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Regulatory Recon: Fresenius to Buy Akorn, German Merck's Biosimilar Busienss After Trial Failures OncoMed Cuts Half its Staff (25 April 2017)

Posted 25 April 2017 | By Michael Mezher 

Regulatory Recon: Fresenius to Buy Akorn, German Merck's Biosimilar Busienss After Trial Failures OncoMed Cuts Half its Staff (25 April 2017)

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

In Focus: US

  • A Good Deal For Eliminating Hepatitis C: Saving Money And Lives (Health Affairs Blog)
  • Nominee to head FDA joined effort to get a drug company more fentanyl (Washington Post)
  • Gottlieb Avoids Written Commitments to Recusal for 22 Companies (FDANews-$)
  • Repeal vs. reality: Don't expect House vote this week (Politico) (Reuters)
  • Sanofi files US antitrust lawsuit against Mylan over EpiPen (Reuters)
  • FDA Mulling Guidance on Who Can Enroll in Cancer Studies (Bloomberg)
  • With a sense of inevitability, OncoMed swings the ax on half of staffers (Fierce) (Endpoints)
  • FDA to Texas and Arizona: Destroy or Export Detained Shipments of Execution Drugs (Focus)
  • The Cardiologist's PCSK9 Script: 6 Months of Frustration (Medpage)
  • The survivors: How an experimental treatment saved patients and changed medicine (STAT)
  • Express Scripts says likely to lose top client Anthem (Reuters) (CNBC)
  • Profit profile helps Lilly shares rebound from Alzheimer's setback (Reuters) (CNBC) (Press)
  • Novartis Q1 profit slips as spending on Alcon, Entresto continue (CNBC)
  • Digital disrupters take big pharma 'beyond the pill' (Financial Times)
  • Supreme Court Preview – Sandoz Inc. v. Amgen Inc. (Patent Docs) (Pink Sheet-$)
  • Army rejects request to deny Sanofi an exclusive license for a Zika vaccine (STAT) (Fierce)

Sponsored Content: Trying to Map Out the Transition to Comply with IDMP Standards?

In Focus: International

  • Fresenius picks up M&A pace with Akorn, Merck KGaA deals (Reuters) (PMLive) (PharmaTimes) (The Street) (BioCentury) (EP Vantage)
  • EMA Chief Guido Rasi's Statements on EU Immunization Week (EMA)
  • Pharma outlook in the MENA region: an insider's view (PharmaLetter-$)
  • Japanese pharma expects 17% growth throughout 2017 (Pharmafile)
  • Barcelona pulls out the stops for EU medicines agency (EurActiv)
  • Pharma Execs Seek Smooth and Quick Transition of EMA Headquarters Out of London (Focus)
  • Sirtex trial miss means beads could stay as back-up (EP Vantage)
  • Canada recommends against testing everyone for hepatitis C (Reuters)
  • Look What Happens When You Pay Attention To Neglected Tropical Diseases (Forbes)
  • AstraZeneca's Tagrisso On Course To Indian Debut, Affordability Vow In Tow (Pink Sheet-$)
  • Indian government goes to war over 75% stent price reduction (Pharmafile)
  • Singapore Court Awards Damages for Loss of "Genetic Affinity" (Genomics Law Report)

US: Pharmaceuticals & Biotechnology

  • FDA Licences Renflexis; Some Firsts for this Remicade Biosimilar (FDA Law Blog)
  • FDA okays Glenmark's first-in-human study for respiratory drug (Economic Times)
  • Novartis confirms that Juliet CAR-T data out in June (Fierce)
  • Pharma Industry Still Not At 'Tipping Point' In Adopting Continuous Manufacturing (Pink Sheet-$)
  • FDA Panel To Weigh Protocol Changes For Two Sarepta Drugs (Pink Sheet-$) (BioCentury)
  • The Broad Institute is testing the limits of what 'nonprofit' means (STAT)
  • NIH Looks to License HIV, Zika Vaccine Technology (Federal Register 1, 2)
  • FDA Offers Draft Guidance on Generic Versions of Opioid Overdose Nasal Spray (Focus)
  • FDA Issues Draft Guidance on Extending Expiration Dates for Doxycycline Stockpiles (Focus)
  • We're All Tired. But When Could Fatigue Mean a Medical Problem? (NYTimes)
  • Is There an End to Malaria Without Quality Medicines? (USP)
  • Earnings Preview: What To Expect From Amgen On Wednesday (Forbes)
  • Aging Research: Plasma Protein Revitalizes the Brain (NIH)
  • Apotex Urges the FDA to Require Testing of Biosimilars on Intended Patient Population (FDANews-$)
  • 25 Percent Dextrose Injection, USP (Infant) by Hospira: Recall - Particulate Matter (FDA)

