UCB Commitment to Addressing Real World Patient Needs on Display at the Annual European Congress of Rheumatology (EULAR 2016)
Geschrieben am 08-06-2016 |
Brussels (ots/PRNewswire) -
For medical and trade media only.
New data highlight breadth of UCB's pioneering portfolio with four
molecules across five indications:
- An oral presentation of data from the two year C-EARLY(TM) Phase 3
study of Cimzia®, exploring different dosing strategies
- Oral presentations from UCB's early pipeline include Phase 1b study
results for bimekizumab for psoriatic arthritis and Phase 1 results
for dapirolizumab pegol for systemic lupus erythematosus
- An oral presentation of Phase 3 data from the STRUCTURE study of
romosozumab for osteoporosis in post-menopausal women
- Long-term data from Phase 3 trials provide analyses of four-year
efficacy and safety of Cimzia® for the treatment of psoriatic
arthritis and axial spondyloarthritis
(Logo: http://photos.prnewswire.com/prnh/20160607/376307LOGO )
UCB, a global biopharmaceutical company focusing on immunology,
neurology and bone treatment and research, is proud to present
pivotal, long-term data on Cimzia® (certolizumab pegol), romosozumab,
early phase molecules bimekizumab and dapirolizumab pegol, and
patient-friendly injection devices in development at the Annual
European Congress of Rheumatology (EULAR 2016) in London, England
(8th - 11th June 2016). These data presentations offer new insights
on the potential to improve patient experience and treatment outcomes
across several diseases including rheumatoid arthritis (RA),
psoriatic arthritis (PsA), axial spondyloarthritis (axSpA), systemic
lupus erythematosus (SLE), and osteoporosis in post-menopausal women.
"The mission of UCB Immunology is to deliver value beyond
expectations to our patients. We know that many people living with
immunological diseases experience suboptimal response on existing
therapies. This unmet need drives UCB's patient-centric approach
towards scientific research and improving the patient experience,"
said Emmanuel Caeymaex, Head of Immunology and Executive Vice
President at UCB, Immunology Patient Value Unit, UCB. "Cimzia® data
at the Annual European Congress of Rheumatology (EULAR 2016) help to
build increased understanding around the product's long-term safety
and efficacy profile, while our pipeline data demonstrate momentum in
bringing innovative new products to patients."
Data highlights will include four-year efficacy and safety data
from both the RAPID-axSpA trial for the treatment of patients with
axSpA, including ankylosing spondylitis (AS) and non-radiographic
axial spondyloarthritis (nr-axSpA), and the RAPID-PsA trial for the
treatment of patients with PsA. Period 2 data from the C-EARLY(TM)
Phase 3 study will be presented, comparing different treatment
strategies by continuing Cimzia® at the standard dose or reducing the
dose frequency versus withdrawal, in disease-modifying antirheumatic
drug (DMARD)-naïve early RA patients who achieved sustained low
disease activity after one year of treatment with certolizumab pegol
combined with optimized methotrexate.
Data being presented from UCB's pipeline include Phase 3 results
from the STRUCTURE study of romosozumab for osteoporosis in
post-menopausal women, Phase 1b results in PsA for bimekizumab
(UCB4940), an investigational monoclonal antibody specifically
designed to potently and selectively inhibit the biological function
of both IL-17A and IL-17F cytokines, and Phase 1 results for
dapirolizumab pegol (CDP7657), an anti-CD40L pegylated Fab' fragment
being evaluated for SLE.
Following is a guide to the UCB-sponsored data presentations:
Presentations on Cimzia® in Rheumatoid Arthritis
1.[OP0227]: A Randomized Double-Blind Treatment Strategy Study
Evaluating Continuation or Reduced-Frequency Dosing of Certolizumab
Pegol versus Withdrawal to Maintain Low Disease Activity in Early RA
Patients (C-EARLY Period 2)
Emery, P. et al.
- Date/Time: Friday 10 June, 11:00
- Session Info: Developments in the treatment of RA; Hall D (oral
presentation)
2. [THU0163]: Early Response as a Predictor of Long-Term Clinical
Response in DMARD-Naïve Patients with Severe, Active and Progressive
RA Treated with Certolizumab Pegol plus Optimized MTX versus
Optimized MTX Alone
Mariette, X. et al.
- Date/Time: Thursday 9 June, 11:45 - 13:30
- Session Info: Rheumatoid arthritis - anti-TNF therapy; Poster area
(poster presentation)
3. [THU0128]: Maintenance of Improvements in Workplace and
Household Productivity and Physical Function at 2 Years in Early RA
Patients with Severe Progressive Disease Who Achieved Sustained Low
Disease Activity following 1 Year of Initial Therapy, with Two Dosing
Frequencies of Certolizumab Pegol
Bingham, C. et al.
