Category Archives: Drugs and Disease

mRNA Vaccine: From Class to Mass

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Coronavirus disease 2019(COVID-19) is giving the world a rollercoaster ride with shoot-up in infection cases globally. With more than 14 crores of infection cases worldwide in 16 months, the world is looking up to a miracle to stop this pandemic. One way of controlling the spread is to get vaccinated. More than 98 crores vaccines have been administered globally till the end of April 2021 and it is still making way to reach people in every corner of the world. India is in its second wave of COVID-19 infection with a tremendous rise in corona infection cases compared to the first wave of infection. But a positive side of this is, the largest vaccination drive of the world is under progress in India and giving positive hope for Indians to overcome this situation.

With COVID-19 a large number of research areas started to work on the war front to explore a possible cure, vaccine, a drug to treat COVID-19. Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) is the disease-causing virus of COVID-19. The First case of COVID-19 was seen in Wuhan, China in 2019. With the increase in the number of cases globally, the World Health Organization (WHO) declared it as a pandemic. With 13 approved vaccines, more than 150 clinical trials, and pre-clinical trials globally every country is trying its best in exploring safe vaccines for the same. Along with traditional vaccines, new generation mRNA vaccines also jumped in this race. These mRNA vaccines are Messenger Ribonucleic acids vaccines. 

WHAT ARE VACCINES AND WHY ARE THEY NEEDED?

A Vaccine is a product that triggers an immune response in our body and produces antibodies without causing the disease itself. So, when we face a real pathogen (Disease causing organism), our body is trained to produce immune defence against it and make antibodies and protect us from getting the disease. 

Vaccines are developed for decades with traditional methods and few new methods have also emerged with time. The older methods included using the whole organism (Inactivated vaccine, Live attenuated vaccine, viral vector vaccine), a subunit vaccine (only a part of the pathogen is used) and a new method is using Genetic material (DNA or RNA vaccine)

WHAT ARE mRNA VACCINES? AND THE HISTORY BEHIND mRNA VACCINES

mRNA vaccines are new generation vaccines wherein mRNA is used to produce the desired protein. It carries a message to the cell and produces protein. Once the protein is produced, the immune system produces antibodies against it. This feature of using mRNA is not a recent technology, it has been researched for its efficiency for use in therapeutics for the betterment of mankind. So, mRNA has now jumped from classroom studies to the mass population to show its safety and disease controlling ability.

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A researcher Katalin Kariko explored the possible uses of mRNA in medical sciences, but she never got a grant for her work and was demoted from her position by a university. But that did not stop her to work. Along with an immunology professor Drew Weissman, she worked to understand immunological benefits by modification of mRNA and published their work through 2005. They modified mRNA to get an entry into the cell, this work was innovative. In 2010, Derrick Rossi and Robert Langer formed the biotech company Moderna, as they saw mRNA’s use for vaccine development and other therapeutic areas. By 2013, one more biotech company BioNTech came into existence looking upon immunotherapies using mRNA work done by Katalin and Weissman. Thus, a new era of pre-clinical testing of mRNA vaccine for various infectious diseases and cancer had already started. HIV, Malaria, Influenza, Rabies were few diseases that were considered to develop mRNA vaccines by preclinical testing in Mice and Non-human primates. But none of these could reach a stage from where it could be used in humans. 

AND CAME THE COVID-19 PANDEMIC

At the end of 2019, when the world was busy planning to welcome 2020 in Wuhan, China people were getting infected by an unknown respiratory disease, which came out to be COVID-19 caused by SARS-CoV-2. This turned out to an outbreak globally in few days.

On 11 January 2020, the first-time genome sequence of SARS-CoV-2 was shared by the Chinese authority. This led to accelerated work by researchers globally for vaccine development. Pfizer/BioNTech vaccine immediately began their vaccine work. Phase I trials were started in April 2020, with required regulatory standards, followed by Phase II/III. On 2 December 2020, UK gave an emergency use approval for this vaccine. MHRA (Medicine and Healthcare products Regulatory Agency) of the UK became the first global medicines regulator to approve an RNA vaccine followed by various other nations also. Vaccine efficacy (is the percentage reduction of disease in a vaccinated group of people compared to an unvaccinated group, using the most favorable conditions)of more than 90% was seen so it was given EUA in many countries. The Pfizer/BioNTech BNT162b2 vaccine was based on the use of nucleoside-modified mRNA (modRNA) which encoded the spike protein found on the surface of the SARS-CoV-2 virus encapsulated in lipid nanoparticles.

