Archive for November, 2019

Aquestive Licenses ALS Therapy Riluzole Oral Film to Zambon in the EU – ALS News Today

Aquestive Therapeutics has granted a development and commercialization license to Zambon Pharma forits investigational oral film formulation of riluzoleas a treatment for amyotrophic lateral sclerosis (ALS) in the European Union (EU).

Under the terms of the agreement, Zambon will be responsible for the regulatory approval and marketing of the new formulation in the EU, and Aquestive will be responsible for manufacturing the product.

Zambon will pay Aquestive an undisclosed sum for the rights of commercialization, as well as specified milestone payments, and royalties on the net sales of the therapy.

We are pleased to announce our collaboration with Zambon to develop and commercialize [rulizole oral film] in the European Union, Keith J. Kendall, CEO of Aquestive, said in a press release.

Thanks to this collaboration with Aquestive, Zambon will further strengthen its commitment to orphan diseases and the [central nervous system] area, enriching its portfolio with a new formulation that will concretely help patients. Zambon is committed to improving peoples quality of life through innovative medicines and modern therapeutic solutions where they are most needed, said Roberto Tascione, CEO of Zambon.

The oral film formulation of riluzole consists of strips that dissolve when placed over the tongue without the need for water.It uses Aquestives PharmFilm technology, which combines permeation enhancers, stabilizers, and polymer blends to ensure steady delivery of the therapy throughout the lining of the mouth.

Riluzole oral film was designed to facilitate intake of medications by ALS patients who have difficulty swallowing.

The U.S. Food and Drug Administration (FDA) is currently reviewing the new drug application of riluzole oral film, under the brand name Exservan. A decision as to whether the formulation will be approved for sale is expected Nov. 30.

Once approved, we believe that riluzole, via our orally administered dosage form, can bring meaningful and positive change for the care of patients who are diagnosed with ALS and face difficulties swallowing or administering traditional forms of medication, Kendall said.

Previous patient studies showed that riluzole oral film can be taken safely twice a day and that it has a pharmacokinetics profile absorption, availability, distribution, metabolism, and elimination by the body equivalent to that of the capsule formulation, Rilutek.

Riluzole was the first treatment approved to treat ALS. It belongs to a class of medications called benzothiazoles and acts by changing the activity of natural substances produced by the body that can damage nerve cells. In ALS, the treatment slows symptomprogression and prolongs survival.

This compound is currently approved under two formulation, as tablets, under the brand name Rilutek, and as an oral liquid solution, under the brand name Tiglutik.

Alejandra has a PhD in Genetics from So Paulo State University (UNESP) and is currently working as a scientific writer, editor, and translator. As a writer for BioNews, she is fulfilling her passion for making scientific data easily available and understandable to the general public. Aside from her work with BioNews, she also works as a language editor for non-English speaking authors and is an author of science books for kids.

Total Posts: 5

Ins Martins holds a BSc in Cell and Molecular Biology from Universidade Nova de Lisboa and is currently finishing her PhD in Biomedical Sciences at Universidade de Lisboa. Her work has been focused on blood vessels and their role in both hematopoiesis and cancer development.

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Aquestive Licenses ALS Therapy Riluzole Oral Film to Zambon in the EU - ALS News Today

German ministers urge EU to lead the way at COP25 in Madrid – EURACTIV

At a Berlin conference to prepare for the UNs annual climate summit (COP25), Environment Minister Svenja Schulze and Foreign Minister Heiko Maas stressed the EUs responsibility in closing the Paris Climate Agreements remaining gaps, particularly by raising the targets at the EU level. EURACTIV Germany reports.

About two weeks before COP25 in Madrid, two MPs from the Socialist Democratic Party (SPD) called on the EU to take on a leadership role at the annual conference. It should close the remaining gaps in the Paris climate agreement, they said.

Europe must play a leading role in climate ambitions. As major emitters, we must send the right signals, Foreign Minister Heiko Maas said on Thursday (14 November). Alluding to the US, he added that in times of national unilateralism, the international community cannot rely on the COP process alone.

