PharmaMar announces “positive results” against the coronavirus and shatters records on the Stock Market

The results of the trials of Aplidin as a treatment against the coronavirus re-launch investor optimism.

The biotechnology of the Spanish stock index, PharmaMar launched in a new rally among expectant investors to the results of the new tests of Aplidin as a treatment against the coronavirus. The hikes accelerate this Friday to pulverize historical records when communicating that the trials have produced “positive results” for both safety and efficacy.

Since last March PharmaMar surprised to announce that its antitumor drug Aplidin could be effective in treating coronavirus, biotech investors have had a possible additional catalyst to accelerate the rally of best value of the entire Spanish Stock Market in 2020.

At the close of yesterday accumulated a 205% revaluation, and today a new push. PharmaMar is once again leading the Ibex rises, with advances that at times exceed 10%, in its best session since joining the Ibex. Their shares thus pulverize their historical records, by far exceeding the maximum of 135.16 euros registered last July. On this day, he breaks the barrier of 140 euros. In this way, your Market value thus reaches 2,600 million euros.

What is behind the rally?

In a statement sent to the CNMV, the company states that “its Aplicov-PC clinical trial with Aplidin (plitidepsin) for the treatment of adult patients with Covid-19, who require hospital admission, has met the primary safety and secondary efficacy objectives“.

The biopharmaceutical details that “the study has shown a marked reduction in viral load in patients between days 4 and 7 after the start of treatment, so that the mean reduction in viral load on day 7 was 50%, and 70% on day 15. More than 90% of the patients included in the trial had medium or high viral loads at the beginning “.

Studies reveal the improvements achieved in the longer term. “80.7% of the patients have been discharged from hospital on or before the 15th day of hospitalization, and 38.2% before the 8th” and “on day 30, in the scheduled clinical visit, none of the patients treated with plitidepsin had developed symptoms or signs derived from Covid-19 infection “.

The “positive results” of the study “in this first group of patients” have led PharmaMar to request and obtain from the Spanish Agency for Medicines and Health Products (AEMPS) the “authorization for an extension of the patient cohort”.

With the data obtained, which will be presented “in scientific congresses and / or in a prestigious medical journal”, PharmaMar advances that “the company will, in the next few days, begin conversations with the regulatory agencies to define the next study of phase III Plitidepsin Registry in COVID-19 Patients Requiring Hospitalization “.

Aplidin vs remdesivir

The publication of the trial results coincides with the latest studies questioning the efficacy of Gilead’s remdesivir as a treatment against Covid-19. According to the WHO, the drug does not achieve significant results in preventing mortality from coronavirus.

Precisely months ago PharmaMar established a comparison of the results of the Aplidin trials with those of remdesivir. Last July it surprised the market by announcing that in certain cell models Aplidin has “shown an antiviral activity between 2,400 and 2,800 times greater than remdesivir”.

In today’s statement PharmaMar avoids comparisons with Gilead’s remdesivir, Although it could give more details in the press conference it has called for next Monday, at 11 am, in order to report the results, and in which the principal investigators of the trial will participate. The press conference “can be accessed electronically”, according to the company.



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Met Opera Cancels 2020-21 Season

The Metropolitan Opera has canceled all performances for its 2020-21 season, saying the coronavirus pandemic remains too great an ongoing health concern.

In a release, the New York City company said Wednesday that, based on the advice of health officials, it could not safely begin operations “until a vaccine is widely in use, herd immunity is established and the wearing of masks and social distancing is no longer a medical requirement.”

The company, one of the most august cultural institutions in the world, previously announced the cancellation of performances through Dec. 30 because of the pandemic. The Met shut down in mid-March, as did other theaters and arts-presenting organizations in the city, though the company initially anticipated a much shorter stoppage of just a few weeks.

The Met added that it plans to resume performances in the fall of next year. Officials announced several productions they are planning for the 2021-22 calendar, including the company premiere of “Fire Shut Up in My Bones,” an opera by jazz trumpeter and composer Terence Blanchard that will open the season on Sept. 27, 2021.

Nevertheless, officials made it clear that the loss of an entire season is no small matter.

“The inability to perform is taking a tremendous toll on our company,” General Manager Peter Gelb said in a statement.

