manufacturing: Trump signed an executive order instructing the FDA to streamline approval processes for new drug manufacturing facilities, eliminate “duplicative and unnecessary requirements”, and collaborate with domestic manufacturers to expedite operations. The order also directs the Environmental Protection Agency to speed up the construction of facilities designed to manufacture prescription drugs, APIs and other raw materials.
Coalition of 19 states, DC sue Trump admin for gutting health agencies
A coalition of 19 Democratic-led states and the District of Columbia (DC) has filed a federal lawsuit in Rhode Island to block the Trump administration's sweeping overhaul of the HHS. The restructuring plan, spearheaded by HHS Secretary RFK Jr. and backed by the Department of Government Efficiency (DoGE), led by Elon Musk, aims to lay off 10,000 employees, consolidate 28 divisions into 15, and close half of HHS’ regional offices.
The plaintiffs argue that these actions unconstitutionally undermine HHS’ capacity to fulfill its statutory obligations. They contend that vital public health services — ranging from vaccine approval to life-saving programs — are being jeopardized.
RFK Jr bets US$ 500 mn on ‘universal vaccines’: HHS has announced a US$ 500 million initiative — ‘Generation Gold Standard’ — to develop universal vaccines targeting multiple virus strains. This marks a pivotal shift from next-gen Covid-specific projects to broader pandemic preparedness efforts. These vaccines aim to provide broad-spectrum protection against multiple strains of pandemic-prone viruses like H5N1 avian influenza and coronaviruses including SARS-CoV-2, SARS-CoV-1, and MERS-CoV. However, the fact that the program uses a 20th century technology has left scientists baffled.
FDA asks some user fee negotiators to return after mass firings: FDA has reportedly asked several staff members to return after they were previously dismissed from critical roles in negotiating user fee agreements with pharmaceutical companies. These agreements are essential for funding FDA’s drug review processes. This marks the second instance this year when the FDA has rehired previously dismissed employees. Around 3,500 FDA employees were laid off as part of a broader restructuring effort initiated by RFK Jr.
Astra’s COPD inhaler beats standard of care in two late-stage asthma trials
AstraZeneca’s triple-combination inhaler, Breztri Aerosphere (budesonide, glycopyrronium and formoterol fumarate), has achieved all primary goals in two phase 3 clinical trials for patients with uncontrolled asthma. Previously approved for treating chronic obstructive pulmonary disease (COPD), Breztri demonstrated significant improvements in lung function compared to standard dual-combination therapies.
Novo gets closer to winning FDA nod for Wegovy pill: Novo Nordisk announced that the FDA has accepted its application for an oral version of Wegovy (semaglutide), a GLP-1 receptor agonist. If approved, this would mark the first oral GLP-1 therapy for chronic weight management. The agency’s decision is expected in the fourth quarter of 2025.
Vertex ends AAV vector research, pauses Moderna-partnered cystic fibrosis trial
Vertex Pharmaceuticals is undergoing significant changes in its gene therapy initiatives, marked by the discontinuation of AAV vector research and a pause in its Moderna-partnered cystic fibrosis (CF) trial. The company announced it will no longer pursue adeno-associated virus (AAV) vectors as a delivery mechanism for its genetic therapy programs.
In addition, Vertex has temporarily paused the multiple ascending dose portion of its phase 1/2 trial for VX-522, an inhaled mRNA therapy developed in collaboration with Moderna, due to tolerability concerns.
J&J’s gene therapy fails in rare eye disease trial: Johnson & Johnson’s investigational gene therapy, botaretigene sparoparvovec (bota-vec), did not meet the primary endpoint in a phase 3 trial for X-linked retinitis pigmentosa (XLRP), a rare inherited eye disease. The therapy failed to significantly improve patients’ ability to navigate a virtual maze, a key measure of functional vision.
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