Unither Pharmaceuticals awarded with “Prix CCI International Brésil – Santos Dumont”

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Unither Pharmaceuticals was selected as a winner of the 2016 “Prix CCI International Brésil – Santos Dumont”. This prize recognizes five years of hard work and increases Unither Pharmaceuticals visibility on their activities and services in Brazil and around the world.
This award is a part of “France-Brazil Foreign Trade 2016 trophies”. It is organized by the “Chambre de Commerce France-Brésil-São Paulo (CCFB-SP)” with the support of the “CCI International” as a part of the “Innovation and Technology” forum held in Sao Paulo October 21, 2016.

Each year the contest rewards one French SMEs that initiated a development project in Brazil or established a local structure (representative office, joint-venture, etc.) and who set up in Brazil for less than 7 years (seconded staff, domicile or registered company).
More information here

Fareva: Jobs offer

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FAREVA is looking for a Business Development Manager / Director for the Northern American market, based in NJ, NYC, CT to manage its injectable / ophthalmic / high potent businesses.

The candidate should have at least 7 years of experience in technical sales in the pharmaceutical industry.

Please contact M. Ed Saxman for further information at ESaxman@hobbstowne.com

Fareva: ready to use products offer

fareva

Fareva is a global leading CDMO for the pharmaceutical industry based in Europe and the US. Our activities also cover API and early stages of formulation (analytical and dosage forms developments). Besides, thanks to strong partnerships, we are developing our ready to use products offer.

Fareva offers flexible solutions for analytical and dosage forms developments, clinical trials, regulatory services and commercial manufacturing for:
– Ophtalmic (BFS, conventional and preservative-free bottles)
– Injectables (freeze-dried vials, ampoules, prefilled syringes)
– Aerosols (conventional, bag-on-valve) and sprays (mechanical, preservative free)
– Suspensions, solutions and gels (bottles, sachets, stick-packs)
– Granules and powders (sticks-packs, sachets, bottle); tablets (uncoated, coated, sugar-coated) and capsules (blisters, bottles) with cytoxic expertise
– Creams, ointments, gel and jellies (single dose, sachets, alu, polyfoil or plastic tubes); sterile ointments and gels (polyfoil or aluminium tubes)
– Suppositories & ovulas
– Food supplements; herbal tea (grade pharma or not)
– Narcotics management and expertise (4 sites)

Fareva also produces APIs in 3 sites and is therefore able to offer a one-stop-shop. API business is appointed by steroid chemistry including aseptic processing (crystallization, micronization and packaging), high potent and toxic chemistry (OEB 4 and 5).

Thanks to strong partnerships, Fareva also develops ready-to-sell products:
– Private label drug products (OTC or under prescription) for common pathologies
– Private label medical devices for oral, rhinological, and skin care (hyaluronic acid, high molecular weight polymer or glycerol based); sea water aerosols; cold spray
– Food supplements ready to use formulas (tablets, capsules, powder sachets or stick-packs, effervescent, orodispersibles and orosolubles, single dose 2 or 3 phases vials)

At Fareva we are happy to highlight 3 products of our offer:
. Antifungal aerosols OTC US monograph: Fareva offers, for the US market, two foot care monograph products: liquid or powder antifungal aerosols containing Miconazole 2% or Tolnaftate 1% for athlete’s foot, jock itch and ringworm treatment.
. Cough & cold OTC syrup: Fareva and one of its partner offers an herbal cough and cold OTC syrup, containing 7 mg/mL dry extract of Hedera helix L. (Ivy leaf), used as an expectorant in case of productive cough.
. Ophthalmic MD: Fareva and one of its partner offers, for Europe, 3 ophthalmic medical devices: preservative free 10 mL bottles using Novelia system (approved by the FDA, from NEMERA), containing Carmellose 0,5%, Hypromellose 0,3% or Hyaluronic Acid 0,2% for eye soothing, lubricating and moisturizing.

If you are looking for development and manufacturing API and FDF in our 15 pharma facilities (among them 8 are FDA approved);
If you are interested in dossiers for drug products or medical devices and ready to use food supplements formulas;

Visit Fareva’s booth

Atmo Guard System® – safe, timely and cost-efficient

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Which factors must be considered to receive the optimum primary packaging solution? How can cost-effectiveness be combined with smooth processes, maximum risk mitigation and safety? And where is comprehensive and reliable support available from a single source? Before being introduced to the market, all products must undergo the required approval processes. In order to offer customers optimal support, Sanner has developed the Atmo Guard System®.

