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Stada’s Specialty division was boosted by the firm’s launch last year of a European Stelara biosimilar, even as generics growth remained muted in Q1.
BioWales in London 2025 showcased the efforts healthtech innovators are making to meet investors on their own turf, illustrating changing attitudes and evolving needs.
Formycon is preparing to start a new era – entering Latin America with its ranibizumab biosimilar, which is expected to be a “good contributor” to the firm’s finances.
The FDA has paused Gilead’s HIV trials of GS-1720 and GS-4182 over safety concerns. The company’s upcoming PrEP PDUFA looks to be unaffected.
Spotlight On Tariffs
Despite near-term cost pressures, Intuitive Surgical is expanding manufacturing and R&D in North America and Europe to meet demand for Ion, X and Xi systems.
Thermo Fisher is aggressively managing its supply chain and cost base using its Practical Process Improvement (PPI) Business System. The company is also increasing investments in US-based manufacturing and R&D, with around $2bn allocated to bolster domestic operations.
Manufacturing shifts, financial planning, and supply chain changes are among the adjustments that medtech leaders are making to Trump-era tariffs. Medtech Insight’s review of first-quarter earnings calls reveals how firms are navigating the impact and uncertainty of evolving trade policies.
Quest reaffirmed its full-year guidance despite macroeconomic concerns and tariff uncertainty. Revenues are expected between $10.7bn and $10.85bn. Adjusted earnings per share (EPS) is estimated in the $9.55 to $9.80 range for the full year, with EPS between $8.62 and $8.87.
Changes At The FDA
Merck’s newly approved Enflonsia for RSV is one of the products expected to be recommended for use by the CDC Advisory Committee on Immunization Practices later this month.
Robert Foster, HHS deputy general counsel and chief counsel for food, research and drugs, is temporarily heading the Office of Chief Counsel, but a permanent appointee is expected after Michael Stuart's confirmation as HHS general counsel.
Cell and gene therapy developers may not have to contend with HHS Secretary Robert F. Kennedy Jr.’s animosity like the traditional pharma industry, but his disinterest in distinguishing between the good and bad actors in the space could backfire.
The group had been laid off as part of the 1 April reduction-in-force, which lead to missed guidance publication deadlines.
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