Two people look into the closed Metropolitan Opera House at Lincoln Center in New York City. The opera closed its doors after officials in March banned large gatherings of people due to the coronavirus.


Photo:

Kathy Willens/Associated Press

The Met, with a pre-pandemic annual budget of around $300 million, has already furloughed its orchestra and chorus in an effort to keep its finances in check during the health crisis.

Mr. Gelb said even when the company resumes performances, it could be some time before attendance reaches pre-pandemic levels in its 3,800-seat theater. The Met plans certain initiatives to make audiences feel more comfortable about returning to the venue, he said, including starting productions earlier in the evening and reducing the running times of operas, which can often easily exceed three hours.

It remains to be seen if other theaters and arts groups will follow the Met’s lead and extend cancellations through the spring, if not later. New York state and city officials haven’t indicated when they plan to allow theaters to welcome back patrons. Last month, they permitted museums in the city to reopen for limited visitation.

In addition to “Fire Shut Up in My Bones,” the Met’s 2021-22 season is scheduled to include two other new operas, Matthew Aucoin’s “Eurydice” and Brett Dean’s “Hamlet.” The season will also feature new productions of such classic works as Verdi’s “Rigoletto” and Donizetti’s “Lucia di Lammermoor.”

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Digital Medicine – France fined US $ 524 million pharmaceutical companies Novartis, Roche and Genentech for “abusive practices”

Paris, France. The French Competition Authority imposed a record fine of 444 million euros (US $ 524 million) on the Swiss laboratories Novartis and Roche and the American Genentech, accused of “abusive practices”.

This is the largest collective fine ever imposed by the French authorities on pharmaceutical companies.

In a statement, the French Competition Authority explained that Genentech, Novartis and Roche engaged in abusive “dominant position” behavior in order to preserve the position and price of Lucentis and to curb the cancer drug Avastin, which does not have authorization to be used in macular degeneration.

Lucentis is a treatment for macular degeneration (AMD), an age-related retinal disease, developed by Genentech, whose capital is linked to that of the Swiss groups Roche and Novartis.

However, doctors realized that another Genentech drug, Avastin, had positive effects on AMD and began to prescribe it despite the fact that it does not have a marketing authorization for this disease.

Avastin costs 30 times less than Lucentis. An Avastin injection costs between 30 and 40 euros, compared to 1.16 euros for Lucentis.

According to the competition authority, Novartis “tried to thwart the initiatives of ophthalmologists who, within the framework of their freedom of prescription, decided to prescribe Avastin, outside of its marketing authorization.”

“Novartis, Roche and Genentech were also sanctioned for having applied a series of blocking measures and for having disseminated an alarming and sometimes misleading message to public authorities about the risks associated with the use of Avastin for the treatment of AMD. ”.

Agencia AFP

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Digital Medicine – Vaccination, in times of pandemic

Mexico City. The coronavirus pandemic is dragging on, and to top it off, the peak season for another infectious disease is just around the corner: influenza. At a time when respiratory diseases have gained relevance in the global public interest, medical experts highlighted during the 3rd Flu Summit: ‘Together protecting the world’, the importance of vaccination against the influenza virus as a priority issue on the agenda national.

As a direct result of vaccination, approximately 2 to 3 million lives are saved each year.[iii] However, being one of the most effective public health interventions, 3 to 5 million serious influenza cases are reported worldwide.[iv] and there is an annual estimate of 290,000 to 650,000 respiratory deaths as a consequence of complications from this disease.[v]

“All people are at risk of contracting influenza, since the disease is easily transmitted by coughing, sneezing or talking, however, there are certain groups of people who are more vulnerable to developing complications associated with influenza such as people who they live with diabetes, cardiovascular and respiratory diseases, those over 50, pregnant women and children, among others. These people should be vaccinated as soon as the influenza season begins, starting in October, ”commented Dr. Ricardo Iglesias, from the University of Buenos Aires, Argentina.

After an influenza infection, the risk of a heart attack increases 10 times, while people living with diabetes are 3 to 6 times more likely to be hospitalized and the risk of death from complications is 6 times greater in this group .[vi] “Fortunately, we can face this scenario thanks to vaccination, which today is the most effective way to prevent influenza and especially for people at high risk of complications,” added Iglesias.

