BioCentury | Aug 15, 2019
Company News

Harmony crosses finish line with Wakix for narcolepsy

FDA approved Wakix pitolisant Thursday, almost two years after Harmony gained U.S. rights to the narcolepsy drug. During 2017-18, Harmony raised $295 million to push it through registration. In October 2017, Harmony Biosciences LLC (Plymouth...
BioCentury | Jun 1, 2019
Product Development

ASCO 2019 abstracts show solid tumor race heating up among bispecifics and CAR Ts

While strong progress in CAR T therapies will again feature at this year’s ASCO meeting, bispecific antibodies are having a moment -- making more inroads into solid tumors than CAR Ts and branching out via...
BioCentury | Mar 22, 2019
Clinical News

Biofrontera planning applications to expand Ameluz indication

Biofrontera said it will submit regulatory applications to FDA and EMA in 3Q19 to expand the indication of Ameluz to include treatment of actinic keratoses lesions on the extremities. The decision follows Phase III data...
BioCentury | Aug 7, 2018
Preclinical News

Blood-based assay could predict Tecentriq's benefit in NSCLC

A blood-based tumor mutation burden (bTMB) assay could predict anti-PD-L1 mAb Tecentriq atezolizumab's clinical benefit in non-small cell lung cancer patients . The Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY), Foundation Medicine Inc. (NASDAQ:FMI) and academic...
BioCentury | Jun 29, 2018
Company News

Renal plays Akebia, Keryx merging

Akebia Therapeutics Inc. (NASDAQ:AKBA) will merge with Keryx Biopharmaceuticals Inc. (NASDAQ:KERX) in an all-stock deal, forming a combined company with one chronic kidney disease compound on the market and another in Phase III testing. Keryx...
BioCentury | Jun 28, 2018
Company News

Renal plays Akebia, Keryx merging

Akebia Therapeutics Inc. (NASDAQ:AKBA) will merge with Keryx Biopharmaceuticals Inc. (NASDAQ:KERX) in an all-stock deal, forming a combined company with one chronic kidney disease compound on the market and another in Phase III testing. The...
BioCentury | Feb 16, 2018
Strategy

Pfizer’s chemistry machine

With the goal of creating a step-change in the optimization of small molecules in discovery research, Pfizer Inc. has built a continuous flow machine that rapidly tests thousands of chemical reactions using submilligram quantities of...
BioCentury | Nov 10, 2017
Clinical News

FDA approves Keryx's Auryxia for non-dialysis-dependent CKD

Keryx Biopharmaceuticals Inc. (NASDAQ:KERX) said FDA approved an sNDA for Auryxia ferric citrate (Fexeric - EU, Riona - Japan, KRX-0502, JTT-751) to treat iron deficiency anemia in patients with non-dialysis-dependent chronic kidney disease (CKD). The oral ferric...
BioCentury | Nov 7, 2017
Financial News

Keryx sags after withdrawing guidance

Keryx Biopharmaceuticals Inc. (NASDAQ:KERX) fell $1.08 (17%) to $5.15 Tuesday after it reported 3Q17 earnings and withdrew its 2017 guidance. The company reported revenues of $15 million for the quarter, falling short of the $18...
BioCentury | Oct 13, 2017
Financial News

Harmony raises $270M, licenses narcolepsy drug

On Oct. 6, CNS company Harmony Biosciences LLC (Plymouth Meeting, Pa.) said it raised $270 million in an equity round from Valor Equity Partners, Fidelity Management & Research Co., HBM Healthcare Investments, Vivo Capital, venBio,...
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