Regulatory Affairs News Channel

FDA targets unlawful internet sales of illegal prescription medicines during International Operation Pangea IX

FDAThe U.S. Food and Drug Administration, in partnership with international regulatory and law enforcement agencies, announced that it took action this week against 4,402 websites that illegally sell potentially dangerous, unapproved prescription drugs to U.S. consumers.

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FDA approves first buprenorphine implant for treatment of opioid dependence

FDAThe U.S. Food and Drug Administration today approved Probuphine, the first buprenorphine implant for the maintenance treatment of opioid dependence. Probuphine is designed to provide a constant, low-level dose of buprenorphine for six months in patients who are already stable on low-to-moderate doses of other forms of buprenorphine, as part of a complete treatment program.

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FDA approves new treatment for inhalation anthrax

FDAOn Friday, March 18, the U.S. Food and Drug Administration approved Anthim (obiltoxaximab) injection to treat inhalational anthrax in combination with appropriate antibacterial drugs. Anthim is also approved to prevent inhalational anthrax when alternative therapies are not available or not appropriate.

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Launch of PRIME - Paving the way for promising medicines for patients

EMAThe European Medicines Agency (EMA) has launched its new PRIME (PRIority MEdicines) scheme to strengthen support to medicines that target an unmet medical need. The scheme focuses on medicines that may offer a major therapeutic advantage over existing treatments, or benefit patients with no treatment options. These medicines are considered priority medicines within the European Union (EU).

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FDA takes additional action to better understand safety of Essure, inform patients of potential risks

FDAThe U.S. Food and Drug Administration has announced actions to provide important information about the risks of using Essure and to help women and their doctors be better informed of the potential complications associated with implantable forms of sterilization.

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FDA providing $2 million in new grants for natural history studies in rare diseases

FDAThe U.S. Food and Drug Administration today announced the availability of $2 million in research grants to fund natural history studies in rare diseases. The aim is to collect data on how specific rare diseases progress in individuals over time so that knowledge can inform and support product development and approval.

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FDA seeks $5.1 billion total for FY 2017

FDAThe U.S. Food and Drug Administration is requesting a total budget of $5.1 billion to protect and promote the public health as part of the President's fiscal year (FY) 2017 budget - an eight percent increase over the enacted budget for FY 2016.

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Boehringer Ingelheim increases acce…

Boehringer Ingelheim is announcing an expansion of its Intellectual Property (IP) enforcement policy. The IP enforcement policy had already been amended in 2007 by an eas...

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AstraZeneca licenses Zurampic to Gr…

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Merck announces survey results expl…

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Pfizer presents promising data from…

Pfizer Inc. (NYSE:PFE) today announced encouraging new data from a Phase 1/2 study of lorlatinib, the proposed generic name for PF-06463922, Pfizer's investigational, nex...

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Bayer Science & Education Found…

Applications for the Bayer Science & Education Foundation's international scholarship programs are now being accepted for this year's round. In the academic sector, ambit...

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Merck Accelerator expands its reach…

Merck, a leading science and technology company, has started this week the application period for the next round of its Accelerator programs in Darmstadt, Germany, and Na...

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Promising treatment prospects for i…

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AstraZeneca today announced it has entered into a commercialisation agreement with Aspen Global Incorporated (AGI), part of the Aspen Group, for rights to its global anae...

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Boehringer Ingelheim and Harvard sc…

Boehringer Ingelheim today announced it has established a research collaboration with the Harvard Stem Cell Institute's - Harvard Fibrosis Network to discover new ways of...

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Call for Abstracts: DIA EuroMeeting…

29 - 31 March 2017, Glasgow, UK. The DIA EuroMeeting 2017 provides a platform for experts from all relevant disciplines within the entire healthcare development and acce...

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New class of protein could treat ca…

A protein designed by researchers at Georgia State University can effectively target a cell surface receptor linked to a number of diseases, showing potential as a therap...

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The U.S. Food and Drug Administration, in partnership with international regulatory and law enforcement agencies, announced that it took action this week against 4,402 we...

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