A Similar mRNA work approach was seen by Moderna and NIH. Within two days they finalized their sequence for vaccine mRNA-1273.The first participant in the phase I study was dosed within 63 days of the sequence selection. Vaccine efficacy of more than 90% was seen in mRNA-1273. On 18 December 2020 USFDA authorized the Emergency use of the vaccine for individuals 18 years or older. Many countries after the USA, have given emergency use approval (EUA)for mRNA-1273 till today. Moderna vaccine mRNA-1273 is composed of nucleoside-modified mRNA (modRNA) encoding a spike protein of SARS-CoV-2, which is encapsulated in lipid nanoparticles.

FUTURE OF mRNA in VACCINES AND THERAPEUTIC AREA

With emerging variants of Coronavirus mRNA vaccines are showing protection against few new variants. Modified mRNA vaccines according to emerging variants are also being developed and studied by many companies worldwide. 6 more mRNA new vaccines are in pipeline, with one in India by Gennova Biopharmaceuticals Ltd in collaboration with HDT biotech, called HGC019. Animal studies have been done and now they are gearing up for Human Clinical Trials. Other vaccines are CureVac by GSK, MRT5500 by Sanofi and Translate Bio, PTX- COVID19-B by Providence therapeutics, one in under development in Thailand, and Pfizer/BioNTech are developing various modified mRNA vaccines. 

With the development of mRNA vaccines, Science has reached the next level of advancement. But this comes with the pros and cons of the substance. The major con is Storage temperature; it requires very low degree storage and that is causing a problem in many countries for storage or transport globally, wherever it is essential. But with the Indian version HGC019, we are hoping this problem might get solved as it is claimed it is stable at 2-8°C. Pros consisted of short time to design and test mRNA vaccine, rapid and easy manufacturing compared to traditional vaccine.

mRNA is also considered to be used in mRNA-based therapies like protein replacement therapy in cardiology, oncology, pulmonary medicines, etc., and treatment of diseases. Hope this mRNA serves as a boon to the biotechnology industry and a golden substance for humankind.

REFERENCES:

  1. Moderna work 
  2. RAPS Vaccine Information
  3. Pfizer Vaccine 
  4. Moderna Vaccine 

Opioid Crisis: How big is the problem, and what are the solutions?

Drugs and Disease

What are opioids?

Opioids (Figure 1) are a class of drugs naturally found in the opium poppy plant that acts on the nervous system to produce a variety of effects, including the relief in pain or pleasure.

Opioid Use Disorder: How big is the problem?

Figure 1: Opioids [2]

 

The clinical term opioid use disorder, also known as opioid abuse, is a multidimensional health issue with complicated causes and no appropriate solution [3]. Therefore, the world is in the midst of an unparalleled, self-inflicted opioid epidemic [1]. In 2016, approximately 275 million people globally used drugs at least once and 27 million people were estimated to be suffering from opioid abuse. In 2015, around 4,50,000 people died as a result of drug use, of which 160,000 were directly related to drug use disorders and about 118,000 with opioid abuse. Approximately, a third and a half of all drug-related deaths are contributed by drug overdose [4].

 

Drug abuse: What are the contributing factors?

Over-prescription: It is one of the significant factors of drug abuse that not only affects adults but also youngsters and children. People who depend on opioids are most likely to get addicted and experience an adverse event [5]. Opioids are responsible for high proportion of fatal drug overdoses around the world because of their ability to cause respiratory depression and death, which can be identified by a triad of signs and symptoms as depicted in Figure 2.

Figure 2: Signs and symptoms of drug overdoses

 

Non- genetic factors: Some non-genetic factors also play a role in opioid addiction such as psychiatric disorder, substance abuse, depression, child abuse, or neglect. Certain personality traits such as impulsivity and sensation-seeking also increase the risk of opioid addiction.

Opioid as pain relievers: Easy or unrestricted availability of opioid pain relievers (medications used for pain relief that falls under the category of opioids) is another reason for high opioid abuse. A survey demonstrated that 22% of the respondents had opioids from an active prescription at home and 21% had medications leftover from the previous prescription of which 66% deliberately kept the medications at home in case there is a requirement in the future. Another survey by Thiels et al. found that more than 60% of pills prescribed by healthcare professionals went unused [6]. Few contributing factors that led to the presence of opioids at home were high family income and high caregiver educations. However, some critics say that the prevalence of opioids in home was not affected by one’s relationship with the youth, race, household type or Medicaid insurance [7]. It is essential that a combination of health, social, economic and lifestyle factors interact with genetic factors to determine an individual risk [3].

