Turacoz's initiative: Spreading Awareness of Breast cancer

We decide the first day of our cancer diagnosis whether we are going to be victims or survivors. We decide to muster up all our strength to fight to win. We decide to stay positive and not let cancer define us. We decide how we are going to handle each day. Yes, there are good days and bad days, but our attitudes determine each day. Hold on to your hopes, dreams, faith and determination, and gather strength from your support systems, because in the fight against cancer, we cannot give up.

Breast Cancer Awareness Month (BCAM), also referred to as National Breast Cancer Awareness Month (NBCAM), is an annual international health campaign organized by major breast cancer charities every October to increase awareness of the disease and to raise funds for research into its cause, prevention, diagnosis, treatment and cure. The campaign also offers information and support to those affected by breast cancer.

October is Breast Cancer Awareness Month, which is an annual campaign to increase awareness of the disease. While most people are aware of breast cancer, many forget to take the steps to have a plan to detect the disease in its early stages and encourage others to do the same. We have made a lot of progress but still have a long way to go.

Turacoz healthcare solutions  understands its social responsibility and is passionate about improving understanding of breast cancer in India and worldwide. Through this medium we intend to spread the word in these  31 days of October’s Breast Cancer Awareness Month (BCAM). This is a critical opportunity to promote breast cancer awareness, share information and provide women across the world with better access to breast cancer care, treatments and services. We will keep you updated with information about the screening, diagnosis, disease management and recent advances in the field of breast cancer. We will also be interacting with healthcare professionals dealing with breast cancer patients, to understand the unmet needs, gaps in medical education and their perspective about the disease.  Turacoz also plans to share some inspiring stories of breast cancer survivors.

On the eve of BCAM, let’s all take a pledge to increase the awareness of this treatable disease if detected early. Turacoz would like to know the steps taken up by you to spread awareness of this dreadful disease in your respective areas.

#FightBreastCancer; #BreastCancerAwarenessMonth

Cardiovascular diseases increasing in Teenagers: Wakeup call on World Heart Day, 29 Sep 2014

Just one day prior to the “World Heart Day”, a school survey conducted from 25 public and private schools in Delhi and NCR region including 3000 students has come out with alarming figures:

• 10% of school children between 13-16 years of age are overweight.
• 35% increased risk of cardiovascular diseases (CVD) in the obese children
• Average age of patients with heart diseases is showing a decline from 50 years to 20 years
• Higher risk of 38% Risk of CVD is highest (38%) in obese young adults with risk factors and lowest (8%) in those with normal weight and no risk factors.
  

Preventive steps to be taken by the parents and school are to help and motivate the child to adopt a healthy lifestyle:

• Diet modifications: less of fast/packaged foods , less sugar and trans-fat and consuming nutritious healthy home cooked foods
• Improving the physical activity by including a compulsory exercise or sports regimen
• Educating parents, children and involving schools in this movement.

In a cross sectional study conducted on 854 high school children, 81% of children were found to have insufficient physical activity with daily consumption of soup, salad or vegetables, and fruit, respectively to be as, 37%, 39% and 21%.

The risk factors in this population were:

• Overweight-16%
• Smoking-13%
• Hypertension-11%
• Impaired glucose metabolism-9%
• Hypertriglyceridemia - 9%
• Hypercholesterolemia - 5%

Poor physical activity, hypertension and overweight were more prevalent in males (p<0.001) whereas females had higher levels of cholesterol (p<0.005) and triglycerides (p<0.001).

Epidemic of childhood obesity becoming prevalent now is an important contributing factor for CVD and mortality in adults now. Many epidemiologic studies have observed that obesity has an impact on the cardiac autonomic modulation which can cause sympathetic overflow and reduced parasympathetic modulation. There is enough evidence to state that life style modifications including diet and physical activity can improve the CAM in the obese and reduce the burden of CVD in the adults.

As parents and healthcare professionals, this should act as an eye opener and we should turn back to basics with healthy home cooked foods, playing physically and restriction of TV, computers and sedentary activities.