It is therefore crucial for the EU to engage in dialogue with other progressive forces and sharpen its goals.

UPDATE: The European Commission warned EU countries today (18 June) that draft national plans for the coming decade are insufficient to achieve the blocs 2030 energy and climate targets. Substantial gaps have been identified on renewables and energy efficiency.

The European Union must do more. We cannot stick to the current climate ambitions we have set, Environment Minister Schulze added. She would support Ursula von der Leyens ambitions for increased climate protection.

Regarding her expectations for COP25, Schulze said she hoped an agreement would be reached on an international credit system for emission certificates that would function without loopholes and without double counting, one of the open negotiating points that should be concluded in Madrid.

Article 6 of the Paris agreement the market mechanism

Article 6 provides for an international regulation which deals with the trading of pollution rights, similar to the EU Emissions Trading Scheme (ETS). Up to now, states have been able to finance environmental measures in other countries under the Kyoto Protocol adopted in 1997 and have offset such carbon savings against their national carbon footprints.

However, the international agreement expires in 2020 and is to be replaced by provisions laid out in the Paris Agreement. It is still unclear according to which rules emissions trading should take place and whether countries will be allowed to finance climate measures abroad and count them as their emission reductions in the future.

It also remains to be seen whether countries will be able to continue to take into consideration their achievements made under the Kyoto Protocol after 2020, once the Paris Agreement comes into effect. While Brazil, China and India have so far argued in favour, critics have warned against greenwashing.

The main objective of the negotiations will be to convince Brazil.

Damage and losses the Warsaw mechanism

The so-called Warsaw mechanism, which provides for financial and technical assistance to regions affected by climate change, will be reviewed and adapted in Madrid. Its primary instrument is the international Green Climate Fund, which currently has $5.6 billion at its disposal.

From 2020, the money pot is to be significantly increased to $100 billion a year. But it is still unclear where the funds will come from, even though many countries have already pledged to raise their funds.

It is also still unclear how losses will be quantified and compensated internationally, and to what extent which countries will be held responsible.

Data collection

At the climate summit, the international community will continue to work on a uniform basis for a global reporting mechanism to report that monitors environmental measures.

At last years COP24, it was possible to draw up uniform guidelines for comparing the national climate contributions of all countries. Bureaucratic regulations for reporting now have to be agreed upon.

The COP25s central objective will also be to persuade the international community to raise its climate targets, which, according to the Paris agreement, should happen every five years. The climate plans presented so far are not sufficient to keep global warming below two degrees, but would instead lead to a three-degree scenario.

In a UN assessment published on 21 September, it was concluded that G20 nations are collectively not on track to meet their Paris Agreement commitments.

At the UN climate summit in New York in September, around 60 countries, therefore, promised to adjust their climate targets accordingly next year.

The European Commission also warned member states in June that their submitted climate plans were inadequate.

The incoming Commission President Ursula von der Leyen is therefore calling for an increase in the EU target for the reduction of greenhouse gas emissions from 40% to 55%, compared to 1990 levels. This is also in line with a demand by the European Parliaments Environment Committee (ENVI).

In a COP25 resolution adopted last week, MEPs called for a minimum increase of 55% and recommended that shipping and air transport be integrated into national climate plans.

Officially, the COP25 will be the last opportunity for all member states to adapt their national climate plans in time, as they must be submitted nine to 12 months before the following COP26 in November 2020.

[Edited by Zoran Radosavljevic]

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German ministers urge EU to lead the way at COP25 in Madrid - EURACTIV

Social Buzz: why isn’t social media marketing as much fun as it used to be? – The Drum

Social media has come of age, but its troublesome teen years have forced platforms like Facebook, Twitter and Instagram to introduce their own rules and best practices around marketing. Have these stipulations killed the original fun that came from interacting with new (and sometimes famous people) in real-time digitally from all around the world?

Ahead of the big event later this month, The Drums Social Buzz Awards jury for 2019 came together to discuss the evolution of social media, as well as why (and how) the fun element has diminished over the years.