 

Opioid abuse: How to resolve the problem?

Basic life support and antagonistic drugs: Fortunately, overdose of opioid can be prevented if the basic life support and naloxone (opioid antagonist) are administered on time. This approach is adopted by many countries and jurisdictions to reduce deaths resulting from an opioid overdose [4].

Appropriate prescription procedures: Emphasis should be made on the proper prescription procedures and expectations of the patient regarding postoperative pain management to bridge the gap of unused opioids. Several approaches are needed to ameliorate the opioid overdose and other problems caused by the opioid abuse if administered measurably (Figure 3) [8]:

Figure 3: Steps to prevent opioid crisis

 

All these measures are a necessity to abate the opioid crisis. However, only half of the countries provide access to the effective treatment of opioid dependence, and less than 10% of the people who need the treatment are receiving it [8].

Drug abuse: What does WHO recommend?

WHO recommendations to prevent opioid crisis [3] are given below:

  1. WHO supports countries to administer the treatment where it doesn’t exist and also helps in monitoring trends in drug use and related harm to have a better understanding of opioid dependence and overdose
  2. WHO supports countries to use the medications rationally, to make the appropriate use of the drug and minimize the misuse/ overuse
  3. WHO recommends to take measures to alleviate the risk of misuse by a careful patient selection and supervising the doses whenever necessary
  4. WHO recommends that naloxone should be made available in the rehabilitation centers to manage opioid overdose and the people who are probably to witness an opioid overdose
  5. WHO provides psychosocial support, promotes detoxification and opioid maintenance treatment (which involves administration of drugs such as methadone and buprenorphine)
  6. A stepped approach was highlighted to manage the pain in cancer patients namely- the WHO cancer pain ladder that recommends initial use of non-opioids, followed by weak opioids and then strong opioids

Although the appropriate use of opioids is a fundamental part of modern analgesia, but the drug abuse has led the problem spin out of control. While there are people suffering from chronic and acute pain, opiates shall remain an essential class of medication in healthcare facilities. Proper emphasis should be given to understand the reasons why people are using these drugs and offer fewer stigmatizing strategies to assist people who use opioids. A three-point approach emphasizing on the prevention, treatment, and rehabilitation of those already affected and who might be at risk in the future may be the holistic solution. Further investigation and success with the prevention approaches and some new strategies devoted to managing the crisis are required in order to respond effectively to such conditions in the future.

 

Turacoz Healthcare Solutions aims to provide information on the latest trends, updates, and advances in the field of clinical research, trials and regulatory affairs. Turacoz Healthcare offers end-to-end support for scientific communications, clinical trial documents and disclosures, regulatory documents writing and submissions, and medico-marketing writing along with e-modules & e-books on healthcare and research.

 

References

  1. Health resources and service administration: [https://www.hrsa.gov/opioids, Accessed on 16th sep, 2019]
  2. John Hopkins Medicine Retrieved from: [https://www.hopkinsmedicine.org/opioids/what-are-opioids.html, Accessed on 16th sep, 2019]
  3. US National Library of Medicine: [https://ghr.nlm.nih.gov/condition/opioid-addiction#resources, Accessed on 16th sep, 2019]
  4. World Health Organisation Retrieved from: [https://www.who.int/substance_abuse/information-sheet/en/, Accessed on 16th sep, 2019]
  5. Stoicea, N., Costa, A., Periel, L., Uribe, A., Weaver, T., & Bergese, S. D. (2019). Current perspectives on the opioid crisis in the US healthcare system: A comprehensive literature review. Medicine, 98(20).
  6. Ziegelmann, M. J., Habermann, E. B., & Gettman, M. T. (2019, May). In Reply—The Importance of Educational Interventions and Regional Analgesia in Tackling the Opioid Crisis in the United States. In Mayo Clinic Proceedings(Vol. 94, No. 5, pp. 921-922). Elsevier.
  7. Garbutt, J. M., Kulka, K., Dodd, S., Sterkel, R., & Plax, K. (2019). Opioids in Adolescents’ Homes: Prevalence, Caregiver Attitudes, and Risk Reduction Opportunities. Academic pediatrics, 19(1), 103-108.
  8. Saloner, B., McGinty, E. E., Beletsky, L., Bluthenthal, R., Beyrer, C., Botticelli, M., & Sherman, S. G. (2018). A public health strategy for the opioid crisis. Public Health Reports, 133(1_suppl), 24S-34S.

