Regulatory Focus™ > News Articles > Regulatory Recon: FDA Rejects Coherus' Neulasta Biosimilar; Chi-Med Seeks CFDA Approval for Cancer D

Regulatory Recon: FDA Rejects Coherus' Neulasta Biosimilar Chi-Med Seeks CFDA Approval for Cancer Drug (12 June 2017)

Posted 12 June 2017 | By Michael Mezher 

Regulatory Recon: FDA Rejects Coherus' Neulasta Biosimilar Chi-Med Seeks CFDA Approval for Cancer Drug (12 June 2017)

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

In Focus: US

  • FDA rejects Coherus' biosimilar for Amgen's Neulasta (Reuters) (Fierce) (BigMoleculeWatch) (Endpoints) (Press)
  • Drug Prices: This Time Is Different (WSJ)
  • FDA Could Act to Pull More Opioid Pain Pills From the US Market (Bloomberg)
  • Big US pharma dealmaking plunges to five-year low (Financial Times)
  • Washington turmoil is proving a bitter pill for Pfizer (Financial Times)
  • Out-Thinking Industry (BioCentury)
  • The FDA Either Will Find Its Voice, Or Get Its Comeuppance, Under Commissioner Gottlieb (Forbes)
  • New frontier in cancer care: Turning blood into living drugs (AP)
  • FDA Approves First Generic Version of Gilead's HIV Drug Truvada (Focus)
  • Seizing on Opioid Crisis, a Drug Maker Lobbies Hard for Its Product (NYTimes) (NPR)
  • AstraZeneca faces up to its year of living dangerously (Financial Times)
  • AstraZeneca CEO warns of 'substantial setback' if new drug fails (Financial Times)
  • AbbVie must pay $15 million in Depakote birth-defect trial: jury (Reuters)
  • Gene Editing Companies Hit Back at Paper That Criticized CRISPR (MIT Technology Review)

Sponsored Content: Going Digital with RIM

In Focus: International

  • WHO DG-elect on high-level US tour to advance new vision for WHO (WHO)
  • The drive for universal health coverage (Financial Times)
  • Chi-Med steps closer to Chinese pharma first with drug filing (Reuters) (Press)
  • EMA's PRAC to Hold First Public Hearing on Use of Valproate Medicines (Focus)
  • Polio outbreak in Syria poses vaccination dilemma for WHO (Reuters)
  • Shock U.K. election result creates uncertainty for biotech (Fierce) (Pink Sheet-$) (ABPI)
  • NICE refuses to expand use of Roche's IPF drug Esbriet (PharmaTimes)
  • India To Streamline Tiered Trial Approval Process – Will It Lift Sponsor Outlook? (Pink Sheet-$)

Pharmaceuticals & Biotechnology

  • Sanofi-Regeneron's Praluent cuts cholesterol in Odyssey trials (Reuters) (Fierce) (Press)
  • Proxy firm ISS advises vote against Mylan board, backing investor group (Reuters)
  • Merck CEO: Gardasil plus pipeline equals big things ahead for vaccines (Fierce)
  • Merck, hedging its bets against Bristol-Myers Squibb and AstraZeneca, strikes up Keytruda-CTLA4 combo trial (Fierce)
  • Conflict-of-Interest Rules Are Holding Back Medical Breakthroughs (Harvard Business Review)
  • A Banner Month for OGD Approvals (Lachman Consultants)
  • Trends and Challenges in Specialty Drugs (Drug Channels)
  • Why Medication Adherence Needs To Be A National Priority (Forbes)
  • 'How Long Have I Got, Doc?' Why Many Cancer Patients Don't Have Answers (KHN)
  • TV Drug Advertising Study Targets Those With Limited Or No Internet Use (Pink Sheet-$)
  • Actelion Spinout Idorsia To List Next Week (BioCentury)
  • Celgene bags option on NK cell-based blood cancer assets (Fierce) (Endpoints)
  • Regulus Dumps Two Drugs, AstraZeneca Sends Back Another, Shares Fall (Xconomy)
  • Xbiotech Sags After Discontinuing Xilonix CRC Study (BioCentury)
  • Like? Pharma and OTC brands get the Facebook treatment at first of many confabs (Fierce)
  • Consumers don't find pharma all that innovative now, but there's hope for the future: Study (Fierce)
  • High potency drugs – from molecule to market (Pharmafile)
  • Roche CEO still optimistic on new breast cancer drug (Reuters)
  • Former Pharma Rep Now Helps Doctors Save Money on Drugs (NBC)
  • Bristol-Myers Squibb Voluntarily Recalls One Lot of Eliquis (apixaban) 5 mg Tablets Due to Tablet Mix-Up (Press)

