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CDMO Recro Gainesville will continue to supply Verapamil SR capsules through 2024 Recro Gainesville, the contract development and manufacturing organization (CDMO) division of Recro Pharma, has amended its existing license and supply agreement with Teva Pharmaceutical to extend the agreement for six years, effective January 1, 2019. Under the terms of the amended agreement, Recro Gainesville will continue to supply Teva with Verapamil SR capsules through 2024 and Teva will continue to be Recro Gainesville’s exclusive U.S. distributor of the product, for which Recro Gainesville is the New Drug Application (NDA) holder. The 2019 Teva agreement provides to Recro Gainesville the same revenue economics as the original agreement, including both manufacturing and profit sharing components. Prior to this amendment, the license and supply agreement with Teva for Verapamil SR was renewable on a year-to-year basis.
Georgia’s life science industry has experienced a 14.9 percent growth in employment during the past decade, according to the results of the 2019 Georgia Life Sciences State of the Industry Report released Wednesday morning. That was nearly double the growth of life sciences employment nationally – 7.7 percent – over the same decade (2007 to 2017). “We can attribute this growth to increased investment in research and our academic institutions,” said Maria Thacker-Goethe, president and CEO of Georgia Bio.
The Gwinnett Chamber, one of the largest suburban Chambers of Commerce in the nation, recently announced its selection for its new President & CEO, effective July 1. Following a four-month search process, members of the Gwinnett Chamber board of directors voted in support of appointing Nick Masino, currently Gwinnett Chamber & Partnership Gwinnett’s Chief Economic Development Officer, to take the reins from Dr. Dan Kaufman, who has served in the role since 2013. “The Gwinnett Chamber of Commerce is pleased and excited to announce the selection of Nick Masino as the new President & CEO of the Chamber to succeed retiring Dr. Dan Kaufman. The Chamber conducted a rigorous search for Dr. Kaufman’s successor, resulting in the interviews of six very capable finalists, with Nick emerging as the unanimous choice of the search committee and the Board of Directors,” said 2019 Gwinnett Chamber Board Chairman Tom Andersen. “Nick brings incredible energy and dynamism to the job, with great experience in having directed economic development for the Chamber through the Partnership Gwinnett initiative for over a decade. He’s well respected, not only in Gwinnett County, but in the entire metropolitan Atlanta region, and, with his experience and skill set, he will clearly be able to hit the ground running in leading the Gwinnett Chamber to new heights. He will continue in the line of extremely talented and effective CEOs for the Gwinnett Chamber.”
Ananya Ganesh Advances to Philadelphia in International Competition Against Top Students Atlanta, GA (April 10, 2019)– Georgia Bio and the Georgia BioEd Institute today named Ananya Ganesh, a junior at The Westminster Schools in Atlanta, GA, as the winner of the 2019 Georgia BioGENEius Challenge, the premier competition for high school students that recognizes outstanding research and innovation in the biotechnology field. As Georgia’s BioGENEius finalist, Ananya will attend the 2019 BIO International Convention, the industry’s trade conference from June 3-6 in Philadelphia, PA where she will engage with leading companies, scientists and innovators currently transforming the scientific landscape in order to gain valuable insights into an industry making significant contributions to the world. While in Philadelphia, Ananya will compete against high school students from the U.S., Canada and Germany in the International BioGENEius Challenge. The student projects will represent a range of biotechnology topics such as healthcare, agriculture, and the environment.
April 10, 2019. WASHINGTON, D.C. – Scott Whitaker, president and CEO of the Advanced Medical Technology Association (AdvaMed), issued the following statement on introduction of bipartisan legislation (H.R. 2207) in the U.S. House of Representatives to permanently repeal the medical device excise tax: “America’s medical technology industry is facing a $20 billion tax increase at year-end, when the current medical device tax suspension expires. Urgent action is essential to protect future medtech innovations that benefit patients and to avoid putting good-paying U.S. jobs at risk. “House introduction today of the Protect Medical Innovation Act in the 116thCongress brings us one step closer to ensuring this innovation-stifling burden on the medtech industry never returns, supporting continued American leadership of this vital industry.
