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Regulus Therapeutics (RGLS) Looks Good: Stock Adds 5.6% in Session

2017-10-03 zacks
Regulus Therapeutics (RGLS - Free Report) was a big mover last session, as the company saw its shares rise nearly 6% on the day. The move came on solid volume too with far more shares changing hands than in a normal session. This continues the recent uptrend for the company for the company—as the stock is now up 37.5% in the past one-month time frame. (49-1)

Amgen (AMGN) Gets CRL for Osteoporosis Drug Evenity's BLA

2017-07-17 zacks
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.

Safety Issues Force the FDA to Turn Down Amgen, UCB SA's Bone Drug

2017-07-17 biospace
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.

Corporate News Blog - Lannett Co. Receives Approval for Cyproheptadine Hydrochloride Syrup

2017-07-17 accesswire
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.

Featured Company News - Lannett Announces Approval for Amantadine Hydrochloride Capsules USP, 100 mg; Set to Launch Before the Flu Season

2017-06-19 accesswire
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.

BRIEF-UCB SA says results from CRIB study on Cimzia show minimal to no placental drug transfer from mother to infant during third trimester of pregnancy

2017-06-13 reuters
* 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:

BRIEF-TCG BDC Inc says it priced its IPO of 9 million shares of common stock at $18.50 per share

2017-06-13 reuters
* TCG BDC Inc says it priced its ipo of 9 million shares of common stock at $18.50 per share

U.S., Europe seek measures to avert expanded airline laptop ban

2017-06-13 reuters
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.

BRIEF-Ares Management LP - transaction was valued at $30.75 million

2017-06-13 reuters
* 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 Provides Positive Long-term Data on Parkinson's Drug

2017-06-09 zacks
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 Epilepsy Drug Shows Positive Result in Phase Ia Study

2017-05-23 zacks
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.

UPDATE 1-UK competition watchdog accuses Merck of obstructing biosimilars

2017-05-23 reuters
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.

Regeneron, Sanofi rheumatoid arthritis drug wins U.S. approval

2017-05-22 reuters
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.

Wall Street opens higher as oil prices, defence stocks rise

2017-05-22 themalaymailonline
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 St. opens higher as oil prices, defense stocks rise

2017-05-22 reuters
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.