Pharma Works – Tenil Sat, 18 Sep 2021 07:29:07 +0000 en-US hourly 1 Pharma Works – Tenil 32 32 Zydus Cadila gets US FDA green light for antidepressant Sat, 18 Sep 2021 05:57:13 +0000
It is a relatively new antidepressant sold by Takeda

Zydus Cadila has stated that it has received approval from the United States Food & Drug Administration to sell the next generation antidepressant Vortioxetine in the United States market.

The drug was first approved around seven years ago and was developed by Danish pharmaceutical manufacturer Lundbeck in the late 2000s.

Around 2007, Japanese pharmaceutical maker Takeda agreed to pay Lundbeck an initial $ 40 million and up to $ 345 million in milestone payments as part of a commercialization deal for US markets. and Japanese. Takeda has also funded most of the development costs since then.

The exact status of the drug at present, with respect to patent protection, is unclear.

For his part, Zydus said he would manufacture the drug at the group’s formulation manufacturing plant in the Ahmedabad SEZ.

With that, the company said, the group now has 322 approvals out of the 400 generic approvals filed in the United States since 2003-04.

Zydus vortioxetine tablets will be sold in strengths of 5 mg, 10 mg and 20 mg.

The drug works by increasing serotonin in the brain by preventing the elimination and reuptake of serotonin in the brain, and is classified as a selective serotonin reuptake inhibitor and serotonin receptor modulator.

Vortioxetine is an agonist of the serotonin 5-HT1A receptor, a partial agonist of the 5-HT1B receptor, and an antagonist of the serotonin 5-HT1D, 5-HT3 and 5-HT7 receptors, as well as an apparent ligand of 1 – adrenergic receptor.

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Transform magazine: it’s time to become aware of brands in large pharma – 2021 Fri, 17 Sep 2021 15:38:21 +0000

Joelle Friedland, co-founder and head of customer service at creative agency Minds + Assembly, writes that healthcare brands need to build relationships with people, both patients and physicians, rather than promoting the functional benefits of a product or service. Healthcare and pharmaceutical brands, Friedland argues, often ignore the physical and emotional reality of what a patient may experience.

We are overloaded with “deep and meaningful” manifests for everyday goods and services. But when it comes to things that really matter – like healthcare, medicine, and pharmaceuticals – we are too often faced with innocuous platitudes. We need communications that compel, that create not only understanding, but belief.

Today, every brand has the same idea: to make an “authentic” connection with their customers, as people, to show the world that they understand – that they understand you. That’s why we end up watching and listening to poetic monologues that deliver the deeply emotional import of all kinds of goods and services, search engines, mutual funds, jeans, and laundry detergents. Everything matters so much!

We are bombarded with messages extolling the virtues of a life lived with these products. Then we come back to Earth with a thud and realize that the lighter clothes are nice, but not life changing. It’s manifesto overload. And it is fallacious and inauthentic. I don’t want to know more about how I can connect with the essence of humanity by buying the right pair of denim (no matter how much I love jeans).

Ironically, those things that actually change life, extend life, or even save lives (health, medicine, and pharmaceuticals), are so often relegated to the bland world of platitudes and sweet statements. We often seem to be one step away from the reality of the situation.

But, this is really a difficult thing. Imagine going to bed every night wondering if your body is going to rebel and your throat is going to close while you sleep. Or accept the fact that to live you have to connect to a tube for 16 hours a day. Or even to face school with a keen awareness, with every step, of the acne that has invaded your face. There are real elements of courage here. And, yes, real elements of beauty.

Let’s be realistic

We recognize that we are not for everyone. In fact, as an agency, we refused contracts to clients when we could have used the revenues. We also turned down pitches that would have been huge if we had won. Some would call it silly. We like to think of it as essential. We will not dilute our product. And we’ve found that there are enough clients who insist on getting to the heart of a disease to find out the real story. This is where we find stories of courage and beauty, communications that will force, that will create not only understanding, but belief.

Make a truer connection

Of course, I have a more important point. It’s that when dealing with the kind of issues that can legitimately claim to be “life or death”, we so often see ideas that fail to connect.

