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New Phase 3b Interim Data from STARDUST Study Show Two-Thirds of Patients with Moderately to Severely Active Crohn’s Disease Achieved Clinical Remission After Two Doses of STELARA® (ustekinumab)

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The Janssen Pharmaceutical Companies of Johnson & Johnson today announced interim data from the Phase 3b STARDUST study. At week 16, 79 percent of patients with moderately to severely active Crohns disease (CD) achieved clinical responsea and 67 percent were in clinical remissionb after receiving one ~6 mg/kg intravenous (IV) dose followed by one 90 mg subcutaneous (SC) dose of STELARA (ustekinumab), open label.1 Intestinal ultrasound (IUS) responses were assessed and were detected as early as week 4.2 Week 16 data (digital oral presentation or DOP 13) and IUS response data (DOP 10) from STARDUST are being presented as part of a digital oral presentation at the 15th Congress of the European Crohns & Colitis Organisation (ECCO).1,2

The primary endpoint of the 48-week STARDUST study is comparative endoscopic responsec among adult patients with CD receiving ustekinumab maintenance therapy.3 At week 16, patients who achieved a ‰¥70 point decrease in Crohns Disease Activity Index scored (CDAI70 responders) were randomised into treat-to-target or routine standard of care treatment groups at a 1:1 ratio.3

Of the 220 CDAI70 responders randomised in the treat-to-target arm, 37 percent achieved endoscopic response at week 16.1 Endoscopy at week 16 was measured only in the treat-to-target group.3 Treat-to-target is a proactive treatment strategy where frequently monitored outcomes, like endoscopic response, biomarkers and clinical symptoms, guide use of the medication.4 STARDUST is the first study of a treat-to-target strategy in CD using endoscopic response to guide treatment.

Crohns disease patients may respond to treatment while continuing to experience internal inflammation that can cause irreversible damage. These patients may benefit from a more proactive, robust treatment approach and less invasive monitoring methods, said Professor Silvio Danesei, Head of the Inflammatory Bowel Diseases Centre at Humanitas Research Hospital, Milan, Italy and principal investigator. I am encouraged by these data that demonstrate the potential clinical utility of the noninvasive IUS method in helping guide treatment of CD and look forward to forthcoming data that may help us better understand the possible benefits of a treat-to-target strategy.

IUS is a complementary method of assessing CD activity, based upon measuring transmural bowel features, like thickness of the bowel wall and presence of hypervascularisation.5 STARDUST is the first study to use IUS for monitoring CD patients in an interventional setting. Future studies need to confirm whether early IUS response at week 4 is predictive of longer-term (i.e., week 16 and up to week 48) clinical and endoscopic outcomes for CD patients.

STARDUST week 16 interim analysis includes 500 participants with moderately to severely active CD receiving an IV induction dose of ustekinumab ~6 mg/kg, followed by an ustekinumab 90 mg SC injection at week 8.1 In the interim analysis, patient response was assessed up to week 16. Participants were either na¯ve to prior biologics or had previously been exposed to no more than one biologic medicine. At week 16, the safety profile for ustekinumab in STARDUST was consistent with the established safety profile observed in Phase 3 inflammatory bowel disease (IBD) clinical trials, as well as that seen in other indications.6,7

As in the current prescribing information, the most common adverse events (AEs) (>5%) in controlled periods of clinical studies with ustekinumab were nasopharyngitis and headache. Most were considered to be mild and did not necessitate discontinuation of study treatment. The most serious adverse reaction that has previously been reported for ustekinumab is serious hypersensitivity reactions, including anaphylaxis. The overall safety profile is similar for adult patients with CD, ulcerative colitis (UC), psoriasis, and psoriatic arthritis.6

STARDUST represents a significant milestone in our commitment to helping Crohns disease patients and the physicians who treat them, said Jan Wehkamp, M.D., Vice President, Gastroenterology Disease Area Leader, Janssen Research & Development, LLC. The data from this study may provide us with key clinical insights which may inform future treatment strategies.

Janssen is presenting a total of 23 abstracts at this years ECCO congress. Ustekinumab is currently approved for the treatment of adults with moderately to severely active CD in the U.S., Canada, the European Union (EU) and Japan.