- Date/Time: Thursday 9 June, 11:45 - 13:30
- Session Info: Rheumatoid arthritis - anti-TNF therapy; Poster area
(poster presentation)
4. [THU0157]: Clinical Outcomes at Week 104 and Analysis of
Associated Baseline Factors after an Initial 1 Year of Certolizumab
Pegol and MTX Treatment in MTX-Naïve Patients with Early RA: Results
from the Second Year of the C-OPERA Study
Atsumi, T. et al.
- Date/Time: Thursday 9 June, 11:45 - 13:30
- Session Info: Rheumatoid arthritis - anti-TNF therapy; Poster area
(poster presentation)
5. [THU0151]: Multicenter, Open-Label Study to Evaluate the
Predictability of Disease Control at Week 52 Based on Early Response
to Certolizumab Pegol (in Combination with Methotrexate) in Italian
Patients with Moderate to Severe Rheumatoid Arthritis: The CZP-SPEED
Study
Sarzi-Puttini, P. et al.
- Date/Time: Thursday 9 June, 11:45 - 13:30
- Session Info: Rheumatoid arthritis - anti-TNF therapy; Poster area
(poster presentation)
Presentations on Cimzia® Devices
6. [SAT0631-HPR]: Chronic Disease and Self-Injection: An
Ethnographic Investigation into the Patient Experience during
Treatment
Schiff, M.H. et al.
- Date/Time: Saturday 11 June, 10:15 - 12:00
- Session Info: Health Professionals in Rheumatology; Poster area
(poster presentation)
7. [THU0639-HPR]: A New Electromechanical Platform for
Subcutaneous Drug Delivery: Results from an EU Usability Study
Domanska, B. et al.
- Date/Time: Thursday 9 June, 11:45 - 13:30
- Session Info: Health Professionals in Rheumatology; Poster area
(poster presentation)
8. [AB0300]: Comparative Usability Study for a Certolizumab Pegol
Auto-Injection Device in Patients with Rheumatoid Arthritis Domanska,
B. et al.
- Session Info: Rheumatoid arthritis - anti-TNF therapy; Publication
only
9. [AB0301]: Comparison of the Bioavailability of a Single Dose of
Certolizumab Pegol Injected Either by a Pre-Filled Syringe or by an
Auto-Injection Device
Astruc, B. et al.
- Session Info: Rheumatoid arthritis - anti-TNF therapy; Publication
only
Presentations on Cimzia® in Axial Spondyloarthritis, including
Ankylosing Spondylitis and Non-Radiographic Axial Spondyloarthritis
10. [SAT0375]: Certolizumab Pegol for the Treatment of Axial
Spondyloarthritis: 4-Year Outcomes from the RAPID-axSpA Trial
van der Heijde, D. et al.
- Date/Time: Saturday 11 June, 10:20
- Session Info: Optimising treatment of axial SpA; Poster area
(poster presentation and poster tour)
11. [SAT0389]: Long-Term Improvements in Workplace and Household
Productivity and Social Participation over 4 Years of Certolizumab
Pegol Treatment in Patients with Axial Spondyloarthritis, including
Ankylosing Spondylitis and Non-Radiographic Axial Spondyloarthritis
van der Heijde, D. et al.
- Date/Time: Saturday 11 June, 10:15 - 12:00
- Session Info: Spondyloarthritis - treatment; Poster area (poster
presentation)
12. [THU0380]: A Single Determination of C-Reactive Protein Does
Not Suffice to Declare a Patient with a Diagnosis of Axial SpA
'CRP-Negative'
Landewé, R. et al.
- Date/Time: Thursday 9 June, 11:50
- Session Info: Axial SpA: Clinical aspects; Poster area (poster
presentation and poster tour)
Presentations on Cimzia® in Psoriatic Arthritis
13. [FRI0471]: Certolizumab Pegol for the Treatment of Psoriatic
Arthritis: 4-Year Outcomes from the RAPID-PsA Trial
Mease, P.J. et al.
- Date/Time: Friday 10 June, 11:45 - 13:30
- Session Info: Psoriatic arthritis; Poster area (poster
presentation)
14. [FRI0472]: Improvements in Joint Outcomes of Psoriatic
Arthritis over 4 Years of Treatment with Certolizumab Pegol in
Patients with and without Prior Anti-TNF Exposure
Mease, P.J. et al.