Questions remained about what this means for brands using the likes of TikTok, Twitter, Instagram and Facebook to generate fame too.

The group, which included brand and agency-side marketers, focused on the impact burgeoning Chinese app TikTok is making in generating engaging content to grow its audience.

Im watching the kids, said Kinda Jackson, managing director of digital for Brands2Life as to how she follows new trends.

When I watch how my two boys are using TikTok and [how they] follow their friends on social, [I learn] from them very simply how to tap into trends and memes and create content around what they are currently talking about," she explained, highlighting brands like Wendy's and Fortnite as ones that have been using TikTok in smart ways.

Picking up on engagement, and how brands can still tap into trends and conversations online, UKTV's director of communications Justine Bower underscored the importance of social listening.

Thats what TikTok is there for, its there to create and for the audience to have fun they are now creators," she added.

Immediate Future chief executive Katy Howell argued that social media has become boring with the industry seemingly forgetting the traditional rules of advertising and marketing still apply in this space too.

We dont entertain enough, she stated. We put out too much business as usual content. Social is so boring; its become mundane and most brands tick a box with someone putting out something every day.

"There is so much diarrhea out there. But the brands who are kicking it are the ones that are dealing with emotions and portraying something that is stand out or maybe risqu and they are tapping into older good quality marketing techniques instead of churning content.

Pointing out that creativity is not restricted by the rules set by each platform, but instead enhanced by the work that goes into working around those restrictions, was Bodgana Butnar, experience strategy lead for Karmarama.

We have to figure out how we want to deliver on the brand objectives that we have and have fun while doing it.

"If we are sticking with [only the ideas] the creators of social media give us then we will forever end up in the same place we are going to have to stop the deluge of brand communications that comes on those platforms by forming gateways where these are the formats, and if you cannot deliver across those formats, thats it, youre done."

Elsewhere, Rebecca Holmes, director of social media at Splendid argued that planning around business objectives (rather than finding ways to surprise audiences) was another factor taking some of the joy out of social media marketing.

Though she did admit those objectives were clearly important, she said it was in surprising audiences that brands would be able to cut through the noise.

If you look at the brands that cut through this year... they have made cut through because they've surprised people with their messaging which audiences didnt expect," she said.

"Its not about how to use native functionality on Instagram, its about surprising someone which is what it ultimately comes down to," she added. "And yes all of those things feed into it but we are [too] focused on all of that strategic laddering up to allow goals and objectives."

Adding that the two factors should not be seen as being mutually exclusive, Saskia Jones, data strategy director for BBH said she believes that the fundamentals of marketing should be adhered to but that the search for fame should be the desired outcome from social media activity.

If you go after fame then all of your other objectives will follow from awareness and profit, all of that will follow. Weve forgotten that, she claimed.

When I first started in social media and paid social wasnt a thing, you had to work hard to entertain people. As soon as you put paid behind it, people got bored and lazy because they could guarantee that a million people would see their post. But the platforms themselves have got us to a place where we are so adherent to their best practice that everything looks the same and everything is wallpaper.

Jones adds that she battles against media agencies who wish to follow platform format guidelines as breaking the rules can make a difference in successfully engaging an audience.

You can ladder-up and drive business results, but it is going back to those fundamentals. For so long social has been a thing we have treated as having different rules but all the best pieces of work we see on social adhere to everything we knew about marketing," she continued. "If it cuts through, its different and distinctive... then it doesnt matter what platform we are talking about."

As to how creativity can breathe on social under platform rules, Karmarama's Butnar believes it is easier to be creative as a result of such marketing restrictions. She also said platforms such as Facebook can't be blamed for clients' wishes to follow them.

"Everybody is trying to get to the same place, but [social networks] must have best practices. If [as advertisers] we're thinking that those rules don't allow us to be creative, then were wrong."

Howell says that the quality of the content being produced is the fundamental ingredient towards success, and that it doesnt need to be complex.

Print advertising hasnt changed much over the last 50 years yet you have some absolutely outstanding examples there," she said, highlighting that skills like copywriting and art direction were being lost in the "rush" to get everything out on social.

