Amicus Therapeutics, Inc.
1 Cedar Brook Drive
Cranbury
New Jersey
08512
United States
Tel: 609-662-2000
Fax: 609-662-2001
Website: http://www.amicusrx.com/
Email: info@amicusrx.com
About Amicus Therapeutics, Inc.
Amicus Therapeutics is a global biotechnology company at the forefront of therapies for rare and orphan diseases. We have a unique set of platform technologies and medicines in development for people living with rare and devastating diseases, including the Lysosomal Storage Disorders Fabry disease and Pompe disease, as well as the genetic connective skin disorder Epidermolysis Bullosa (EB).
The needs of patients in the rare disease community are at the center of our inventive science, our commercial organization, and our clinical programs. Our goal throughout all levels of the organization is to make a meaningful difference in the lives of these patients and their caregivers.
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287 articles with Amicus Therapeutics, Inc.
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Under the agreement, Thermo Fisher will provide Amicus with immediate clinical and commercial manufacturing capabilities and capacity for Amicus’ intrathecal AAV Batten disease gene therapy programs.
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The deal broadens their work together from three to six programs for rare genetic diseases, as well as rights to collaborative R&D of novel gene therapies for lysosomal disorders and 12 additional rare diseases.
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1Q2019 Life Science Growth Announcements
4/18/2019
In the first quarter of 2019, more than 30 life science companies* announced expansions, new locations, increased funding, new trial and product launches and various other news pointing to a growing industry. -
Amicus Therapeutics, headquartered in Cranbury, New Jersey, announced it is launching a Global Research and Gene Therapy Center of Excellence in Philadelphia.
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WuXi Biologics and Amicus Sign Exclusive Manufacturing Partnership
2/11/2019
WuXi Biologics ("WuXi Bio") (2269.HK), development and manufacturing, and Amicus Therapeutics ("Amicus") (Nasdaq: FOLD), a global, patient-dedicated biotechnology company focused on discovering, developing and delivering high-quality medicines for people living with rare metabolic diseases, announced that the companies have entered into an exclusive commercial manufacturing partnership for Amicus' Pompe biologic ATB200.
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Over the course of 2018, the FDA approved 59 different novel drugs that range for the treatment of various cancers, chronic obstructive pulmonary disease (COPD), traveler’s diarrhea, migraine headaches and more.
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Amicus Therapeutics Announces Presentation and Poster at the 23rd International Congress of the World Muscle Society
10/2/2018
Amicus Therapeutics today announced that an oral presentation and a poster highlighting its development program AT-GAA for Pompe disease will be included at the 23rd International Congress of the World Muscle Society, to be held October 2-6, 2018 in Mendoza, Argentina.
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Movers and Shakers Oct. 1
10/1/2018
Here's a look at who shook things up in the world of pharma and biotech this week. -
The past few days has had a flurry of activity in the industry with leadership changes. Let's take a look at some of those!
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Amicus Therapeutics, headquartered in Cranbury, New Jersey, inked a definitive agreement for 10 gene therapy programs licensed from Nationwide Children’s Hospital through the acquisition of Celenex.
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Amicus Therapeutics Acquires Gene Therapy Portfolio of Ten Clinical and Pre-Clinical Stage AAV Programs in Neurologic Lysosomal Storage Disorders
9/20/2018
License with Nationwide Children’s Hospital (NCH) through the Acquisition of Celenex (NCH Spinout)
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Amicus Therapeutics, headquartered in Cranbury, New Jersey, held a Type C meeting with the U.S. Food and Drug Administration (FDA) regarding its regulatory path for AT-GAA for Pompe Disease. The company released its plans for the drug.
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A patient advocacy organization is putting its weight behind an effort to urge the U.S. Food and Drug Administration to reconsider its recent decision to reject a treatment for the rare lipid disorder familial chylomicronemia syndrome (FCS). That rejection lead to a round of layoffs at Akcea.
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FDA Approves Eight Novel Drugs in August
8/31/2018
The U.S. Food and Drug Administration has had a busy August. In addition to the number of draft guidance documents the agency issued during the month, the FDA has also been busy approving a number of new treatments for a variety of diseases. -
The U.S. Food and Drug Administration has done another about-face. Days after rejecting Regeneron’s attempt to secure a supplemental approval for Eylea, the FDA has now approved a new dosing label for the drug in wet age-related macular degeneration (wet AMD).
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This week had three important target action dates, known as Prescription Drug User Fee Act (PDUFA) dates, for the U.S. Food and Drug Administration (FDA). The agency got ahead of its schedule and approved all of these drugs ahead of schedule. Let’s take a look.
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FDA approves new treatment for a rare genetic disorder, Fabry disease
8/10/2018
The U.S. Food and Drug Administration today approved Galafold (migalastat), the first oral medication for the treatment of adults with Fabry disease. The drug is indicated for adults with Fabry disease who have a genetic mutation determined to be responsive ("amenable") to treatment with Galafold based on laboratory data.
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On April 23, the FDA’s arthritis advisory committee will take another look at Eli Lilly's re-submission for their moderate-to-severe rheumatoid arthritis drug.
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Today, on this 11th World Rare Disease Day, life science companies, organization and activists have come together to raise awareness about these diseases and the needs of therapies for patients.
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Amicus Therapeutics Prices Underwritten Offering of Common Stock
2/16/2018
The offering is expected to close on February 21, 2018, subject to customary closing conditions.