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    EU Advances SPC Waiver Proposal

    The European Union's proposal to allow manufacturing waivers to supplementary protection certificates (SPC) took a step forward on Wednesday after EU ambassadors backed the EU Council's position on the proposed regulation during a meeting of the Committee of the Permanent Representatives (Coreper).   "The draft regulation is expected to remove the competitive disadvantages faced by EU-based manufacturers of generics and biosimilars vis-à-vis manufacturers established o...
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    FDA Revises Draft Guidance on Rare Diseases

    The US Food and Drug Administration (FDA) has updated a 2015 draft guidance on rare diseases, with new information gleaned since the original draft was released. Among the revisions to the 24-page draft guidance, according to FDA, are updates to the natural history studies section, the inclusion of issues for evaluating and validating biomarkers as surrogate endpoints, a discussion of additional flexibility on the non-clinical aspects of the evaluation of novel drug com...
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    FDA Approves First Generic Version of Lundbeck’s Sabril

    The US Food and Drug Administration (FDA) on Wednesday approved Teva Pharmaceuticals’ first generic tablet version of Lundbeck’s seizure medicine Sabril (vigabtrin). Vigabatrin tablets are FDA-approved for the treatment of refractory complex partial seizures (CPS) as an adjunctive therapy in patients 10 years of age and older who have responded inadequately to several alternative treatments. The vigabatrin powder market had US sales of approximately $333 million for the...
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    Recon: Massachusetts AG Says Sackler Family Pushed Opioid Sales

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Sacklers Directed Efforts to Mislead Public About OxyContin, New Documents Indicate ( NYTimes ) ( Reuters ) ( WSJ ) ( NBC ) FDA nervous about PDUFA ( Politico ) ( CNN ) Senators Ask FDA to Update Rules on Certain Pot Products ( NYTimes ) ABC documentary on Theranos features ex-CEO deposition tapes ( Reuters ) Can Trump claim credit for $26 billion in savings ...
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    FDA Drafts Guidance on Tentatively Approved ANDAs

    In a first for the US Food and Drug Administration (FDA) during the shutdown, the agency has posted new draft guidance to assist generic drug applicants in preparing and submitting amendments to tentatively approved abbreviated new drug applications (ANDAs), including requests for final approval. “We are posting this document on the FDA website as Federal Register (FR) publication is not currently available for this document,” the agency said. “This posting is to provid...
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    EU Restricts Slovak Manufacturer’s GMP Certificate Over Spate of Deficiencies

    Unimed Pharma, a Slovakia-based pharmaceutical manufacturer, drew a statement of noncompliance after an inspection revealed two critical and 21 major good manufacturing practices (GMP) deficiencies. The statement of noncompliance took issue with the firm’s manufacturing operations for sterile products, including aseptically prepared small volume liquids and batch certification. The statement was issued by the Slovakian State Institute for Drug Control (SIDC), following ...
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    Updated: UK Parliament Rejects Brexit Agreement as EFPIA Warns of Threats to Patient Safety

    EU biopharmaceutical industry group EFPIA on Tuesday said that the UK parliament’s decision to reject the Brexit withdrawal agreement, by a vote of 432 to 202, and political declaration increases the prospect of the UK leaving the EU in a disorderly manner on 30 March 2019. The UK's Brexit committee said Wednesday that the government must come up with a decision by Monday, 21 January at the latest on what it proposes to do next. The committee said that there are four op...
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    Gottlieb, Marks Detail Plans to Advance Development of Cell and Gene Therapies

    US Food and Drug Administration (FDA) Commissioner Scott Gottlieb and Center for Biologics Evaluation and Research (CBER) Director Peter Marks on Tuesday detailed plans for the agency to keep pace with an expected influx of applications for cell and gene therapies over the coming years.   "The FDA is witnessing a surge of cell and gene therapy products entering early development, evidenced by a large upswing in the number of investigational new drug (IND) applications,...
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    FDA Restarts Some Drug, Biologic and Device Inspections

    Following Sunday’s announcement that more FDA staffers would come back to work without pay, US Food and Drug Administration (FDA) Commissioner Scott Gottlieb on Tuesday revealed on Twitter the approximate numbers of those returning. “About 400 total staff are being engaged in this mobilization. The vast majority are inspectors and others are professionals who work in support inspectors,” Gottlieb tweeted. Of those 400, about 100 will deal with high-risk medical devic...
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    Canada Completes Transition to MDSAP

    Most companies in the Canada market were able to meet the 1 January deadline to complete the transition into the Medical Device Single Audit Program (MDSAP), according to Canada’s MEDEC. "We have been flooded with transition packages and we're going through all of them," Ian Sullivan, regulatory affairs specialist at Health Canada' Medical Devices Bureau, told Focus . The stack of transition packages has taken priority over calculating the final statistics on exact...
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    Recon: Edwards Pays Boston Scientific $180M to End Patent Dispute

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Lawmakers want feds to look at how a Bristol-Celgene deal affects prices and competition ( STAT ) ( Letter ) Edward Lifesciences pays Boston Scientific $180 million to end patent row ( Reuters ) Biopharma Dealmaking in 2018 ( Nature ) 2018 FDA approvals hit all-time high — but average value slips again ( Nature ) Vermont Report Finds that the Costs of Prescri...
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    Pfizer Halts Development of Five Preclinical Biosimilar Assets

    Pfizer on Tuesday told Focus that it’s halting the development of five preclinical biosimilar assets, though the company will continue to market three biosimilars and develop five other biosimilars in mid- to late-stage development. Joining a handful of other companies – from Boehringer Ingelheim to Momenta to Sandoz and more -- in exiting the US biosimilar space in some shape or form, Pfizer’s exit reiterates the need to raise questions about the viability of the US ...