The Sanner Atmo Guard System® relies on real, product-specific data and takes all relevant factors into account. Thus customers obtain reliable measuring results backed by safe and proven processes. As true primary packaging expert, Sanner has an extensive know-how regarding moisture input. The holistic approach of the Atmo Guard System® makes sure that all steps and aspects are incorporated in the process. This way, customers gain time and can be sure that their chosen packaging meets all required criteria – be it for drop-in, integrated or individual desiccant packaging solutions.

The Sanner Atmo Guard System® is designed according to the motto “as much desiccant as needed, as little as possible”. Sanner engineers put their focus on the ideal interaction of product, desiccant and packaging. By taking into account the right parameters, they define the most economic packaging solution. This way, customers receive the ideal solution for a safe, timely and cost-effective market launch.

Visit Sanner’s booth 

Tekni-Plex has exhibited the latest in high-performance film structures, closure liners for pharma, medical device packaging at All4Pack in Paris

tekniplex

Wayne, Pa. Tekni-Plex was exhibiting the latest film and closure liner offerings for pharmaceutical and medical device packaging at All4Pack in Paris (14 Nov. – 17 Nov.) Hall 7 booth C125.

Its Tekni-Films business unit has discussed its copolyester film series with grades that provide a cost effective alternative to PETG for thermoformed medical tray packaging. The company is also still offering a laminated alternative to PVC for thermoformed pharmaceutical blister applications.

Tekni-Films were also displaying its super-high barrier PVDC coating and a wide variety of other multilayer packaging structures which deliver the stringent oxygen and water vapor barrier properties necessary to protect pharmaceutical and medical device products.

The company’s Tri-Seal closure liners business unit was featuring its EdgePull™ tamper-evident induction seals which feature low peel force to remove. Available globally, EdgePull has been developed to provide food, beverage, pharmaceutical, nutraceutical, health and beauty aids and personal care products with protection and easy-opening functionality advantages.

Tri-Seal also was discussing its dynamic new high temperature wax technology which delivers enhanced closure liner performance for packages stored or sold in warmer global climates. The company also promoted its HS 8501 and HS 8502 liners which provide superior resistance for aggressive agricultural or household chemicals, packaged in PET and HDPE containers, respectively.

With manufacturing locations across the globe, Tekni-Plex is ideally positioned to meet the business continuity needs of pharmaceutical and medical device manufacturers regardless of their location.

Visit Tekni-plex’s booth

Novartis acquires Selexys Pharmaceuticals Corporation

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Novartis acquires Selexys Pharmaceuticals Corporation and SelG1 antibody for reduction of pain crises in sickle cell disease (SCD)

Novartis has acquired Selexys Pharmaceuticals Corporation, a company specializing in development of therapeutics in certain hematologic and inflammatory disorders. Novartis exercised its right to acquire Selexys following receipt of results of the SUSTAIN study, a Phase II trial evaluating the use of SelG1, an anti-P-selectin antibody, in the reduction of vaso-occlusive pain crises in patients with sickle cell disease (SCD). Results from the study will be presented during the Plenary Scientific Session at the 58thAmerican Society of Hematology (ASH) Annual Meeting on December 4, 2016, in San Diego, California.

“Sickle cell disease affects millions of people around the world and there are limited therapies available for treatment of vaso-occlusive pain crises, a very common complication of the disease,” said Bruno Strigini, CEO of Novartis Oncology. “With this acquisition, Novartis is able to leverage its leadership in hematology research to advance development of a potential new treatment option for patients living with this debilitating condition.”

Novartis obtained the exclusive right to acquire Selexys and SelG1 in 2012. Prior to the acquisition, Selexys Pharmaceutical Corporation was a privately held biopharmaceutical company headquartered in Oklahoma City, Oklahoma. Terms of the deal could total up to $665 million in upfront, acquisition and milestone payments.

Survey Reveals Most People Don’t Know Heart Disease Is the No. 1 Killer of People with Type 2 Diabetes

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Boehringer Ingelheim and Lilly launch For Your SweetHeart™, an educational campaign to help bridge knowledge gap and encourage people with type 2 diabetes to know their cardiovascular risk

Physician and host of The Doctors, Dr. Travis Stork, joins the campaign to urge people with type 2 diabetes and their loved ones to take action by taking the Heart You Quiz

A new national survey of more than 1,500 adults, including 501 who have type 2 diabetes, finds that three out of four Americans and two out of every three people with type 2 diabetes don’t know that heart disease is the number one health-related killer of people with type 2 diabetes. The survey also finds more than half (52 percent) of adults with type 2 diabetes do not understand that they are at an increased risk for heart disease and related life-threatening events, such as heart attack, stroke or even death. To address this critical information gap, Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) are launching For Your SweetHeart™: Where diabetes and heart disease meet. The For Your SweetHeart campaign aims to raise awareness of the link between type 2 diabetes and heart disease and to encourage people with type 2 diabetes to know their risk and speak to their healthcare provider, for the sake of their health and the people they cherish the most.