Done well, branding in this industry has the power to enhance the experience that people living with disease can have with a brand, and this can have overwhelmingly positive effects, including presenting a genuinely optimistic view of the brand. what life could be like with the benefits of the brand. . But you have to face reality head-on and find beauty and authenticity in it.

A new belief system

Additionally, many brands in the pharmaceutical and healthcare industries are guilty of promoting the functional benefits of their products, rather than forming meaningful relationships with people to improve their lives.

Brands often ignore the reality of what a person is actually experiencing, thereby downplaying the physical and emotional reality. But by showing how a person’s life might be different with a particular brand, and how they might meet their needs and serve a meaningful purpose, pharmaceutical and healthcare companies have the potential to forge strong and credible relationships. . And it works. We know this from experience.

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FDAnews Announces FDAnews Webinar Training Pass for Drug and Device Manufacturers | New Fri, 17 Sep 2021 04:00:00 +0000

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PharmaZell and Novasep Enter into Exclusive Negotiations in New Campaign to Create a Technology-Driven Leader for Small Complex Molecules and ADCs Globally Thu, 16 Sep 2021 17:20:00 +0000

Novasep is a major player in CDMO in the development and manufacture of small complex molecules mainly for pharmaceutical and biotechnology customers. The company operates a wide range of differentiated technologies, including high energy and cryogenic chemistries and industrial scale chromatography. It is a world leader in ADCs and HPAPIs, rapidly growing targeted cancer therapy segments.

Novasep’s capabilities are highly complementary to PharmaZell’s expertise in manufacturing complex APIs requiring special handling procedures or technologies. The combination of the two companies would create a leading, highly diverse and highly differentiated API and CDMO manufacturing platform. The combined business would be able to leverage a comprehensive and broad technology suite for complex molecules and a global production footprint to support pharmaceutical and biotech customers throughout a drug’s lifecycle. The combined activity would generate nearly 500 million euros in turnover and employ nearly 2,000 people across seven production and R&D sites in Europe (Germany, France and Italy), two sites in India and one in the United States.

The proposed transaction would be supported by PharmaZell’s current majority shareholder, Bridgepoint. Bridgepoint Group PLC is the world’s leading listed private asset growth investor focused on the mid-market with € 27 billion in assets under management and a local presence in the United States, Europe and China.

The planned acquisition remains subject to the fulfillment of the usual conditions precedent for this type of transaction, in particular the information and consultation of works councils and other regulatory authorizations.

The press release is available in pdf.

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SOURCE Novasep

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Global Transdermal Drug Patches Market Industry Outlook 2021 – Noven, Hercon Pharmaceuticals, Johnson & Johnson, Mylan – Stillwater Current Wed, 15 Sep 2021 09:42:56 +0000 unveiled the publication of a new study entitled Global Transdermal Medicated Patches Market 2021-2027, which contains data on local and global markets and is expected to provide a cost-effective assessment from 2021 to 2027. Lawmakers and business leaders can use the results to make more realistic critical decisions. This report discusses current market trends, expanding application terms, and market landscapes, which may be useful to businesses in the Transdermal Patches market.

The study examines the information on the outline and main activities of the figurines market. The report takes an in-depth look at the global transdermal patch industry, which will have a significant impact on the growth of the market. It also examines potential advances in the promotion of P&MS as well as the findings of other studies. It’s a comprehensive guide to understanding aspects of the industry and forming an alliance for them.


Global Transdermal Patches Market Reviewed is segmented into

Used for hypertension, used for contraception, used for analgesia, used for quitting smoking, used for angina, used for hormone replacement

The statistical survey for transdermal drug patches is divided into

Fentanyl transdermal patch, nicotine transdermal patch, buprenorphine transdermal patch, clonidine transdermal patch, oxybutynin transdermal patch, others

Notable dynamic venture capital players in the market:

Noven, Hercon Pharmaceuticals, Johnson & Johnson, Mylan, Immune Pharmaceuticals, Novartis, DURECT Corporation, Teikoku Pharma USA, Agile Therapeutics, Pocono, Xel Pharmaceuticals

The study covers the main topographical regions in which the company operates, including

