Teva starred in price-fixing scheme, but 19 other companies 'willingly' joined, attorneys general claim

ERIC SAGONOWSKY | May 13, 2019 | 141 views

In what could be "the largest cartel case in the history of the United States," as Connecticut Attorney General William Tong called it, 44 states sued 20 generics makers on Friday for price fixing and personally named 15 of those companies' executives.

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Why Is Diversity of Thought Essential for Developing a Winning Strategy?

Article | August 18, 2021

In developing or evolving a strategy, there are key decision moments. Those are the moments where you are deciding where you need to focus, what you need to excel at to win there, and where and how to allocate resources to get to a point in the future. At these moments, it is the contest of ideas that matters. Having choices matters. Having a cross-functional team participating in the development of strategy is one way of ensuring that you are going to be more successful at generating choices before you start making choices. What Is a Cross-functional Team? A cross-functional team is a collection of individuals with varied skillsets from different areas of a business collaborating to achieve a common goal. Why Are Cross-functional Teams Essential for Business Success? Having this diverse set of minds analysing the situation, considering the big picture and the organisation’s capabilities, and the needs of all stakeholders, inspires teams to think about the choices they have differently and more creatively. For example, in a pharmaceutical setting, the medical affairs team brings knowledge of the data, unmet needs, and insight into clinical practice. Access and reimbursement teams identify the right data and take the lead in building that value story to accelerate market access and product uptake. It is incumbent upon commercial to hear their ideas, obtain their perspective and secure their alignment to all strategy decisions. Cross-functional collaboration can help break down silos. Research suggests that working in silos and not sharing data with team members from other departments can cost a company close to $8,000 per day in wasteful expenses. Time is widely recognised as a scarce resource: we need quick access to accurate and real-time insights to make effective business decisions. Real time insight will come from those closest to the customer, so it is important for cross-functional members from different geographies to participate in the development of strategy. Improved insight is a source of sustainable competitive advantage. One single version of the truth is what is required for the right narrative to take place. The right narrative will lead to the right decisions. One single version of the truth is more easily achieved by cross-functional team members working closely together. Better Innovation & Creativity: Individuals with diverse skillsets often explore a problem in different ways. When different people working in different capacities come together, they think outside the box to significantly improve outcomes. It is a great way to come up with concepts that distinguish companies from their competitors. Achieving alignment with strategy across functions and geographies: Today, businesses are moving faster than ever and organisations are seeing possible competitors in areas they never knew existed before. With so much choice about where to focus, you really want your workforce to align around one strategy. Underperformance is inevitable if everybody is off working in ten different directions. Improving the customer experience: Creating an effective customer experience is about more than just ensuring your customers receive the products and services they desire in a timely and efficient manner. It’s also about creating touchpoints with real people who can organically evangelise and grow your brand through their social media and offline interactions with friends and family. Your customers are engaging with multiple communication channels– official websites, social platforms, virtual platforms, medical science liaisons, sales reps, and more. Everyone needs to be aware of, and understand, the moments that matter to your customer and the business along that customer journey and how they contribute to delivering that positive experience. This is more likely to be achieved with a cross-functional approach to strategy development. Business Agility: Cross-functional teams are typically small, adaptable, and flexible. Such teams can move faster as they don’t have to wait and rely on other departments or external sources. They can help in tackling any silo mentality and bridge gaps between team members. They can come together to consider new information and/or changes to adapt the strategy if necessary and/or react to any setbacks immediately. They are better placed to make decisions when problem-solving amidst uncertainty. In summary, the rapidly changing environment and new information requires medical affairs, along with access and reimbursement and commercial, to work together, to ensure that patient’s benefit from the value of new innovative therapies. Companies stand a better chance of creating a winning strategy if it is created by a cross-functional and geographically diverse team. With every team member bringing their abilities and knowledge to the table, the strategy over time can only move from strength to strength. However, if not supported correctly, a cross-functional team working on strategy can be dysfunctional and chaotic, and result in a laborious and time-consuming approach to strategy development. Digital strategy platforms such as Nmblr offer an inclusive and structured process to facilitate a strategy discussion and allow people to bring forward ideas. They do this by: working against silos – the structure provided, levels the playing field. The guidance provided equips people from different disciplines to contribute to the conversation.

