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Biologics

Singapore ADC Specialist Axcynsis Nets Novel Payload To Address Drug Resistance

Singapore ADC Specialist Axcynsis Nets Novel Payload To Address Drug Resistance

Axcynsis is developing a derivative of the chemotherapy agent Yondelis as a new payload, which the Singapore venture will first apply to a Claudin 6-targeting ADC it plans to take into a Phase I trial in the US, its chairman, CEO and founder tells Scrip in an interview.

UK’s ProBiotix Strikes Probiotic Distribution Deals In Ukraine And Greece

UK’s ProBiotix Strikes Probiotic Distribution Deals In Ukraine And Greece

ProBiotix Health has announced two commercial partnerships for the distribution of its probiotic ingredients, with Deutsch-Pharm in Ukraine and Eifron in Greece respectively.

How Syngene Is Revving Up Capabilities In ADCs, PROTACs

How Syngene Is Revving Up Capabilities In ADCs, PROTACs

Syngene’s CEO talks to Scrip about how the firm is deepening capabilities in areas like ADCs, PROTACs and why the US Inflation Reduction Act may not necessarily shrink outsourced small molecule work. The executive also shares his view on the China ‘rebalancing’ trend amid geopolitical tensions and the US BIOSECURE Act.

Trio Of US Approvals Pushes UCB's Bimzelx Towards Blockbuster Status

Trio Of US Approvals Pushes UCB's Bimzelx Towards Blockbuster Status

The Belgian drugmaker’s dual IL-17A and IL-17F inhibitor is now approved for four indications in the US, with another in hidradenitis suppurativa expected soon, and analysts believe that UCB’s peak sales forecast of €4bn could be on the conservative side.

US FDA’s CBER Seeks Associate Director Overseeing Rare Disease Work

US FDA’s CBER Seeks Associate Director Overseeing Rare Disease Work

Rare disease activities within the biologics center will gain more prominence with a senior official overseeing them.

Lilly Challenges US FDA Classification Of Obesity Drug Retatrutide, Citing Chevron Overturn

Lilly Challenges US FDA Classification Of Obesity Drug Retatrutide, Citing Chevron Overturn

Determining what falls within the statutory definition of ‘biological product’ is an interpretative question that courts, rather than the agency, must resolve, Lilly said in a lawsuit repeatedly citing the US Supreme Court’s June decision in Loper Bright.

Quick Listen: Scrip's Five Must-Know Things

Quick Listen: Scrip's Five Must-Know Things

In this week's podcast edition of Five Must-Know Things: summer ADC dealmaking continues apace; a look at cell therapies in Japan; Pfizer’s new US digital consumer platform; Galapagos’s US point of care CAR-T study; and Novartis partners with Lindy on biologics delivery.

Honey, I Shrunk The Drugs: Novartis, Lindy Partner On Biologics Delivery

Honey, I Shrunk The Drugs: Novartis, Lindy Partner On Biologics Delivery

Novartis is paying Lindy potentially more than $900m to use its technology for making intravenous biologics available for subcutaneous injection using autoinjectors.

New Domestic Partnerships Help DualityBio Become China ADC Bellwether

New Domestic Partnerships Help DualityBio Become China ADC Bellwether

China's Duality Biologics, founded in 2020, has developed two-thirds of its clinical-stage antibody-drug conjugates by combining antibodies acquired from domestic peers with its proprietary linker-payload platform.

Navigator Medicines Emerges With $100m, Autoimmune Candidate

Navigator Medicines Emerges With $100m, Autoimmune Candidate

Backed by Forbion and RA Capital, Navigator will focus on novel OX40-targeted therapies for autoimmune diseases, with a clinical candidate in-licensed from IMBiologics.