# # #

Key definitions a Clinical response is defined as a decrease in Crohns Disease Activity index (CDAI) score from baseline of ‰¥100 points (CDAI100), or a CDAI score of <150.8 b Clinical remission is defined as a CDAI score of <150.8 c Endoscopic response was defined by a 50 percent reduction from baseline in simple endoscopic score (SES-CD).3 d CDAI is a frequently used measure to assess the severity of CD, giving a score from 0“600; a higher score indicates more severe disease activity.8

About the STARDUST Trial3 STARDUST is a randomised, international, multi-centre, interventional Phase 3b study evaluating the proportion of patients with endoscopic response, defined as a ‰¥50% reduction from baseline in simple endoscopic score for Crohns disease (SES-CD) at week 48. STARDUST is evaluating 500 participants receiving an IV induction dose of ustekinumab 6 mg/kg, followed by an ustekinumab 90 mg SC injection at week 8. At week 16, patients with a CDAI reduction of ‰¥70 points (CDAI70) were randomised to treat-to-target or standard of care treatment arms (1:1 ratio) and will be followed through the end of the study (48 weeks). Primary endpoint data are anticipated for presentation later this year.

About Crohns Disease (CD) CD is one of the two main forms of IBD, which affect up to 1.7 million people across Europe.9 CD is a chronic inflammatory condition of the gastrointestinal tract with no known cause, but the disease is associated with abnormalities of the immune system that could be triggered by a genetic predisposition, diet or other environmental factors. Symptoms of CD can vary but often include abdominal pain and tenderness, frequent diarrhoea, rectal bleeding, weight loss and fever.10 There is currently no cure for CD.11

About STELARA (ustekinumab)6 In the EU, ustekinumab is approved for the treatment of adult patients with moderate to severe CD who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a TNF‘alpha antagonist, or have medical contraindications to such therapies. Ustekinumab is also approved for the treatment of adults with moderately to severely active UC who have had an inadequate response with, or lost response to, or were intolerant to either conventional therapy or a biologic, or have medical contraindications to such therapies. In addition to CD and UC, ustekinumab has been approved for the treatment of two further immune-mediated conditions in the EU: psoriasis and psoriatic arthritis.

Ustekinumab is approved alone or in combination with methotrexate (MTX) for the treatment of active psoriatic arthritis in adult patients when the response to previous non-biological disease-modifying antirheumatic drug therapy has been inadequate. Ustekinumab is also approved for the treatment of moderate to severe plaque psoriasis in children and adolescent patients aged six years and older who are inadequately controlled by, or are intolerant to other systemic therapies or phototherapies, and is also approved for the treatment of moderate to severe plaque psoriasis in adults who failed to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporine, MTX or psoralen plus ultraviolet A.

The Janssen Pharmaceutical Companies of Johnson & Johnson maintain exclusive worldwide marketing rights to STELARA.

Important safety information6 The most common AEs (>5%) in controlled periods of clinical studies with ustekinumab were nasopharyngitis and headache. Most were considered to be mild and did not necessitate discontinuation of study treatment. The most serious adverse reaction that has been reported for ustekinumab is serious hypersensitivity reactions, including anaphylaxis. The overall safety profile is similar for adult patients with CD, UC, psoriasis, and psoriatic arthritis.

Please refer to the Summary of Product Characteristics for full prescribing information for ustekinumab: https://www.medicines.org.uk/emc/product/7638/smpc

About the Janssen Pharmaceutical Companies of Johnson & Johnson At Janssen, were creating a future where disease is a thing of the past. Were the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension.

Learn more at www.janssen.com/emea. Follow us at www.twitter.com/JanssenEMEA.

Janssen-Cilag International NV, the marketing authorisation holder for STELARA in the EU, and Janssen Research & Development, LLC, are part of the Janssen Pharmaceutical Companies of Johnson & Johnson.

Cautions Concerning Forward-Looking Statements This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding regulatory approvals and benefits of a new treatment option for STELARA (ustekinumab). The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialise, actual results could vary materially from the expectations and projections of Janssen-Cilag International NV, and any of the other Janssen Pharmaceutical Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behaviour and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended 30 December, 2018, including in the sections captioned Cautionary Note Regarding Forward-Looking Statements and Item 1A. Risk Factors, and in the companys most recently filed Quarterly Report on Form 10-Q, and the companys subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

