00:46 , Aug 4, 2018 |  BioCentury  |  Finance

Functions of formulation

Halozyme Therapeutics Inc. is quickly expanding the reach of its Enhanze platform on the back of regulatory approvals for products that are now gaining market share, plus a playbook for streamlined early development it can...
20:07 , Jul 13, 2018 |  BC Week In Review  |  Clinical News

EMA's CHMP recommends CAR Ts, rare disease therapies

EMA's CHMP recommended for approval Kymriah tisagenlecleucel and Yescarta axicabtagene ciloleucel, the first two CAR T therapies backed by the committee. CHMP also recommended a handful of other Orphan drug candidates, including Cablivi caplicizumab, a key...
20:20 , Jun 29, 2018 |  BC Extra  |  Company News

CHMP backs CAR Ts, Orphan candidates

EMA's CHMP recommended for approval Kymriah tisagenlecleucel and Yescarta axicabtagene ciloleucel, the first two CAR T therapies backed by the committee. CHMP also recommended a handful of other Orphan drug candidates, including Cablivi caplicizumab, a...
18:05 , May 25, 2018 |  BioCentury  |  Finance

HKEX’s on-demand experts

The Hong Kong stock exchange is well aware its investor base is new to the high-risk, high-reward nature of its newly hatched biotech chapter and has no qualms about admitting its own lack of expertise....
23:44 , Mar 9, 2018 |  BC Extra  |  Company News

Coherus gains on plans to resubmit BLA for Neulasta biosimilar

Coherus BioSciences Inc. (NASDAQ:CHRS) rose $2.75 (30%) to $11.85 on Friday after announcing in its earnings that it will resubmit a BLA for CHS-1701, with plans to launch the product in the U.S. next half....
18:00 , Mar 9, 2018 |  BC Week In Review  |  Company News

Caladrius gets late-stage cell therapy from Shire

Shire plc (LSE:SHP; NASDAQ:SHPG) granted Caladrius Biosciences Inc. (NASDAQ:CLBS) an exclusive, worldwide license to data and regulatory filings for a late-stage CD34+ cell therapy program to treat refractory angina. Shire will receive an upfront payment...
20:18 , Feb 2, 2018 |  BC Week In Review  |  Clinical News

EMA grants CTI extension to respond to Day 120 questions for pacritinib

CTI BioPharma Corp. (NASDAQ:CTIC) said EMA's CHMP granted it a three month extension to submit responses to a Day 120 list of questions regarding its MAA for pacritinib (BAX 2201, ONX 0803, SB1518) to treat...
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...
16:56 , Jan 12, 2018 |  BC Week In Review  |  Company News

Mallinckrodt divests hemostasis portfolio for $185M

In an effort to refine its pipeline, specialty pharmaceutical company Mallinckrodt plc (NYSE:MNK) sold surgical site bleeding products Preveleak Surgical Sealant and Recothrom Thrombin topical to Baxter International Inc. (NYSE:BAX). Mallinckrodt receives an upfront payment...
01:00 , Jan 3, 2018 |  BC Extra  |  Preclinical News

CYLD expression could slow progression of NASH

In a paper published in Nature Medicine, researchers at Wuhan University and Weill Cornell Medicine found that increasing expression of the deubiquitinating enzyme cylindromatosis turban tumor syndrome (CYLD) reversed progression of non-alcoholic steatohepatitis (NASH) in...