For her part, Dr. Flor Muñoz, from Texas Children’s Hospital in the United States of America, mentioned that “Despite all efforts, influenza viruses continue to represent one of the greatest infectious disease challenges worldwide, hence the importance of protecting against influenza and especially now that it will coexist with the circulation of SARS – Cov2 that causes COVID-19 ”. She also stressed that “It is very important to vaccinate the school-age population, since they are considered super-spreaders of the virus to the rest of the community. Only in 2019, this group was the second most affected by influenza, hence vaccination for this population group becomes important during the influenza season that is about to begin ”.

The challenge: recover vaccination schedules

Currently, the world faces multiple health challenges ranging from outbreaks of vaccine-preventable diseases such as measles and diphtheria, to doubts about the benefits of vaccines (reluctance or rejection) that threaten to reverse the progress made. in the fight against vaccine-preventable diseases.[vii]

Due to the COVID-19 pandemic and according to the World Health Organization (WHO) and the United Nations Children’s Fund (UNICEF), vaccination coverage rates worldwide have gone down.[viii]. So far in 2020, in Mexico vaccination coverage of children under one year of age decreased by 21% versus the first half of 2019[ix] and only 4 out of 10 children under one year of age have an incomplete vaccination schedule,[x] For this reason, today more than ever and despite the pandemic, it is extremely important to go to vaccinate babies and children following all safety measures since the clinics remain open and the vaccination programs have not stopped.

For his part, Dr. Gary Marshall, Pediatric Infectologist and Chief of the Division of Pediatric Infectology at the University of Louisville School of Medicine, stated that: “Vaccines are among the great achievements that humanity has had and represent one of the safest medical developments in the world, as its main function is disease prevention. On the contrary, resistance to vaccination can lead to significant damage to health and the suspension of vaccination services could become a great threat to life. “

“We continue to face challenges such as access and distrust in vaccines that keep us exposed to threats that could be fatal if not attended to in time, so it is relevant to share scientific information on the subject in order to increase trust and therefore increase vaccination rates ”. Today more than ever and in the face of the panorama that the world is experiencing, we must understand the value of vaccination and make use of all the vaccines that today can help us prevent more than 26 diseases ”, concluded Marshall.

For its part, Sanofi Pasteur reinforced its commitment to protecting public health through the essential supply of influenza vaccine worldwide and reaffirmed its purpose to continue working so that no one suffers or dies from a preventable disease caused by vaccination.

Drafting MD

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[i] UNICEF (2020). Immunize the children who need it most, available at: https://www.unicef.org/es/immunizacion

[ii] WHO (2019). WHO launches new global influenza strategy, available at: https://www.who.int/es/news-room/detail/11-03-2019-who-launches-new-global-influenza-strategy

[iii] UNICEF (2020). Immunize the children who need it most, available at: https://www.unicef.org/es/immunizacion

[iv] WHO (2018). Influenza (Seasonal), available at: https://www.who.int/news-room/fact-sheets/detail/influenza-(seasonal)

[v] WHO (2019). WHO launches new global influenza strategy, available at: https://www.who.int/es/news-room/detail/11-03-2019-who-launches-new-global-influenza-strategy

[vi] Sanofi Pasteur (2020). Influenza is a serious infection that can have unexpected, severe consequences, disponible en: https://www.sanofi.com/-/media/Project/One-Sanofi-Web/Websites/Global/Sanofi-COM/Home/media-room/fact-sheet/Backgrounder_SP_Influenza_EN_20200811.pdf?la=en&hash=3263B4212502ECC20B3D3895DD0D6DFF

[vii] PAHO (2019). What are the top 10 health threats in 2019, available at: https://www.paho.org/hq/index.php?option=com_content&view=article&id=14916:ten-threats-to-global-health-in -2019 & Itemid = 135 & lang = en

[viii] WHO (2020). WHO and UNICEF warn of a decrease in vaccinations during COVID-19, available at: https://www.who.int/es/news-room/detail/15-07-2020-who-and-unicef- warn-of-a-decline-in-vaccinations-during-covid-19

