01:12 , Jun 28, 2019 |  BC Extra  |  Company News

June 27 Company Quick Takes: Zogenix soars; plus Gardasil, Darzalex, Soliris and more

Zogenix shares surge after agreement to resubmit Fintepla NDA  Zogenix Inc. (NASDAQ:ZGNX) closed up $8.24 (21%) to $47.65 on Thursday after the company announced it had reached an agreement with FDA to resubmit its NDA...
00:02 , Jun 26, 2019 |  BC Extra  |  Company News

June 25 Company Quick Takes: Conatus restructuring; plus Almirall-Dermira, Acer, Glenmark and more

Conatus cuts headcount by 40% to extend runway  Conatus Pharmaceuticals Inc. (NASDAQ:CNAT) said it will lay off 40% of its staff and suspend development of caspase 1 inhibitor CTS-2090 in a bid to extend its...
22:52 , Apr 26, 2019 |  BC Extra  |  Company News

European regulatory roundup: CHMP opinions and a Portola approval

EMA's CHMP recommended a basket of approvals, including Dovato dolutegravir/lamivudine, Libtayo cemiplimab and two orphan therapies. Also Friday, the European Commission granted conditional approval to Ondexxya andexanet alfa from Portola Pharmaceuticals Inc. (NASDAQ:PTLA) to reverse...
20:41 , Mar 22, 2019 |  BC Week In Review  |  Clinical News

Allergy's birch pollen vaccine misses in Phase III

Allergy Therapeutics said Pollinex Quattro Birch missed the primary endpoint in the Phase III B301 trial to treat birch pollen-induced seasonal allergic rhinitis. Pollinex Quattro Birch failed to significantly improve the total combined symptom medication...
20:43 , Dec 21, 2018 |  BC Week In Review  |  Clinical News

CHMP backs Besremi for polycythemia vera, two Shionogi drugs

EMA's CHMP recommended a basket of approvals and label extensions on Dec. 14, including Orphan Drug Besremi ropeginterferon alfa-2b to treat polycythemia vera and a pair of treatments from Shionogi & Co. Ltd. (Tokyo:4507). The...
23:22 , Dec 14, 2018 |  BC Extra  |  Company News

CHMP backs Besremi for polycythemia vera, two Shionogi drugs

EMA's CHMP recommended a basket of approvals and label extensions on Friday, including Orphan Drug Besremi ropeginterferon alfa-2b to treat polycythemia vera and a pair of treatments from Shionogi & Co. Ltd. (Tokyo:4507). The agency...
16:38 , Sep 21, 2018 |  BC Week In Review  |  Clinical News

argenx planning Phase III for thrombocytopenia therapy

argenx S.E. (Euronext:ARGX; NASDAQ:ARGX) said it plans to start Phase III testing of IV efgartigimod (ARGX-113) to treat primary immune thrombocytopenia (ITP) after reporting that the compound led to clinically meaningful platelet count improvements in...
22:45 , Sep 17, 2018 |  BC Extra  |  Clinical News

argenx planning Phase III for thrombocytopenia therapy

argenx S.E. (Euronext:ARGX; NASDAQ:ARGX) said it plans to start Phase III testing of IV efgartigimod (ARGX-113) to treat primary immune thrombocytopenia (ITP) after reporting that the compound led to clinically meaningful platelet count improvements in...
16:57 , Aug 3, 2018 |  BC Week In Review  |  Clinical News

FDA approves Shionogi's thrombocytopenia drug

FDA approved Mulpleta lusutrombopag from Shionogi & Co. Ltd. (Tokyo:4507) to treat thrombocytopenia in adults with chronic liver disease who are scheduled to undergo a medical or dental procedure. Mulpleta is the second drug to...
20:40 , Jul 31, 2018 |  BC Extra  |  Company News

FDA approves Shionogi's thrombocytopenia drug

FDA approved Mulpleta lusutrombopag from Shionogi & Co. Ltd. (Tokyo:4507) to treat thrombocytopenia in adults with chronic liver disease who are scheduled to undergo a medical or dental procedure. Mulpleta is the second drug to...