Sources:

1. Press release: Overweight kids in Delhi-NCR are more prone to cardiovascular diseases: ASSOCHAM. Available at http://assocham.org/prels/shownews.php?id=4705
2. Rocha T et al. Cardiovascular risk profile of high school students: A cross-sectional study.Rev Port Cardiol. 2014 Sep 12. pii: S0870-2551(14)00182-6.
3. Liao D et al. Childhood obesity and autonomic dysfunction: risk for cardiac morbidity and mortality.Curr Treat Options Cardiovasc Med. 2014 Oct;16(10):342.

Save Her Heart - World heart day 29th september

‘Women can’t get heart attacks’- it is a biggest myth. Since 1984, more women than men have died of heart disease each year and yet much of the medical community still largely considers it a “men’s disease.”

Do you know Heart disease kills ten times more women than breast cancer each year, more than all other cancers combined? You may be surprised to know that that 1 out of every 3 women will develop heart disease in their lifetime, and this number is getting closer to 1 in 2! 

"Cardiovascular disease kills 480,000 women a year, about one per minute".

On this #worldheartday, let’s all of us pledge to save a woman’s heart. Be it your mother, sister, daughter or yourself. The good news is there is a lot you can do to reduce your risk of developing heart disease. The earlier you start thinking about your heart, the better it is.

Know your symptoms

 ‘Women may have less extreme symptoms of heart disease than men, so they may be more likely to ignore warning. The most important thing is for women to listen to their guts, and to make sure their doctor takes their complaints serious. 

• ·         Increased shortness of breath with customary activities
• ·         Unusual extreme fatigue*
• ·         Significant indigestion especially with exertion
• ·         Feelings of nausea/vomiting
• ·         Dizziness
• ·         Pain or pressure in the back or high chest, between shoulder blades
• ·         Pain or discomfort (pressure) in one or both arms, neck, jaw, back, shoulder or stomach

Attack the #heartattack

'Let’s accept, women worry - just not about themselves.'

Mothers, wives, daughters – they will care about their family but forget to care about themselves.As a woman, you are the heart of a family; just imagine their life without you. Don’t you think you need to protect your heart? Ladies, here are the best things you can do to prevent heart disease are:

• Take responsibility for your health.
• Chose a healthy lifestyle
• Eat & Cook heart-healthy
• Control your weight.
• Get regular physical activity.
• Don’t smoke.
• Lower your LDL cholesterol (the "bad" type). 
• Control your blood pressure.
• Relax

Finally, saw this new Saffolalife advertisement yesterday. Watch it and pledge to protect her heart on this #worldheartday. #saveherheart #worldheartday #protect her heart

Europe approves Gilead's cancer drug Zydelig amid challenging pricing environment

Less than two months after the FDA approved Gilead Sciences' ($GILD) first cancer drug, 
Zydelig, the European Medicines Agency (EMA) has followed suit, green-lighting the drug for use in treating two blood cancers. The approval puts Gilead well on track to meet analyst expectations that Zydelig (idelalisib) will be hauling in $1.2 billion in annual sales by 2020, though there's little doubt Gilead will face pressure from European health agencies to keep a lid on the new drug's price.

Zydelig is among a new class of drugs known as PI3k inhibitors. It was approved in the U.S. to treat chronic lymphocytic leukemia (CLL), relapsed follicular B-cell non-Hodgkin lymphoma (FL) and small lymphocytic lymphoma. The EMA approved the drug for use in CLL and FL. In CLL, the approval was supported by late-stage data showing that when added to Roche's ($RHHBY) Rituxan, Gilead's drug prevented the cancer for progressing for twice as long as Rituxan alone, according to the Gilead statement. The EMA approved the drug f"Although chemo-immunotherapy is initially used to treat both CLL and FL, relapse is common and many patients run out of treatment options to treat the disease as it progresses," said Peter Hillmen, a professor and hematologist at Britain's Leeds Teaching Hospitals NHS Trust, in a statement released by Gilead. "Thus, Zydelig is a welcomed treatment option that offers a new approach in the management of these cancers."

No word yet on how Gilead plans to price Zydelig in Europe, but the company will likely face questions, particularly from the National Institute for Health and Care Excellence (NICE), the U.K.'s drug-price watchdog, which decides what drugs will be covered by the government. NICE has said "no" to several pricey cancer drugs lately, including Roche's Kadcyla for breast cancer, and Johnson & Johnson's ($JNJ) prostate cancer treatment Zytiga.

In September, NICE threatened to bypass drugmakers altogether when assessing the value of new drugs and instead go to the EMA to obtain clinical trial data.