Reaching Millions of Hearts Across the USA

Cardiovascular disease (which includes heart disease and other problems with the heart and blood vessels like heart attacks and strokes) causes approximately two-thirds of deaths in people with type 2 diabetes, making it the number one cause of death. But the good news is, the sooner people understand their risk, the sooner they can talk to their healthcare provider to learn more about the link between type 2 diabetes and potentially life-threatening heart attacks, strokes or even death.

To help raise awareness of this critical issue, Boehringer Ingelheim and Lilly have teamed up with board-certified emergency medicine physician and host of the Emmy award-winning show The Doctors, Dr. Travis Stork, to encourage the millions of people with type 2 diabetes and their “sweethearts” to better understand the connection between diabetes and heart disease.

“In the emergency room, I regularly see people with type 2 diabetes experiencing life-threatening events like heart attacks or strokes,” said Stork. “Few know they are more likely to experience these kinds of complications simply because they have diabetes. I’ve joined the For Your SweetHeart campaign because awareness of heart disease risk is critical for people with type 2 diabetes and their loved ones, and taking action today may help save lives.”

For Stork, it’s also a personal issue that hits close to home. “My grandfather had type 2 diabetes, and from him, I learned a lot about the importance of managing the disease before I ever became a doctor. I urge everyone with type 2 diabetes to visit ForYourSweetHeart.com, take and share the Heart You Quiz to learn about their risk for heart disease, then talk to their healthcare provider.”

People with diabetes have an increased risk of heart disease for a number of reasons, including high blood pressure, abnormal blood lipids and obesity. Uncontrolled diabetes damages blood vessels, making them more prone to injury from high blood pressure and from plaque build-up and inflammation in the arteries. Boehringer Ingelheim and Lilly surveyed 1,505 people on their understanding of the link between type 2 diabetes and heart disease. The survey was comprised of a nationally representative sample including: 1,004 adults 18 years and older in the U.S. and 501 adults 18 years and older in the U.S. who have type 2 diabetes. The survey found:

If people with type 2 diabetes knew they were at increased risk of heart disease, 99 percent responded that they would be likely do something about it. More than 80 percent said they would change their diet/eating habits, exercise and speak with their healthcare provider to decrease their risk of heart disease

Less than 35 percent of people overall and only 41 percent of people with type 2 diabetes surveyed were aware that those with type 2 diabetes are at increased risk for heart attack

“The truth is cardiovascular disease is the leading cause of death among people with diabetes, but there is hope. The earlier people with diabetes understand this risk, the sooner they become engaged and take action to help reduce their chances of heart attacks, strokes or even death,” said Paul Fonteyne, president and CEO, Boehringer Ingelheim Pharmaceuticals, Inc. “We’re excited to launch For Your SweetHeart to encourage people with type 2 diabetes to assess their risk through the Heart You Quiz and to speak with their healthcare provider about the link between diabetes and heart disease. The most important thing people can do is know everything they can about their health and encourage their loved ones to do the same.”

“People with diabetes are two to four times more likely to develop cardiovascular disease than people without diabetes,” said Mike Mason, vice president, U.S., Lilly Diabetes. “Educating the public about this important health crisis is just another component of our responsibility and commitment to delivering the best care for people with type 2 diabetes. We hope this initiative will encourage people to take action, not only for themselves, but also for their sweethearts.”

About For Your SweetHeart: Where diabetes and heart disease meet

For Your SweetHeart is a U.S. initiative to raise awareness of the link between type 2 diabetes and heart disease and to encourage people with type 2 diabetes to know their heart disease risk and speak to their healthcare provider, for the sake of their health and the people they cherish the most. Learn more about the For Your SweetHeart initiative and take and share the Heart You Quiz at ForYourSweetHeart.com.

The For Your SweetHeart survey was conducted online, between Oct. 24 and Nov. 1, 2016, among a nationally representative sample of n=1,505 respondents, including: n=1,004 adults 18 years and older in the U.S. (including n=364 type 2 diabetes “sweethearts,” or those who know someone with diabetes) and n=501 adults 18 years and older in the U.S. who have type 2 diabetes.

