22:55 , May 19, 2017 |  BioCentury  |  Strategy

Full set in hemophilia

Pfizer Inc. ’s deal with Sangamo Therapeutics Inc. brings in what the pharma believes is the last of three mechanisms it needs to cover the hemophilia population with new non-factor replacement therapies. The companies announced...
02:38 , Feb 11, 2017 |  BioCentury  |  Strategy

Building Bioverativ

Biogen Inc. ’s newly minted hematology spinout Bioverativ Inc. will have at least three years to build market share for its hemophilia therapies and flesh out its pipeline before gene therapies potentially hit the market....
00:53 , Dec 31, 2016 |  BioCentury  |  Finance

Delivering takeouts

  BioCentury’s 25th annual Buyside View finds biotech investors focusing on mid-cap names with late-stage or marketed products that could become M&A targets. “The main theme playing at the moment is investors like us are...
07:00 , Oct 10, 2016 |  BC Week In Review  |  Clinical News

Idelvion albutrepenonacog alfa regulatory update

CSL said Japan approved Idelvion albutrepenonacog alfa for bleeding in hemophilia B patients. The product is indicated as routine prophylaxis to prevent or reduce the frequency of bleeding episodes; on-demand control; and perioperative management of...
07:00 , May 16, 2016 |  BC Week In Review  |  Clinical News

Idelvion albutrepenonacog alfa regulatory update

The European Commission approved Idelvion albutrepenonacog alfa from CSL for the treatment and prophylaxis of bleeding in patients with hemophilia B. The company said Idelvion will be launched in Europe “in the coming months.” Idelvion...
07:00 , Apr 4, 2016 |  BioCentury  |  Finance

1Q approvals

1Q approvals Company Approval Alexion Pharmaceuticals Inc. (NASDAQ:ALXN) Japan approves Kanuma sebelipase alfa to treat lysosomal acid lipase deficiency (LAL-D) Amgen Inc. (NASDAQ:AMGN) Japan approves Repatha evolocumab to treat familial hypercholesterolemia or hypercholesterolemia in patients...
07:00 , Mar 14, 2016 |  BC Week In Review  |  Clinical News

Idelvion recombinant coagulation Factor IX regulatory update

FDA approved a BLA from CSL’s CSL Behring subsidiary for Idelvion recombinant coagulation Factor IX in adults or children with hemophilia B. CSL plans to launch Idelvion the week of March 21. The product is...
08:00 , Mar 7, 2016 |  BC Week In Review  |  Clinical News

Idelvion albutrepenonacog alfa regulatory update

EMA’s CHMP recommended approval of Idelvion albutrepenonacog alfa from CSL for the treatment and prophylaxis of bleeding in patients with hemophilia B. Idelvion is approved in Canada and is also under review in the U.S.,...
01:23 , Mar 5, 2016 |  BC Extra  |  Company News

FDA approves CSL's Idelvion

FDA approved Idelvion albutrepenonacog alfa ( CSL654 ) from CSL Ltd. (ASX:CSL) to prevent or control bleeding in adults or children with hemophilia B. Last week, EMA's CHMP recommended marketing authorization of the fusion protein...
00:57 , Feb 27, 2016 |  BC Extra  |  Company News

Hemo B therapies among several CHMP nods

EMA's CHMP recommended marketing authorization for several new medicines, including two to treat and prevent bleeding in hemophilia B patients: Alprolix eftrenonacog alfa from Biogen Inc. (NASDAQ:BIIB) and Idelvion albutrepenonacog alfa ( CSL654 ) albutrepenonacog...