| 04.27.18 | Sanofi GLP-1 hit by GI issues as it works on new test, as dosing also hit s Vertex’s Kalydeco follow-up

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Today's Rundown

GI toxicity hits midstage Sanofi GLP-1 drug as patients drop out FDA has dosing questions for Vertex’s Kalydeco follow-up Alexion’s Soliris successor clears phase 3, teeing up filings [Sponsored] Can the SEC step in to support small businesses if Congress stalls? Jennifer Doudna's new CRISPR company will tackle disease detection FDA demand puts Compugen’s solid tumor checkpoint trial on ice Allergan's ubrogepant aces second phase 3 migraine trial CAR-T 2.0? A split, universal and programmable system EuroBiotech Report—Sanofi hires Reed, loses Larsen; MorphoSys nails IPO, Mereo fails IPO; and Adocia FiercePharmaAsia—Takeda’s hard-won Shire deal and Nektar I-O pact; Daiichi’s DMD flop Chutes & Ladders—Sanofi hires ex-Roche executive as new R&D chief

Featured Story

GI toxicity hits midstage Sanofi GLP-1 drug as patients drop out

Friday, April 27, 2018

Sanofi said gastrointestinal concerns have made its experimental GLP-1 phase 2 drug SAR425899 “not acceptable for clinical use,” but it is undertaking new tests to try to get around dosing issues, which it blames for the AEs.

This week's sponsor is Deloitte.

FDA has dosing questions for Vertex’s Kalydeco follow-up

Friday, April 27, 2018

Against a backdrop of strong first-quarter sales for its cystic fibrosis drug, Vertex has revealed that its longer-acting version of Kalydeco has been held up by an FDA request for more data—but analysts suggest it could be a bigger issue for rival developers.

Alexion’s Soliris successor clears phase 3, teeing up filings

Friday, April 27, 2018

A phase 3 trial of Alexion’s Soliris successor ALXN1210 has met its primary and key secondary endpoints. The success positions Alexion to file for approval and shield itself from an anticipated assault on its cash cow paroxysmal nocturnal hemoglobinuria franchise.

[Sponsored] Can the SEC step in to support small businesses if Congress stalls?

Monday, April 23, 2018

Congress is debating whether to include small businesses in the Senate’s bank bill. But the SEC has an opportunity to take action on SOX 404(b) on its own.

Jennifer Doudna's new CRISPR company will tackle disease detection

Thursday, April 26, 2018

Mammoth Biosciences launched Thursday, with technology out of UC Berkeley and a mission to develop a CRISPR-based platform that can detect any biomarker containing DNA or RNA.

FDA demand puts Compugen’s solid tumor checkpoint trial on ice

Friday, April 27, 2018

The FDA has temporarily blocked Compugen’s plans to start a phase 1 trial of PVRIG-targeting cancer drug COM701. Officials caused the delay by demanding to see additional CMC information before signing off on the study.

Allergan's ubrogepant aces second phase 3 migraine trial

Friday, April 27, 2018

Allergan's ubrogepant is on a roll—the oral CGRP drug has hit the mark in a second phase 3 migraine trial, cementing the company's plans to file for approval in 2019.

CAR-T 2.0? A split, universal and programmable system

Thursday, April 26, 2018

Recent FDA approvals have validated the use of chimeric antigen receptor T cells (CAR-Ts) to fight blood cancers, but the technology is still far from perfect. A Boston University team has devised what they call the "Swiss army knife" of CAR-T to address problems with current CAR-T systems and potentially apply them to more tumor types.

EuroBiotech Report—Sanofi hires Reed, loses Larsen; MorphoSys nails IPO, Mereo fails IPO; and Adocia

Thursday, April 26, 2018

In this week's EuroBiotech Report, Sanofi names Reed as R&D chief, MorphoSys supersizes IPO, Mereo drops listing plan and more.

FiercePharmaAsia—Takeda’s hard-won Shire deal and Nektar I-O pact; Daiichi’s DMD flop

Friday, April 27, 2018

It took five tries, but Takeda finally persuaded Shire to consider a buyout bid; Nektar and Takeda paired up their candidates in a non-Hodgkin lymphoma trial; Daiichi Sankyo pushed its DMD prospect ahead despite mixed early-phase data; Indian drugmakers were slapped by manufacturing regulators; plus more pharma industry news from Asia.

Chutes & Ladders—Sanofi hires ex-Roche executive as new R&D chief

Friday, April 27, 2018

Sanofi picks ex-Roche executive John Reed to replace retiring R&D chief Elias Zerhouni; Advaxis brings on former Rosetta Genomics chief Kenneth Berlin as CEO; and Urovant steals Allergan's key urology VP, alongside a handful of other senior leaders from Allergan and Avanir. Those moves plus more hirings, firings and retirings throughout the industry.

This week's sponsor is PharmaCord.

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