North America (United States, Canada and Mexico), Europe (Germany, France, United Kingdom, Russia and Italy), Asia-Pacific (China, Japan, Korea, India and Southeast Asia), South America (Brazil, Argentina, etc.), Middle East and Africa (Saudi Arabia, Egypt, Nigeria and South Africa)


It offers an unbiased and comprehensive assessment of existing examples, factors, road obstacles, limitations, progress, conceivable outcomes and unreasonable development districts, which will help all partners to develop organizational designs in line with the development models. current and future market. Further, this research inspects market opportunities for each geologic region with respect to development rate, macroeconomic outlook, buyer purchasing practices, transdermal patch market interest, and sourcing circumstances.

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Telephone: + 1-201-465-4211

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Reusable sheet masks last after a year of washing and drying Fri, 10 Sep 2021 16:43:40 +0000

Reusable cloth masks that people have been using for a year or more can look a little worse for wear. But new research from the University of Colorado at Boulder shows that washing and drying them does not reduce their ability to filter virus particles.

“This is good news for sustainability,” said lead author Marina Vance, assistant professor in the Paul M. Rady Department of Mechanical Engineering. “That cotton mask that you washed, dried and reused?” It’s probably still fine, don’t throw it away.

The study, published in the journal Aerosol and air quality research, also confirms previous research that layering a cotton mask over a surgical mask – snug against the face – offers more protection than fabric alone.

Science for sustainability

Since the start of the pandemic, around 7,200 tonnes of medical waste has been generated every day, much of which is disposable masks.

“We were really bothered at the start of the pandemic, when we would go hiking or going downtown, and seeing all these disposable masks littering the environment,” said Vance, who is also a faculty member for the program. of environmental engineering.

So Vance was eager to join forces when scientists from the nearby National Renewable Energy Laboratory (NREL) approached her to study the impact of washing and drying on reusable sheet masks.

Their process was fairly straightforward: create squares of double-ply cotton, subject them to repeated washes and dryings (up to 52 times, the equivalent of a weekly wash for a year), and test them every seven cycles of. cleaning approx.

Although the masks weren’t tested with real people – instead, they were mounted on one end of a steel funnel through which the researchers could monitor a constant flow of air and airborne particles. – the researchers tested the masks under realistic to real conditions, with high humidity levels and temperatures to mimic the impact on the mask of our breathing.

While the cotton fibers began to fall apart over time after repeated washing and drying, the researchers found that this did not significantly affect the filtration efficiency of the fabric.

The only noticeable change was that the resistance to inhalation has increased slightly, meaning the mask may feel a bit harder to breathe after some wear and tear.

Mask fit is essential

A key caveat is that they performed the tests using a “perfect fit” in the lab.

“We assume there is no space between the mask material and the person’s face,” Vance said.

The shape of each person’s face varies considerably. So, depending on the shape of a mask and how the person fits it, it may or may not fit well. Previous research has shown that an ill-fitting mask can pass up to 50% of the airborne particles we inhale and exhale, as well as the virus.

So which mask to wear?

This study is not the first to find that fabric masks offer less protection than surgical masks or a layered combination of surgical and fabric masks.

By measuring the quality of filtration of the air breathed by the mask – protecting the person wearing the mask, not reducing transmission from the source – this study found that cotton fabric masks filtered up to 23% of the smallest particle size (0.3 microns) the virus can travel on. Bandanas filtered even less, at just 9%.

In comparison, surgical masks filtered between 42-88% of the tiny particles, and cotton masks on surgical masks achieved nearly 40% filtration efficiency. Unsurprisingly, the KN95 and N95 masks performed the best, filtering out 83-99% of these particles.

But while this study found that sheet masks on their own offer less protection against the virus than a layered approach or disposable masks, such as surgical masks, KN95 and N95, there is still important information. for those who rely on fabric for its comfort, affordability, and reuse. , said Vance.

“I think the best mask might be the one you’re actually going to wear,” Vance said. “And it will fit your face perfectly without being too uncomfortable.”