[ix] General Directorate of Health Information (2019-2020). Dynamic Cubes. Services Granted 2019 and 2020, available at: http://sinba08.salud.gob.mx/cubos/cubosis2019_plataforma_sinba.htm and http://sinba08.salud.gob.mx/cubos/cubosis2020_sinba.htm

[x] General Directorate of Health Information (2019-2020). Dynamic Cubes. Services Granted 2019 and 2020, available at: http://sinba08.salud.gob.mx/cubos/cubosis2019_plataforma_sinba.htm and http://sinba08.salud.gob.mx/cubos/cubosis2020_sinba.htm

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Digital Medicine – Hemophilia Federation launches campaign to inform patients about the availability of treatments in public health institutions

Mexico City. With almost 30 years of work in providing access to health for people living with hemophilia in Mexico, the Federation of Hemophilia of the Mexican Republic (FHRM) presented the campaign #TodosfamiliaTodosHemofilia that aims to inform people living with this condition on access to treatment and a prophylaxis scheme, which is currently guaranteed in the national health system.

Today the community that lives with Hemophilia, still faces different problems to have access to treatment, among them are: ignorance of diagnosis, that the patient is in communities far from specialized health institutions, lack of information about the availability of treatment and not having social security.

Although treatment is already available, of the more than 5,800 people living with hemophilia in Mexico, only 30% of the pediatric population and 8% of the adult population have access to a prophylactic treatment scheme1, this means It is applied periodically to prevent bleeding and joint damage.

Minerva Cruz, president of the FHRM board of directors, affirmed that, “we can all join this campaign thanks to technology, since, by sharing it with a message, a video, an audio or an image, we could change someone’s life still miles away; a simple action like this would help us to inform and detect possible patients ”, he highlighted.

Hemophilia is the deficiency or absence of factor VIII (type A) or factor IX (type B), which prevents the blood from clotting as it should, lack of treatment generates mainly motor sequelae and an episode of bleeding not treated correctly or in time can have a fatal outcome.

At present, hemophilia should no longer be a death sentence, nor cause disabilities, since today there are all therapeutic alternatives for a person living with hemophilia to have a full and unlimited life, as long as they have the appropriate treatment , adequate and sufficient.

“We are facing an unprecedented effort in Mexico, in which the government, health institutions and civil society have joined in order to help people living with hemophilia, but it is important to raise awareness among the patient and their families so that they attend to the health institutions to receive the treatment ”, concluded the representative of the FHRM.

The campaign will have a nationwide multimedia outlet, through the Federation’s social networks (Website, Facebook and YouTube), radio and peripherals, with the aim of impacting both Internet users and the most vulnerable populations for who access to information is more limited.

For more information on this condition, the Federation makes available the page Hemofilia.org.mx

Drafting MD

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Digital Medicine – Irma Egoavil new president of AMIIF

Mexico City. The Board of Directors of the Mexican Association of Pharmaceutical Research Industries AC (AMIIF), formalized the appointment and protest of Irma Egoavil as president of the Association for the rest of the period March 2020- March 2021.

Irma Egoavil, General Director of Ferring México and who previously served as Vice President of AMIIF, takes over from Ana Longoria, who will assume a new role at Novartis.

With Irma Egoavil in the presidency, the AMIIF will continue:

· Building alliances between the public sector, academia, civil society and the private sector to promote timely access to innovative therapies that have a significant and positive impact on people’s lives.

· Generating proposals that point towards the sustainability of the national health system in terms of coverage, financing and quality.

· Promoting the clinical research agenda and a knowledge economy that encourages, fosters and protects innovation.

· Promoting solid regulatory systems and high quality standards.

· Reinforcing the social agenda of this industry to achieve a greater impact on the health system and on society in general.

In Mexico, the innovative pharmaceutical industry has served as a strategic sector for economic and social development for 70 years. AMIIF member companies invest around $ 300 million annually in clinical research and generate 55,000 direct jobs and more than 240,000 indirect jobs.

Irma is a doctor graduated from La Salle University, has experience in research in child nutrition, having collaborated in the Nutrition Research unit of the Pediatric Hospital of the Centro Médico Nacional Siglo XXI. She studied pharmaceutical marketing at the INSEAD Business School in France and a master’s degree in Bioethics and Law at the University of Barcelona.