# # #

References

  1. Danese S, et al. Clinical and endoscopic response to ustekinumab in Crohns Disease: Week 16 interim analysis of the STARDUST trial [Presentation for DOP13] Presented at the 15th Congress of the European Crohns & Colitis Organization (ECCO) 12-15 February 2020; Vienna, Austria.
  2. Kucharzik T, et al. Intestinal ultrasound response and transmural healing after ustekinumab induction in Crohns Disease: Week 16 interim analysis of the STARDUST trial substudy. [Presentation for DOP10] Presented at the 15th Congress of the European Crohns & Colitis Organization (ECCO) 12-15 February 2020; Vienna, Austria.
  3. ClinicalTrials.gov. Study of Treat to Target Versus Routine Care Maintenance Strategies in Crohn’s Disease Patients Treated With Ustekinumab (STARDUST). Identifier NCT03107793. Available at: https://clinicaltrials.gov/ct2/show/NCT03107793. Accessed February 2020.
  4. Smolen J, et al. Treating rheumatoid arthritis to target: 2014 update of the recommendations of an international task. Ann Rheum Dis 2015;0:1“13.
  5. Fraquelli M, et al. Impact of intestinal ultrasound on the management of patients with inflammatory bowel disease: how to apply scientific evidence to clinical practice. Dig Liver Dis 2020;52:9“18.
  6. European Medicines Agency. STELARA Summary of product characteristics. 2020. Available at: https://www.medicines.org.uk/emc/product/7638/smpc. Accessed February 2020.
  7. Sandborn WJ, et al. Long-term efficacy and safety of ustekinumab for Crohn’s disease through the second year of therapy. Aliment Pharmacol Ther 2018;48:65“77.
  8. Feagan BG, et al. Ustekinumab as induction and maintenance therapy for Crohns disease. NEJM 2016;375:1946“60.
  9. Ng SC, et al. Worldwide incidence and prevalence of inflammatory bowel disease in the 21st century: a systematic review of population-based studies. Lancet 2017;390:2769-78.
  10. Crohns and Colitis Foundation. Crohns disease. Available at: https://www.crohnscolitisfoundation.org/what-is-crohns-disease/overview. Accessed February 2020.
  11. Mayo Clinic. Crohns disease. Available at https://www.mayoclinic.org/diseases-conditions/crohns-disease/symptoms-causes/syc-20353304. Accessed February 2020.

i Professor Danese is a paid consultant for Janssen. He has not been compensated for any media work.

CP-137007 February 2020

Media Contact:

Emily Bone

Mobile: +44 787-639-4360

[email protected]

Investor Contacts:

Chris DelOrefice

Office: +1 (732) 524-2955

Lesley Fishman

Office: +1 (732) 524-3922

News

Suncity Group Named Title Sponsor for Local Arts Events

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Fully Supports Macau’s Cultural Industry and the Recovery of Macau

 

MACAU, CHINA – Media OutReach – 20 September 2020 – To revitalize the development of Macau’s cultural industry, Suncity Group fully supports the local arts event, rooting for Macau citizens and local artists through series of astonishing and diversified music entertaining events. ‘Suncity Group Rooting for Macau – SIM! Music Festival 2020’ is the first musical performance of series events title sponsored by Suncity Group, ended perfectly at the Cotai Arena, Venetian Macau on September 19.

[View Image]

Maria Helena de Senna Fernandes, Director of Macau Government Tourist Office, Mr. Kevin Ho, Macau Deputy to the National People’s Congress of PRC, Mr. Alvin Chau, Chief Executive Officer and Director of Suncity Group and President of Macau Artistes Association, Dr. Wilfred Wong, President and Executive Director of Sands China Ltd. attended the event 

‘Best Performance Award’ was awarded to Classic heritage- The Final Trigger by Mr. Alvin Chau

[View Image]

Local singers, artists, dancers and more than 200 people from the industry were assembled to organise this music festival

 

With the purpose of ‘reigniting the local performing arts power’, a group of outstanding local singers, artists, dancers and more than 200 people from the industry were assembled to organise this music festival. A total of 12 units did their utmost to compete in the same stage with singing and dancing. There was no cessation to the excitement and the symphony of applause and cheers in the whole night.

 

The organisers have specially invited Mr. Kevin Ho, Macau Deputy to the National People’s Congress of PRC, Dr. Wilfred Wong, President and Executive Director of Sands China Ltd., Mr. Alvin Chau, Chief Executive Officer and Director of Suncity Group and President of Macau Artistes Association to serve as adjudicators and presenters, witnessing and supporting this diversified music festival that belongs to Macau with the other officiating guests. It shot in the arm of Macau’s cultural industry which has been gradually recovering after the pandemic. After a series of stiff competitions and wonderful performances by the participating units, the ‘Best Styling Award’ went to Walk with Scamper, the ‘Best Teamwork Award’ was awarded to Girls Rock, the ‘Best Positive Energy’ was given to Bacalhau Talkshow & Band, and finally the ‘Best Performance Award’ was awarded to Classic heritage- The Final Trigger by Mr. Alvin Chau.

