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By PharmaCompass
2025-05-01
Impressions: 374 (Article) || 1 (Video)
Ever since US President Donald Trump has talked about a “major tariff” on drug imports coming “very shortly”, we have witnessed a rise in announcements by drugmakers on their plans to invest in US manufacturing to avoid those taxes. This week, AbbVie announced a US$ 10 billion investment in US operations, while Thermo Fisher Scientific committed US$ 2 billion. Similarly, AstraZeneca said it will shift some manufacturing to the US while Amgen talked about an expansion of its biomanufacturing facility in the US.
An Ernst & Young report has said that 25 percent tariffs on imported pharmaceuticals could increase annual drug costs by nearly US$ 51 billion and raise drug prices in the US by up to 12.9 percent.
In deals, German pharmaceutical company Merck KGaA is strengthening its cancer treatment portfolio through the acquisition of US biotech firm SpringWorks Therapeutics for US$ 3.9 billion. Novartis is acquiring California-based biotech Regulus Therapeutics in a deal valued at up to US$ 1.7 billion. And Sanofi sold its 50 percent controlling stake in its consumer healthcare unit Opella, for € 10 billion (US$ 11.36 billion) to US private equity firm Clayton, Dubilier & Rice (CD&R).
In drug approvals, the US Food and Drug Administration (FDA) has okayed Johnson & Johnson’s Imaavy (nipocalimab-aahu) for the treatment of generalized myasthenia gravis (gMG). FDA also approved Abeona Therapeutics’ Zevaskyn, the first cell-based gene therapy for recessive dystrophic epidermolysis bullosa, a severe genetic skin disorder.
Meanwhile, FDA has delayed its decision on Stealth BioTherapeutics’ elamipretide for ultra-rare Barth syndrome. It has missed its April 29 deadline and has not provided a new timeline. And Novavax faced a setback as the FDA requested a new clinical trial for its Covid vaccine due to intervention by officials of the Health and Human Services (HHS), which is under Robert F. Kennedy Jr.
AbbVie to invest US$ 10 bn to expand US footprint; Astra, Amgen, Thermo Fisher to boost US presence
AbbVie is planning a US$ 10 billion investment in its US operations, a strategic move as the company faces potential US tariffs on pharmaceutical imports. Even AstraZeneca has said it is shifting the production of some medicines sold in the US from Europe to America, in order to avoid Trump’s tariffs. According to a report published in The Guardian, Pascal Soriot, AstraZeneca’s chief executive, warned that well-paid advanced manufacturing and research jobs could move to the US in the long run.Meanwhile, FDA has approved AbbVie’s Rinvoq (upadacitinib) for the treatment of adults with giant cell arteritis (GCA), making it the first and only oral Janus kinase (JAK) inhibitor approved for this chronic inflammatory condition.
Thermo Fisher, Amgen boost US presence: Thermo Fisher Scientific has announced a US$ 2 billion investment to expand its US operations over the next four years, aiming to enhance domestic manufacturing and research capabilities in the life sciences sector. The investment includes US$ 1.5 billion allocated to bolster US manufacturing facilities and an additional US$ 500 million earmarked for research and development.
Similarly, Amgen has announced a US$ 900 million expansion of its biomanufacturing facility in New Albany, Ohio, increasing its total investment in the region to over US$ 1.4 billion.
Proposed pharma tariffs can make drugs 13% costlier for Americans, says EY report
A proposed 25 percent US tariff on imported pharmaceutical products could increase annual drug costs by nearly US$ 51 billion, according to a recent Ernst & Young (EY) report commissioned by the Pharmaceutical Research and Manufacturers of America (PhRMA). The study warns that if these costs are passed on to consumers, US drug prices could rise by up to 12.9 percent. In 2023, the US imported US$ 203 billion worth of pharmaceuticals.
Merck KGaA expands cancer portfolio with US$ 3.9 bn SpringWorks acquisition
German pharmaceutical company Merck KGaA has announced its agreement to acquire US-based biotech firm SpringWorks Therapeutics for approximately US$ 3.9 billion. SpringWorks, headquartered in Stamford, Connecticut, specializes in developing treatments for rare tumors and cancers. SpringWorks has two FDA approved drugs — Ogsiveo (nirogacestat) and Gomekli (mirdametinib) — in its portfolio.
Novartis to acquire kidney disease drugmaker Regulus for up to US$ 1.7 bn
Novartis has announced plans to acquire Regulus Therapeutics, a California-based biotech firm specializing in kidney disease treatments, in a deal valued at up to US$ 1.7 billion. The acquisition centers around Regulus’ experimental kidney disease drug, farabursen, to treat a life-threatening kidney disease. This potential first-in-class drug is expected to enter a late-stage study this year to test it for the treatment of autosomal dominant polycystic kidney disease.
Sanofi sells stake in Opella for US$ 11.4 bn: Sanofi has finalized the sale of a 50 percent controlling stake in its consumer healthcare unit, Opella, for € 10 billion (US$ 11.36 billion) to US private equity firm Clayton, Dubilier & Rice (CD&R). The French drugmaker intends to reinvest the proceeds into innovative medicines and vaccines.
FDA okays J&J’s immune disorder drug Imaavy to treat muscle-weakening disorder
FDA has approved Johnson & Johnson’s new therapy, Imaavy (nipocalimab-aahu), for the treatment of generalized myasthenia gravis (gMG) in patients aged 12 and older who are anti-acetylcholine receptor (AChR) or anti-muscle-specific kinase (MuSK) antibody positive. J&J anticipates that Imaavy could achieve peak annual sales of over US$ 5 billion.
Okays Abeona’s gene therapy for rare skin disorder: FDA has approved Zevaskyn (prademagene zamikeracel), marking the first cell-based gene therapy for recessive dystrophic epidermolysis bullosa (RDEB), a rare and severe genetic skin disorder. Developed by Abeona Therapeutics, Zevaskyn is designed for both adult and pediatric patients.
Delays decision on Stealth’s med for ultra-rare Barth syndrome: FDA has once again delayed its decision on Stealth BioTherapeutics’ application for elamipretide, a treatment for Barth syndrome, an ultra-rare genetic mitochondrial disorder. Originally, FDA had set a Prescription Drug User Fee Act (PDUFA) action date of April 29, 2025, but has now informed the company that it will not meet this deadline.
Demands new trial for Novavax’s Covid vaccine: FDA has requested that Novavax conduct a new clinical trial to demonstrate the effectiveness of its delayed Covid-19 vaccine, according to a report by the Wall Street Journal. This decision follows intervention by HHS officials, and comes after FDA missed its April 1 deadline for approving the vaccine. Novavax’s vaccine is currently distributed under emergency use authorization. The company is seeking to convert this into a full approval.
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