• ReconRecon

    Recon: BioMarin Snags FDA Approval for Palynziq, India Considers Price Controls on More Devices

    In Focus: US BioMarin scores long-sought FDA nod for Palynziq, but its $192K launch could be tough ( Fierce ) ( BioPharma Dive ) ( PMLiVE ) ( Endpoints ) ( Reuters ) ( PharmaTimes ) Imagen Tech wins de novo clearance for OsteoDetect wrist fracture software ( MassDevice ) ( MIT Technology Review ) ( MD Magazine ) ( FDA ) Prothena axes half its staff after phase 3 catastrophe ( pharmaphorum ) ( Fierce ) ( Scrip- $) AstraZeneca caps its big win in lung cancer with posit...
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    Australia Hits Pause on Implementing Regulatory Changes for Device 3D-Printing

    Australia’s Therapeutic Goods Administration (TGA) is delaying implementation of regulatory changes proposed for the additive manufacturing, or 3D-printing, of devices, following requests from stakeholders to provide clarifications.   “The TGA plans to further explore other areas that were identified as requiring additional clarity prior to implementing regulatory change,” the regulatory authority said in a Thursday notice.   TGA received 24 comments on the regulat...
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    Australia Spells Out Regulatory Requirements on Lab-Developed IVDs

    Australia’s Therapeutic Goods Administration (TGA) unveiled guidance Thursday explaining how a laboratory can meet in vitro diagnostic (IVD) regulatory requirements.   The regulatory framework applies to IVDs manufactured and/or modified in-house, though those that are supplied outside of a laboratory or laboratory network, as well as those developed solely for research purposes, fall outside of the requirements’ scope, TGA clarified.   Australian laboratories’ t...
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    Recon: EC Approves 4th Infliximab Biosimilar

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US J&J Loses Second Talc-Asbestos Trial and Damages May Grow ( Bloomberg ) ( Fierce ) ( Reuters ) Recro Pharma shares plummet after FDA rejects non-opioid pain shot ( Reuters ) ( BioPharma Dive ) ( Endpoints ) Medtronic tops estimates with fiscal Q4, 2018 results ( MassDevice ) ( Star Tribune ) ( Reuters ) Solicitor General Urges High Court To Take Up Merck's Fosama...
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    FDA Proposes to Ease Regulatory Controls Over Software Used in Blood Establishments

    Following up on work initiated in 1998, the US Food and Drug Administration (FDA) issued a proposed rule to categorize blood establishment computer software (BECS) and accessories into class II. More than 220 BECS and accessories have received FDA clearance and these all currently fall into class III—reserved for those medical devices that pose a higher risk of patient illness or injuries, such as pacemakers and heart valves. FDA’s decision is based on the recommenda...
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    Amgen Snags FDA Approval for Migraine Drug With $6900 Annual List Price

    Amgen received US Food and Drug Administration (FDA) approval for its Aimovig (erenumab-aooe). The first FDA-approved migraine prevention drug—administered via a monthly self-injection using the pharmaceutical giant’s SureClick autoinjector device—for use in adult populations falls under a “new class of drugs that work by blocking the activity of calcitonin gene-related peptide, a molecule that is involved in migraine attacks,” according to a late Thursday FDA announcem...
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    Recon: Accent Therapeutics Launches with $40M, J&J Drops Alzheimer’s Candidate

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Accent Therapeutics Launches with $40 Million: Focus on RNA-Modifying Proteins ( BioSpace ) ( Fierce ) ( Endpoints ) ( Boston Business Journal -$) ( C&EN ) Johnson & Johnson scraps Alzheimer's trials on safety concerns ( Reuters ) ( Endpoints ) ( The Pharma Letter ) ( PharmaTimes ) ( Scrip -$) ( Fierce ) AstraZeneca sales hit by generic competitors to Crestor stat...
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    House Committee Advances Spending Bill With $300M Boost to FDA Budget

    The House Appropriations Committee approved a spending bill Wednesday for FY 2019 on a vote of 31-20, with a budget authority for the US Food and Drug Administration (FDA) of $3.1 billion—up from $2.8 billion in fiscal 2018.   The bill includes a committee recommendation for a net increase in the amount allocated for medical product safety and effectiveness of about $300 million, and hikes for FDA initiatives.   As part of the $400 million in additional FDA funding...
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    Recon: NICE Backs Roche’s Tecentriq for Routine Use in Pre-Treated Bladder Cancer

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Study Finds More Isn't Better for Roche Breast Cancer Drug ( Bloomberg ) ( WSJ ) ( Reuters ) ( AP News ) ( NPR ) ( NYT ) The first drug for opioid withdrawal has gotten the green light — and it targets risky symptoms that others ignore ( Business Insider ) ( Focus ) ( Reuters ) ( Endpoints ) ( WSJ ) ( Pharmacy Times ) FDA faults IQVIA for errors in opioid sales da...
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    US WorldMeds Wins FDA Nod for First Non-Opioid to Treat Opioid Withdrawal Symptoms

    Specialty drug company US WorldMeds’ Lucemyra (lofexidine hydrochloride) became the first non-opioid treatment for the management of opioid withdrawal symptoms among adults to receive US Food and Drug Administration (FDA) approval on Wednesday, according to an agency announcement.   The oral tablet is intended to supplement long-term treatment plans for managing opioid use disorder by reducing the release of norepinephrine, which is believed to contribute towards opioi...
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    FDA Hones In On Critical Issues With Recruitment, Inclusion of Women in Clinical Trials

    The US Food and Drug Administration (FDA) is looking to break down barriers hindering the availability of clinical trial data on women by focusing on two critical issues—enrollment and new products designed for treating conditions that are gender-unique.   FDA Commissioner Scott Gottlieb highlighted some of the actions the agency is pursuing as part of the two-pronged approach during a Wednesday debate hosted by FDA’s Office of Women’s Health (OWH), noting that the “ye...
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    FDA Exempts Surgical Apparel From 510(k) Requirements

    Single-use, disposable respiratory protective devices intended for medical professionals’ use in healthcare settings will no longer be subject to premarket notification requirements, following an order the US Food and Drug Administration (FDA) finalized Wednesday.   The final exemption order—proposed last December—is intended to reduce regulatory burden on manufacturers of the class II (special controls) devices and eliminate the associated costs.   The exempted de...