06:23 , Jan 19, 2018 |  BC Week In Review  |  Clinical News

EC approves Shire's Adynovi for hemophilia A

The European Commission approved Adynovi (BAX 855) from Shire plc (LSE:SHP; NASDAQ:SHPG) for on-demand and prophylactic use in hemophilia A patients ages 12 and older. The pegylated form of recombinant Factor VIII is approved in...
16:26 , Jan 12, 2018 |  BC Week In Review  |  Company News

Shire to split neuro and rare disease businesses

Shire plc (LSE:SHP; NASDAQ:SHPG) said it will split its neuroscience and rare disease businesses into two divisions. The separation comes after the pharma said in its 2Q17 earnings report that it was evaluating options for...
23:54 , Jan 9, 2018 |  BC Extra  |  Company News

Shire splits neuro and rare disease businesses

Shire plc (LSE:SHP; NASDAQ:SHPG) said it will split its neuroscience and rare disease businesses into two divisions. The separation comes after the pharma said in its 2Q17 earnings report that it was evaluating options for...
21:21 , Nov 16, 2017 |  BC Extra  |  Company News

FDA approves Genentech's Hemlibra for hemophilia A

FDA approved once-weekly subcutaneous Hemlibra emicizumab-kxwh from the Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children with hemophilia A with...
01:00 , Nov 16, 2017 |  BC Week In Review  |  Clinical News

CHMP recommends Shire's Adynovi for hemophilia A

EMA's CHMP recommended approval of Adynovi (Adynovate - U.S., Japan; BAX 855) from Shire plc (LSE:SHP; NASDAQ:SHPG) to treat and prevent bleeding in hemophilia A patients ≥12 years of age. The pegylated form of recombinant...
23:32 , Nov 10, 2017 |  BC Extra  |  Company News

CHMP recommends basket of therapies

EMA's CHMP recommended approval of a host of therapies, including Fasenra benralizumab to treat asthma, Adynovi for hemophilia A and Prevymis letermovir (MK-8228) to prevent cytomegalovirus (CMV) infection. CHMP backed approval of Fasenra from AstraZeneca plc...
19:58 , Aug 4, 2017 |  BC Week In Review  |  Company News

Shire evaluating neurology pipeline

In its 2Q17 earnings report, Shire plc (LSE:SHP; NASDAQ:SHPG) said it will evaluate options for its neurology franchise, with the potential of spinning out the company’s core ADHD business into an independent public company. The...
23:20 , Aug 3, 2017 |  BC Extra  |  Company News

Shire evaluating neurology pipeline

In its 2Q17 earnings report, Shire plc (LSE:SHP; NASDAQ:SHPG) said it will evaluate options for its neurology franchise, with the potential of spinning out the company’s core ADHD business into an independent public company. The...
00:26 , Apr 15, 2017 |  BioCentury  |  Product Development

Outside factors

This year could see the first regulatory submission from a coming wave of new therapies for hemophilia prophylaxis that do not simply replace missing clotting factors, which has been the standard for care for decades....
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. Given...