- Date/Time: Friday 10 June, 11:45 - 13:30
- Session Info: Psoriatic arthritis; Poster area (poster
presentation)
Presentations on Cimzia® Across Indications
15. [THU0620]: Gender, Disease Activity, Anxiety and Depression
Levels Are Related to the Levels of Fears of Patients with Rheumatoid
Arthritis or Axial Spondyloarthritis: A Cross-Sectional Study of 672
Patients
Gossec, L. et al.
- Date/Time: Thursday June 9, 11:45 - 13:30
- Session Info: Epidemiology, health services and outcome research;
Poster area (poster presentation)
16. [THU0619]: Lifestyle Beliefs of 672 Patients with Rheumatoid
Arthritis or Axial Spondyloarthritis
Gossec, L. et al.
- Date/Time: Thursday June 9, 11:45 - 13:30
- Session Info: Epidemiology, health services and outcome research;
Poster area (poster presentation)
Presentations on Cimzia® Safety
17. [THU0136]: Use of a Global Risk Score to Identify Patients
with Rheumatoid Arthritis at Risk of Serious Infectious Events During
Certolizumab Pegol Treatment
Curtis, J.R. et al.
- Date/Time: Thursday 9 June, 11:45 - 13:30
- Session Info: Rheumatoid arthritis - anti-TNF therapy; Poster area
(poster presentation)
Presentation on Bimekizumab in Psoriatic Arthritis
18. [OP0108]: Bimekizumab, a Monoclonal Antibody that Inhibits
Both IL-17A and IL-17F, Produces a Profound Response in Both Skin and
Joints: Results of an Early-Phase, Proof-of-Concept Study in
Psoriatic Arthritis
Glatt, S. et al.
- Date/Time: Friday 10 June, 10:20
- Session Info: Expanding therapeutic options in spondyloarthritis;
Hall B (oral presentation)
Presentation on Dapirolizumab Pegol
19. [OP0040]: Peripheral Blood Transcriptional Changes Elicited by
Treatment of Systemic Lupus Erythematosus (SLE) Patients with
Dapirolizumab Pegol (a Pegylated Anti-CD40L Fab')
Ranger, A. et al.
- Date/Time: Thursday 9 June, 10:30
- Session Info: Advances in SLE Therapeutics; Hall D (oral
presentation)
Presentation on Romosozumab
20. [OP0100]: Superior Gains in Bone Mineral Density and Estimated
Strength at the Hip for Romosozumab Compared With Teriparatide in
Women With Postmenopausal Osteoporosis Transitioning From
Bisphosphonate Therapy: Results of the Phase 3 Open-label STRUCTURE
Study
Langdahl, B. et al.
- Date/Time: Thursday 9 June, 10:20
- Session Info: Clinical Osteoporosis: new insights; Capital Suite 02
(oral presentation)
About Romosozumab
Romosozumab is an investigational bone-forming monoclonal antibody
and is not approved by any regulatory authority for the treatment of
osteoporosis. It is designed to work by inhibiting the protein
sclerostin, and has a dual effect on bone, both increasing bone
formation and decreasing bone resorption. Romosozumab is being
studied for its potential to reduce the risk of fractures in an
extensive global Phase 3 program. This program includes two large
fracture trials comparing romosozumab to either placebo or active
comparator in more than 10,000 postmenopausal women with
osteoporosis. Amgen and UCB are co-developing romosozumab.
About Bimekizumab
Bimekizumab is an investigational monoclonal antibody specifically
designed to potently and selectively inhibit the biological function
of both IL-17A and IL-17F, two key pro-inflammatory cytokines. IL-17A
and IL-17F are involved in chronic inflammatory processes that drive
many severe skin and joint diseases. It is planned that dose-ranging
studies for bimekizumab will start this year. Bimekizumab is not
approved by any regulatory authority worldwide.
About Dapirolizumab Pegol
Dapirolizumab pegol (CDP7657) is an anti-CD40L pegylated Fab'
being developed in systemic lupus erythematosus (SLE) jointly with
Biogen, and has completed a clinical Phase 1b study at the end of
2014. The compound is scheduled to progress to Phase 2 in 2016 and is
not approved by any regulatory authority worldwide.
About Cimzia in the EU/EEA
In the EU, Cimzia in combination with methotrexate (MTX) is
indicated for the treatment of moderate to severe active RA in adult
patients inadequately responsive to disease-modifying anti-rheumatic
drugs (DMARDs) including MTX.
Cimzia can be given as monotherapy in case of intolerance to MTX
or when continued treatment with MTX is inappropriate. Cimzia in
combination with MTX is also indicated for the treatment of severe,
active and progressive RA in adults not previously treated with MTX
or other DMARDs.
