| 02.25.22 | Russia's war on Ukraine likely to disrupt clinical trials; Biohaven takes a shot at BMS' failed DMD drug

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Today's Rundown

UPDATED: Pharmas operating in Ukraine, Russia work to ensure access to medicines, while analysts foresee trial disruptions Biohaven to take a chance on Bristol Myers' once-failed DMD med Shionogi files for approval of oral COVID-19 antiviral in Japan, brushing off missed clinical endpoint in race to market Sponsored: Recommended Strategies for Your Next Biomarker-Driven Clinical Trial AbbVie ditches fibrosis program it paid Morphic $20M for in 2020 MacroGenics switches horses in CD123 race, canning flotetuzumab in favor of next-gen successor Johnson & Johnson, distributor giants finalize $26B opioid settlement as states pile into landmark deal Cedars-Sinai, Stanford develop AI to spot 2 difficult-to-diagnose heart conditions Eli Lilly, Boehringer Ingelheim's Jardiance clinches heart failure edge with FDA nod for wider label Cloud R&D developer Benchling inks first buyout to support in vivo studies Anti-cancer drug isolated from Asian tree promotes weight loss in obese mice Fierce Pharma Asia—Enhertu's HER2-low breast cancer win; Takeda's $2B gene therapy pact; Xtandi march-in campaign Chutes & Ladders—A new Spark, in CEO form, at Roche's gene therapy biotech

Featured Story

UPDATED: Pharmas operating in Ukraine, Russia work to ensure access to medicines, while analysts foresee trial disruptions

By Kyle LaHucik,Annalee Armstrong,Max Bayer,Eric Sagonowsky,Kevin Dunleavy

Russia's invasion of Ukraine could affect clinical studies as there are more than 250 trials with at least one site in the Eastern European nation, according to ClinicalTrials.gov. Karuna Therapeutics noted one of its schizophrenia trials has no clear timeline because 10 of 19 sites are in Ukraine.

This week's sponsor is Farrar-Trane Scientific.

Biohaven to take a chance on Bristol Myers' once-failed DMD med

By Max Bayer

Biohaven is taking over Bristol Myer Squibb’s once-failed treatment for Duchenne muscular dystrophy through a worldwide licensing agreement, with plans to develop taldefgrobep alfa in spinal muscular atrophy.

Shionogi files for approval of oral COVID-19 antiviral in Japan, brushing off missed clinical endpoint in race to market

By Nick Paul Taylor

Shionogi is about to find out what it takes to get a COVID-19 antiviral to market in Japan. Having missed the primary clinical endpoint in a phase 2b, Shionogi has filed for approval on the strength of evidence its oral antiviral S-217622 reduces viral load and certain symptoms.

AbbVie is ditching work on all the alpha V beta 6 (αvβ6) inhibitors that it paid $20 million to license from Morphic Therapeutic in 2020. The Big Pharma is culling the work because of a suspected on-target "safety signal" from preclinical testing.

MacroGenics switches horses in CD123 race, canning flotetuzumab in favor of next-gen successor

By Nick Paul Taylor

MacroGenics has called time on the development of CD123xCD3 bispecific flotetuzumab. While the drug cleared the interim efficacy threshold in an early-phase trial, the potential dosing and safety advantages of its preclinical successor have persuaded MacroGenics to discontinue development.

Johnson & Johnson, distributor giants finalize $26B opioid settlement as states pile into landmark deal

By Angus Liu

Johnson & Johnson and three major U.S. drug distributors—AmerisourceBergen, Cardinal Health and McKesson—have each decided to finalize a landmark $26 billion settlement to resolve claims that they helped fuel the opioid crisis.

Cedars-Sinai, Stanford develop AI to spot 2 difficult-to-diagnose heart conditions

By Andrea Park

The algorithm is designed to flag indicators of hypertrophic cardiomyopathy, where the heart muscle thickens, and cardiac amyloidosis, also known as stiff heart syndrome, in which normal heart muscle is replaced by amyloid deposits.

Eli Lilly, Boehringer Ingelheim's Jardiance clinches heart failure edge with FDA nod for wider label

By Fraiser Kansteiner

The U.S. FDA on Thursday blessed Lilly and Boehringer’s Jardiance with a label expansion to curb the risk of cardiovascular death and hospitalization for heart failure in adults. The move comes after the partners in November sent off an FDA application for the med to treat adults with heart failure independent of left ventricular ejection fraction.

Cloud R&D developer Benchling inks first buyout to support in vivo studies

By Conor Hale

Benchling claimed Overwatch Research, a Northern Ireland-based startup that provides end-to-end software for managing preclinical in vivo studies.

Anti-cancer drug isolated from Asian tree promotes weight loss in obese mice

By Angus Liu

Camptothecin, derived from the Camptotheca tree native to China, is known as a cytotoxic agent with cancer-killing effects. A group of Chinese scientists found the drug also has the potential to tackle obesity.

Fierce Pharma Asia—Enhertu's HER2-low breast cancer win; Takeda's $2B gene therapy pact; Xtandi march-in campaign

By Angus Liu

AstraZeneca and Daiichi Sankyo's Enhertu posted a first-in-class win in HER2-low breast cancer. Takeda signed a deal worth up to $2 billion to develop non-viral gene therapies. U.S. lawmakers lent support to a march-in petition asking the government to sidestep patents protecting Astellas and Pfizer's Xtandi. And more.

Chutes & Ladders—A new Spark, in CEO form, at Roche's gene therapy biotech

By Kyle LaHucik

Roche's Spark Therapeutics says goodbye to co-founding CEO Jeffrey Marrazzo April 1 as chief operating officer takes over. Adagio CEO departs without explanation. And Mnemo Therapeutics poaches Bayer EVP.