"We've gotten lazy we have this format, this carousel, we want to hack this channel but the reality is the fundamental bit is getting your copy right. A one-liner works brilliantly for that market and audience, and your visuals are impactful whether they are six seconds or seven minutes long.

Finally, Deborah King, head of paid social at Essence revealed she feels frustrated when deliberating over whether social is still fun. Advertisers, she argued, need to go back to basics in terms of who the target audience is and reaching them through quality advertising creative ideas.

Our team is always looking at how our best practice isnt killing the creativity but enhancing it and we are getting to the point now where we have people who understand the craft of creative and content but also the algorithms," she said.

So social media can remain a fun environment despite the imposed restrictions brands face when utilising the platforms, it seems.

It just takes good old-fashioned ideas and a strong tone of voice in order to form a community that wants to be surprised and amused by a brands work.

The Drum's Social Buzz Awards winners will be announced on Wednesday 27 November at The Marriott Hotel, Grosvenor Square, London.

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Social Buzz: why isn't social media marketing as much fun as it used to be? - The Drum

How Social Media Marketing is Impacting Your Business – Promotion World

Social media marketing is one of the most powerful platforms. It provides high brand exposure. There are more than 3.5 billion people available on social media platforms. With the help of social media, businesses are gaining great opportunities to easily communicate with people and create brand awareness, promote products and services in an effective and efficient manner.

One of the great results of social media marketing is that you can easily reach the audience you are targeting. Keep communicating with them, give the response to their doubts and issues swiftly and keep monitoring the social media pages of your competition.

By Piyush Jain, CEO of Simpalm

Here are the top 5 positive effects of social media marketing for business-

1 Multiple Touchpoints Between Customer and Business

Social media is the main platform to interact with customers and gain attention. Research shows that there are 42% of people who expect to get a response through social media within sixty minutes. There are different social media platforms available in the market. These platforms include Facebook, Linkedin, Twitter, Instagram. These are very powerful media channels to engage and easily communicate with your customers.

Such multiple touchpoint customer service plays a very important role in business growth.

2 Reach A Bigger Audience

According to marketing experts, social media has completely changed the way business works. Social media has increased business traffic by 75%. It is one of the best platforms to improve brand awareness and stay connected with customers.

Social media is one of the most important sources for people to know more about business and its workings. They get knowledge about the business's latest products and services, promotions, deals, etc.

With the help of a social media platform, a business can easily share its business news. They can post the photos of their workings and share products and services which they provide. This will help to build customer trust and gain more potential and permanent customers.

By Micah Solomon, Customer service expert

3 Effect Brand Awareness

Social media platforms provide wide opportunities for brands to show some creativity to others by promoting and running social media campaigns. It is one of the best tactics to engage with the audience, grab their attention and improve brand awareness.

One cannot build a brand easily. It takes a long time, dedication, and constantly proving the customers that they can trust in our brand. There are many tactics which are going to help you build brand awareness by using social media platforms.

Social media will allow you to connect with a large number of an audience where you can create good and attractive content, use of attractive infographics and good quality images will gradually help your brand to build in the eyes of the audience.

4 Improves Customer Service

We have seen so many times customer posting complaints and feedback on social media platforms. This has completely changed the face of customer service. Nowadays, people prefer to post on social media instead of talking at call centers. People are posting problems on social media to gain instant attention from the brand.

Brands are getting instant feedback about their work and services on social media platforms. This helps brands to improve their services instantly. Every comment, post related to the services are helping in brand development. Brands are also working hard to get good comments and positive replies from their customers on social media. This is helping them to get more customers.

Business should always try to provide good quality of services to its customers and never take their complaints and feedback for granted. They can make you or break you.

