Posts Tagged “Drug Safety”

Korean medicines regulator investigates 4 allogenic cell therapy producers

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Korean medicines regulator investigates 4 allogenic cell therapy producers

The pharmaceutical industry is paying keen attention to why the Ministry of Food and Drug Safety (Korea) conducted an urgent inspection of four cell therapy developers. Industry sources said the ministry raided Kolon Life Science, Tego Science, Bio Solution, and Medipost at 10 a.m. Monday. The ministry did not provide detailed reasons for the emergency inspection, but biotech industry observers speculate that the four companies could have some issues with the post-approval management system.

The four drugmakers produce allogenic cell therapies. Recently, a report by Money Today Network said the four poorly managed allogenic cell therapies. Cell therapy is divided into two types — autologous cell therapy and allogeneic cell therapy. Autologous cell therapy is relatively safe and easy to manage, as the patient’s cells are extracted and cultured to be injected back to the patient.

In contrast, allogeneic cell therapy extracts cells from a donor and injects them into many other patients. As it is easy to mass-produce, many companies have rushed to develop allogeneic cell therapies. However, patients should be careful because a changed donor of cells could change the main ingredient of the treatment.

Due to such risk, the ministry has set up rules for approval of…

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Brexit uncertainty adds significant risk to EU medicines access

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Brexit uncertainty adds significant risk to EU medicines access

Next week, leaders of the 28 countries making up the European Union will meet in Brussels to try to hammer out the terms of Britain’s exit from the coalition, or Brexit. It will be one of the last chances to do so before the country departs on March 29, 2019.

Britain stunned the world in June 2016 when a slight but significant majority of voters elected to leave the EU. The decision has left many businesses, including pharmaceutical firms, rushing to prepare for the changes that Brexit will bring. “A vote to leave is the gamble of the century,” David Cameron, then British prime minister, wrote months ahead of the referendum. “And it would be our children’s futures on the table if we were to roll the dice.”

Belonging to the EU means being part of the single market, which allows people, goods, services, and money to move freely across member countries’ borders. The difficulty of disentangling these political and economic ties has led to more than a year and a half of messy negotiations, as politicians struggle to agree on how the future relationship between the UK and the EU should look. Options have ranged from what news media…

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Karolinska Institutet PROFORMA improving drug safety in East Africa

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Karolinska Institutet PROFORMA improving drug safety in East Africa

Lifting the standards of drug safety in East Africa is the aim of a new project led by the Karolinska Institutet in Sweden.

While access to drugs and vaccines has increased in many African countries over recent years, the systems for monitoring treatment effects and reporting side-effects require further development, according to the institute. To remedy the problem the Karolinska Institutet is leading an international collaboration project on pharmacovigilance – dedicated to improving drugs safety – in four countries in East Africa.

Scientific coordinator for the project, Eleni Aklillu said: “The main aim of this project is to strengthen the national infrastructures for drugs safety monitoring in our partner countries in Africa. This involves developing regulatory capacity for routine surveillance and reporting, and training of staff working in healthcare and medical services and regulatory authorities.”

‘Drugs safety monitoring’

The project – known as PROFORMA – involves researchers from the Swedish institute working in partnership with researchers and experts from universities and regulatory authorities in Ethiopia, Kenya, Tanzania and Rwanda. Some regional and international stakeholders in the field of drugs safety are also taking part.

The PROFORMA is estimated to last five years and involve training at Master’s and postgraduate level…

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Voluntary drug price restraint didn’t work in the 1990s, and won’t now

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Voluntary drug price restraint didn’t work in the 1990s, and won’t now

In late May, President Trump announced that, within two weeks, major pharmaceutical companies would agree to large, voluntary price concessions. Restraining drug prices was a major theme of Trump’s campaign for the presidency, so it is not surprising that he is eager for some prominent drug manufacturers to publicly signal plans for holding prices down, for which he will then claim credit.

