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1:07 PM, May 18, 2018  |  BC Week In Review | Clinical News  |  Clinical Status

Agenus shifts focus to cervical cancer from first-line NSCLC

Agenus Inc. (NASDAQ:AGEN) said in its 1Q18 earnings report that it shifted its developmental strategy to first seek approval of its checkpoint inhibitors as a second-line treatment for cervical cancer instead of as a first-line...
1:00 PM, May 18, 2018  |  BC Week In Review | Company News  |  Deals

Biogen intends to increase stake in Samsung Bioepis

Samsung BioLogics Co. Ltd. (KSE:207940) said it received a letter from partner Biogen Inc. (NASDAQ:BIIB) in which the biotech said it intends to exercise its option to increase its stake in Samsung Bioepis, a JV...
12:43 PM, May 18, 2018  |  BC Week In Review | Company News  |  Deals

Novo Nordisk in stem cell therapy deals

Lund University (Lund, Sweden) and Duke-NUS Medical School (Singapore) each partnered with Novo Nordisk A/S (NYSE:NVO; CSE:NOVO B) and granted the company rights to develop stem cell-based therapies. The therapies are based on Biolaminins from...
12:42 PM, May 18, 2018  |  BC Week In Review | Clinical News  |  Regulatory

FDA approves Aimovig as first CGRP inhibitor for migraines

FDA approved Aimovig erenumab from Amgen Inc. (NASDAQ:AMGN) and Novartis AG (NYSE:NVS; SIX:NOVN) late on May 17 to prevent migraine in adults. The drug is the first calcitonin gene-related peptide (CGRP) inhibitor approved for the...
12:42 PM, May 18, 2018  |  BC Week In Review | Clinical News  |  Regulatory

FDA accepts NDA for Insmed's ALIS

Insmed Inc. (NASDAQ:INSM) said FDA accepted and granted Priority Review to an NDA for ALIS (amikacin liposome inhalation suspension) to treat non-tuberculous mycobacterial lung disease caused by Mycobacterium avium complex (MAC). The PDUFA date is...
12:42 PM, May 18, 2018  |  BC Week In Review | Clinical News  |  Clinical Status

Novartis to start head-to-head trial of Cosentyx and Tremfya

Novartis AG (NYSE:NVS; SIX:NOVN) plans to begin the head-to-head Phase IIa ARROW trial to compare Cosentyx secukinumab to Tremfya guselkumab for 16 weeks in 40 patients with Stelara ustekinumab-resistant plaque psoriasis. The pharma expects to...
12:41 PM, May 18, 2018  |  BC Week In Review | Clinical News  |  Regulatory

FDA accepts resubmitted Coherus biosimilar BLA for review

Coherus BioSciences Inc. (NASDAQ:CHRS) said FDA accepted for review a resubmitted BLA for CHS-1701, a proposed biosimilar of neutropenia drug Neulasta pegfilgrastim from Amgen Inc. (NASDAQ:AMGN). Its BSUFA date is Nov. 3. FDA issued a complete...
12:14 PM, May 18, 2018  |  BC Week In Review | Financial News  |  Completed Offerings

Karyopharm closes $155M follow-on

Cancer company Karyopharm Therapeutics Inc. (NASDAQ:KPTI) raised $155 million through the sale of 10.5 million shares at $14.75 in an follow-on underwritten by J.P. Morgan, Jefferies, Leerink, Canaccord Genuity, JMP, H.C. Wainwright and Baird. The...
12:13 PM, May 18, 2018  |  BC Week In Review | Financial News  |  Completed Offerings

Stapled peptide company FOG raises $66M series B

FOG Pharmaceuticals Inc. (Cambridge, Mass.) raised $66 million in a series B round led by 6 Dimensions Capital. New investors GV, Blue Pool Capital, Horizons Ventures, Nan Fung Group and Leerink Partners also participated, as...
12:13 PM, May 18, 2018  |  BC Week In Review | Financial News  |  Amended Offerings

Iterum sets IPO range

Antibiotics company Iterum Therapeutics plc (Dublin, Ireland) amended its proposed IPO on NASDAQ on May 16 and now plans to sell 5.3 million shares at $14-$16. At the $15 midpoint, the company would raise $80...

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