Regulatory Focus™ > News Articles > Regulatory Recon: AbbVie Buys Priority Review Voucher for Record Breaking $350 Million (20 August 20

Regulatory Recon: AbbVie Buys Priority Review Voucher for Record Breaking $350 Million (20 August 2015)

Posted 20 August 2015 | By Michael Mezher 

Regulatory Recon: AbbVie Buys Priority Review Voucher for Record Breaking $350 Million (20 August 2015)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher and @RAPSorg on Twitter.

In Focus: US

  • AbbVie Buys Priority Review Voucher for Record Breaking $350 Million (Reuters) (NPR) (FierceBiotech) (SCRIP-$) (Pink Sheet-$)
  • FDA Approves Its First ‘Clocked’ ANDA (Pink Sheet-$)
  • AbbVie : FDA View On Amarin Disclosures Undercuts 'Same Labeling' For Biosimilars (Pink Sheet-$)
  • 'Purple Book' Is Not Quick Fix For Biosimilar Labeling Issues, Companies Say (Pink Sheet-$)
  • 'Female Viagra' seen more a pace-setter than moneymaker (Reuters)
  • Bias Charged in PCSK9 Inhibitor Findings (MedpageToday)
  • Cempra's solithromycin gets Fast Track (BioCentury)
  • Rare disease companies must compete for clinical trial participants (MedCityNews) (WSJ)
  • The “Big and Bold” 21st Century Cures Act (USHR)
  • Special Cases for UDI Requirements (FDA Imports)
  • FDA launches pilot to experiment with common, global submission format (FierceMedicalDevices)

In Focus: International

  • CHMP backs survival claim for lung cancer drug Giotrif (PharmaPhorum)
  • EU Supply Chain 'Safety Feature' Not Required For Advanced Cell-based Products And Some Others (Pink Sheet-$) (SCRIP-$)
  • Australian Govt Explains How 5% Drug Price Cut Will Work (SCRIP-$)
  • Australian Pharma Warns Against Removing Orphan Fee Incentives (PharmAsiaNews)
  • Indian Court Reserves Order In Controversial Rotavirus Vaccine Case (SCRIP-$)
  • EU ban on GVK-tested drugs a great concern: Nirmala Sitharaman (Economic Times)
  • Chinese regulators easing multi-region clinical trial hurdles (FiercePharmaAsia)
  • China issues new drug approval guidelines (BioCentury)
  • Mexicans look to TPP talks with concerns over secrecy, biotechnological drugs (PharmaLetter-$)
  • Update on International Generic Drug Regulators Pilot (PharmaLetter-$)

US: Pharmaceuticals and Biotechnology

  • AbbVie Buys Priority Review Voucher for Record Breaking $350 Million (Reuters) (NPR) (FierceBiotech) (SCRIP-$) (Pink Sheet-$)
  • FDA Approves Its First ‘Clocked’ ANDA (Pink Sheet-$)
  • AbbVie : FDA View On Amarin Disclosures Undercuts 'Same Labeling' For Biosimilars (Pink Sheet-$)
  • 'Purple Book' Is Not Quick Fix For Biosimilar Labeling Issues, Companies Say (Pink Sheet-$)
  • 'Female Viagra' seen more a pace-setter than moneymaker (Reuters)
  • Bias Charged in PCSK9 Inhibitor Findings (MedpageToday)
  • Sprout CEO on FDA's approval of women's sex drug Addyi (CBS News)

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

  • Cempra's solithromycin gets Fast Track (BioCentury)
  • Phase 3 results for investigational therapy ITCA 650 in type 2 diabetes (MNT)
  • FDA Accepts BOTOX (onabotulinumtoxinA) Resubmission for the Treatment of Lower Limb Spasticity in Adults (Press)
  • Navidea Reports Publication of Lymphoseek Comparative Results in Injection Site Pain Study in Breast Cancer (Press)
  • Edge Therapeutics Reports Positive Top-Line Phase 1/2 NEWTON Trial Results of EG-1962 in Aneurysmal Subarachnoid Hemorrhage (Press)
  • Aurobindo Pharma gets USFDA nod to market ulcer drug (Economic Times)
  • First trial targeting mutation, not cancer type, gives mixed results (Reuters)
  • Jardiancedemonstrated cardiovascular (CV) risk reduction in people with type 2 diabetes at high risk for CV events (Press)

