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LYNCHBURG, Va.--(BUSINESS WIRE)--BWXT has been awarded a contract to manufacture additional Common Missile Compartment (CMC) tube assemblies for Columbia Class nuclear submarines.


ALPHARETTA, Ga.--(BUSINESS WIRE)--Cartiva, Inc. (Company), a developer of innovative products for treating cartilage damage and osteoarthritis, announced today that it has completed enrollment and treatment of all 50 patients in a multi-center study evaluating the safety and effectiveness of Cartiva Synthetic Cartilage Implant (SCI) for first carpometacarpal (CMC) joint osteoarthritis at the base of the thumb. The study was conducted at nine sites in Canada and the United Kingdom. Basal thumb a


News Article | April 17, 2017
Site: www.prlog.org

-- http://chemiclabs.com Chemic Laboratories Inc. and Tamarack today announced establishment of a formal three year renewable Joint Cooperation Agreement. Tamarack will represent Chemic in certain business development activities primarily in the areas of product development as it pertains to extractables and leachables Single-Use Systems (SUS) and traditional API and DP CMC services. Under this agreement, Tamarack will serve as a business development conduit to facilitate continued Chemic growth and provide our customers with an additional means of attentive and personalized service."Chemic is delighted to enter into this formal agreement. "Tamarack's team is the exact group we have been looking for to best represent us in the mid-west territory and we look forward to a long and lasting relationship"said Joseph St. Laurent, President and CSO of Chemic Laboratories Inc. "This Joint Agreement allows our two companies to immediately take advantage of our individual expertise's and continue as an important resource for our customers.""Tamarack could not be more pleased to be working with Chemic.  Chemic has a strong reputation as a high-quality organization that has helped so many of its customer successfully prepare products for market, which fits well with Tamarack's customer focus strategy" stated Todd Kapp, CEO of Tamarack Business Development Enterprises, LLC. "Offering state of the art technologies and services is critical to development of life saving products and taking this next step with Chemic will help us facilitate the process."


News Article | April 20, 2017
Site: www.pressat.co.uk

Safran Helicopter Engines is proud to announce the signing of its first support contract in South Korea with Aero Peace. This 5Star Plans Business agreement will cover the Arriel 1D1 engine powering Aero Peace's AS350B2. The contract has been announced during Rotorcraft Asia in Singapore, in the presence of Bruno Even, Chief Executive Officer of Safran Helicopter Engines and Mr. Hanbaek Kim, Business Development Director of Aero Peace. 5Star Plans contracts have already been signed in Spain, Norway and United States. Aero Peace's contract is the first one finalized in Asia. 5Star Plans is a new Safran Helicopter Engines support contract designed for customers operating up to five helicopters. It offers five different levels of service covering scheduled and unscheduled events, standard exchange, preferential engine pool access, warranty extension and (depending on customer profile and mission types) by-the-hour support. Bruno Even commented: 'This contract takes our commercial relationship with Aero Peace to greater heights. We appreciate their confidence in our program and look forward to supporting them in over the years ahead.' Mr. Kim said: '5Star Plans is perfectly tailored to supporting our missions and we are confident that Safran will meet our requirements'. For the last four years, Aero Peace has been a level 1 & 2 Safran Certified Maintenance Center (CMC) for Arriel 1E2, 1D1, 2S1 and 2S2 engines to support civil customers in South Korea.