Trump isn’t the first president to pressure drug companies on their prices. Bill Clinton campaigned on ending pharmaceutical “price gouging.”  Once in office in 1993, he and First Lady Hillary Clinton proposed limits on drug price inflation in their health reform plan. They also wanted to create an independent panel to oversee the industry’s pricing decisions.

The Clinton plan rattled drug manufacturers. To slow the plan’s political momentum, several major companies stepped forward in early 1993 and said they had “turned over a new leaf” on pricing. For three years, they would keep aggregate price hikes within the general rate of inflation, which the industry estimated would save consumers $7 to $9 billion during that period.

The drug industry’s 1993 commitment to voluntarily price restraint had no lasting effect on what Americans pay for drugs, but it may have contributed to the demise of the Clinton reform…

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Legalities Surrounding Pharmaceutical Industry In UAE – Food, Drugs, Healthcare, Life Sciences – United Arab Emirates

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Legalities Surrounding Pharmaceutical Industry In UAE – Food, Drugs, Healthcare, Life Sciences – United Arab Emirates

What are the main laws and regulations governing pharmaceutical companies in the United Arab Emirates? The primary piece of legislation governing pharmaceutical companies in the United Arab Emirates is Federal Law Number 4 of 1983 concerning the Pharmaceutical Profession and Pharmaceutical Institutions (the Pharmaceutical Law). This law applies to pharmacists, pharmaceutical establishments, and governs the import, manufacture, and distribution of pharmaceutical products. Articles 63 to 67 of the Pharmaceutical Law deals with the registration of pharmaceuticals. Article 47 of the Pharmaceutical Law states that a company must obtain a license to open a pharmaceutical company and Article 48, 55 and 56 lists the conditions that the company should meet to obtain the license. These include, among others, the requirement that the company is composed of different sections (production section, chemical section, disinfection section, and bacteriological laboratories) and that licensed pharmacists should supervise the factory. Article 49 mandates that the application for a license to open a pharmaceutical company should be accompanied by the factory’s contract of establishment/ articles of association and also the permit issued to the manager and the pharmacists, among other documents. Federal Law Number 14 of 1995 regarding counter-measures against narcotic drugs and psychotropic substances regulate the import…

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Trump’s Call For #RightToTry Experimental Drug Access: A Nothingburger For Patients And Families

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Trump’s Call For #RightToTry Experimental Drug Access: A Nothingburger For Patients And Families

I agree 100% with President Trump’s State of the Union statement that patients with life-threatening illnesses should have the opportunity for access to experimental drugs outside the confines of a clinical trial, also known as “compassionate use” or by the hashtag #RightToTry.

But the U.S. Food and Drug Administration already operates such an expanded access program (EAP) that approves over 99% of requests for such medicines, biologic agents and medical devices. In fact, you and I, doctors, legislators — even the president — have access to all the information needed to make such a request today. Updated as recently as Jan. 4, and remarkably user-friendly as federal paperwork goes, the FDA’s process to provide compassionate access to drugs outside a clinical trial has existed in some form since 1987. Add to this, drug companies are already required by 2016 law to publicly disclose their corporate policies on compassionate use.

So why was #RightToTry legislation singled out last night in the State of the Union address? Good question.

The short answer is that passing #RightToTry legislation is an easy win for politicians that accomplishes little-to-nothing to improve patient access to experimental medicines. Advocates claim that the existing FDA processes (regular clinical trials plus expanded access) help…

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FDA-Required Studies of Approved Drugs Make a Big Difference for Public Health

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Drugs are approved by FDA based upon substantial evidence from clinical trials that the medicine will be both effective and safe for use if prescribed according to its labeling. However, there may be issues that need additional evaluation after approval. For example, post-approval studies may be needed to confirm clinical benefit when a drug is approved under accelerated approval provisions. Additionally, post-approval studies can allow for further evaluation of a potential safety issue or better characterize risk factors for a known safety issue. Once a drug is approved, a larger population and wider range of patients will use the drug than were studied before approval. With this larger experience, new potential safety issues may emerge that were not seen in the studies prior to approval, and such issues may require additional evaluation.