He has more than 23 years of experience in the pharmaceutical market in Mexico and Spain, as well as more than 12 years in highly specialized areas, achieving results through team development and promoting the integration of multidisciplinary teams. She has worked in companies such as Janssen, Roche and Celgene where she was the first employee in Mexico and had the opportunity to open the affiliate and start operations in Mexico. Since October 2016, she has been the General Director of Ferring México, where she is in charge of the commercial and manufacturing operations. She has been a member of the Board of Directors of AMIIF for three years and leads the Communication Commission of the Association.

Drafting MD

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Digital Medicine – Irma Egoavil new president of AMIIF

Mexico City. The Board of Directors of the Mexican Association of Pharmaceutical Research Industries AC (AMIIF), formalized the appointment and protest of Irma Egoavil as president of the Association for the rest of the period March 2020- March 2021.

Irma Egoavil, General Director of Ferring México and who previously served as Vice President of AMIIF, takes over from Ana Longoria, who will assume a new role at Novartis.

With Irma Egoavil in the presidency, the AMIIF will continue:

· Building alliances between the public sector, academia, civil society and the private sector to promote timely access to innovative therapies that have a significant and positive impact on people’s lives.

· Generating proposals that point towards the sustainability of the national health system in terms of coverage, financing and quality.

· Promoting the clinical research agenda and a knowledge economy that encourages, fosters and protects innovation.

· Promoting solid regulatory systems and high quality standards.

· Reinforcing the social agenda of this industry to achieve a greater impact on the health system and on society in general.

In Mexico, the innovative pharmaceutical industry has served as a strategic sector for economic and social development for 70 years. AMIIF member companies invest around $ 300 million annually in clinical research and generate 55,000 direct jobs and more than 240,000 indirect jobs.

Irma is a doctor graduated from La Salle University, has experience in research in child nutrition, having collaborated in the Nutrition Research unit of the Pediatric Hospital of the Centro Médico Nacional Siglo XXI. She studied pharmaceutical marketing at the INSEAD Business School in France and a master’s degree in Bioethics and Law at the University of Barcelona.

He has more than 23 years of experience in the pharmaceutical market in Mexico and Spain, as well as more than 12 years in highly specialized areas, achieving results through team development and promoting the integration of multidisciplinary teams. She has worked in companies such as Janssen, Roche and Celgene where she was the first employee in Mexico and had the opportunity to open the affiliate and start operations in Mexico. Since October 2016, she has been the General Director of Ferring México, where she is in charge of the commercial and manufacturing operations. She has been a member of the Board of Directors of AMIIF for three years and leads the Communication Commission of the Association.

Drafting MD

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Digital Medicine – Suicide, second cause of death among young people

Mexico City. Suicide is a growing public health problem around the world, so its prevention should be considered a priority. At the international level, more than 800,000 people commit suicide annually, that is, every second 40 people kill themselves. In the last 45 years suicide rates have increased by 60% globally. Suicide is currently the second leading cause of death among 15 to 29 year olds.

Suicide is a reality that hurts and hurts an entire society; It causes a strong emotional burden on the family and friends of people who for some reason decided to take their own lives, since in addition to the pain of loss, it generates feelings of guilt regarding a fatal event that could have been avoided.

In Mexico, the numbers of hopelessness have also increased in the last 50 years, especially among young people of working age and elderly men. In 2017, the total number of deaths due to suicide was 6,494, with a more pronounced trend in men (8.7 per 100,000) than in women (1.9 per 100,000), the national average being 5.2 per 100,000 inhabitants. . The group from 20 to 24 years old stands out, with a rate of 15.1 suicides for every 100,000 young men.

Suicide, a complex and multifactorial problem

Despite the high emotional and economic burden that suicide means, this is an event that can be prevented by identifying risk factors and improving the mental health of the population. Dr. Edilberto Peña, neuropsychiatrist and teacher in medical sciences, explains that the first step to prevent suicide is to focus on its causes, which are multiple. “Suicide is a complex problem, involving psychological, social, biological, cultural and environmental factors.”