US: Pharmaceuticals and Biotechnology: General

  • Study: US Clinical Research Dropped 32 Percent In 2014 (MedDeviceOnline)
  • Rare disease companies must compete for clinical trial participants (MedCityNews) (WSJ)
  • FDA Makes Available 18 Years of NARMS Isolate-level Data on Enteric Bacterial Isolates (FDA)
  • Testosterone and “Age-Related Hypogonadism” — FDA Concerns (NEJM)
  • FDA Seeks Feedback on Improving Excipients Database (FDANews)

US: Medical Devices

  • Special Cases for UDI Requirements (FDA Imports)
  • FDA launches pilot to experiment with common, global submission format (FierceMedicalDevices)
  • FDA's infusion pump warning sends 'powerful message' on risk management (FierceHealthIT)
  • PMA Medical Device Preemption Decision – Better Late Than Never (Drug and Device Law)
  • First commercial weight-loss balloon implanted in US by Mayo Clinic (FierceMedicalDevices)
  • Researchers Successfully Grow Five Week Old Fetal Brain (medGadget)
  • FDA clears NOWDiagnostics' drop-of-blood test for early detection of pregnancy (FierceDiagnostics)
  • FDA warns LaserCap maker Transdermal Cap (MassDevice)
  • 9 Manufacturer Volunteers Needed For FDA Malfunction Reporting Pilot Program (Gray Sheet-$)
  • FDA raises fees for medical device export certificates (MassDevice)
  • PAD: FDA approves Boston Scientific’s Innova stent (MassDevice)
  • Stephen Hawking's Speech Computer Now Offers Hope To Thousands With ALS (Forbes)
  • Vaginal Mesh Debacle Breeds Questionable Profit Schemes (Medpage Today)

US: Assorted and Government

  • The “Big and Bold” 21st Century Cures Act (USHR)
  • PTO Proposed Rule Gives Limited Relief To Patent Owners In IPR Cases (Pink Sheet-$)          

Upcoming Meetings and Events              

Europe

  • CHMP backs survival claim for lung cancer drug Giotrif (PharmaPhorum)
  • EU Supply Chain 'Safety Feature' Not Required For Advanced Cell-based Products And Some Others (Pink Sheet-$) (SCRIP-$)
  • European Commission grants approval for Novartis' Odomzo in basal cell carcinoma (Press) (PharmaLetter-$)
  • Allergan's new purchase Kythera files lead product in EU (SCRIP-$)

Canada

  • Release of Draft (Step 2) International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) Guidance: Q3C(R6): Impurities: Guideline for Residual Solvents (Health Canada)
  • Release of Draft (Step 2) International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) Guidance: M4E(R2): Enhancing the Format and Structure of Benefit-Risk Information in ICH (Health Canada)
  • Summary Basis of Decision – Movantik (Health Canada)
  • Summary Basis of Decision – Plegridy (Health Canada)

Australia

  • Australian Govt Explains How 5% Drug Price Cut Will Work (SCRIP-$)
  • Australian Pharma Warns Against Removing Orphan Fee Incentives (PharmAsiaNews)
  • Australia approves Hospira's biosimilar (BioSpectrum) (PharmaLetter-$)

India

  • EU ban on GVK-tested drugs a great concern: Nirmala Sitharaman (Economic Times)
  • Sun Pharma gets USFDA approval for acne drug (Economic Times) (PharmaLetter-$)
  • Indian Court Reserves Order In Controversial Rotavirus Vaccine Case (SCRIP-$)

China

  • Chinese regulators easing multi-region clinical trial hurdles (FiercePharmaAsia)
  • China issues new drug approval guidelines (BioCentury)

Other International

  • Mexicans look to TPP talks with concerns over secrecy, biotechnological drugs (PharmaLetter-$)
  • Update on International Generic Drug Regulators Pilot (PharmaLetter-$)

General Health and Other Interesting Articles

  • Russian doll disease is a virus inside a parasite inside a fly (New Scientist)
  • Expression of a Single Gene Lets Scientists Grow Hepatitis C Virus in the Lab (ICT)
  • How The FDA Works: A Primer For The Novice Biotech Investor (Forbes)
  • New CDC tool illustrates changes in antibiotic resistance (CDC)
  • Heading Back To School? So Are Drug-Resistant Lice (Forbes)
  • Is low sexual desire in women a medical condition? (CBS News)

Regulatory Reconnaissance #622 – 20 August 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 @Michael_Mezher 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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