News Article | April 24, 2017
Site: www.theguardian.com

Stock markets surged and the euro jumped sharply after centrist candidate Emmanuel Macron won the first round of the weekend’s French presidential election, easing fears of a victory by the far-right Front National. France’s Cac index climbed more than 4% to a nine-year high, its best daily performance since August 2015, as investors bet that Macron would defeat the other runoff candidate, the FN’s Marine Le Pen on 7 May. The first vote put Macron on 23.75% with Le Pen on 21.53%. The result was seen as the most market-friendly outcome, putting the independent former investment banker in pole position to fend off the anti-EU Le Pen. The euphoric mood spilled over into other stock markets, with Germany’s Dax up 3.3% to a new closing peak and the FTSE 100 recovering 2.1% to 7,264 after last week’s slump in the wake of the UK general election announcement. . The FTSE 250 added more than 1% to hit a record closing high, while in Asia the Nikkei 225 ended up nearly 1.4%. On Wall Street, US markets also rallied, with the Dow Jones Industrial Average up by about 200 points or nearly 1% by lunchtime and the Nasdaq Composite technology index hitting its best ever level. Banking shares were among the leading gainers across the globe, lifted by the prospect of a more certain economic outlook for the eurozone if the EU-friendly Macron wins the final round of the election. The VIX volatility index – the so-called fear index – fell by 22%, its biggest daily drop since the day after Donald Trump’s US election victory last November. Meanwhile, the single currency hit a five-and-a-half month high against the dollar. Although it came off its best levels, it was still up about 1% against the dollar and the pound as European markets closed. Sterling had its worst day against the euro since last October and analysts cautioned the currency was likely to remain volatile before the latest European Central Bank meeting on Thursday. French government 10-year bond prices rose to three-month highs as concerns about the election eased. Michael Hewson at CMC Markets said: “For markets, this was always the least bad option, with most expecting Mr Macron to become president in two weeks’ time as the other candidates endorse him over Marine Le Pen. “But for all his market and EU-friendly rhetoric, Emmanuel Macron will face the same problems previous French presidents have faced, which means he will have to reach out across the political divide. This lack of support is likely to make him a lame duck president, only able to affect minor tweaks or changes.” Trevor Greetham, the head of multi asset at Royal London Asset Management, said: “It’s worth noting that the French election is likely to be the first of several risks to test markets as thin summer trading comes into view. “Signs of a temporary peaking out in global growth, the impact of tightening moves in China and, first up, a potential government shutdown in the US at the end of this week, mean investors can’t pop the champagne corks just yet.”


News Article | May 4, 2017
Site: www.prweb.com

RMC Pharmaceutical Solutions, Inc. enhances its global expert services team with the addition of Duane Bonam and Molly Sherrard as senior consultants. Duane brings over 25 years of experience in bio-pharmaceutical process development, manufacturing support, and global CMC regulatory filings including marketing applications and post-approval changes. His expertise is with the development, scale-up and improvement of investigational and commercial manufacturing processes, process characterization, qualification and verification and QbD, viral clearance and safety issues; as well as authorship and technical review of CMC sections in regulatory filings. Before joining RMC, Duane was at Amgen for over 15 years. As a Scientific Director, he supported late-stage development and commercial processes, implementation of QbD, and participated in the FDA QbD pilot program. Prior to Amgen, Duane was at Wyeth (formerly Genetics Institute) where he helped develop the purification process for recombinant Factor IX and provided ongoing commercial life-cycle support. Duane received his Ph.D. in biochemistry from the University of Wisconsin, and a B.S in chemistry/biochemistry from the University of Illinois. “As RMC’s global reputation for excellence continues to grow, Duane brings valuable strategic and tactical CMC experience to RMC,” said Timothy Joy, President of RMC. “Duane’s depth of experience in highly successful programs, lets him hit the ground running with practical, knowledgeable hands-on execution and assistance that our clients have come to expect from RMC. Several of our staff have worked with Duane in the past, and we’re confident that he will fit in well with RMC’s “Bolt On” strategy for CMC development for all kinds of pharmaceutical and biological products” Molly comes to RMC with over 18 years of pharmaceutical experience gained across technical and leadership roles at several large-scale API manufacturing and drug product packaging sites. Prior to joining RMC, Molly established her adaptive skillsets with successful roles as a production engineer, manager API manufacturing and operational excellence at Pfizer; and manager of packaging technology and project manager at Bristol-Myers Squibb and AstraZeneca. She also brings extensive experience with quality investigations, process improvement, new product launches, packaging line startup, general technical operations support and multiple implementation options to meet global product serialization expectations. Molly received a Bachelor of Science in Chemical Engineering from the University of Kentucky, as well as training in the Rath & Strong Method 4 Lean methodology and Project Management Professional certification from the Project Management Institute. “Molly’s solid engineering background and technical project management leadership, which transcends both API manufacturing and drug product packaging systems, is exemplified in her cross-functional adaptability and expertise,” said Timothy Joy, President of RMC. “We expect that Molly’s broad background, commitment to success and her contemporary understanding of key global product packaging and commercialization challenges, will have an immediate positive impact on our RMC teams and the clients they support.” Founded in 2004, RMC is the privately-held global leader providing Bolt-on CMC™ expert services to the pharmaceutical, biotechnology, medical device and allied industries. RMC was founded to provide comprehensive services to companies developing and commercializing health care products and has now served more than 150 different clients across North America, Europe and Asia. Through our Bolt-on CMC™ expert services offering, RMC provides an experienced integrated team to directly support Chemistry, Manufacturing and Control (CMC) areas such as process, analytical and formulation development; quality control/quality assurance; and oversight of GMP manufacturing. RMC experts also support the full range of pharmaceutical development and commercialization of GxP activities. Our clients have access to the considerable expertise of the RMC team, as well as physical assets; including an analytical and process development laboratory, document management, and advanced software tools. For more information about RMC and how we can help you, please visit http://www.rmcpharma.com.


