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Latest Biosimilar Stories

2014-01-17 20:22:00

DUBLIN, Jan. 17, 2014 /PRNewswire/ -- Actavis plc (NYSE: ACT) today confirmed that the United States District Court for the District of New Jersey found United States Patent No. 7,704,984 (the '984 Patent) to be valid and infringed by Lupin Pharmaceuticals, Inc. and Amneal Pharmaceuticals Abbreviated New Drug Applications (ANDAs) for generic versions of Actavis' Lo Loestrin(®) Fe (norethindrone acetate and ethinyl estradiol tablets, ethinyl estradiol tablets and ferrous fumarate...

2014-01-15 23:22:58

Xtalks presents an exciting live webinar on Thursday, January 30, 2014 at 11:00am EST (4pm GMT). Join keynote speaker Joerg Bluemel, Director of Toxicology within Biologics Safety Assessment / Translational Sciences at MedIummune for a one-hour discussion on nonclinical and clinical Safety Assessment of Biosimilars. Toronto, Canada (PRWEB) January 15, 2014 This webinar will focus on EMA and FDA regulatory perspectives on nonclinical and clinical safety assessment in biosimilars....

2014-01-09 23:20:23

The Biosimilar products market is segmented into recombinant non-glycosylated proteins, recombinant glycosylated proteins, and recombinant peptides. (PRWEB) January 09, 2014 The “Biosimilars Market Product [Recombinant Non-Glycosylated Proteins (Insulin, Filgrastim, Somatropin), Glycosylated (Monoclonal Antibodies, Erythropoietin), Peptides (Glucagon, Calcitonin)] & Application (Oncology, Blood Disorders) - Global Forecast to 2018”, provides a detailed overview of the major...

2014-01-08 20:21:24

Ask Agency to require that biosimilars bear distinguishable names to enhance patient safety WASHINGTON, Jan. 8, 2014 /PRNewswire-USNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen) today submitted a Citizen Petition to the U.S. Food and Drug Administration (FDA) asking the agency to require biosimilars to bear nonproprietary names that are similar to, but not the same as, those of their reference products or of other biosimilars. The Petition states...

2014-01-08 16:26:48

DUBLIN, Jan. 8, 2014 /PRNewswire/ -- Actavis plc (NYSE: ACT) today announced that it has received approval from the U.S. Food and Drug Administration (FDA) on its Abbreviated New Drug Application (ANDA) for Telmisartan Immediate-Release Tablets, 20 mg, 40 mg and 80 mg, a generic equivalent to Boehringer Ingelheim's Micardis(®). Actavis intends to launch the product immediately. As a "first applicant" to submit a substantially complete ANDA, Actavis is eligible for 180 days of...

2014-01-08 08:27:23

- JHL Biotech to develop and commercialize BL-9020 in China and additional Southeast Asia countries - JERUSALEM and HSINCHU, Taiwan, Jan. 8, 2014 /PRNewswire/ -- BioLineRx (NASDAQ: BLRX; TASE: BLRX), a clinical-stage biopharmaceutical company dedicated to identifying, in-licensing and developing promising therapeutic candidates, and JHL Biotech, a biopharmaceutical company that develops, manufactures, and commercializes biologic medicines, announced today that they have entered into...

2014-01-07 08:32:32

REDWOOD CITY, Calif., Jan 7, 2014 /PRNewswire/ -- Denny Lanfear, President and CEO of Coherus Biosciences, will present at the J.P. Morgan 32(nd) Annual Healthcare Conference on Wednesday, January 15 at the Westin St. Francis in San Francisco, CA., beginning at 4:30pm Pacific Standard Time. (Logo: http://photos.prnewswire.com/prnh/20120507/SF01448LOGO) "Coherus' upcoming presentation at the conference marks an important milestone for our Company. This event will introduce...


Word of the Day
call-note
  • The call or cry of a bird or other animal to its mate or its young.
'Call-note' is newer than 'bird-call,' which originally referred to 'an instrument for imitating the note of birds' but now also refers to 'the song or cry of a bird.'
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