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BioWorld - Sunday, June 14, 2026
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Regeneron, Sanofi kick off skin cancer drug BLA backed by new phase II data

Dec. 13, 2017
By Michael Fitzhugh

A new FDA filing for the PD-1 checkpoint inhibitor cemiplimab now underway represents more than simple progress for Regeneron Pharmaceuticals Inc. and Sanofi SA. The filing, supported by top-line results from a pivotal phase II trial in the world's second most deadly skin cancer, could lead to approval for a drug key to realizing strategic goals at both companies.


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Financings

Dec. 13, 2017
Soleno Therapeutics Inc., of Redwood City, Calif., said it entered a definitive agreement with certain institutional and accredited investors to raise aggregate gross proceeds of about $15 million through the private placement of its equity securities.
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Sanofi's Dengvaxia faces legal threat, investigations after Philippines suspension

Dec. 13, 2017
By David Ho
HONG KONG – Controversy has continued to mount in the Philippines around Sanofi Pasteur Ltd.'s dengue vaccine, Dengvaxia, which is now facing questions about its effectiveness and the manner and speed with which the government adopted it in its national vaccination program.
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Psioxus enters clinic with tumor-targeting gene therapy, earns milestone from BMS

Dec. 13, 2017
By Nuala Moran
LONDON – Psioxus Therapeutics Ltd. has received approval for a phase I trial of NG-348, the first of its gene therapy for tumor products, triggering a $15 million milestone from partner Bristol-Myers Squibb Co. (BMS).
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As U.S. pays global tab on drug innovation, golden age could be wearing thin

Dec. 13, 2017
By Mari Serebrov
Are drug prices turning what's being called the golden age of science into the gilded age in the U.S.? That's the question Sen. Tim Kaine (D-Va.) posed Tuesday as the Senate Health, Education, Labor and Pensions (HELP) Committee held its third hearing on high drug prices.
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Dezima team regroups in startup Northsea to advance NASH candidate

Dec. 13, 2017
By Nuala Moran
LONDON – Newco Northsea Therapeutics BV has sailed onto the scene with a portfolio of structurally engineered fatty acids and a €25 million (US$29.4 million) series A funding round to take the lead product, icosabutate (PRC-4016), through phase IIb in the treatment of nonalcoholic steatohepatitis (NASH).
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Clementia starts first global phase III trial in ultra-rare bone disorder

Dec. 13, 2017
By Michael Fitzhugh
Just four months out from its $128.2 million August IPO, Montreal-based Clementia Pharmaceuticals Inc. is moving palovarotene, its lead candidate, into a registrational phase III trial testing its ability to treat fibrodysplasia ossificans progressiva (FOP), an ultra-rare bone disorder.
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Bioverativ compass points True North with BIVV-009 pivotal effort in CAgD

Dec. 13, 2017
By Marie Powers
ATLANTA – Bioverativ Inc. wasted little time moving the monoclonal antibody (MAb) BIVV-009 into phase III development after picking up the complement C1s subcomponent inhibitor, previously known as TNT-009, in its potential $825 million acquisition of True North Therapeutics Inc. (See BioWorld Today, May 24, 2017.)
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Lagoon boon swoon: Data from Murano helps Abbvie, waters in CLL still churning

Dec. 13, 2017
By Randy Osborne
ATLANTA – Abbvie Inc.'s vice president of oncology, Gary Gordon, told BioWorld that his firm aims to "restate the standard of care" in chronic lymphocytic leukemia (CLL), and the firm moved another step closer with full results from the phase III Murano trial, detailed in a late-breaking session at the American Society of Hematology meeting.
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In the clinic

Dec. 13, 2017
Proteostasis Therapeutics Inc., of Cambridge, Mass., disclosed positive study results across all three of the company's cystic fibrosis (CF) pipeline programs. Those include a study in CF subjects for PTI-428, a cystic fibrosis transmembrane conductance regulator (CFTR) amplifier; interim data for a study in CF subjects for PTI-801, a new generation CFTR corrector; and studies in healthy volunteers for PTI-808, a CFTR potentiator, and the combination of PTI-428, PTI-801 and PTI-808.
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