 

New Drugs For HIV: Making An Impact On HIV Treatment

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The global statistics for HIV/AIDS 2017 have revealed that around 37 million people across the globe were affected by HIV, out of which 1.8 million were children. 1.8 million new cases of HIV were registered in 2017, making it about 5,000 new cases per day.

Around 75% of the total people affected by HIV were aware of their condition, whereas the rest 25% were yet to be examined. HIV screening is very important and crucial for its prevention and treatment. 21.7 million HIV positive people, globally, were having the access to antiretroviral therapy (ART).

Though the deaths due to AIDS have been reduced by 51 %, globally, there is still a lot to be done for this condition. Till date, we have no cure for HIV. There are various advancements in the drugs for HIV treatment, but there hasn’t anything been invented yet that can cure HIV forever. In such a case, every new drug invented and approved is a ray of hope for many HIV patients worldwide.

New drugs approval for HIV:

Recently, the US Food and Drug Administration gave its approval to two new drugs developed for treating HIV-1, the most common form of the virus.

Over the decades, this disease has been researched upon and understood by various scientists and efforts have been made to find treatment for the same. This approval signifies the potential and improvement in the treatment of the ailment and states that the options for treating the condition have now increased.

Known drug manufacturer, Merck, announced that FDA have approved the two new antiretroviral drugs- Delstrigo & Pifeltro.

These oral medications are targeted toward those adult HIV patients who have not been exposed to antiretroviral treatments before. These medications aren’t meant for the patients who have been previously receiving the antiretroviral treatments.

The approval for these drugs was granted posted the successful phase 3 clinical trial of these 2 drugs. The trial involved 700 participants for each drug. Both the medicines had same side effect of reducing the cholesterol levels.

People with HIV are now living longer life and with the recent statistics it can be inferred that very soon HIV positive people will live longer than 50 years. In such situation they are most likely to be exposed to issues like high cholesterol. So, in such conditions, the side effects of these drugs can prove beneficial as they lower down the cholesterol.

No single drug is effective for HIV patients. So, people who are looking forward to these drugs must consult their doctor beforehand to figure out the most suited treatment for them.

Choosing a certain drug or treatment regimen depends highly on various factors such as other medical issues faced by the patient, possible side effects and drug interactions. As more and more drug being available for the treatment, customized treatments can be generated keeping in mind patient’s condition.

The complexity of HIV/AIDS is still highly misunderstood by people in general and a lot is yet to be done in treatment of HIV.

Turacoz Healthcare Solutions hopes that more and even better drugs will be manufactured in near future which will make a positive impact on the treatment of HIV/AIDS and hopes that the new drugs manufactured will help in treating HIV and benefit HIV positive people.

Being a medical communication company, Turacoz wishes for HIV positive people to live a long and healthy life. Turacoz offers medical writing services like clinical trial support, pharmacovigilance support, regulatory writing, etc. and is updated on the recent advancements in the treatment of various diseases.

To know more, write us at [email protected]

Time for India to adopt orphan drugs

Drugs and Disease, , , ,

What are orphan drugs?

The term orphan drug refers to any drug or biological product intended for treatment, prevention or diagnosis of a rare disease. The definition of rare disease varies across countries but typically considers the prevalence of the disease, severity and existence of alternative therapies. As per WHO, a disease is considered rare if it affects ≤ 1 in 1000 population. In Unites states, a condition is rare if it affects fewer than 200,000 people in the country while in European union, it’s for < 1 in 2000 people.

Examples of rare disease include genetic disease, rare cancers., infectious tropical disease and degenerative disease. Oncology products account for greatest number of orphan drug designations.

Why Orphan?

Considering the high cost of drug development and lower patient pool, it becomes unviable for pharmaceutical companies to invest in these rare diseases, thus naming them orphan. In lack of proper diagnostic tools and treatment options, the patient’s suffering widens and poses a challenge for the doctor, society and the Government. To overcome this, the government and several NGOs provide incentives to drug companies to develop and market such drugs. The support is extended by the federal legislature through various research grants, market exclusivity, access to centralized facilities, free scientific advice, tax credits and fee reduction.

Adoption of Orphan drugs

Orphan designation may be granted at any stage of drug development if proper scientific justification is provided for its intended use. Efficacy, safety and quality of the drug should be satisfied to receive market authorization.

USA was the first country to pass orphan drug act in 1983 followed by Japan in 1993, Australia in 1997 and EU in 2000.