FDA’s ability to require post-approval studies, referred to as post-marketing requirements (PMRs), has evolved over time. Prior to 2007, FDA could require post-approval studies for the few drugs approved under the accelerated approval pathway, for the rare drugs approved based solely on animal studies and, in certain cases, for drugs that may be used in pediatric populations. If FDA wanted other types of post-approval studies, it would…

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Looking ahead: Some of FDA’s major policy goals for 2018

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Twice a year the federal government publishes the “Unified Agenda of Federal Regulatory and Deregulatory Actions” (Unified Agenda), which provides the American public with insight into regulations under development or review throughout the federal government. For the U.S. Food and Drug Administration (FDA), it gives us an opportunity to outline some of our efforts to modernize our approach to our work and improve our efficiency, while fulfilling our mandate to protect and promote the public health and uphold FDA’s gold standard for regulatory decision-making. While many of FDA’s policies are advanced through guidance documents and other proposals, this annual list of proposed regulations provides one element of our policy agenda.

Patients and consumers across our country depend on us to regulate products in a predictable, efficient, science-based manner. We also serve the public health by efficiently advancing innovations and therapies that improve patient care, enhance choice and provide competition; by aggressively taking action against serious threats to public health, such as opioid addiction and addiction to the nicotine in cigarettes; by empowering patients, consumers and healthcare providers with accurate and up-to-date information; and by recognizing when scientific innovations warrant new, more flexible regulatory approaches in order to make sure advances in…

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Samsung Bioepis’ trastuzumab biosimilar gets EC approval for breast cancer

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Trastuzumab, which is a monoclonal antibody, is the active substance in Ontruzant. This antibody binds with high affinity and specificity to the human epidermal growth factor receptor 2 (HER2) gene.

The binding results in the inhibition of the proliferation of tumour cells that overexpress the HER2 gene, which is considered to be one of the causes in the development of breast cancer.

Samsung Bioepis president & CEO Christopher Hansung Ko said: “Breast cancer remains the most common form of cancer affecting women. We hope Ontruzant will play an important role expanding patient access to trastuzumab across the region.

“Through relentless process innovation and an uncompromising commitment to quality, we remain dedicated to advancing one of the industry’s strongest biosimilar pipelines, so that more cancer patients and healthcare systems across Europe will benefit from biosimilars.”

Ontruzant’s approval in Europe comes after the positive opinion adopted by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) in mid-September.

The drug is the first trastuzumab biosimilar to be approved in Europe.

MSD, which goes by Merck in the US and Canada, will commercialize the Samsung Bioepis trastuzumab biosomilar.

The approval of Ontruzant from the Commission applies to all the…

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Stop Big Pharma from ‘getting away with murder’

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Few things are more infuriating to consumers than the constant, surging increases in drug prices. Americans under 65 are projected to pay an additional 11.6% this year, while seniors are expected to see increases of 9.9%. These increases follow similar ones in recent years.

Price hikes like these, which run well above inflation and wage growth year after year, are a keen indication of how the drug industry lacks market fundamentals. Or, as President Trump put it Monday, prescription drug prices “are out of control” and the big pharmaceutical companies “are getting away with murder.”

This has happened in some cases because generic drug makers have begun to act like the name-brand producers they were supposed to compete with. Mylan, for instance, is a generic drug maker. It is also the company that bought the  EpiPen auto-injector and jacked up its prices to obscene levels.

Mostly, it is the result of brand-name drug companies using ploys to keep generics off the market.

One favored technique is to simply pay generic makers to keep their products out of drugstores. These “pay to delay” schemes are often embedded in some kind of legal dispute designed to obscure the wildly anti-competitive nature of the deal.

Another tactic is…

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