Formed in 2010, and financed with investment capital and presales from China, Crimson Forest Entertainment has successfully financed and acquired several films for international and North America distribution. PALI ROAD was the first Hawaii-China co-production, starring Jackson Rathbone from the "The Twilight Saga," Sung Kang from "Fast & Furious," Henry Ian Cusick, known for his roles in "L.O.S.T.,"  and "The 100," and Chinese Celebrity Michelle Chen. The film premiered at the Hawaii International Film Festival and went on to win several awards, including "Best Actress" "Best Cinematography" and a "Best Director" award at the 12th Annual Chinese American Film Festival. The film was released theatrically, both in North America and China, and in Malaysia earlier this month. Formed in 1993 and growing into one of the top independent distributed labels in North America, Hannover House, Inc. has direct distribution relationships for all major theatre circuits, principal media outlets, and wholesale access to major home video retailers and mass merchants.  Hannover House has released more than 50 films to theatres and more than 300 titles to the Home Video Market in the United States, including titles such as "Grand Champion" (with Bruce Willis, Julia Roberts and George Strait) and director Joel Schumacher's teen angst thriller "Twelve" (starring Curtis "50-Cent" Jackson, Emma Roberts, Ellen Barkin and Chase Crawford). "There is a growing need for specialty independent distributors," said Jonathan Lim, CEO of Crimson Forest Entertainment. "There is a lot of quality product out there that is being ignored and we are excited that Hannover House has partnered with us in releasing these films. It will bring much needed diversity to audiences in North America, and growing commercial success for the combined company," he concluded. "A Crimson Forest and Hannover House merger is expected to fill the demand from independent and international productions, which seek distributors that have direct access to theatrical, as well as Home Video and VOD & Digital sales," said Eric Parkinson, CEO of Hannover House. "We're optimistic about what these new opportunities and corporate structure will bring to Hannover House and our shareholders and excited by the upcoming titles that we will be announcing and releasing in the upcoming weeks, which we fully anticipate will have a substantial impact on the growth of our combined company, " said Parkinson. One of the first new titles to be released under the combined Crimson Forest – Hannover House structure is the $20-million dollar action thriller feature "Shockwave" starring Andy Lau and Jiang Wu. The film will be co-released together with CMC Pictures in North America next month. Under the newly merged company, the board of directors will be comprised as follows: Jonathan Lim (Chairman), Eric Parkinson (CEO), Fred Shefte (President) and Tom Sims (V.P. Sales).  The existing offices for Hannover House, Inc. and its affiliate Medallion Releasing, Inc. in Fayetteville, Arkansas will remain as the primary distribution operations office.  The Los Angeles offices for Crimson Forest will serve as the company's corporate and production headquarters, and the Crimson Forest office in Shanghai, China, will continue to operate as the finance office for the funding of new productions and releasing costs. Crimson Forest is also negotiating for the acquisition of other, complementary media companies to add to the enhanced distribution entity. Included in the corporate merger are Hannover House affiliates, Medallion Releasing, Inc. and Bookworks, Inc., respectively handling theatrical and publishing ventures. For more information, contact ERIC PARKINSON, Hannover House, Inc. / Medallion Releasing, Inc., 479-521-5774 or 818-481-5277, Eric@HannoverHouse.com. To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/crimson-forest-and-hannover-house-initiate-corporate-merger-to-become-major-independent-distributor-300445930.html