Other authors of this publication include: Sumit Sankhyan, Sameer Patel, and Hannah Teed of the University of Colorado Boulder; Karen N. Heinselman, Peter N. Ciesielski, Teresa Barnes, and Michael E. Himmel from the Renewable Resources and Enabling Sciences Center at the National Renewable Energy Laboratory.

– This press release was originally posted on the University of Colorado at Boulder website

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Years after Pfizer adopted buyout option, AM-Pharma finds new partner for renal drug – Endpoints News Wed, 08 Sep 2021 07:00:00 +0000

A few years ago, Pfizer passed on an option to buy back AM-Pharma and its recombinant human alkaline phosphatase for kidney failure following some mixed Phase II data. Now the program has attracted a new partner – and an approval could mean a big win for AM-Pharma.

Tokyo-based Kyowa Kirin is investing $ 23.6 million initially for the exclusive rights to develop and commercialize ilofotase alfa in Japan. There’s still $ 148 million in biobucks at stake, which is a $ 290 million deal with “double-digit tiered royalties” and drug procurement fees.

AM-Pharma will be responsible for an ongoing Phase III study, which aims to enroll up to 1,600 patients with acute renal failure associated with sepsis and is expected to produce data in 2023. The company is also on the cusp of to obtain a phase I PK, safety and tolerance study in Japan. After that, Kyowa Kirin will bring the candidate to the regulators.

Sepsis is a potentially fatal organ dysfunction that is caused by an inappropriate host response to infection. The kidney is the most frequently affected organ, leading to ARI, which occurs in 40 to 60% of intensive care admissions, according to partners.

Ilofotase alfa works by dephosphorylating substances that can trigger the immune system by devastating the kidneys, thereby detoxifying them and reducing inflammation. In a phase II trial, a dose of 1.6 mg / kg showed a relative reduction in mortality of 46% compared to the placebo group (p = 0.022). However, the drug missed its primary endpoint of improving kidney function in seven days.

“Short-term improvement in kidney function was actually more of a design for the Phase II study so that the most optimal dose could be chosen,” said CEO Erik van den Berg. Terminal news in 2019. “It’s kind of a biomarker if you will. For phase III, strict clinical endpoints must be chosen, and the endpoint preferred by regulators is mortality in this context. “

Pfizer had paid $ 87.5 million for a minority stake in AM-Pharma and an exclusive option to buy out the rest of the company in 2015. The pharmaceutical company withdrew from the deal after reading Phase II, citing “internal strategic reasons”. But AM-Pharma still continued a phase III trial, enrolling the first patient in its pivotal REVIVAL study in November. The trial was planned with a little help from Cowen Healthcare Investments and a loan from the European Investment Bank last March.

“Based on the number of successful international partnerships they have, they are the ideal partner to support the commercialization of ilofotase alfa in Japan,” van den Berg said of Kyowa Kirin in a statement.

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Amlodipine and Olmesartan Market Size, Trends and Key Players – Glenmark Pharmaceuticals, Teva, Torrent Pharmaceuticals, Daiichi Sankyo, Accord Healthcare, Macleods Pharmaceuticals, Alembic Pharmaceuticals, Aurobindo, Matrix Laboratories Sat, 04 Sep 2021 05:56:32 +0000

New Jersey, United States, – The Amlodipine and olmesartan market The research report is a detailed study of the Amlodipine and Olmesartan industry that specializes in identifying the growth potential of the Amlodipine and Olmesartan market and potential opportunities in the market. Secondary research data comes from government publications, interviews with experts, journals, surveys and trusted journals. The recorded data covers a decade, followed by a systematic review to conduct an in-depth study of influencers in the amlodipine and olmesartan market.

The Amlodipine and Olmesartan market was valued at USD XXX billion in 2019 and is expected to reach USD XXX billion by 2027, with a CAGR of XX% from 2020 to 2027.

