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Amgen Inc. (AMGN - Free Report) and partner UCB SA (UCBJF - Free Report) announced that the FDA has issued a complete response letter (CRL) for the biologics license application (BLA) for Evenity (romosozumab). Amgen is looking to get Evenity approved for the treatment of postmenopausal women with osteoporosis.
THOUSAND OAKS, Calif. and BRUSSELS, July 16, 2017 /PRNewswire/ -- Amgen (NASDAQ: AMGN) and UCB (Euronext Brussels: UCB) today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter for the Biologics License Application (BLA) for EVENITY™* (romosozumab) as a treatment for postmenopausal women with osteoporosis.
LONDON, UK / ACCESSWIRE / July 17, 2017 / Pro-Trader Daily takes a look at the latest corporate events and news making the headlines for Lannett Co., Inc. (NYSE: LCI), following which we have published a free report that can be viewed by signing up at http://protraderdaily.com/optin/?symbol=LCI. The Philadelphia based Company announced on July 14, 2017, that it has received consent from the US Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Cyproheptadine Hydrochloride Syrup (Cyproheptadine Hydrochloride Oral Solution, USP) 2 mg/5 mL, the therapeutic equivalent to the reference standard drug, Cyproheptadine Hydrochloride Syrup (Cyproheptadine Hydrochloride Oral Solution USP) by Lyne Laboratories, Inc.
LONDON, UK / ACCESSWIRE / June 19, 2017 / Pro-Trader Daily takes a look at the latest corporate events and news making the headlines for Lannett Co., Inc. (NYSE: LCI). The Company announced on June 16, 2017, that it has received approval from the US Food and Drug Administration (FDA) for Amantadine Hydrochloride Capsules USP, 100 mg, of Sandoz Pharmaceuticals. The product was initially branded and marketed as Symmetrel® Capsules, 100 mg.
* UCB SA says results from CRIB study on Cimzia demonstrate minimal to no placental transfer of drug from mother to infant during third trimester of pregnancy Source text for Eikon: Further company coverage:
* TCG BDC Inc says it priced its ipo of 9 million shares of common stock at $18.50 per share
WASHINGTON, June 13 The U.S. Department of Homeland Security will meet European officials this week to discuss new security measures that could prevent the U.S. government expanding a ban on laptops beyond flights from ten airports primarily in the Middle East.
* Ares management LP - Ares Management Funds and Truamerica Multifamily acquire 240-unit apartment community in Phoenix for $31 million Source text for Eikon: Further company coverage:
Adamas Pharmaceuticals, Inc. (ADMS - Free Report) presented expanded analysis from an ongoing open label phase III study – EASE LID 2 – on its lead candidate, ADS-5102 extended-release capsules. The candidate is being evaluated for the treatment of levodopa-induced dyskinesia (LID) associated with Parkinson’s disease (PD).
Adamas Pharmaceuticals, Inc. (ADMS - Free Report) announced positive data from the phase Ia study evaluating ADS-4101 (lacosamide) for the treatment of partial onset seizures in epilepsy. ADS-4101 is a modified version of UCB SA’s (UCBJF) Vimpat, which is approved in the U.S., EU and Japan for the same indication.
LONDON Britain's competition watchdog has accused Merck & Co of operating an unfair discount scheme for its medicine Remicade that it said was designed to restrict competition from so-called biosimilar copies.
The U.S. Food and Drug Administration approved Regeneron Pharmaceuticals and Sanofi's biotech drug for adults with moderate to severe rheumatoid arthritis, the two companies said on Monday.
While the political developments in Washington continue to play on investors’ minds, sentiment has been bolstered by the strong quarterly earnings season. — Reuters picNEW YORK, May 22 — Wall Street gained in early trading today, helped by higher oil prices and as defense stocks rose after a US$110 billion (RM473.5 billion) arms deal between the United States and Saudi Arabia.
Wall Street gained in early trading on Monday, helped by higher oil prices and as defense stocks rose after a $110 billion arms deal between the United States and Saudi Arabia.
May 21 Hunstman Corp and Clariant AG are set to announce their merger on Monday, creating a chemical manufacturer with a market value of more than $14 billion, people familiar with the matter said on Sunday.
May 21 Amgen Inc and UCB SA on Sunday said their experimental osteoporosis drug, which is awaiting a U.S. approval decision, met the primary and key secondary goals of a late stage study but a higher rate of serious heart problems were reported that had not been seen in earlier studies.
Amgen Inc and UCB SA on Sunday said they do not expect their experimental osteoporosis drug to win U.S. approval this year after a higher rate of serious heart-related side effects were observed in a late stage clinical trial.
* Facebook videos of violent deaths while marked as disturbing don't always have to be deleted as they can help create awareness of issues like mental illness- Guardian
This is the second in a series of three blog posts on bandits for recommendation systems.
UCB has a strong core in CNS and immunology, but growth in Cimzia could be limited by biosimilars and Vimpat is facing a patent challenge.
GlaxoSmithKline plc (GSK - Free Report) , one of the largest health care companies, reshaped its business following Mar 2015 completion of the three-part, inter-conditional transaction with Novartis AG (NVS - Free Report) . Under the deal, Glaxo sold oncology assets to Novartis and acquired Novartis’ Vaccines business (excluding influenza vaccines).
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David Bowers, Klemens Fheodoroff, Patricia Khan, Julian P Harriss, Khashayar Dashtipour, Laxman Bahroo, Michael Lee, Denis Zakharov, Jovita Balcaitiene, Virgilio Evidente; European Neurological Review, 2016;11(2):87-95 DOI: https://doi.org/10.17925/ENR.2016.11.02.87
Amgen Inc. (AMGN - Free Report) and partner UCB SA (UCBJF - Free Report) announced that they have submitted an application seeking marketing approval for its investigational monoclonal antibody romosozumab to Japan’s Pharmaceuticals and Medical Devices Agency (PMDA). The companies are looking to get romosozumab approved for the treatment of osteoporosis in postmenopausal women at an increased risk of fracture.
BRUSSELS, Belgium and MENLO PARK, Calif., Oct. 03, 2016 (GLOBE NEWSWIRE) -- UCB (Euronext:UCB) and Dermira, Inc. (NASDAQ:DERM) today announced topline results from CIMPASI-2, a Phase 3, multi-center, placebo-controlled clinical trial evaluating the efficacy and safety of CIMZIA® (certolizumab pegol) in adult patients with moderate-to-severe chronic plaque psoriasis. In the CIMPASI-2 trial, CIMZIA demonstrated statistically significant improvements for both co-primary endpoints compared to placebo at both treatment doses.