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VIEWS AND ANALYSIS

Modern Phenotypic Drug Discovery

Article | April 20, 2021

Nature Reviews Drug Discovery makes these points well. It goes over historical and recent successes of the phenotypic approach, and discusses some areas that it's opening up for discussion and research. One of these is the long-vexed question of polypharmacology: what do you do when your active compound doesn't seem to have a single target, but rather hits a whole list of stuff at varying degrees of potency? Seen from a pure target-based viewpoint, this is a failure, and you'd better start working on something else. But to be honest, there are a lot of drugs out there (and not all of them ancient legacy compounds by any means) that work this way, even if their developers didn't think so at the time. So it's not to be disparaged on principle, but that said, it's still a difficult area to make progress in because of all the variables. A good enough phenotypic hit, though, makes its own case that it's worthy of further investigation and development, even if it's not "clean" by rigorous target-based standards. But as always, your phenotypic screen had better be a good one. That is, it had really better model the human disease in a useful way, and have a good signal/noise. The authors note that you're much better off with assays that involve a gain-of-function/gain-of-signal readout, as opposed to ones that could read out just through cellular stress or cytotoxicity, which is an invitation to chase your tail. Another area the paper brings up is searching lower-molecular-weight compounds than are usually screened, down to fragment-sized. There are quite a few useful drugs out there with really low molecular weights - ibuprofen, aspirin, metformin, dimethyl fumarate, lacosamide and more - and any screening program would be happy to have discovered something as useful as those. As the authors note, hits like these in phenotypic screens might be another case of polypharmacology, or they might be hitting pathways whose "tone" we have not understood well (and for which micromolar inhibitors might work out just fine). At any rate, there might be an opportunity for fragment phenotypic screening, and even of covalent fragments (which will call for even more attention to the validity of the underlying screening model, I'd say). The paper discusses the question of target ID, which for most phenotypic programs feels like a natural progression. Most of us are innately biased towards thinking in terms of drug targets, so when a phenotypic compound emerges we want to know what it's "really" doing. And most of the time, there is such a target in there somewhere, although finding it can be quite a haul. I know of several compounds that have been kicking around for years that are obviously doing something in the assays, but no one has ever been able to pin down quite what that is! This paper makes the case for getting out of a binary mindset for target identification. They point out, correctly, that target ID is a means to an end, and that you do not actually need to identify your target to go on to clinical trials and go to the FDA for approval. I always find it surprising to find how many people are surprised by that, but it's true. You also need to realize that knowing a target may not tell you nearly as much as you would want about a compound's mechanism of action, if your new target lands in the middle of a bunch of not-well-worked-out biology. There's a good case to be made that modern chemical biology and imaging techniques have made it easier to progress things, even if you're not quite sure how they're working. We can extract huge amounts of information about the cellular effects of a given compound, and if you do a good job of matching this against a closely related structure that's phenotypically inactive, you can make a lot of headway. This doesn't mean that you shouldn't bother trying to find the target - as mentioned, this is a great way to expand the knowledge of the underlying disease, and can lead to other new programs spinning off of the phenotypic effort. But it does mean that you shouldn't freeze in fear if you don't have a target to point to. The FDA wants to see safety and efficacy, and that's what we should want to see, too, for starters. But as the paper notes at the end, phenotypic screening is going to advance at the pace of good model development. Many of these same chem-bio tools can be brought to bear on this question as well, along with advances in cell culture, organoids, and other new assay technologies. You're not going to be able (realistically) to recapitulate all the features of a human disease, so you will probably find yourself concentrating on certain features that you can make the case for driving a project on. I was very happy to see this paper reference Jack Scannell's paper on translatability (blogged about here), because its point is crucial to the whole phenotypic screening endeavour. If your underlying assay is flawed, there is nothing you can do in any other part of the project to make up for it. A poorly translatable assay is a sign that you should spend your time trying to fix it, or to go do something entirely different instead. It is not a sign that you should just keep on going, because "it's the best thing we've got". If it isn't good enough, it isn't good enough. I don't get to quote A. E. Houseman much around here, but he's right: "The toil of all that be. Helps not the primal fault; It rains into the sea. And still the sea is salt." If you don't fix your assay up front, you are raining into the sea.

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Tips for Managing Chronic Pain Beyond Prescription Painkillers

Article | September 13, 2019

Painkillers like Oxycontin, Percocet, and Vicodin, have been prescribed by primary physicians, surgeons, dentists, and other healthcare providers to patients suffering from varying levels of pain. Though these medications have proven to be an effective source of pain relief, they have also proven to be highly addictive. In fact, it has even been reported that there are more cases of a drug overdose and deaths from prescription painkillers than heroin or cocaine. While there are a number of factors that play into this opioid epidemic, educating doctors and patients on alternative solutions to managing chronic pain is a great place to start combatting this nationwide crisis.

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What are the advantages of PCD Pharma Company?