--Combined Company to Launch Slate of High-Profile Films for Theatrical, Home Video and International Release-- LOS ANGELES, April 26, 2017 /PRNewswire/ -- Feature Film Production Company Crimson Forest Entertainment Group Inc. (OTC: CRIM) and specialty theatrical and home video distributor Hannover House, Inc. (OTC: HHSE) have confirmed plans to merge operations under a stock-swap and financing plan, scheduled to be effective as of May 1, 2017. The combined company will immediately launch production activities on a slate of high-profile feature films that will drive the theatrical, home video and international release schedules for the coming years. Formed in 2010, and financed with investment capital and presales from China, Crimson Forest Entertainment has successfully financed and acquired several films for international and North America distribution. PALI ROAD was the first Hawaii-China co-production, starring Jackson Rathbone from the "The Twilight Saga," Sung Kang from "Fast & Furious," Henry Ian Cusick, known for his roles in "L.O.S.T.,"  and "The 100," and Chinese Celebrity Michelle Chen. The film premiered at the Hawaii International Film Festival and went on to win several awards, including "Best Actress" "Best Cinematography" and a "Best Director" award at the 12th Annual Chinese American Film Festival. The film was released theatrically, both in North America and China, and in Malaysia earlier this month. Formed in 1993 and growing into one of the top independent distributed labels in North America, Hannover House, Inc. has direct distribution relationships for all major theatre circuits, principal media outlets, and wholesale access to major home video retailers and mass merchants.  Hannover House has released more than 50 films to theatres and more than 300 titles to the Home Video Market in the United States, including titles such as "Grand Champion" (with Bruce Willis, Julia Roberts and George Strait) and director Joel Schumacher's teen angst thriller "Twelve" (starring Curtis "50-Cent" Jackson, Emma Roberts, Ellen Barkin and Chase Crawford). "There is a growing need for specialty independent distributors," said Jonathan Lim, CEO of Crimson Forest Entertainment. "There is a lot of quality product out there that is being ignored and we are excited that Hannover House has partnered with us in releasing these films. It will bring much needed diversity to audiences in North America, and growing commercial success for the combined company," he concluded. "A Crimson Forest and Hannover House merger is expected to fill the demand from independent and international productions, which seek distributors that have direct access to theatrical, as well as Home Video and VOD & Digital sales," said Eric Parkinson, CEO of Hannover House. "We're optimistic about what these new opportunities and corporate structure will bring to Hannover House and our shareholders and excited by the upcoming titles that we will be announcing and releasing in the upcoming weeks, which we fully anticipate will have a substantial impact on the growth of our combined company, " said Parkinson. One of the first new titles to be released under the combined Crimson Forest -- Hannover House structure is the $20-million dollar action thriller feature "Shockwave" starring Andy Lau and Jiang Wu. The film will be co-released together with CMC Pictures in North America next month. Under the newly merged company, the board of directors will be comprised as follows: Jonathan Lim (Chairman), Eric Parkinson (CEO), Fred Shefte (President) and Tom Sims (V.P. Sales).  The existing offices for Hannover House, Inc. and its affiliate Medallion Releasing, Inc. in Fayetteville, Arkansas will remain as the primary distribution operations office.  The Los Angeles offices for Crimson Forest will serve as the company's corporate and production headquarters, and the Crimson Forest office in Shanghai, China, will continue to operate as the finance office for the funding of new productions and releasing costs. Crimson Forest is also negotiating for the acquisition of other, complementary media companies to add to the enhanced distribution entity. Included in the corporate merger are Hannover House affiliates, Medallion Releasing, Inc. and Bookworks, Inc., respectively handling theatrical and publishing ventures. For more information, contact ERIC PARKINSON, Hannover House, Inc. / Medallion Releasing, Inc., 479-521-5774 or 818-481-5277, Eric@HannoverHouse.com.