For Your SweetHeart was developed and sponsored by Boehringer Ingelheim and Eli Lilly and Company. Elements of the campaign, including the For Your SweetHeart survey and Heart You Quiz, were reviewed and validated by a steering committee of leading cardiologists and endocrinologists.

Participating medical experts:

Karol E. Watson, M.D., Ph.D., FACC, professor of medicine/cardiology, co-director, UCLA Program in Preventive Cardiology, director, UCLA Barbara Streisand Women’s Heart Health Program

Ty J. Gluckman, M.D., FACC, FAHA, medical director, Clinical Transformation, Providence Heart and Vascular Institute, Portland, Oregon

Matthew Budoff, M.D., professor of medicine, UCLA, Endowed Chair of Preventive Cardiology, program director, Division of Cardiology, Los Angeles Biomedical Research Institute

Leigh Perreault, M.D., associate professor of medicine, Division of Endocrinology, Metabolism and Diabetes, Affiliate Center for Global Health, University of Colorado Anschutz Medical Campus, associate professor of epidemiology, Colorado School of Public Health

Anne Peters, M.D., director, USC Clinical Diabetes Program, professor, Keck School of Medicine of USC

About Diabetes and Cardiovascular Disease

Approximately 29 million Americans and an estimated 415 million people worldwide have diabetes, and nearly 28 percent of Americans with diabetes—totaling eight million people—are undiagnosed. In the U.S., approximately 12 percent of those aged 20 and older have diabetes. Type 2 diabetes is the most common type, accounting for an estimated 90 to 95 percent of all diagnosed adult diabetes cases in the U.S. Diabetes is a chronic condition that occurs when the body does not properly produce or use the hormone insulin.

Due to the complications associated with diabetes, such as high blood sugar, high blood pressure and obesity, cardiovascular disease is a major complication and the leading cause of death associated with diabetes. People with diabetes are two to four times more likely to develop cardiovascular disease than people without diabetes. Approximately 50 percent of deaths in people with type 2 diabetes worldwide and approximately two-thirds of deaths in people with type 2 diabetes in the U.S. are caused by cardiovascular disease. In the U.S., health care costs for managing cardiovascular conditions in patients with diabetes totaled more than $23 billion in 2012.

Having diabetes can shorten a person’s lifespan by as much as six years compared with someone without diabetes.* And having both diabetes and a history of heart attack or stroke can shorten a person’s lifespan by as much as 12 years compared with someone without these conditions.**

* Based on having a history of diabetes at age 60.

** Based on having a history of diabetes and heart attack or stroke at age 60.

Boehringer Ingelheim and Eli Lilly and Company

In January 2011, Boehringer Ingelheim and Eli Lilly and Company announced an alliance in diabetes that centers on compounds representing several of the largest diabetes treatment classes. This alliance leverages the strengths of two of the world’s leading pharmaceutical companies. By joining forces, the companies demonstrate commitment in the care of patients with diabetes and stand together to focus on patient needs.

Catalent Celebrates Ground Breaking For Expanded Biologics Facility

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Catalent Pharma Solutions, the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products, celebrated its ground breaking for a new $34 million extension to its state-of-the-art Madison, Wisconsin biologics manufacturing facility on Friday, Oct. 21. When completed, the additional 22,000 square feet of space will accommodate a new 2 x 2,000 liter single-use bioreactor system, allowing the company to support late-phase clinical and commercial production of up to 4,000 liter batches. The new footprint will also support expansion of analytical and process development laboratories, as well as additional office space.

The ground breaking ceremony, led by Lieutenant Governor of Wisconsin Rebecca Kleefisch and Catalent President and Chief Executive Officer John Chiminski, marks the beginning of construction at the site that will eventually create more than 100 new jobs.

“I want to thank the company for its continued commitment to Wisconsin by deciding to grow here,” said Lt. Governor Kleefisch. “This expansion will further enhance the Madison region’s leadership position in the pharmaceutical and health industries.”

The Wisconsin Economic Development Corporation (WEDC) has awarded Catalent with up to $1 million in state tax credits over the next three years. The actual amount of credits the company will receive is contingent upon the level of capital investment in Madison during the three-year period.

“Our continued investment in biologics capabilities is in direct response to market demand, where underlying growth for large molecules is expected to exceed that for small molecule drugs,” commented Barry Littlejohns, Catalent’s President of Drug Delivery Solutions. “We are immensely proud of our facility, and the people here in Madison who have helped achieve our customers’ program milestones and move toward larger commercial programs,” he added.

