FDA Initiates Response Efforts Post Hurricane Florence
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The US Food and Drug Administration (FDA) has taken action to support recovery from Hurricane Florence, particularly to prevent drug shortages from pharmaceutical companies manufacturing important drugs. The hurricane struck…

FDA Issues Guidances To Implement Drug Supply Chain Security Act
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The FDA has issued two final guidances and one draft guidance for implementing the Drug Supply Chain Security Act (DSCSA), a law that specifies requirements for building an electronic, interoperable…

FDA Finds More Impurities in Recalled High Blood Pressure Drug Valsartan
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The FDA has found an additional impurity in its ongoing investigation of several recently recalled drug products containing the active pharmaceutical ingredient (API) valsartan, used to treat high blood pressure…

Wacker Invests in Biotech Site
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Wacker, a Munich, Germany-based chemical company, has expanded its biologics production facilities in Jena, Germany, with a new microbiology laboratory and equipment for process and product characterization. “In recent years,…

Sun Pharma Wins FDA OK to Produce Glaucoma Drug at Halol Plant
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The US Food and Drug Administration (FDA) has approved a new drug application (NDA) for Xelprostm (latanoprost ophthalmic emulsion) 0.005%, an eye-pressure reducer, from Sun Pharmaceutical Industries, a Mumbai, India-headquartered…

Allergan To Acquire Biopharm Bonti for $195 Million
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Allergan has agreed to acquire Bonti, a Newport Beach, California-based clinical-stage biopharmaceutical company focused on developing and commercializing fast-acting neurotoxin programs for aesthetic and therapeutic applications. Following completion of the…

US Senate Passes Opioid Crisis Bill
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The US Senate has passed The Opioid Crisis Response Act of 2018, bipartisan legislation that included over 70 proposals from five Senate committees to address the challenge of opioid misuse…

GSK Expands Canadian Rx Drug Mfg Plant for OTC Production
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GlaxoSmithKline (GSK) has invested $36 million to modernize its site in Mississauga, Ontario, Canada into a consumer healthcare and prescription supply site. The investment enabled facility modifications, new equipment purchases,…

Sanofi To Restructure Two Global Business Units
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Sanofi has announced plans to change the organizational structure of two of its global business units (GBUs) to provide greater focus on its operations in mature markets and emerging markets.…

GSK Announces Staff Reductions in US Biz
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Following a business review, GlaxoSmithKline (GSK) has announced staff reductions of up to 650 employees across its US business, primarily in sales and back-office operations. These changes are part of…