Amlodipine and olmesartan are a mixture of medicines that can be used alone or with other medicines to treat high blood pressure, hypertension, heart attacks and kidney problems. A mixture of amlodipine and olmesartan takes on different mechanisms of action and may be responsible for a more effective lowering of blood pressure. They both work by relaxing the blood vessels so that blood can flow more efficiently. Amlodipine acts as a calcium channel blocker (CCB). It affects the passage of calcium through the cells of the heart and blood vessels. Thus, amlodipine relaxes the blood vessels and improves the blood and oxygen supply to the heart while reducing its workload. Olmesartan acts as an angiotensin II receptor blocker (ARB). It works by blocking material in the body that causes blood vessels to contract. Thus, olmesartan relaxes the blood vessels. This lowers blood pressure and increases the supply of blood and oxygen to the heart.

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The report covers an in-depth analysis of the major market players in the market, along with their business overview, expansion plans, and strategies. The major players studied in the report include:

Glenmark Pharmaceuticals, Teva, Torrent Pharmaceuticals, Daiichi Sankyo, Accord Healthcare, Macleods Pharmaceuticals, Alembic Pharmaceuticals, Aurobindo, Matrix Laboratories, Ajanta Pharma.

Amlodipine and olmesartan market segmentation

Amlodipine and Olmesartan Market, By Product

• 5/20 mg tablets
• Tablets 10/20 mg
• Tablets 5/40 mg
• Tablets 10/40 mg

Amlodipine and Olmesartan Market, By Application

• Hospital
• Pharmacy

The Amlodipine and Olmesartan market report has been segmented on the basis of various categories such as product type, application, end user, and region. Each segment is evaluated based on CAGR, share and growth potential. In the regional analysis, the report highlights the potential region which is anticipated to create opportunities in the Amlodipine and Olmesartan Market in the coming years.

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Scope of Amlodipine and Olmesartan Market Report

Report attribute Details
Market size available for years 2021 – 2028
Reference year considered 2021
Historical data 2015 – 2020
Forecast period 2021 – 2028
Quantitative units Revenue in millions of USD and CAGR from 2021 to 2028
Covered segments Types, applications, end users, etc.
Cover of the report Revenue forecast, company ranking, competitive landscape, growth factors and trends
Regional scope North America, Europe, Asia-Pacific, Latin America, Middle East and Africa
Scope of customization Free customization of the report (equivalent to 8 working days for analysts) with purchase. Add or change the scope of country, region and segment.
Price and purchase options Take advantage of personalized shopping options to meet your exact research needs. Explore purchasing options

Geographic segment covered in the report:

• North America (United States and Canada)
• Europe (UK, Germany, France and rest of Europe)
• Asia-Pacific (China, Japan, India and the rest of the Asia-Pacific region)
• Latin America (Brazil, Mexico and the rest of Latin America)
• Middle East and Africa (GCC and rest of Middle East and Africa)

Key questions answered in the report:

  • What is the growth potential of the amlodipine and olmesartan market?
  • Which product segment will take the lion’s share?
  • Which regional market will emerge as a pioneer in the years to come?
  • Which application segment will experience strong growth?
  • What growth opportunities might arise in the amlodipine and olmesartan industry in the years to come?
  • What are the most significant challenges facing the Amlodipine and Olmesartan market in the future?
  • Who are the leading companies in the amlodipine and olmesartan market?
  • What are the main trends that are positively impacting the growth of the market?
  • What growth strategies are the players considering to stay in the Amlodipine and Olmesartan market?

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New president unveiled in pharmaceutical company Wed, 01 Sep 2021 06:30:41 +0000


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The new chairman of pharmaceutical company Burton Clinigen was revealed this morning (September 1).

Peter Allen will leave the company and will be replaced as President by Elmar Schnee.

Schnee has recently served on the board of directors of Jazz Pharmaceuticals, since 2014. He works as a non-executive director on several other boards of directors of pharmaceutical companies, including Santhera AG and Calliditas AB, alongside several others. private biopharmaceutical companies.

Shaun Chilton, President and CEO of Clinigen, said: “I would like to thank Peter on behalf of the board and personally for his leadership and valuable contributions since Clinigen IPO in 2012. I appreciated to work with Elmar to this day and look forward to working more closely with him as we continue to grow the business and create value.

Schnee said: “Clinigen has built a strong global business that is uniquely positioned to provide end-to-end service to pharmaceutical customers. I look forward to continuing to work with the board and management as we build on the company’s successes to date and realize the full potential of its lifecycle platform.

