Business Strategies

Licensing agreement expands Polpharma’s footprint in Latin America while supporting Libbs’ strategy to grow access to advanced biologics in Brazil.

Private Company Edition: Three out of eight $100m-plus venture capital financings so far in December were raised by China-based biotech firms – $110m for SanegeneBio, $108m for D3 Bio and $100m for OTR – reflecting growing interest in drug candidates from the country.

The US FDA approved the biologic as a twice-yearly add-on for patients with severe asthma with an eosinophilic phenotype.

The FDA rejection of Alvotech’s AVT06 Eylea biosimilar was revealed as part of a wider funding update outlining a $108m bond placement and continued heavy R&D investment.

The US FDA approved LIB Therapeutics’ Lerochol (lerodalcibep), a PCSK9-inhibiting protein therapeutic injected once-monthly that does not require refrigeration, for adults with high cholesterol, including those with HeFH.

After years of regulatory setbacks, Amphastar has secured FDA approval for its first pen device combination product, targeting a $585m Forteo market.

“We have rarely, if ever, enforced this requirement” FDA says announcing enforcement discretion regarding requirement for disclaimer about supplement structure/function and other label claims to be printed on every panel of a product’s package.

Phase III results for gamma secretase inhibitor varegacestat in the treatment of desmoid tumors appear superior on both efficacy and safety to Merck KGaA’s Ogsiveo (nirogacestat).

Hikma has initiated a leadership transition, with CEO Riad Mishlawi stepping down after just two years in the role, as margin pressure in its core Injectables business and operational delays weigh on performance.

Urban Retreat didn’t cooperate with Direct Selling Self-Regulatory Council’s review or “indicate any intent to comply with” recommendations to discontinue claims for its Balance Capsules. LoveBiome responded sufficiently to merit a DSSRC recommendation to pull three health claims.

The launch of Tyzavan, a ready-to-use vancomycin premix, comes amid plans to accelerate growth for Hikma’s injectables portfolio and strengthen its European and US market presence.

FOPO Edition: Capitalizing on positive data, eight drug developers priced follow-on public offerings that brought in $3.2bn, including $650m each for Terns and Structure plus $602m for Kymera.