Opened in April 2013, Catalent’s Madison facility is the home of the company’s proprietary GPEx® cell line technology, used to create high-yielding mammalian cell lines. Catalent provides development, manufacturing and analytical services for new biological entities (NBEs) and biosimilars from the Madison facility. It was designed for flexible cGMP production, from 10 liter up to 1,000 liter scale, and non-GMP production up to 250 liter scale, and features extensive use of single-use technologies and unidirectional flow to maximize efficiency. Manufacturing is supported by integrated analytical, process and formulation development capabilities and separate microbiology and quality control functions. Work to extend its integrated analytical capabilities was completed in January 2016, and Catalent has also completed investments to expand process development capability at the site, including integration of an Ambr® 15 microbioreactor system into its cell line and upstream development process, providing overall reductions in timelines and increases in expression levels.

Visit Catalent’s booth

Pharmapack Europe: 2017 marks 20 years of the pharma packaging and drug delivery event!

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Meet with leading suppliers and discover the latest innovations in the industry

Pharmapack Europe (#PharmapackEU), organised by UBM EMEA, is a two-day exhibition and conference dedicated to pharmaceutical packaging, drug delivery and affiliated industries. Next year’s event is on 1 & 2 February 2017 at Paris Expo Porte de Versailles (Hall 4), Paris.

2017 marks the event’s 20th successful year, and over its lifetime it has grown in size, profile and popularity from a bi-annual event to a major annual show that attracts 5,100+ visitors and over 380 exhibitors from more than 70 countries around the world.

Attendees and delegates range from CEOs and CMCs to pharmacists and business execs, and work in every area from R&D and drug development to purchasing, engineering, marketing, logistics and business development.

Innovation is at the very heart of Pharmapack. An Innovation Gallery showcases selected industry innovations from exhibitors, while Innovation Tours guided by industry experts take visitors on a tour to innovating exhibitors’ stands.

The newest addition for 2017, the Pharmapack Start-up Hub, is designed to let innovative young pharma firms benefit from valuable networking and learning opportunities at a price that suits their budget. This dedicated area on the show floor gives them a unique platform to showcase their ideas, meet potential customers, partners and investors and forge new relationships that will help them develop for years to come.

The Pharmapack Awards recognize new products that are set to shape the future of the industry, in two categories. The Exhibitor Innovations category is dedicated to Pharmapack exhibitors who have developed a new product. For those who are not exhibiting, there is the Health Product category. This latter category distinguishes the packaging of new health products introduced to the market, or the improvement of the packaging of an existing health product (for human or veterinary use).

Both Awards recognize products that have significantly contributed to the proper use of medication, increased patient/user safety and compliance or represent a significant step towards sustainable packaging.

Pharmapack is a unique opportunity to sharpen up technical and industry knowledge. The extensive content programme comprises two days of conferences, a one-day Serialisation, Track and Trace Symposium, a day of Workshops and a Learning Lab that hosts short, sharp presentations on key topics from exhibitors throughout the 2 show days.

Dedicated networking areas and a special drinks reception mean there’s never a shortage of new faces to meet. It’s a unique opportunity for companies to boost their networks and kick-start their growth.

For more information visit here and get registered for Pharmapack Europe 2017!

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The UK has approved a new drug product for glaucoma treatment, delivered with Novelia®, Nemera’s multidose preservative-free eyedropper

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The Novelia® system is the first and only preservative-free multidose eyedropper UK-approved for a glaucoma drug.
Thanks to its unique innovative design, Novelia® has been approved as packaging component and delivery system of multidose drug product formulated without preservatives.

“This approval sets an important milestone for Novelia®” said Fanny Sellier, Category Manager of Nemera. “We’re excited to make it easier for UK patients to use preservative-free glaucoma drugs”

One way of keeping multi-dose eye droppers safe for patients is to add preservatives to the formulation. However, the use of preservatives can cause allergies or ocular irritation, and some can even cause a toxic response, damaging patients’ eyes[*]. Any such reactions are even more an issue for patients who rely on long term use of eye drops for chronic conditions, like glaucoma.

The alternative way to keep eye droppers contamination-free is by the intelligent use of technology. Rather than relying on the anti-microbial properties of preservatives to kill bacterias, the ideal approach is to prevent their entry into the bottle in the first place.

A viable alternative to the use of sterile filters for multi-dose preservative-free eye droppers is a non-return valve system used in conjunction with a silicone membrane to filter the incoming air. Novelia®: a multidose closing tip system avoids the need for preservatives in the drug and prevents bacterial contamination over the duration of treatment.

* Report of the International Dry Eye Workshop. Ocul Surf 2007; 5[2]; 65-204.

Visit Nemera’s booth