Article | February 17, 2020

PCD Pharma stands for propaganda distribution. A PCD company gives brand name and support to its franchises. They also provide distribution rights and monopoly rights within a particular region. If a person wants to establish their business, it is a must for them to know the pros and cons of the business to make a sound decision. Needless to mention that PCD company has a lot to contribute in the medical filed. Worldwide in a medical field, A PCD Pharma Company is playing an essential and crucial role in the rapid growth. The pharma industry is progressing t a fast pace. The company uses the latest technologies for each brand which ensures the safety of products and accepts the responsibility of human health & life by providing better outcomes. To have a drug license number and company registration, the cost to establish the company is quite cost-effective that is15000-20000rs. So this gives people a brilliant opportunity to have their unit without digging a big hole in their bank balance. Indian produces exquisite quality products, which make pharma companies a considerable success.

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Stevanato Group Announces Expansion of Corporate Headquarters

Stevanato Group | November 18, 2021

Stevanato Group, a global provider of drug containment, drug delivery and diagnostic solutions to the pharmaceutical, biotechnology and life sciences industries, today announced the expansion of its corporate headquarters with the construction of a new facility in Piombino Dese, Italy to advance operations and growth of the Company. The new 6,750 square meter facility is expected to support the optimization of Stevanato Group’s industrial footprint, with about 2,500 square meters dedicated to increasing the production of high-value products. In addition to hosting offices, the Italian analytical services site, and R&D space, it is also expected to include new glass syringe forming lines devoted to boosting the production of EZ-fill® solutions, which are pre-sterilized drug containment solutions that reduce total cost of ownership and time-to-market for pharmaceutical companies. “We are very proud of the global growth and evolution that Stevanato Group has achieved over the recent years, and we are always exploring new opportunities and ways to meet our customers’ needs. Further increasing our production capabilities here at home through this new space we expect to be able to bridge capacity demands while our exciting projects in the U.S. and China are underway. Importantly, this expansion is further validation of the hard work of our employees, the demand for our innovative products and the continued growth of our business, and we expect it to allow us to be well positioned to build on our current momentum and advance development initiatives that are expected to directly benefit all of our customers and stakeholders around the world.” Franco Moro, CEO of Stevanato Group Construction of the new building began in September 2021. The Company expects to install and validate new lines in the second quarter of 2022, and expects industrial production to begin between late second quarter and early third quarter of 2022. Stevanato Group’s new flagship building represents an important development in its 2020-2023 Industrial Plan, including efforts to meet increasing global demand for premium products. As part of these efforts, the Company recently operationalized two additional lines for EZ-fill® vials and syringes manufacturing in Italy and, in 2022, plans to add two more lines devoted to EZ-fill® syringes as well as one dedicated line for Alba® syringes, the breakthrough solution for biologics. The expansion underway is part of the Company’s expected plans to triple production of EZ-fill® pre-fillable sterile syringes by 2023 and to increase production of EZ-fill® sterile vials and cartridges 19x by 2023, compared to 2016 numbers. Stevanato Group’s new building also marks the Company’s ongoing dedication to and investment in the local Piombino Dese community, where it has been headquartered for more than 60 years. The new building is expected to act as the counterpart to another facility at the Piombino Dese headquarters, recently completed in 2020, also used for the production of syringes and that hosts solar electric panels. These panels produce 160kWp of electricity per year and are intended to provide electricity to both buildings, as Stevanato Group remains committed to sustainability. To that end, the new building is also intended to have a partial recovery system enabling it to reuse water used for washing in production. About Stevanato Group Founded in 1949, Stevanato Group is a leading global provider of drug containment, drug delivery and diagnostic solutions to the pharmaceutical, biotechnology and life sciences industries. The Group delivers an integrated, end-to-end portfolio of products, processes and services that address customer needs across the entire drug life cycle at each of the development, clinical and commercial stages. Stevanato Group’s core capabilities in scientific research and development, its commitment to technical innovation and its engineering excellence are central to its ability to offer value added solutions to clients. Forward-Looking Statements This press release may include forward-looking statements. The words "expected", "expects", “intended”, "plans" and similar expressions (or their negative) identify certain of these forward-looking statements. These forward-looking statements are statements regarding the Company's intentions, beliefs or current expectations concerning, among other things, the size and use of the plant, the construction and timing of its plant, impact of the plant of the Company’s business and results of operations and the nature of the plant once complete. The forward-looking statements in this press release are based on numerous assumptions regarding the Company’s present and future business strategies and the environment in which the Company will operate in the future. Forward-looking statements involve inherent known and unknown risks, uncertainties and contingencies because they relate to events and depend on circumstances that may or may not occur in the future and may cause the actual results, performance or achievements of the Company to be materially different from those expressed or implied by such forward looking statements. Many of these risks and uncertainties relate to factors that are beyond the Company's ability to control or estimate precisely, such as future market conditions, currency fluctuations, the behavior of other market participants, the actions of regulators and other factors such as the Company's ability to continue to obtain financing to meet its liquidity needs, changes in the political, social and regulatory framework in which the Company operates or in economic or technological trends or conditions. Readers should therefore not place undue reliance on these statements, particularly not in connection with any contract or investment decision. Except as required by law, the company assumes no obligation to update any such forward-looking statements.