The World Health Organization (WHO) indicates that mental disorders, such as major depression, bipolar disorder, alcohol-drug abuse and schizophrenia, are a very important factor associated with suicide, with a total prevalence of 80 to 100% of mental disorders in cases of completed suicide.

“Most suicides have been preceded by verbal or behavioral warning signs, although some of them are committed without prior warning. Still it is important to know the warning signs, such as statements or threats of suicide, deep hopelessness, drug or alcohol use, getting rid of loved possessions, saying goodbye or asking for forgiveness, isolation, hurting themselves, talking about death as a way out of problems or presenting abrupt changes from a state of euphoria to a state of deep sadness “, indicated Dr. Peña.

The neuropsychiatry specialist warned that the Covid-19 crisis may be a risk factor for an increase in suicides. “The problems triggered by the pandemic can generate psychological mediators such as sadness, worry, fear, anger, frustration and guilt.”

In times of Covid-19 there are psychosocial risk factors associated with suicide such as social isolation, loss of loved ones, stigma towards people with Covid-19 and their families, loss of employment and financial stressors, interruption of education and anxiety about the future, domestic violence and alcohol use, fragmentation and social tension, availability of means to commit suicide and low-resource settings.

Suicide prevention and intervention strategies promote social well-being

Through timely and effective interventions, based on treatment and support, both suicides and suicide attempts can be prevented. Dr. Peña explained that among the specific prevention strategies are accompaniment in grief; promote tools to promote mental health; mitigate the adverse effects of isolation; implement educational and awareness programs for patients, families and healthcare providers; facilitate problem solving, and avoid loneliness and disconnection.

“Therapeutically speaking, there are effective ways to prevent suicide, such as pharmacotherapy, psychotherapy and follow-up after an attempt. It is also important to restrict access to lethal methods and share good practice guides with the media, ”said the specialist. Antidepressant management significantly reduces the rate of suicide attempts, especially in young populations.

At the government level, a comprehensive legislative strategy is necessary to establish policies that help prevent suicide, improve mental health care for the population, and provide tools for specialists who attend to this public health problem. Dr. Peña de León pointed out that until now there is no article in the General Health Law that refers to any prevention strategy or action against suicide.

For her part, Sara Montero, general director of Mexico, Central America and the Andean Countries of Lundbeck pointed out that: “A single life lost by suicide means a lot. The way forward is for authorities, health professionals and society to work together to prevent suicide, and the time to act is now. As a global company and leader in mental health, we collaborate with authorities, patient groups and other interested sectors in different countries to support communities and society in the prevention of suicide ”.

Drafting MD
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1. Pan American Health Organization (PAHO) / ​​World Health Organization (WHO). World Suicide Prevention Day 2019. “Working together to Prevent Suicide”. Available at: https://www.paho.org/hq/index.php?option=com_docman&view=download&slug=trabajando-juntos-para-prevenir-el-suicidio-claudina-cayetano-esp&Itemid=270&lang=es
2. World Health Organization. Suicide. Available at: https://www.who.int/es/news-room/fact-sheets/detail/suicide#:~:text=%20Datos%20y%20cifras%20%201%20Cerca%20de,en%20pa % C3% ADses% 20de% 20income% 20low% 20y …% 20More% 20
World Health Organization. Suicide prevention. Available at: https://www.who.int/mental_health/prevention/suicide/suicideprevent/es/
3. Pan American Health Organization (PAHO) / ​​World Health Organization (WHO). World Suicide Prevention Day 2019. “Working together to Prevent Suicide”. Available at: https://www.paho.org/hq/index.php?option=com_docman&view=download&slug=trabajando-juntos-para-prevenir-el-suicidio-claudina-cayetano-esp&Itemid=270&lang=es
4. Hernández Bringas, Héctor Hiram; Flores Arenales, René. Suicide in Mexico. National Autonomous University of Mexico. Pap. poblac vol.17 no.68 Toluca Apr./Jun. 2011.Available at: http://www.scielo.org.mx/scielo.php?script=sci_arttext&pid=S1405-74252011000200004
5. INEGI. “Statistics regarding the World Suicide Prevention Day (September 10)” Available at: https://www.inegi.org.mx/contenidos/saladeprensa/aproposito/2019/suicidios2019_Nal.pdf