By Blake Morgen, Customer Experience Consultant

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How Social Media Marketing is Impacting Your Business - Promotion World

SAP CMO Alicia Tillman Talks Social Impact, B2B Marketing And The Trust Deficit – Forbes

I recently had a phone conversation with one of the worlds most influential CMOs to get her views on modern marketing. We discussed social impact responsibility, fighting slavery in the supply chain, expectations for CMOs, B2B vs. B2C marketing, and consumer data and trust. In her own words, heres how SAPs Alicia Tillman described a few of the top challenges and priorities that come with leading one of the worlds largest tech companies:

Alicia Tillman, CMO of SAP

On brands social impact responsibility:

When you work for a company the size of SAPover 100,000 employees, over 480,000 customers, with locations across 180 countries we are absolutely in a position to impact change. We have the resources needed to make a difference, and frankly weve always believed its our responsibility given the breadth and depth and the scale of our company to do so. When we look at whats driving todays headlinesclimate change, diversity and inclusionbusinesses predominantly hold the top spot in these headlines be it good or bad. And as the world around us transforms, and people are getting more comfortable with their voices, they are speaking out. They are calling for change, and they're looking for companies as one entity and their leaders to lead through that change.

We support and use the United Nations 17 sustainable development goals as the framework in which we look where SAP has the resources and technology to impact across the SDGs. Working to end poverty, protect the planet, fight diseases, ensure prosperitythis is what the UN SDGs are all about.

On fighting slavery in the supply chain:

If you think about one of the greatest issues in the supply chain, its forced labor conditions. This is modern slavery that is a problem created due to a lack of transparency in the supply chain.

Weve partnered with an organization called Made in a Free World. Made in a Free World is focused on understanding where in the world there are known forced labor conditions. If you look at our transactional data, we have an ability based on where transactions are happening to see if it is in one of these areas of the world that Made in the Free World is tracking.

So we now have an ability to say, Look, some of the subcontractors or suppliers that you are buying from, when we follow the transaction data, we are sensing that there is perhaps some activity happening in a part of the world where there are known forced labor conditions. So we now have an ability to bring them that transparency, which is one of the SDG goals that is there to help create fair and equal rights and equality from a labor conditions standpoint.

On ever-evolving expectations for CMOs:

Youre required to be so much more than a marketer; you really need to be a well-rounded business leader. You need to understand every facet of your company: what each functional area is working to achieve, how they measure success, what the future roadmap is for the company, the way in which your CEOin my case, I have two CEOs nowthe things that are important to them and the strategic counsel that you need to be in a position to be able to lend to them. And to take that role and truly lean in on the business strategy.

On B2B vs. B2C marketing:

Regardless of the job title you hold we're all human beings, and there is so much that has evolved today in what drives the buying processin particular, that emotion. We need to be able to understand the feelings of our customers so that we can ensure that we're both marketing in the way that's going to be emotionally relevant to them in addition to speaking to the overall value and challenges that our technology helps solve within a company. I think the lines are beginning to blur even more, and that will continue to happen. As marketers at a B2B company, which has historically only targeted a decision maker, if youre selling technology you only talked about the capabilities of a product. Its broadened so much, and the direction its mostly gone into is to think like a consumer and therefore market like a consumer because thats what the consumer population expects from us today.

On consumer data and trust:

We operate in a marketplace where there's a tremendous trust deficit. Consumer trust is at an all-time low, and a big part of what has driven that trust deficit is misuse of data. There are many companies over the past few years that have found themselves in headlines, due to this very fact, that they have misused data without the consent of their customers. We also have a tremendous gap in perception of experiences between consumers and brands they interact with.

There was a study by Gartner that showed 80% of CEOs believe that theyre delivering an exceptional customer experience whereas only 8% of consumers agree with that statement. So that has created a tremendous experiential gap that gives us an opportunity to look at data. When you read the research, consumers are more than willing to allow companies to use their data if it's going to enable the company to deliver them a better customer experience, but the customer has to be aware of that. Regulatory actions such as GDPR have enabled this privacy and regulation thats been needed, and weve adhered to the highest level possible. Transparency needs to always be priority No. 1. And that always needs to be grounded in building an incredibly solid infrastructure to enable the protection of the data and to use it in a way that enhances the experience of the customer.

This interview has been edited for length and clarity.

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SAP CMO Alicia Tillman Talks Social Impact, B2B Marketing And The Trust Deficit - Forbes