Gilead itself has gotten some pushback from NICE on its new hepatitis C treatment Sovaldi. The drug is priced at $57,000 a course in the U.K.--much lower than its $84,000 price in the U.S.--but NICE still went back to Gilead in June and asked for more evidence that Sovaldi is worth its price. NICE issued a provisional OK in August and is expected to release its final appraisal on Sovaldi later this year.

In the U.S., analysts are reporting that Gilead has priced Zydelig lower than its top competitor, Johnson & Johnson's Imbruvica (ibrutinib)--$7,200 per month vs. $8,200. When added to Rituxan or another cancer treatment, however, the cost of Gilead's therapy could rise to $12,000, they estimate.

Zydelig won't be competing for market share on price alone. Analysts warn that in the U.S., pickup could be slowed by a black-box warning on the product that highlights such side effects as colitis, lung inflammation and potential fatal liver problems. Imbruvica doesn't have a black box. And there's more competition to come: AbbVie's ($ABBV) Rituxan.

Read More About Gilead's statement.

P.S. : Contact Turacoz Healthcare Solutions for any requirement in medical communications. Turacoz team is comprised of qualified medical writers with an experience ranging from 3 years to 30 years. The team is well equipped to take on projects of regulatory writing, scientific publications and medico-marketing related documents. 

Fierce Pharma News

New Deal : Merck licenses experimental psoriasis drug to India's Sun Pharma

Merck & Co Inc said it had licensed its experimental psoriasis drug to Indian generic maker Sun Pharmaceutical Industries Ltd for $80 million. Under the agreement, Sun Pharma will acquire the worldwide rights to the drug, tildrakizumab, for all possible indications. The drug is currently in late-stage trials for use in chronic plaque psoriasis, an inflammatory skin disease. 

Merck will continue all clinical development and regulatory activities, which will be funded by Sun Pharma. Upon product approval, Sun Pharma will be responsible for regulatory activities, including manufacturing and marketing the approved product, the companies said. Merck's shares were down about 1 percent at $59.41 on the New York Stock Exchange on Wednesday. Sun Pharmaceutical's shares closed at 792.40 rupees on the National Stock Exchange of India.

P.S. : Contact Turacoz Healthcare Solutions for any requirement in medical communication for pharmaceutical and biotech companies. Turacoz team is comprised of qualified medical writers with an experience ranging from 3 years to 30 years. The team is well equipped to take on projects of regulatory writing, scientific publications and medico-marketing related documents. They have thorough knowledge and understanding of ICH guidelines in different geographical regions, medical writing guidelines by ICMJE (International Committee of Medical Journal Editors), and region wise/client specific assignments.

Europe Approves Roche’s Rheumatoid Arthritis Drug

The European Commission has approved a new indication for Roche’s rheumatoid arthritis drug RoActemra to treat patients in the early phase of the disease. The latest approval for RoActemra (tocilizumab) applies to patients with severe, active and progressive RA who previously have not been treated with methotrexate, the company said. The drug is the first interleukin-6 receptor antagonist approved in Europe for early RA, when treatment may change the course of disease and prevent irreversible damage to joints and long-term disability, Roche said.

The new indication was based on a study that showed RoActemra treatment with and without methotrexate achieved greater inhibition of structural joint damage compared with methotrexate alone. In April, the subcutaneous formulation of RoActemra received EC approval for treatment of moderate to severe RA in patients who are either intolerant to or have failed to respond to other treatments.

RA is an autoimmune disease that affects about 40 million people worldwide. — Jonathon Shacat

Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.

Well, having a new product in the market or buying rights of a new product and getting it positioned in the favor of consumer’s need could be a gruesome process for any company.  Turacoz’s Brand communication team can plan and assist new product launch and develop strong brand communication for your product/services to reach the target audience effectively and efficiently.

We strongly focus on identification of target audience/consumers, communication mediums, and the big idea of the campaign, hitches and budget of the project. Our ground-breaking techniques to represent drug information to the target audience will enhance the product launch and ultimately sales within desired time line. We believe in 360 degree brand communication which involves print, media and digital solutions for your product branding. We create clear, innovative and interactive communication messages.