6. Hernández Bringas, Héctor Hiram; Flores Arenales, René. Suicide in Mexico. National Autonomous University of Mexico. Pap. poblac vol.17 no.68 Toluca Apr./Jun. 2011.Available at: http://www.scielo.org.mx/scielo.php?script=sci_arttext&pid=S1405-74252011000200004
7. California Central Coast Family Services Agency. Suicide warning signs. Available at: http://fsa-cc.org/wp-content/uploads//2014/01/Señales-de-Alerta-de-Suicidios.pdf
8. Brown & Schuman, 2020; Gunnell et al., 2020; Thakur & Jain, 2020
9. Brent DA. Antidepressants and Suicidality. Psychiatr Clin North Am. 2016;39(3):503-512. doi:10.1016/j.psc.2016.04.002.

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Sanofi, increasingly confident in its vaccines against covid-19

The confidence of Sanofi in their candidates for vaccine against him coronavirus has risen this summer and the French drugmaker is already preparing to start clinical trialsits chief executive told Reuters.

The company is working on two of the more than 150 potential vaccines that are currently being developed around the world to deal with the pandemic of covid-19, which has claimed more than 831,000 lives and caused an economic collapse.

One of the Sanofi candidates will use a adjuvant manufactured by the British company GlaxoSmithKline (GSK) for increase its effectiveness. This potential antidote will be built on an existing base commissioned to develop vaccinations for him treatment from gripe.

The other, developed by the American company Translate Bio, uses a different technology known as MRNA.

“The first data say that we are on the right track and that we have a vaccine,” Paul Hudson said in an interview on Friday, August 28, 2020, referring to the vaccine that is being developed with GSK and that it will be ready to start the clinical trials next month.

About 30 experimental vaccines against the coronavirus are already in the human trial phase. But Hudson pointed out in June that the probability of Sanofi getting a vaccine with a effectiveness superior at 70% it was higher than that of its rivals, partly due to its experience in this field.

“Our confidence has increased. We have to work like everyone else in manufacturing large quantities of doses. But we will have one, maybe two vaccines next year,” Hudson said.

Translate Bio pointed out last Tuesday that the mRNA vaccine had achieved a immune response in non-human trials and expected the human test from November.

Sanofi has closed agreements for vaccine and adjuvant with U.S and Kingdom United, and is in advanced conversations with the European Union to deliver up to 300 million doses.

But the EU offers only one partial protection against the legal risks derived from possible side effects of vaccines, European representatives indicated earlier this week, a move that is hampering deals and is in contrast to US policy.

With vaccines against covid-19, which develop at record speed during the pandemic, there is potentially an increased risk that they may have unexpected consequences or they are not effective.

In this sense, financial coverage is a key issue in the negotiations of the pharmaceutical with governments.

Until now, no coronavirus vaccine has been approved, except the one authorized in Russia before the large-scale trials phase.

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Trump signs executive orders to reduce drug prices

MIAMI.- The president of the U.S, Donald Trump signed on Friday, four orders that seek to reduce the cost of drugs for Americans.

The first order requires federally qualified health centers to roll over massive discounts on insulin and epinephrine received from the pharmaceutical some low-income Americans.

The second order “will allow state plans to import drugs and authorize the re-importation of insulin products manufactured in the United States.”

https://twitter.com/WhiteHouse/status/1286786906680893442

The third will prohibit secret agreements between pharmaceutical companies and intermediaries to offer more discounts directly at pharmacies.

The fourth executive order signed by the president is intended for the United States to pay the lowest price available “In economically comparable countries” for Medicare Part B drugs.

The president said the new provisions “will lead to a massive reduction in drug costs. I have been waiting for this day for a long time,” he said.

“We are going to hold the fourth order until August 24, in the hope that the pharmaceutical companies will come up with something that will substantially reduce the price of drugs,” Trump said during the ceremony.

“I am dismantling the system that is many decades old,” he declared, promising “massive” savings. However, consumers may have to wait a while to take advantage of the new benefits.

SOURCE: DRAFTING

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