 

Mr. Chau said, ‘2020 is the year full of difficulties. With the impact of the pandemic, performing arts and cultural industries in mainland China and Macau have been hard hit. Most of the large-scale musical performances have also been suspended. “Suncity Group Rooting for Macau – SIM! Music Festival 2020” as the first music festival of this year, it undoubtedly brings more positive energy to Macau society as well as the cultural industry, pro-actively supporting the development of Macau’s industrial diversification.’

 

As the first extraordinary music feast of series events ended, ‘Suncity Group Rooting for Macau – SIM! Full Band festival 2020’, also title sponsored by Suncity Group, comes immediately thereafter and will be held on September 26. 13 teams of local rock bands will spare no effort to inspire local Macau citizens and awaken their rocking soul. There are also DJ performances, cold beer and snacks at that night, creating a diversified and dynamic rock music festival with hyper performances and mouth-watering delicacies. It once again roots for the recovery of Macau’s economy.

 

As an enterprise rooted in Macau, Suncity Group is committed to the motherland and Macau. With actively fulfilling its social responsibilities, the Group strives to support the recovery of cultural industry in mainland China and Macau as well as the diversified development of Macau in cooperating to national policies and long-term development of China. Through the title sponsorship of the series arts events, Suncity Group hopes to bring more positive energy and get the uptick of confidence to the Macau society.

 

High-resolution images can be downloaded in the gallery:

https://dropbox.suncity-group.com/url/0919sim

About Suncity Group

Suncity Group was founded in 2007. Since establishment, Suncity Group has been striving to provide the extraordinary VIP entertainment service for our guests, and we then opened a number of VIP Clubs in various 6-star hotels and resorts throughout Macau with the rapid growth of our business. Meanwhile, we successively set up exclusive VIP Clubs in Manila, Seoul, Incheon, Phnom Penh and Da Nang, etc.

 

Adhering to the spirit of “Innovating With Diversity, Striving For Success”, Suncity Group spared no effort to develop high-end entertainment services and products as well as roll out global VIP loyalty program for the selected members to enjoy entertainment, travel, catering services, luxury shopping and motion picture. Today, the scope of our business covers most sectors, especially in the fields of global travel, film production, concert and event planning, catering and luxury goods.

 

As a Macau born and bred enterprise, Suncity Group is not only devoted to develop the Asian market, but also oriented to expand the global network. In the future, we will surely continue to diversify our VIP entertainment services, attract more exclusive members and make every effort to promote our business in every corner of the world.

 

Official Website | www.suncitygroup.com.mo/en

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CNOOC Limited Announces Commencement of Production at Liuhua 16-2 Oilfield / 20-2 Oilfield Joint Development Project

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HONG KONG, Sept. 20, 2020 /PRNewswire/ — CNOOC Limited (the "Company", SEHK: 00883, NYSE: CEO, TSX: CNU) announced today that Liuhua 16-2 oilfield/ 20-2 oilfield joint development project has commenced production.

Liuhua 16-2 oilfield / 20-2 oilfield joint development project is located in Eastern South China Sea. The average water depth of the joint development project is approximately 410 meters.  One 150,000 DWT FPSO and three underwater production systems are newly built. A total of 26 development wells are planned to be put into production and development. The project is expected to reach its peak production of approximately 72,800 barrels of crude oil per day in 2022.

CNOOC Limited holds 100% interest of Liuhua 16-2 oilfield/ 20-2 oilfield joint development project.

– End –

Notes to Editors:

More information about the Company is available at http://www.cnoocltd.com.

*** *** *** ***

This press release includes "forward-looking statements" within the meaning of the United States Private Securities Litigation Reform Act of 1995, including statements regarding expected future events, business prospectus or financial results. The words "expect", "anticipate", "continue", "estimate", "objective", "ongoing", "may", "will", "project", "should", "believe", "plans", "intends" and similar expressions are intended to identify such forward-looking statements. These statements are based on assumptions and analyses made by the Company in light of its experience and its perception of historical trends, current conditions and expected future developments, as well as other factors the Company believes are appropriate under the circumstances. However, whether actual results and developments will meet the expectations and predictions of the Company depends on a number of risks and uncertainties which could cause the actual results, performance and financial condition to differ materially from the Company’s expectations, including but not limited to those associated with fluctuations in crude oil and natural gas prices, macro-political and economic factors, changes in the tax and fiscal regimes of the host countries in which we operate, the highly competitive nature of the oil and natural gas industry, the exploration and development activities, mergers, acquisitions and divestments activities, environmental responsibility and compliance requirements, foreign operations and cyber system attacks.  For a description of these and other risks and uncertainties, please see the documents the Company files from time to time with the United States Securities and Exchange Commission, including the Annual Report on Form 20-F filed in April of the latest fiscal year.