The documents that can help in the branding or positioning RoActemra could be any or many of the following:

Product monographs

Case report

Patient education material

Details Aids (DA) and Visual Aids

Newsletters

Slide sets

Sales and pharmacist training

Mylan Ireland to buy US rights of Arixtra injection from Aspen

Mylan Ireland has entered into an agreement with Aspen Global to acquire the US commercialization, marketing and intellectual property rights relating to Arixtra (fondaparinux sodium) Injection and the authorized generic (AG) of Arixtra. Arixtra is indicated to treat prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE) in patients undergoing hip fracture surgery, including extended prophylaxis, hip replacement surgery, knee replacement surgery or abdominal surgery who are at risk for thromboembolic complications. Under an interim distribution arrangement with Aspen, Mylan is already selling Arixtra in the US, while Apotex is currently selling the AG of Arixtra, which will be transitioning to Mylan Institutional by end of 2014.

Well, having a new product in the market or buying rights of a new product and getting it positioned in the favor of consumer’s need could be a gruesome process for any company.  Turacoz’s Brand communication team can plan and assist new product launch and develop strong brand communication for your product/services to reach the target audience effectively and efficiently.

We strongly focus on identification of target audience/consumers, communication mediums, and the big idea of the campaign, hitches and budget of the project. Our ground-breaking techniques to represent drug information to the target audience will enhance the product launch and ultimately sales within desired time line. We believe in 360 degree brand communication which involves print, media and digital solutions for your product branding. We create clear, innovative and interactive communication messages.

The documents that can help in the branding or positioning Arixtra could be any or many of the following:

Product monographs

Case report

Patient education material

Details Aids (DA) and Visual Aids

Newsletters

Slide sets

Sales and pharmacist training

Read more at PBR

Contrave gets U.S. approval: Only the third anti-obesity drug available

A new diet pill Contrave got approval to be sold in the United States on Wednesday, only the third obesity treatment in more than a decade to win approval from the Food and Drug Administration. Made by Orexigen Therapeutics Inc, Contrave is a combination of the antidepressant bupropion and Orexigen's formulation of naltrexone, designed to prevent drug dependence. Because Contrave contains an antidepressant, it will carry a warning about increased risk of suicidal thoughts and behaviors. Contrave joins Vivus Inc's Qsymia and Arena Pharmaceuticals Inc's Belviq, both approved in 2012, in the battle to be the treatment of choice and at least one analyst expects the new entrant's sales to top that of its rivals by 2016.

"For all the obesity drugs that are out there, only 30 to 40 percent of the health maintenance organizations pay for obesity coverage," said Daniel Lang, analyst on RS Investments' Value Fund, which holds a stake in all three companies. Historically, weight loss drug developer's have met with regulatory ire, as debilitating side effects associated with their pills led to their forced removal.

Regulatory submissions are the most decisive milestone drugs like these. Quality regulatory document submissions can speed-up the time to market a drug, bring the advantage of new treatment to patients, and conserve patent life. 

At Turacoz Healthcare Solutions, Our team of medical writers have a clear understanding of the global regulatory requirements/expectations and International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. Our medical writers are experienced in delivering protocols, investigational brochures, clinical study reports, and documents for IND and NDA submissions.

·         Study Synopsis and Protocol

·         Investigator’s brochures

·         Informed consent form

·         Clinical study report (CSR)

·         Common Technical Document (CTD)

·         Integrated Summary of Efficacy (ISE)

·         Integrated Summary for Safety (ISS)

·         Periodic Safety Update Report (PSUR)

·         Development Safety Update Report (DSUR)

·         Risk management plan (RMP)

·         Package Insert

Read more at Reuters

Is Stigma and Ineffective communication hindering the control efforts for Ebola virus?

The current Ebola outbreak in West Africa is still going strong despite all the efforts and activities being carried out.

According to Keiji Fukuda, MD, WHO assistant director-general for health security and David Nabarro, MD, senior UN coordinator, some of the factors contributing to the inability to conquer the disease are:

• Not enough beds at the hospital or transportation to the hospital
• Affected affected communities are uninformed about the facts of the disease, how to make a decision and steps to protect themselves
• Stigma attached with the disease and the patients suffering from it

WHO has launched the Ebola response roadmap which includes formation and execution of a plan to coordinate the international response to the outbreak.
Turacoz Healthcare Solutions, as a concerned medical communication company understands the importance of proper communication to the community including healthcare professionals. An extensive health campaign supported by an effective communication can really go a long way to eradicate the disease, reduce the disease burden and improve the overall health outcome of the community.