Cimzia has been shown to reduce the rate of progression of joint
damage as measured by X-ray and to improve physical function, when
given in combination with MTX.
Cimzia, in combination with MTX, is also indicated for the
treatment of active psoriatic arthritis in adults when the response
to previous DMARD therapy has been inadequate. Cimzia can be given as
monotherapy in case of intolerance to methotrexate or when continued
treatment with methotrexate is inappropriate.
Cimzia is also indicated in the EU for the treatment of adult
patients with severe active axial spondyloarthritis (axSpA),
comprising:
- Ankylosing spondylitis (AS) - adults with severe active AS who have
had an inadequate response to, or are intolerant to non-steroidal
anti-inflammatory drugs (NSAIDs).
- Axial spondyloarthritis (axSpA) without radiographic evidence of AS
- adults with severe active axSpA without radiographic evidence of
AS but with objective signs of inflammation by elevated C-reactive
protein (CRP) and/or Magnetic Resonance Imaging (MRI) who have had
an inadequate response to, or are intolerant to NSAIDs.
Important Safety Information about Cimzia in the EU/EEA[1]
Cimzia was studied in 4,049 patients with rheumatoid arthritis
(RA) in controlled and open label trials for up to 92 months. The
commonly reported adverse reactions (1-10%) in clinical trials with
Cimzia and post-marketing were viral infections (includes herpes,
papillomavirus, influenza), bacterial infections (including abscess),
rash, headache (including migraine), asthaenia, leukopaenia
(including lymphopaenia, neutropaenia), eosinophilic disorder, pain
(any sites), pyrexia, sensory abnormalities, hypertension, pruritus
(any sites), hepatitis (including hepatic enzyme increase), injection
site reactions, and nausea. Serious adverse reactions include sepsis,
opportunistic infections, tuberculosis, herpes zoster, lymphoma,
leukaemia, solid organ tumours, angioneurotic oedema,
cardiomyopathies (includes heart failure), ischemic coronary artery
disorders, pancytopaenia, hypercoagulation (including
thrombophlebitis, pulmonary embolism), cerebrovascular accident,
vasculitis, hepatitis/hepatopathy (includes cirrhosis), and renal
impairment/nephropathy (includes nephritis). In RA controlled
clinical trials, 4.4% of patients discontinued taking Cimzia due to
adverse events vs. 2.7% for placebo.
Cimzia is contraindicated in patients with hypersensitivity to the
active substance or any of the excipients, active tuberculosis or
other severe infections such as sepsis or opportunistic infections or
moderate-to-severe heart failure.
Serious infections including sepsis, tuberculosis and
opportunistic infections have been reported in patients receiving
Cimzia. Some of these events have been fatal. Monitor patients
closely for signs and symptoms of infections including tuberculosis
before, during and after treatment with Cimzia. Treatment with Cimzia
must not be initiated in patients with a clinically important active
infection. If an infection develops, monitor carefully and stop
Cimzia if infection becomes serious. Before initiation of therapy
with Cimzia, all patients must be evaluated for both active and
inactive (latent) tuberculosis infection. If active tuberculosis is
diagnosed prior to or during treatment, Cimzia therapy must not be
initiated and must be discontinued. If latent tuberculosis is
diagnosed, appropriate anti-tuberculosis therapy must be started
before initiating treatment with Cimzia. Patients should be
instructed to seek medical advice if signs/symptoms (e.g. persistent
cough, wasting/weight loss, low grade fever, listlessness) suggestive
of tuberculosis occur during or after therapy with Cimzia.
Reactivation of hepatitis B has occurred in patients receiving a
TNF-antagonist including Cimzia who are chronic carriers of the virus
(i.e. surface antigen positive). Some cases have had a fatal outcome.
Patients should be tested for HBV infection before initiating
treatment with Cimzia. Carriers of HBV who require treatment with
Cimzia should be closely monitored and in the case of HBV
reactivation Cimzia should be stopped and effective anti-viral
therapy with appropriate supportive treatment should be initiated.
TNF antagonists including Cimzia may increase the risk of new
onset or exacerbation of clinical symptoms and/or radiographic
evidence of demyelinating disease; of formation of autoantibodies and
uncommonly of the development of a lupus-like syndrome; of severe
hypersensitivity reactions. If a patient develops any of these
adverse reactions, Cimzia should be discontinued and appropriate
therapy instituted.
