BioSpace News Archive

BioMidwest

Rockwell Medical Provides Investor Update

Rockwell Medical, Inc. provided an update to its investors.

June 29, 2018
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6 min read
Policy

Amneal Announces Favorable Ruling Regarding Patent Validity for Zomig® (zolmitriptan) Nasal Spray

Amneal Pharmaceuticals, Inc. announced that a panel of three Circuit Judges of the U.S. Court of Appeals for the Federal Circuit has affirmed the March 30, 2017 ruling of Judge Richard G. Andrews of the U.S. District Court, District of Delaware

June 29, 2018
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8 min read
FDA

gel-e expands its OTC label

US FDA clearance of the Company’s first flowable product paves the way for the next-generation of high-performance First Aid

June 29, 2018
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2 min read
Policy

Puma Biotechnology Receives Positive CHMP Opinion Recommending Approval of NERLYNX® for Extended Adjuvant Treatment of HER2-Positive Early Stage Breast Cancer

Puma Biotechnology, Inc. announced that on June 28, 2018 the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending marketing authorisation for the medicinal product NERLYNX® (neratinib)

June 29, 2018
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5 min read
FDA

ACADIA Pharmaceuticals Announces FDA Approval of New Dosing Formulation and Strength for NUPLAZID® (Pimavanserin)

Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced Food and Drug Administration (FDA) approval of a new capsule dose formulation and...

June 29, 2018
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6 min read
Drug Development

Arrowhead Presents New Clinical Data on ARO-AAT at Alpha-1 National Education Conference

Arrowhead Pharmaceuticals Inc. will present preclinical and initial clinical data on ARO-AAT

June 29, 2018
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5 min read
Job Trends

Researchers at University of Nevada, Reno rethink future of neuroscience

Mind-blowing research, including new understanding of enhanced senses and schizophrenia, is changing the landscape of brain science

June 29, 2018
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2 min read
Policy

Bristol-Myers Squibb Receives Positive CHMP Opinion Recommending Approval of Opdivo (nivolumab) for the Adjuvant Treatment of Adult Patients with Melanoma

First and only PD-1 agent to receive positive CHMP opinion in the adjuvant setting

June 29, 2018
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31 min read
Policy

European CHMP Adopts Positive Opinion for Yescarta® (axicabtagene ciloleucel) for the Treatment of Relapsed or Refractory DLBCL and PMBCL, After Two or More Lines of Systemic Therapy

Kite, a Gilead Company (Nasdaq: GILD), today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion on the company’s Marketing Authorization Application (MAA) for Yescarta® (axicabtagene ciloleucel)

June 29, 2018
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4 min read
Deals

EDGC Celebrates Listing on KOSDAQ

Eone-Diagnomics Genome Center has successfully completed the ceremony celebrating its listing on the Korea Securities Dealer Automated Quotation (KOSDAQ) at the Korea Exchange on June 26.

June 29, 2018
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2 min read