Read more at http://www.medscape.com/viewarticle/831079?nlid=64443_2046&src=wnl_edit_medn_peds&spon=9

Cost is a focus for GSK for the new wave of biotech lung drugs

A new group of biotech lung drugs that have produced promising results in clinical tests are now up against the issue of how cost-effective that are. The first is likely to be launched next year by GlaxoSmithKline. Rival firms including Teva Pharmaceutical Industries and AstraZeneca are racing to develop similar injectable drugs for patients with severe asthma, who do not respond adequately to traditional inhalers. It is all in pursuit of a new market that analysts believe may be worth around $7.5 billion in annual sales. GSK, the leader in asthma treatments since launching its Ventolin inhaler in 1969, consolidated its position in the new field by presenting late-stage Phase III data on its experimental drug mepolizumab at the European Respiratory Society congress in Munich on Monday. 

As Gsk planned cost-effectiveness studies to show the value of its new product, documentations and research that goes into the whole process is very scientific and extensive. This is called the Real World Evidence Solutions (RWE).

The Turacoz Healthcare Solution’s team comprises of multidisciplinary professionals who are highly experienced in developing documents in real world evidence settings. Our RWE experts can provide information at every stage of a drug’s development by providing a thorough research, understanding of disease, treatment patterns and performance of the product. RWE solutions are the combination of the best available research (primary and secondary) evidence with clinical experience along with ascertaining patient needs.

After testing the efficacy and safety of a drug for clinical trials, the drug comes to the market. The health care stakeholders have to think beyond the randomized controlled trials (RCTs) for making the drug worthy for the payers: private insurance companies, government or individuals. In the broader sense only efficacy is not sufficient for the drug to perform well and contribute to the healthcare. Assessing effectiveness is an equally important to convince the stakeholders and policy makers to include the drug in the treatment guidelines and adapt for the state prescription. The RWE is the comprehensive understanding about the working of the drug outside the controlled clinical trial environment. 

·         Observational Study

·         Consensus or Clinical Practice Guidelines

·         Systematic Review

·         Meta -analysis

·         Cost-effectiveness Analysis and Cost-Benefit Analysis

·         Health Technology Assessment (HTA) submissions

·         Publications and Poster Presentation

Read more at : Reuters.

AstraZeneca boosted by start of new cancer drug trial

Hopes are boosted for colorectal cancer patients with the news that AstraZeneca had moved its immuno-oncology medicine MEDI-4736 into a mid-stage study in colorectal cancer. The drug, which is designed to help the immune system fight tumours, will be tested in 48 patients with advanced disease in the Phase II trial. AstraZeneca is already studying MEDI-4736 in lung cancer and head and neck cancer.

MEDI-4736 is part of a closely-watched class of drugs known as anti-PD-L1 therapies, which block a tumour's ability to evade the immune system's defences. MEDI-4736 is seen as AstraZeneca's most important new drug hope and it was one of several experimental products flagged by the company in May in a bid to convince investors the group has a healthy future as an independent company.

The new open-label Phase II study, which is not yet open for patient recruitment, is being run by the New York-based Memorial Sloan-Kettering Cancer Center in collaboration with AstraZeneca.

Well, in Clinical trials like these, Regulatory submissions are the most decisive milestone for a client like AstraZeneca in their clinical research. Quality regulatory document submissions can speed-up the time to market a drug, bring the advantage of new treatment to patients, and conserve patent life. At Turacoz Healthcare Solutions, Our team of medical writers have a clear understanding of the global regulatory requirements/expectations and International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. Our medical writers are experienced in delivering protocols, investigational brochures, clinical study reports, and documents for IND and NDA submissions.

·         Study Synopsis and Protocol

·         Investigator’s brochures

·         Informed consent form

·         Clinical study report (CSR)

·         Common Technical Document (CTD)

·         Integrated Summary of Efficacy (ISE)

·         Integrated Summary for Safety (ISS)

·         Periodic Safety Update Report (PSUR)

·         Development Safety Update Report (DSUR)

·         Risk management plan (RMP)

·         Package Insert