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

  • Sanofi And Regeneron Announce FDA Approval Of A New Once-Monthly Dosing Option For Praluent® (Alirocumab) Injection (Press)
  • New Data Suggest Positive Effects of Sanofi Genzyme's Aubagio® (teriflunomide) on Cortical Gray Matter Atrophy (Press)
  • Sanofi and Regeneron Announce FDA Approval of a New Once-Monthly Dosing Option for Praluent® (alirocumab) Injection (Press)
  • Santen Announces U.S. FDA Filing Acceptance of New Drug Application (NDA) for Intravitreal Sirolimus (DE-109) in the Treatment of Non-Infectious Uveitis of the Posterior Segment (Press)
  • Transgene and Bristol-Myers Squibb Announce Clinical Research Collaboration to Evaluate TG4010 in Combination with Opdivo and Standard Chemotherapy in First Line Non-Small Cell Lung Cancer (Press)

US: Medical Devices

  • This Is Neat: Billionaire Vinod Khosla Is Betting On A Handheld Diagnostic Test (Forbes)
  • Philips shares rise on Q1 earnings beat, despite slow sales growth (MassDevice)
  • Bard shares soar on solid Q1, BD merger (MassDevice)
  • ALung Submits IDE Application to FDA Seeking Approval to Conduct Pivotal Study of the Hemolung RAS (Press)
  • 3Shape wins expanded FDA nod for Ortho System orthodontic software suite (MassDevice)
  • Medtronic Drug-Coated Balloon (DCB) Demonstrates Consistent Results in Two New Analyses of Complex PAD Patients (Press)
  • Medtronic Announces Most Advanced StealthStation(TM) for Neurosurgery (Press)

US: Assorted & Government

  • Public pans GOP's latest approach to replacing ACA (Washington Post)
  • Government costs could rise $2.3 billion without Obamacare payments: study (Reuters)
  • See how the opioid epidemic swept across the United States (STAT)
  • CHIP Offers Families With Seriously Ill Kids More Financial Protection Than ACA Plans (KHN)
  • HHS, States Move To Help Insurers Defray Costs Of Sickest Patients (KHN)
  • Reluctant Patients, Hispanic Men Pose A Costly Challenge To The Health System(KHN)
  • States with the highest child vaccine rates (CBS)
  • Brace yourself, pharma: Your beloved tax inversions could make a comeback (Fierce)
  • Judge Says Clinics In Meningitis Outbreak Can Blame FDA (Law360-$)
  • California Has A Deadly Problem With Regulating Naturopathic Doctors (Forbes)

Upcoming Meetings & Events


  • Getting a feel for biomanufacturing at the Biotech Training Facility (BioPharmaReporter)
  • BPI Europe 2017: Biomanufacturing industry goes Dutch (BioPharmaReporter)
  • French Study Confirms Teratogenic Risks Of Valproate; Other Drugs In The Spotlight Too (Pink Sheet-$)
  • Quarter of cancer patients visit GP three times with no diagnosis (Pharmafile)
  • List of centrally authorised products requiring a notification of a change for update of annexes (EMA)
  • Draft revised guideline on the conduct of bioequivalence studies for veterinary medicinal products (EMA)
  • Reflection paper on anthelmintic resistance (EMA)


  • Kissei gives up on dry eye drug (PharmaLetter-$)             
  • Zai Gains China Rights To Paratek's Omadacycline (BioCentury)


  • Pharma companies discuss order on generic drugs (Economic Times)
  • Availability, accessibility key to affordable drugs (Economic Times)
  • Government considering Afghanistan, Myanmar's proposal to boost pharma exports (Economic Times)
  • Only 230 generic drugs available at AIIMS' medical store (Economic Times)
  • Centre cracks whip, no stent can be withdrawn, for now (Economic Times)
  • Health ministry gearing up to eliminate malaria by 2030 (PharmaBiz)
  • Jubilant Life gets USFDA nod for hypertension drug (Economic Times)
  • Alembic Pharma gets USFDA nod for anti-hypertension drugs (Economic Times)


  • Iodinated Contrast Media - Potential Risk of Hypothyroidism (Health Canada)
  • Orexigen Therapeutics announces new drug submission for Contrave in Canada (BioSpectrum)

Other International

General Health & Other Interesting Articles

  • Will We Ever Get a Better Male Contraceptive? (MIT Technology Review)
  • Long-term birth control is the most reliable. So why do so few young women use it? (Washington Post)
  • Video Games Help Model Brain's Neurons (NYTimes)

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

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

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