It is difficult to understand that countries like India and China being two of the largest in terms of population size still lack the designation of orphan drugs and national legislation for them. It creates a substantial negative impact on patients affected with such diseases.

The rare diseases are estimated to affect 72-96 million people in India. Though rare disease policy was drafted by Indian Government in 2017, it has yet to see the light of the day. The policy is the first major step by the government which recommends genetic counselling, as well as pre-natal and antenatal screening. Indian Council of Medical Research (ICMR) has launched a registry for Indian rare diseases to collect data for policy framing and guide future research. Beyond funding, a more holistic approach and faster implementation is the need of the hour to facilitate the adoption of orphan drugs.

Turacoz Healthcare Solutions takes an initiative to sensitize general population and pharmaceutical companies on the challenges faced by people affected with rare disease and take adequate steps via regular screening to limit such conditions. Turacoz is a medical communication company that provides scientific/medical/ regulatory writing support to the industry and is serving their clients in developing new drug applications, protocol writing for research, and medico marketing support. To get the assistance you can get in touch with us at [email protected]

A guide to Alzheimer’s care: Tips for daily tasks

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It is estimated that nearly 44 million people worldwide have Alzheimer’s or related dementia. The total number of people with Alzheimer’s is projected to almost double every 20 years.

What really scares me is Alzheimer’s or premature senility, losing that ability to read and enjoy and to write. And you do it, and some days maybe aren’t so good, and then some days, you really catch a wave, and it’s as good as it ever was: – Stephen King

Patience and flexibility are of most importance in Alzheimer’s patients care. Practical tips to be considered by caregivers when handling patients with Alzheimer’s are illustrated in the figure. This helps maintain a sense of independence, dignity and boost their confidence as the patient becomes dependent on caregiver for his/her daily needs.

A guide to Alzheimer’s care: Tips for daily tasks

Figure 1: Tips for caregivers’ family and friends of patient on how a person with Alzheimer’s disease should be cared.

Handling patients with Alzheimer’s disease

Caring for patients with Alzheimer’s disease is challenging, and in many instances the caregiver also falls into depression if they are not supported by friends and family. One of the major challenges a caregiver faces is the change in behaviour of the patient. Both the patient and the caregiver find it difficult to manage the daily basic activities like bathing, eating dressing etc.

  • Tackling communication challenge in Alzheimer’s Disease

Communicating with a patient with Alzheimer’s can be challenging as both understanding and being understood pose a problem. Thus, always try to communicate in simple words and short sentences, avoiding distractions. In many cases the patient finds it difficult to frame sentences to communicate. Have patience and provide them the words he/she is looking for. Give them enough time to respond.

  • Tips to reduce bathing and showering challenge in Alzheimer’s disease

Plan bathing or shower for time of the day when the patient is calm and is ready for bathing. Try to make it a routine. The patient must be made comfortable. As the patient is sensitive to temperature, test the water temperature before bath.

  • Dressing a person with Alzheimer’s disease

Try to get the patient dressed same time each day and make it a routine. Give the patient time to dress and encourage the patient to dress himself/herself.

  • Getting a Person with Alzheimer’s disease to Eat

Try to maintain familiar meal time routine. Ensure a calm, relaxed environment free of distractions during meal time. This helps to reduce confusion and anxiety of patients. Caregivers must ensure that patients are drinking enough water to avoid dehydration. Routine oral check-ups have to be done.

  • Exercises and Activities for people with Alzheimer’s disease

Always watch for agitations. Simple and easy activities which will enhance his/her skills will be more effective than teaching them something new. Exercises can improve the patients’ health and help them to sleep better.

  • Incontinence in patients with Alzheimer’s disease

This is a common problem faced by the patients as the disease progress. Limit fluids containing caffeine and other diuretics.

  • Sleep Problems for Caregivers and a Person with Alzheimer’s disease

Many patients with Alzheimer’s faces ‘sundowning syndrome’, where the patient gets agitated and irritated during bed time. Exercises and physical activity with minimized day time naps helps the patient to get a sound sleep during night.

  • Hallucinations and delusion in patients with Alzheimer’s disease

In most cases hallucination and delusions are signs of physical illness. In such situations avoid arguing with the patient and distract the patient attention to some other topics. Check whether the patient has access to any dangerous objects that can cause harm to others and the patient himself/herself.

