→ Bolstered by priority review and a breakthrough therapy designation, Bristol-Myers Squibb’s Opdivo/Yervoy has been approved for a subset of colorectal cancer patients who’ve run out of options. The FDA gave the green light — covering microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin and irinotecan combo — based on an ongoing Phase II trial. Eighty two out of 119 patients received treatment prior to the Checkmate-142 study; 46% in that sub-population, and 49% overall, responded to the I/O combo. Serious adverse reactions occurred in 47% of all patients — somewhat reflected in the list of safety warnings that come with the approval. The recommended dosing schedule involves an IV infusion every three weeks for four doses, followed by Opdivo maintenance therapy.
→ More than a year after two friends charged with insider trading by swapping nonpublic info on their respective biotech companies, the verdict is in: guilty — for conspiracy and securities fraud. Schultz Chan, who worked for Akebia Therapeutics $AKBA at the time, and Songjiang Wang, a former Merrimack Pharmaceuticals $MACK staffer, received the verdict from a jury in Boston following a two-week trial.
According to a criminal complaint, the duo were working a two-way deal where Chan — then Akebia’s director of biostatistics — fed insider info on Akebia’s trial data to Wang, the director of statistical programming at Merrimack, who reciprocated with the scoop on Merrimack drugs. One of the deals allegedly yielded a $288,000 profit.
Both men, who have denied wrongdoing in the past and declined to comment after the trial, are scheduled to be sentenced in early October.
→ Akcea $AKCA has scored its first drug approval since spinning out of Ionis $IONS, as European regulators come through with an approval for inotersen following a thumbs up from the EMA committee. To be marketed as Tegsedi, the drug treats hereditary TTR amyloidosis by blocking production of the transthyretin (TTR) protein. The green light gives Ionis and the majority-owned Akcea an important leg up against rival Alnylam, whose patisiran has a US PDUFA date that’s two months ahead of inotersen’s in October. “With the EC’s decision, TEGSEDI is now the world’s first and only RNA-targeted therapeutic approved for patients with hATTR amyloidosis,” said Akcea CEO Paula Soteropoulos. “We are ready to launch Tegsedi along with our patient and physician support services across Europe.”
→ The respiratory experts at AstraZeneca are wading into gene therapy for a novel approach to treating chronic lung disease with a new collaboration. Emeryville, CA-based 4D Molecular Therapeutics will contribute its discovery platform to help identify and engineer the AAV vector that will be best suited to deliver the drug the partners will develop together. MedImmune, the biologics arm of the UK pharma giant, has committed to playing a role in the whole process — from early stage development to commercialization (which 4DMT will presumably be involved in). Financial details were not disclosed.
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