FDA Approves EVENITY™ (romosozumab-aqqg) For The Treatment Of Osteoporosis In Postmenopausal Women At High Risk For Fracture
One in Two Women in the United States Will Suffer a Fracture in Her Lifetime Due to Osteoporosis(1) EVENITY is the First and Only Bone Builder With a Dual Effect That Both Increases Bone Formation and Decreases Bone Loss(2) EVENITY Rapidly Reduces Fracture Risk and Builds New Bone With 12 Months of Therapy(2) THOUSAND OAKS, Calif. and BRUSSELS, April 9, 2019 /PRNewswire/ -- Amgen (NASDAQ: AMGN) and UCB (Euronext Brussels: UCB) today announced that the U.S. Food and Drug Administration (FDA) has approved EVENITY™ (romosozumab-aqqg) for the treatment of osteoporosis in postmenopausal women at high risk for fracture. EVENITY is the first and only bone builder with a unique dual effect that both increases bone formation and to a lesser extent reduces bone resorption (or bone loss) to rapidly reduce the risk of fracture. A full course of EVENITY therapy is 12 monthly doses administered by a healthcare provider.2 Since osteoporosis is a chronic disease, continued therapy with an anti-resorptive agent should be considered once EVENITY therapy is completed.
An Alpharetta company that is working on treatments for eye disease patients has named a member of its board of directors as interim CEO. George Lasezkay succeeds Daniel H. White as chief executive of Clearside Biomedical Inc. (NASDAQ: CLSD). White resigned as president, CEO and as a member of the Clearside board to pursue other opportunities, according to a company announcement. Lasezkay has served as an independent director on the boards of a number of domestic and foreign emerging biopharmaceutical companies for the past 15 years. He has been a director of Clearside since August 2017. Previously, he served as executive vice president and general counsel at Acucela Inc., a development stage company that identifies and develops ophthalmic therapeutics. For the 10 years prior to Acucela, he was president of Horizon Pharma Group, a private life sciences consultancy practice. Prior to Horizon, Lasezkay was corporate vice president for corporate development at Allergan Inc.
Washington, D.C. (April 4, 2019) – Congressman Doug Collins was recognized today by the Biotechnology Innovation Organization (BIO) for his leadership as an Innovator in Biotechnology. Congressman Collins received the award in conjunction with today’s BIO Legislative Day Fly-In. BIO’s Innovator in Biotechnology award recognizes Members of Congress who have been collaborative partners, advocates, and champions of the biotechnology and life sciences industries. “The life sciences industry in Georgia provides jobs for over 32,000 people. Congressman Collins has been an invaluable advocate for the biotechnology community – both in Georgia’s 9th District and the nation at large,” said Maria Thacker Goethe, President & CEO, Georgia Bio. “On behalf of the Georgia life science industry, we thank him for outstanding leadership and dedication to supporting the innovative capacity and job-creating potential of American life science companies.”
Washington, D.C. (April 4, 2019) – Senator Johnny Isakson was recognized today by the Biotechnology Innovation Organization (BIO) for his leadership as an Innovator in Biotechnology. Senator Isakson received the award in conjunction with today’s BIO Legislative Day Fly-In. BIO’s Innovator in Biotechnology award recognizes Members of Congress who have been collaborative partners, advocates, and champions of the biotechnology and life sciences industries. “The life sciences industry in Georgia provides jobs for over 32,000 people. Senator Isakson has been an invaluable advocate for the biotechnology community – both in Georgia and the nation at large,” said Maria Thacker, President and CEO of Georgia Bio. “On behalf of Georgia’s life science industry, we thank him for outstanding leadership and dedication to supporting the innovative capacity and job-creating potential of American life science companies.”
The European Medicines Agency (EMA) has accepted Takeda’s marketing authorisation application for its subcutaneous formulation of Entyvio (vedolizumab) for maintenance therapy in moderately to severely active ulcerative colitis and Crohn’s disease. If approved, the drug would be the only maintenance therapy to offer the options of both intravenous or subcutaneous formulations across ulcerative colitis or Crohn’s disease. The company proposes to make it available in both pre-filled syringe and pen options, helping provide greater choice in how patients receive therapy.
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