  • Wandering: A problem for a person with Alzheimer’s disease

People with Alzheimer’s tend to wander away from their home. Always ensure that the patient carries some sort of identification. Notify local authorities in advance regarding this problem. Always try to keep the doors locked.

Turacoz is a medical communications company, providing customized and cost-effective services in regulatory writing, publication writing, medico-marketing writing, and support for conducting medical advisory board meetings.

Turacoz healthcare solutions, aims to increase awareness about Alzheimer’s disease and with this blog, provide useful tips to caregivers, family and friends of Alzheimer’s patients.

Orphan Drugs: Global Market Scenario and Regulations

Drugs and Disease

Global Market Scenario for Orphan Drugs

Orphan drugs are the drugs which are used for treatment of orphan/ rare diseases. After being neglected for a long time, the global market for orphan drugs is now witnessing a boom. The market is showing a constant growth and is expected to reach US$225 billion by 2024 due to recognition of their importance in healthcare. Other than this, the growth in orphan drugs is further attributed to recent advances in research modalities, increasing awareness and incidence of rare diseases, and improved incentives by regulatory authorities for development of orphan drugs. Favorable regulatory policies for orphan drug market in the United States have led to a fast growth of this market across the world. Pharmaceutical companies such as Actelion Pharmaceuticals Ltd., AbbVie, Inc., Alexion, Inc., Bayer AG and, AstraZeneca Plc are the key players in the orphan drug market.

Evolution of Orphan Drug Market Over the Years

As already mentioned, favorable regulations for the orphan drugs plays an important role in their increasing development and market growth. This is evident from the increasing numbers of orphan drugs in market from just 38 orphan drugs in 1983 to over 500 orphan drugs hitherto. Furthermore, over 230 orphan drugs had been approved by FDA in past decade and numbers are still increasing.

Development of Regulations and Guidelines for Orphan Drugs

Growth in orphan drug development led to emergence of US Orphan Drug Act 1983. With its’ successful outcomes, the act was then adopted by other nations in different customized forms. Below is the summary of the current regulations and guidelines for orphan drugs in different countries:

United States Orphan Drug Act

The act came into existence in 1983 and underwent further amendments in 1984, 1985, 1988, 1990 and, 1992. This act prioritized the treatment of rare diseases by facilitating research and development in field with provision of large amount of incentives for the same. Further, the act reduced the cost of developing new orphan drugs by wavering the fees at different stages of drug development such as new drug application fee, annual establishment and product fees after drug approval. Moreover, the act has a provision of tax credits on clinical research for orphan drugs along with the rights of exclusive marketing of product by pharmaceutical company for 7 years of development.

Japanese Orphan Drug Regulation

This act was formulated in 1993. As per these guidelines any drug would be categorized as orphan drug if it fulfills below mentioned criteria:

  • The disease targeted by orphan drug should be either incurable without any existing treatment or else the efficacy and safety profile of the new drug should surpass the ones already existing in market.
  • The prevalence of the rare condition must be less than 50,000; or the incidence must be 4/10,000 individuals.

The evaluation of new orphan drugs as per guidelines is done on priority basis resulting in fast track approvals and marketing authorizations. Further, pharmaceutical company would get added on incentives due to extended validity period of about 10 years. Moreover, reimbursement of 50% of drug development cost and waivers of taxes up to 6% on research and development of orphan drugs as per guidelines further ads onto the profits generation by pharmaceutical companies.

European Orphan Drug Act

This act came into existence in 1999. As per European Union (EU), the companies sponsoring orphan drug can participate in consultations and provide scientific advice related to development of orphan drugs. The fee for protocol assistance and follow-up is completely reduced by the act. Further the act waivered off all the fees for pre-authorization inspections. Moreover, there is provision for 50% reduction in fees on new marketing approval applications by large sized enterprises. The act also eliminated complete charges for not only marketing authorization, but post-approval charges are also wavered during the first year. However, this is applicable only to small and medium companies. Further profits to pharmaceutical companies can come from the provision of 10 years of exclusive marketing as per the act.

Turacoz Healthcare Solutions take an initiative to draw attention of healthcare providers and pharmaceutical companies towards the changing trend in global market scenario for orphan drugs. Further, this blog provides updated information about rules and regulations related to these drugs different countries. Turacoz provides high quality end to end scientific/medical writing support to the industry and academia. We expertise in several clinical trial related documents like Investigator Brochures (IBs), Protocols, Clinical Study Reports (CSRs), Clinical Evaluation Report (CER) and Common Technical Documents (CTDs) Prescribing Information (PI).