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Teva subsidiary inks distribution deal with Israeli medical marijuana product maker

FiercePharma | September 13, 2019

As drugmakers dip their toes into the water of cannabis-based drugs, major companies have so far mostly shied away from diving in. Now, a Teva subsidiary is looking for the on-ramp with a distribution deal with an Israeli medical cannabis company. Israeli subsidiary Salomon, Levin, Elstein (SLE) inked a deal with Canndoc, a publicly traded producer of GMP cannabis products, to distribute to Israeli hospitals, health maintenance organizations and all pharmacies, Canndoc said in a release. SLE will also provide logistical support to distribute Canndoc’s products abroad to countries that support the sale and distribution of medical cannabis. "The agreement brings together our well-established pharmaceutical distribution network with Canndoc's high quality medical cannabis industry presence and market leadership," SLE CEO Aviad Bossi said in a statement. "Beyond the operations in Israel, this agreement will provide Canndoc significant logistical capabilities that can support Canndoc's exporting operations from Israel."

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Teva expands blood pressure drug recall in the US amid cancer fears

Pharmaphorum | June 14, 2019

Teva has expanded a recall of losartan potassium tablets after tests revealed a potential human carcinogen in the blood pressure drug. The Israeli pharma earlier this week recalled six lots of the drug containing unacceptable levels of a nitrosamine impurity. This builds on a decision in April when Teva withdrew 35 lots after detecting the same impurity known as NMBA (N-Nitroso-N-methyl-4-aminobutyric acid). According to a recall notice shared by the FDA, Teva had sold bulk lots of the drug to California-based Golden State Medical Supply. The bottles were in sizes containing 30, 90 or 100 tablets. People affected by the recall should continue taking their drugs and ask a doctor or pharmacist about alternatives or replacements, the FDA said. This is because stopping the medication without replacement could cause more harm than continuing with the treatment course. Teva needs to maximise its revenues to pay off huge debts it incurred when it acquired Allergan’s generics business in 2016 for $40.5 billion. The company posted a loss for the first quarter of the year of $97 million, compared with a $1.1 billion profit in the first quarter of 2018.