News Article | April 28, 2017
Site: co.newswire.com

Since January 2017, Lisa Stotts has been serving as chief financial officer at CMC Energy Services (http://cmcenergy.com), based in Fort Washington, PA, with locations in Connecticut, Maryland, Massachusetts, and New Jersey. Stotts’ decades-long career spans several appointments as CFO and vice president of finance for multi-million dollar companies, in addition to extensive accounting leadership experience for Marriott International, Inc. Stotts, who earned her undergraduate degree in accounting from the University of Maryland and an MBA from St. Joseph’s University, says she chose CMC for its distinct mission and tradition of being women owned and women operated. Founded in 1977 by Doris Ikle, CMC Energy Services designs and implements energy efficiency programs for more than 20 utilities. The company continues to be certified as a women-owned business by the Women’s Business Enterprise National Council (WBENC). CMC Energy Services will be the first WEBENC company Stotts has led, and she’s delighted. “What attracted me first and foremost is the mission,” says Stotts. “Helping people, the ratepayers, especially low-income customers, that was meaningful for me. I can do what I do anywhere, but at CMC people are top of mind for senior leadership and our board.” Prior to joining CMC, Stotts consulted with CMF Associates in Philadelphia and in that capacity served as interim chief financial officer for various companies. Previously she served as chief financial officer for Soleo Healthcare, formerly Biomed, in Sharon Hill, Pa. She also spent nearly a decade at Maxwell Systems, Inc., in King of Prussia, leading the finance and accounting department as vice president. Her early career was spent at Marriott International, Inc. in Washington, D.C. supporting hotel operations and maximizing profitability. It was at Marriott, where Stotts cultivated her strength in customer relations. CMC Energy Services has invested significantly in its customer services capacity; most recently in a newly implemented customer care center. She points to Marriott founder J. Willard Marriott for the sage counsel she learned as a Marriott manager and continues to practice today: "Take care of associates and they'll take care of your customers." But joining a company whose tagline is “Conserving Energy, Preserving the Future,” is also compelling for Stotts. “Regardless of what you might believe about global warming, we all understand the diminishing resources of our planet,” she says. “At CMC, we’re acting responsibly. There’s a big education component to what we do. When auditors go out to a home, they teach many things homeowners never knew.” While new to the energy industry, Stotts notes that her inherently curious nature is an asset to the company on pace for continued growth. In 2015, the company acquired Competitive Resources, Inc., which has recently been rebranded as CMC Energy Services. “One of the things I bring to the table is a different way of looking at things,” says Stotts, who is also a committed marathon competitor. “By nature, I question everything to learn, but also to think about the process at the very core.” On the connection between professional success and long-distance running, Stotts says both require stamina. “My perspective on running is that it creates a balance,” she explains. “I am able to unplug completely and focus on the training required to meet the challenges of running half and full marathons.  This is very consistent with the persistence required for change, keep a steady pace and remember it’s not a sprint.”


