Regulatory Focus™ > News Articles > Regulatory Recon: FDA Approval for Pfizer's Lung Disease Drug Rapamune (29 May 2015)

Regulatory Recon: FDA Approval for Pfizer's Lung Disease Drug Rapamune (29 May 2015)

Posted 29 May 2015 | By Alexander Gaffney, RAC

Regulatory Recon: FDA Approval for Pfizer's Lung Disease Drug Rapamune (29 May 2015)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

In Focus: US

  • FDA approves Rapamune to treat LAM, a very rare lung disease (FDA) (Reuters)
  • FDA Releases New ANDA Refuse-to-Receive Guidance (FDA) (Lachman)
  • Otsuka loses lawsuit challenging FDA approval of generic Abilify (Reuters) (FDA Law Blog)
  • Court Rejects FDA’s “One-to-Many” Complex Mixture NCE Exclusivity Decision on VASCEPA (FDA Law Blog)
  • FDA Releases Guidance on ICH M7: Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk (FDA)
  • Boston Scientific slapped with $100M verdict in vaginal mesh suit (Fierce) (Bloomberg)
  • FDA asks dermal filler makers to indicate risk of serious injury (FDA) (FDA) (Reuters)
  • How the VA addresses medical device security (Fierce)

In Focus: International

  • EU Ombudsman Looking Into New Clinical Trial Rules (Politico)
  • Challenges ahead for European clinical trials (MNT)
  • Rare Disease Groups Launch EU Push for Greater Recognition (Politico)
  • Guideline on the adventitious agent safety of urine-derived medicinal products (EMA)
  • Concept paper on new guidance for importers of medicinal products (EMA)
  • Over 1,000 certificates withdrawn as EU notified bodies toughen up (Clinica-$)
  • China Probes Official Who Supervised Medical Device Sector (Bloomberg) (Reuters)

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US: Pharmaceuticals and Biotechnology

  • FDA approves Rapamune to treat LAM, a very rare lung disease (FDA) (Reuters)
  • FDA Releases New ANDA Refuse-to-Receive Guidance (FDA) (Lachman)
  • Otsuka loses lawsuit challenging FDA approval of generic Abilify (Reuters) (FDA Law Blog)
  • Court Rejects FDA’s “One-to-Many” Complex Mixture NCE Exclusivity Decision on VASCEPA (FDA Law Blog)
  • FDA Releases Guidance on ICH M7: Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk (FDA)
  • New Legislation Seeks to Incentivize OTC Status for Contraceptives by Granting Priority Review and Waiving PDUFA Application User Fee (FDA Law Blog) (Congress)
  • Following Through On Breakthrough: What’s Next For FDASIA Success? (RPM Report-$)
  • FDA Official Says Time is Right for Exploring ‘Regulatory Commitments’ for Post-Approval Changes (Gold Sheet-$)
  • Guidance: Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food -- General Approach to Establish an Acute Reference Dose (FDA)
  • Will the 21st Century Cures Bill Lower Standards for Some Drug Approvals? (Pharmalot)
  • Alabama House Passes Right to Try Bill (Al)
  • Schakowsky Pushes For Disclosure Of Drug Research Costs (IHP-$)
  • 2014 Drug Recalls: Contamination Surge Enters Fifth Year (Gold Sheet-$)
  • Top Dem: Trade deal could restrict access to cheaper medicines (The Hill)
  • Wockhardt hopes to resolve FDA ban on two plants in FY 2016 (India Times)

US: Pharmaceuticals and Biotechnology: Clinical Study Results, Filings and Designations

  • Merck files all-oral hepatitis C therapy in US (PMLive) (Press)
  • Heron's nausea drug meets goal in late-stage trial, shares soar (Reuters)

US: Pharmaceuticals and Biotechnology: General

  • Big Pharma and Insurers Play Nice (Bloomberg)
  • AARP report: Decreases in generics prices are slowing down (DSN) (AP)

US: Medical Devices

  • Boston Scientific slapped with $100M verdict in vaginal mesh suit (Fierce) (Bloomberg)
  • FDA asks dermal filler makers to indicate risk of serious injury (FDA) (FDA) (Reuters)
  • How the VA addresses medical device security (Fierce)
  • FDA Reclassifies Rectal Control Systems (FDA)

US: Dietary Supplements

  • One year after overdose, Ohio bans pure caffeine, powdered alcohol (PharmPro)
  • Seller of “Miracle Mineral Solution” Convicted for Marketing Toxic Chemical as a Miracle Cure (DOJ)

Upcoming Meetings and Events

Europe

  • EU Ombudsman Looking Into New Clinical Trial Rules (Politico)
  • Challenges ahead for European clinical trials (MNT)
  • Rare Disease Groups Launch EU Push for Greater Recognition (Politico)
  • Guideline on the adventitious agent safety of urine-derived medicinal products (EMA)
  • Concept paper on new guidance for importers of medicinal products (EMA)
  • Over 1,000 certificates withdrawn as EU notified bodies toughen up (Clinica-$)
  • Russia makes it easier to skirt imported drug sale norms (Fierce)
  • Council of EU takes own view on single-use device reprocessing (Clinica-$)
  • European Medicines Agency Validates Gilead’s Marketing Application for Fixed-Dose Combination of Emtricitabine and Tenofovir Alafenamide for HIV Treatment (Press)
  • mHealth in Europe: Next steps (EC)
  • NICE recommends new licences for autoinflammatory disorders (PharmaTimes)
  • Synjardy granted marketing authorisation in the EU for the treatment of adults with type 2 diabetes (EUPharmaReview)

China

  • China Probes Official Who Supervised Medical Device Sector (Bloomberg) (Reuters)

Australia

  • Drugmakers seen hit under Australia budget deal with pharmacies (Fierce)

Other International

  • ASEAN Countries Make Progress in Harmonizing Pharmaceutical Quality Guidelines (Gold Sheet-$)

General Regulatory And Interesting Articles

  • Depression Treatments Inspired By Club Drug Move Ahead In Tests (NPR)

Regulatory Reconnaissance #565 – 29 May 2015

Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory news stories from around the globe. Each weekday morning, we aim to bring you the latest highlights of new approvals, meetings, legal and political developments, regulations and guidance, and the latest trends with the potential to impact regulatory affairs professionals and the industry in which they work.

Need to contact the editor of Regulatory Reconnaissance? Find him on Twitter at @AlecGaffney or send him an email at news@raps.org.

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.


Categories: Recon, Regulatory News

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