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PHARMACY MARKET

Stevanato Group Announces Expansion of Corporate Headquarters

Stevanato Group | November 18, 2021

Stevanato Group, a global provider of drug containment, drug delivery and diagnostic solutions to the pharmaceutical, biotechnology and life sciences industries, today announced the expansion of its corporate headquarters with the construction of a new facility in Piombino Dese, Italy to advance operations and growth of the Company. The new 6,750 square meter facility is expected to support the optimization of Stevanato Group’s industrial footprint, with about 2,500 square meters dedicated to increasing the production of high-value products. In addition to hosting offices, the Italian analytical services site, and R&D space, it is also expected to include new glass syringe forming lines devoted to boosting the production of EZ-fill® solutions, which are pre-sterilized drug containment solutions that reduce total cost of ownership and time-to-market for pharmaceutical companies. “We are very proud of the global growth and evolution that Stevanato Group has achieved over the recent years, and we are always exploring new opportunities and ways to meet our customers’ needs. Further increasing our production capabilities here at home through this new space we expect to be able to bridge capacity demands while our exciting projects in the U.S. and China are underway. Importantly, this expansion is further validation of the hard work of our employees, the demand for our innovative products and the continued growth of our business, and we expect it to allow us to be well positioned to build on our current momentum and advance development initiatives that are expected to directly benefit all of our customers and stakeholders around the world.” Franco Moro, CEO of Stevanato Group Construction of the new building began in September 2021. The Company expects to install and validate new lines in the second quarter of 2022, and expects industrial production to begin between late second quarter and early third quarter of 2022. Stevanato Group’s new flagship building represents an important development in its 2020-2023 Industrial Plan, including efforts to meet increasing global demand for premium products. As part of these efforts, the Company recently operationalized two additional lines for EZ-fill® vials and syringes manufacturing in Italy and, in 2022, plans to add two more lines devoted to EZ-fill® syringes as well as one dedicated line for Alba® syringes, the breakthrough solution for biologics. The expansion underway is part of the Company’s expected plans to triple production of EZ-fill® pre-fillable sterile syringes by 2023 and to increase production of EZ-fill® sterile vials and cartridges 19x by 2023, compared to 2016 numbers. Stevanato Group’s new building also marks the Company’s ongoing dedication to and investment in the local Piombino Dese community, where it has been headquartered for more than 60 years. The new building is expected to act as the counterpart to another facility at the Piombino Dese headquarters, recently completed in 2020, also used for the production of syringes and that hosts solar electric panels. These panels produce 160kWp of electricity per year and are intended to provide electricity to both buildings, as Stevanato Group remains committed to sustainability. To that end, the new building is also intended to have a partial recovery system enabling it to reuse water used for washing in production. About Stevanato Group Founded in 1949, Stevanato Group is a leading global provider of drug containment, drug delivery and diagnostic solutions to the pharmaceutical, biotechnology and life sciences industries. The Group delivers an integrated, end-to-end portfolio of products, processes and services that address customer needs across the entire drug life cycle at each of the development, clinical and commercial stages. Stevanato Group’s core capabilities in scientific research and development, its commitment to technical innovation and its engineering excellence are central to its ability to offer value added solutions to clients. Forward-Looking Statements This press release may include forward-looking statements. The words "expected", "expects", “intended”, "plans" and similar expressions (or their negative) identify certain of these forward-looking statements. These forward-looking statements are statements regarding the Company's intentions, beliefs or current expectations concerning, among other things, the size and use of the plant, the construction and timing of its plant, impact of the plant of the Company’s business and results of operations and the nature of the plant once complete. The forward-looking statements in this press release are based on numerous assumptions regarding the Company’s present and future business strategies and the environment in which the Company will operate in the future. Forward-looking statements involve inherent known and unknown risks, uncertainties and contingencies because they relate to events and depend on circumstances that may or may not occur in the future and may cause the actual results, performance or achievements of the Company to be materially different from those expressed or implied by such forward looking statements. Many of these risks and uncertainties relate to factors that are beyond the Company's ability to control or estimate precisely, such as future market conditions, currency fluctuations, the behavior of other market participants, the actions of regulators and other factors such as the Company's ability to continue to obtain financing to meet its liquidity needs, changes in the political, social and regulatory framework in which the Company operates or in economic or technological trends or conditions. Readers should therefore not place undue reliance on these statements, particularly not in connection with any contract or investment decision. Except as required by law, the company assumes no obligation to update any such forward-looking statements.

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Teva subsidiary inks distribution deal with Israeli medical marijuana product maker

FiercePharma | September 13, 2019

As drugmakers dip their toes into the water of cannabis-based drugs, major companies have so far mostly shied away from diving in. Now, a Teva subsidiary is looking for the on-ramp with a distribution deal with an Israeli medical cannabis company. Israeli subsidiary Salomon, Levin, Elstein (SLE) inked a deal with Canndoc, a publicly traded producer of GMP cannabis products, to distribute to Israeli hospitals, health maintenance organizations and all pharmacies, Canndoc said in a release. SLE will also provide logistical support to distribute Canndoc’s products abroad to countries that support the sale and distribution of medical cannabis. "The agreement brings together our well-established pharmaceutical distribution network with Canndoc's high quality medical cannabis industry presence and market leadership," SLE CEO Aviad Bossi said in a statement. "Beyond the operations in Israel, this agreement will provide Canndoc significant logistical capabilities that can support Canndoc's exporting operations from Israel."

Read More

Teva expands blood pressure drug recall in the US amid cancer fears

Pharmaphorum | June 14, 2019

Teva has expanded a recall of losartan potassium tablets after tests revealed a potential human carcinogen in the blood pressure drug. The Israeli pharma earlier this week recalled six lots of the drug containing unacceptable levels of a nitrosamine impurity. This builds on a decision in April when Teva withdrew 35 lots after detecting the same impurity known as NMBA (N-Nitroso-N-methyl-4-aminobutyric acid). According to a recall notice shared by the FDA, Teva had sold bulk lots of the drug to California-based Golden State Medical Supply. The bottles were in sizes containing 30, 90 or 100 tablets. People affected by the recall should continue taking their drugs and ask a doctor or pharmacist about alternatives or replacements, the FDA said. This is because stopping the medication without replacement could cause more harm than continuing with the treatment course. Teva needs to maximise its revenues to pay off huge debts it incurred when it acquired Allergan’s generics business in 2016 for $40.5 billion. The company posted a loss for the first quarter of the year of $97 million, compared with a $1.1 billion profit in the first quarter of 2018.

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