Consequently, all of the forward-looking statements made in this press release are qualified by these cautionary statements. The Company cannot assure that the results or developments anticipated will be realised or, even if substantially realised, that they will have the expected effect on the Company, its business or operations.

*** *** *** ***

For further enquiries, please contact:

Ms. Jing Liu
Manager, Media & Public Relations
CNOOC Limited
Tel: +86-10-8452-3404
Fax: +86-10-8452-1441
E-mail: [email protected]

Ms. Ada Leung 
Hill+Knowlton Strategies Asia
Tel: +852-2894-6225
Fax: +852-2576-1990
E-mail: [email protected]

Photo – https://photos.prnasia.com/prnh/20200911/2914374-1LOGO?lang=0

 

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SHAREHOLDER ALERT: Pomerantz Law Firm Reminds Shareholders with Losses on their Investment in Odonate Therapeutics, Inc. of Class Action Lawsuit and Upcoming Deadline – ODT

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NEW YORK, Sept. 19, 2020 — Pomerantz LLP announces that a class action lawsuit has been filed against Odonate Therapeutics, Inc.  (“Odonate” or the “Company”) (NASDAQ: ODT) and certain of its officers.   The class action, filed in United States District Court for the Southern District of California, and docketed under 20-cv-01828, is on behalf of a class consisting of all persons other than Defendants who purchased or otherwise, acquired Odonate securities between December 7, 2017, and August 21, 2020, both dates inclusive (the “Class Period”), seeking to recover damages caused by Defendants’ violations of the federal securities laws and to pursue remedies under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 (the “Exchange Act”) and Rule 10b-5 promulgated thereunder, against the Company and certain of its top officials.

If you are a shareholder who purchased Odonate securities during the class period, you have until November 16, 2020, to ask the Court to appoint you as Lead Plaintiff for the class.  A copy of the Complaint can be obtained at www.pomerantzlaw.com.   To discuss this action, contact Robert S. Willoughby at [email protected] or 888.476.6529 (or 888.4-POMLAW), toll-free, Ext. 7980. Those who inquire by e-mail are encouraged to include their mailing address, telephone number, and the number of shares purchased. 

[Click here for information about joining the class action]

Odonate was founded in 2013 and is based in San Diego, California.  Odonate is a pharmaceutical company that develops therapeutics for the treatment of cancer.  The Company is focused on developing tesetaxel, an orally administered chemotherapy agent. 

Tesetaxel is in Phase 3 clinical study for patients with locally advanced or metastatic breast cancer (“MBC”), called the CONTESSA trial, which is evaluating tesetaxel in combination with capecitabine in patients with MBC.

The complaint alleges that throughout the Class Period, Defendants made materially false and misleading statements regarding the Company’s business, operational, and compliance policies.  Specifically, Defendants made false and/or misleading statements and/or failed to disclose that: (i) tesetaxel was not as safe or well-tolerated as the Company had led investors to believe; (ii) consequently, tesetaxel’s commercial viability as a cancer treatment was overstated; and (iii) as a result, the Company’s public statements were materially false and misleading at all relevant times.

On August 24, 2020, during pre-market hours, Odonate issued a press release announcing top-line results from the CONTESSA trial.  Although the study met its primary endpoint, tesetaxel plus capecitabine was associated with Grade 3 or higher neutropenia (low levels of white blood cells), which occurred in 71.2% of patients with the combination treatment versus 8.3% for capecitabine alone.  Various other Grade 3 or higher treatment-emergent adverse events (“AEs”) were also associated with tesetaxel plus capecitabine versus capecitabine alone.  Further, discontinuation rates were 4.2% from neutropenia and 3.6% from neuropathy, and the overall discontinuation rate was 23.1% in the treatment group compared to 11.9% in the capecitabine alone group.

On this news, Odonate’s stock price fell $15.21 per share, or 45.35%, to close at $18.33 per share on August 24, 2020.

The Pomerantz Firm, with offices in New York, Chicago, Los Angeles, and Paris is acknowledged as one of the premier firms in the areas of corporate, securities, and antitrust class litigation. Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, the Pomerantz Firm pioneered the field of securities class actions. Today, more than 80 years later, the Pomerantz Firm continues in the tradition he established, fighting for the rights of the victims of securities fraud, breaches of fiduciary duty, and corporate misconduct. The Firm has recovered numerous multimillion-dollar damages awards on behalf of class members. See www.pomerantzlaw.com.

CONTACT: Robert S. Willoughby Pomerantz LLP [email protected]

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