This seminar on veterinary medicine regulations will provide attendees with a comprehensive understanding of FDA's veterinary drug approval process. The U.S. Food and Drug Administration's Center for Veterinary Medicine or CVM is responsible for the approval of veterinary drug products intended for both family pets and food-producing animals. FDA regulates not all products intended for animal use. Jurisdiction over animal products including licensed biologics such as vaccines is shared with a number of other federal agencies. For example, animal vaccines, animal disease diagnostic devices and some animal biologics are regulated by the U.S. Department of Agriculture's Animal and Plant Health Inspection Service or APHIS; and products such as flea and tick collars are regulated by the Environmental Protection Agency. This two day interactive course will cover: - Premarket approval process - Various sections of a New Animal Drug Application - Strategies for navigating the FDA approval process and for expending product approval - The nature of shared jurisdiction over veterinary products in certain cases. - Understand how the U.S. Food and Drug Administration regulates veterinary drug product. - Understand how FDA's Center for Veterinary Medicine is organized. - Discuss the process by which veterinary drug products are reviewed and approved. - Learn how to open an INAD File and request fee waivers. - Obtain a working knowledge of various sections included within an NADA. - Develop a deep understanding of what is needed to substantiate product characterization, target safety and effectiveness. - Analyze FDA's rules governing chemistry, manufacturing and controls or CMC. - Understand the various components of an animal field study to support product approval. - Discuss the difference between FDA's various user fees and fee waivers. - Identify the elements of an FDA compliant label. - Develop a corporate compliance strategy covering labeling, marketing and advertising. - Problem solving methods to mitigate regulatory enforcement risks. - Explain how jurisdiction is split between various Federal agencies in a certain cases. - Learn how animal feed, veterinary devices, OTC drug products and nutritional supplement are regulated in the U.S. Introduction to Veterinary Drug Approval process - FDA's jurisdiction and Center's relevant to Animal Health - Center for Food Safety and Applied Nutrition (CFSAN) - Center for Drug Evaluation and Research (CDER) - Center for Veterinary Medicine (CVM) - Specifics of CVM - Intro to the FDCA, AMDUCA, ADAA, MUMS, etc and guidance (GFI) - Overview of FDCA and regulations - Introduction to FDA GFI Overview of Veterinary Drug Development Discovery/Acquisition - Preliminary Patent Protection Concerns Submissions - Open INAD File - NADA (8 sections) - 5 Major Technical Sections - Chemistry, Manufacturing and Controls (CMC) - Safety (target animal safety study) - Efficacy (field study) - Human Food Safety (human food safety studies for food-producing animals) - Environmental Impact (EA/CE) - 3 Minor Technical Sections - All other information - Labeling - Freedom of Information Summary (FOI) Brief Description of cGxP (GMP, GLP, &GCP) CMC - API: name, structure, properties - API manufacturing - Clinical Trial material - Final Formulation Target Animal Safety - Content and format - Final Study Reports - Monitoring and Reporting Adverse Drug Events Human Food Safety - Analysis of Drug Residues - Toxicology - Residue Chemistry - Microbial Food Safety - Regulatory Method Relied Upon by Sponsor Effectiveness - Dosage Characterization - Substantial evidence (e.g. dose confirmation and clinical field studies) - All other information related to effectiveness - Proposed effectiveness-related labelling - Effectiveness Guidance Documents - The 7 Major Phases of Animal Field Studies - Planning - Study Initiation - In-life Activities - Site close-out - Data management - Biostatistical analysis - Report Writing Approval Process: Chemistry, Manufacturing Controls, Environmental Impact & Managing Clinical Trials - Environmental Impact - Categorical Exclusions - Environmental Assessments (EA) - Common EA Components - Environmental Impact Statements (EIS) - Labeling - FOI - AOI Animal Drug User Fees and Related Fee Waivers - Veterinary Drug User Fees and Fee Reductions and Waivers - Animal Drug User Fee Act (ADUFA) - Applies to Innovators Only - Animal Generic Drug User Fee Act (ADGUF) - Applies to Generic Manufacturers - ANADA sections - CMC - BE (Safety & Efficacy) - HFS - All others - Types of User Fees - Animal Drug Application and Supplement Fee - Animal Drug Product Fee - Animal Establishment Fee - Animal Drug Sponsor fee - Types of Fee Waivers and Reductions - Procedures, Timing and FDA Evaluation of Waivers or Reductions - FDA decision on approval Introduction to FDA's Regulation of Veterinary Feed, OTC Drugs and Supplements - Animal Feed - GRAS - Feed Labeling - AAFCO - Veterinary Feed Directive (VFD) - Veterinary OTC Drugs and Nutritional Supplements - Regulatory Agencies - CVM Compliance Policy - CPG 690.150 & CPG 690.100 - Veterinary Medical Devices CPG 655.100 USDA (CVB, APHIS, FSIS) & EPA - USDA's Animal and Plant Health Inspection Service - Virus Serum Toxin Act - Animal vaccines - Animal biologics - Animal disease diagnostic devices - EPA - Flea & Tick Products - Insect Repellants such as Equine Fly Sprays - State Registrations Non-Approval-Related Considerations - Extra-Label Drug Use - Compounding - Noncompliance and Enforcement - FDA Enforcement Authority over Development, Manufacture, Marketing, and Distribution - FDA's Office of Regulatory Affairs (ORA): Responsible for field activities, imports, inspections, and enforcement policy - Local, State, and Tribal governments - CVM's Office of Surveillance and Compliance - Types of Enforcement Actions Importance of Patent Protection: Right to Enforce For more information about this conference visit http://www.researchandmarkets.com/research/h6p6wc/the_veterinary To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/two-day-veterinary-drug-approval-process-and-fda-regulatory-oversight-course-kansas-city-missouri-united-states---june-13-14-2017---research-and-markets-300444055.html

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