Allen added, “I am proud to have spent nine years as President of Clinigen. During this time, the company has grown and become a global leader in providing global access to medicines, delivering significant value to patients, customers and shareholders. I have every confidence in Clinigen’s continued success.

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TailorMed’s tough challenge to reform U.S. healthcare Sat, 28 Aug 2021 09:26:05 +0000

It’s no secret that America’s complicated healthcare system can cause confusion, bureaucratic nightmares, not to mention significant financial burdens on its citizens. It is technically made up of many organizations, usually healthcare providers, insurance companies, independent providers, and hospital systems that all deliver healthcare in their own way. Despite being one of the top countries in the world, it is ranked 29th in terms of access and quality of health care, which means many Americans don’t get the help they need. ‘they are not protected by private companies.

“We found that it was necessary to find ways so that patients could continue to receive the treatment they needed without going bankrupt or without affecting their clinical results, but also without relying solely on their financial capacities,” explained TailorMed co-founder and CEO Srulik Dvorsky. According to Dvorsky, even if there is external funding – usually in the form of philanthropy, government grants, or through drug companies – sometimes the patient does not even know where to look for additional or third-party help.

Co-founder and CEO of TailorMed, Srulik Dvorsky. Photo: Shlomi Yosef

“We have seen that patients do not necessarily know all the resources but in addition, there are plenty of providers, whether hospitals, pharmacies, or large networks, who do not set up the necessary infrastructure to enable patients to obtain funding. ”

With that in mind, Dvorsky admitted that the TailorMed team had become “almost obsessed” when they wondered who would eventually benefit from a new service, but also who would be willing to pay for such a solution. Founded in 2016, Dvorsky and his co-founder, Adam Siton (CTO) have found a way to harness technology to improve the financial performance of healthcare providers and reduce hardship for patients. It provides a personalized projection of a person’s personal expenses and then finds appropriate cost reduction opportunities based on available assistance programs. In June 2021, the company raised $ 20 million, bringing its total funding to $ 28 million.

For the team, the United States was an obvious place to start their business. “(We) spent about a year trying to figure out what is a big enough problem that deserves to be solved with technology, and decided to do it not in Israel but in the United States due to the size of the Marlet. I think that early stage companies should build their initial product in the target market. Israel could have been that to begin with because we are small and everyone knows everyone, but we decided to try to understand the problem in the United States. And have essentially been exposed to a variety of different barriers in care, such as how patients do not necessarily have access to the care they need. ”

Today, TailorMed works with major pharmacies and provider bases such as Walgreens and UnityPoint to ensure patients can get financial help. Dvorsky reveals that TailorMed works in two main areas, generally around drug costs. First, there is the treatment of chronic conditions – like heart failure – which requires months or years of medication that patients may not adhere to if they cannot spare the change.

The second is specialized care – conditions like oncology, MS and others. “There are incredible advances in the type of treatment, or drug, that have been developed or approved in recent years… but the cost of each drug is incredibly high. It starts at tens of thousands of dollars per year and can grow into hundreds of thousands per year. No one can afford it, whether it’s a middle-income family or, in many cases, a wealthy population.

Much of what TailorMed does is based on data. Medical records, billing systems and payers are all analyzed to best meet the needs of patients, as well as the interests of pharmaceutical companies who must sell and continue to sell the drugs that sick people need. “If you have a diabetic patient who needs their insulin every month, it could cost a few hundred dollars a month. If this patient cannot pay for their treatment, then Pharma will not be able to deliver this drug to the end patient, ”he said.

Healthcare in the United States is, indeed, complicated. It seems quite foreign for countries like Israel and the UK to consider balancing rising medical costs that run into tens or hundreds of thousands of dollars each month. And while the company, which has 40 employees in Israel and 20 in the United States, still expected to someday reach the United States like many other local startups, its location as a starting point was less a dream than it was. ‘a necessity. While there are plans for expansion, Dvorsky admits he has his hands full in helping those in the free land pay for their lives.

“At the moment we have our hands full trying to solve this very complicated problem,” he said.

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