With the current knowledge, a possible risk for the development of
lymphomas, leukaemia or other malignancies in patients treated with a
TNF antagonist cannot be excluded. Rare cases of neurological
disorders, including seizure disorder, neuritis and peripheral
neuropathy, have been reported in patients treated with Cimzia.
Adverse reactions of the hematologic system, including medically
significant cytopaenia, have been infrequently reported with Cimzia.
Advise all patients to seek immediate medical attention if they
develop signs and symptoms suggestive of blood dyscrasias or
infection (e.g., persistent fever, bruising, bleeding, pallor) while
on Cimzia. Consider discontinuation of Cimzia therapy in patients
with confirmed significant haematological abnormalities.
The use of Cimzia in combination with anakinra or abatacept is not
recommended due to a potential increased risk of serious infections.
As no data are available, Cimzia should not be administered
concurrently with live vaccines. The 14-day half-life of Cimzia
should be taken into consideration if a surgical procedure is
planned. A patient who requires surgery while on Cimzia should be
closely monitored for infections.
Cimzia was studied in 325 patients with active axial
spondyloarthritis (axSpA) in a placebo-controlled clinical trial for
up to 30 months and in 409 patients with psoriatic arthritis (PsA) in
a placebo-controlled clinical trial for up to 30 months. The safety
profile for axSpA and PsA patients treated with Cimzia was consistent
with the safety profile in RA and previous experience with Cimzia.
Please consult the full prescribing information in relation to
other side effects, full safety and prescribing information. European
SmPC date of revision 17th December 2015.
http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Produc
t_Information/human/001037/WC500069763.pdf
References
1. Cimzia® EU Summary of Product Characteristics. Accessed 1st May
2016 from http://www.ema.europa.eu/docs/en_GB/document_library/EPA
R_-_Product_Information/human/001037/WC500069763.pdf
About UCB
UCB, Brussels, Belgium (http://www.ucb.com) is a global
biopharmaceutical company focused on the discovery and development of
innovative medicines and solutions to transform the lives of people
living with severe diseases of the immune system or of the central
nervous system. With more than 7 700 people in approximately 40
countries, the company generated revenue of EUR 3.9 billion in 2015.
UCB is listed on Euronext Brussels (symbol: UCB). Follow us on
Twitter: @UCB_news
Forward looking statements - UCB
This press release contains forward-looking statements based on
current plans, estimates and beliefs of management. All statements,
other than statements of historical fact, are statements that could
be deemed forward-looking statements, including estimates of
revenues, operating margins, capital expenditures, cash, other
financial information, expected legal, political, regulatory or
clinical results and other such estimates and results. By their
nature, such forward-looking statements are not guarantees of future
performance and are subject to risks, uncertainties and assumptions
which could cause actual results to differ materially from those that
may be implied by such forward-looking statements contained in this
press release. Important factors that could result in such
differences include: changes in general economic, business and
competitive conditions, the inability to obtain necessary regulatory
approvals or to obtain them on acceptable terms, costs associated
with research and development, changes in the prospects for products
in the pipeline or under development by UCB, effects of future
judicial decisions or governmental investigations, product liability
claims, challenges to patent protection for products or product
candidates, changes in laws or regulations, exchange rate
fluctuations, changes or uncertainties in tax laws or the
administration of such laws and hiring and retention of its
employees. UCB is providing this information as of the date of this
press release and expressly disclaims any duty to update any
information contained in this press release, either to confirm the
actual results or to report a change in its expectations.
There is no guarantee that new product candidates in the pipeline
will progress to product approval or that new indications for
existing products will be developed and approved. Products or
potential products which are the subject of partnerships, joint
ventures or licensing collaborations may be subject to differences
between the partners. Also, UCB or others could discover safety, side
effects or manufacturing problems with its products after they are
marketed. Moreover, sales may be impacted by international and
domestic trends toward managed care and health care cost containment
and the reimbursement policies imposed by third-party payers as well
as legislation affecting biopharmaceutical pricing and reimbursement.
ots Originaltext: UCB Pharma
Im Internet recherchierbar: http://www.presseportal.de
Contact:
, UCB:
Corporate Communications
France Nivelle
Global Communications, UCB
T +32-2-559-9178
france.nivelle@ucb.com
Laurent Schots
Media Relations, UCB
T+32-2-559-92-64
Laurent.schots@ucb.com
Investor Relations
Antje Witte
Investor Relations, UCB
T +32-2-559-94-14
antje.witte@ucb.com
Brand Communications
Andrea Levin Christopher
Immunology Communications, UCB
T +1-404-483-7329
andrea.levin@ucb.com
HQ/0516/MPR/00013
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