Pharmaceuticals and Biotechnology: Study Results, Filings and Designations

  • Gilead Submits New Drug Application to U.S. Food and Drug Administration for Fixed-Dose Combination of Bictegravir, Emtricitabine and Tenofovir Alafenamide for HIV Treatment (Press)
  • With an FDA decision looming, Flexion touts new data spotlighting a safety edge for osteoarthritis drug (Endpoints)
  • Fibrocell Receives Rare Pediatric Disease Designation from FDA for FCX-013 for Treatment of Localized Scleroderma (Press)
  • Novo's Xultophy beats basal-bolus insulin at cutting hypoglycemia, spurring weight loss (Fierce)
  • Lexicon diabetes pill hits endpoint in another phase 3, teeing up regulatory filings by partner Sanofi (Fierce) (BioCentury)
  • Xtandi Timeline Speeds Up In Non-Metastatic CRPC Trial (BioCentury)
  • Merck, Pfizer trot out more support for latecomer SGLT2 candidate ertugliflozin (Fierce) (Endpoints) (Press)
  • Lilly's Galcanezumab Significantly Reduces Number of Migraine Headache Days for Patients with Migraine: New Results Presented at AHS (Press)
  • Jardiance® (empagliflozin) tablets to be studied in chronic kidney disease (Press)
  • New Analysis Shows Sanofi's Soliqua 100/33 Lowered HBA1CBy More Than 2 Percent In Patients With Screening Levels Greater Than 9 Percent (Press)
  • Sanofi plots real-world data push as Toujeo slashes hypoglycemia risks in seniors (Fierce) (Press)
  • Exelixis Announces Initiation of Phase 1b Trial of Cabozantinib in Combination with Atezolizumab in Patients with Locally Advanced or Metastatic Solid Tumors (Press)
  • Seres Therapeutics Initiates SER-109 Phase 3 Study in Patients with Multiply Recurrent C. difficile Infection (Press)
  • Bioverativ Announces FDA Acceptance of Investigational New Drug Application for BIVV001 to Treat Hemophilia A (Press)

Medical Devices

  • Updates to FDA's eMDR System Planned Through October 2017 (Emergo)
  • Cures Act Left Drug-Device Distinction Murky, Panel Says (FDANews-$)
  • Robotics are helping paralyzed people walk again, but the price tag is huge (Washington Post)
  • GenMark Receives FDA 510(k) Market Clearance for Its ePlex® Instrument and Respiratory Pathogen Panel (Press)

US: Assorted & Government

  • UNC oncologist and researcher named head of the National Cancer Institute (Washington Post)
  • From Obamacare To Trumpcare (Health Affairs Blog)
  • HHS Requests Feedback On ACA Regulations; Evidence On Effect Of CSR Payment Uncertainty Continues To Mount (Updated) (Health Affairs Blog) (Federal Register)
  • Flexibility That A.C.A. Lent to Work Force Is Threatened by G.O.P. Plan (NYTimes)
  • New House Bill Would Force FDA's Hand On Office-Use Compounding (IHP-$)
  • Opioid Dealers Embrace the Dark Web to Send Deadly Drugs by Mail (NYTimes)
  • Latest Updates To Ediscovery for Defendants Cheat Sheet (Drug & Device Law)
  • Colgate Asks Court to Stay Action until FDA Defines "Natural" (FDA Law Blog)
  • J&J's Ethicon wins Philly pelvic mesh trial (MassDevice) (Law360-$)
  • Anti-trust regulators want more from BD, Bard on $24B merger (MassDevice)

Upcoming Meetings & Events


  • Helsinn gives up on Zealand's GI candidate elsiglutide after trial flop (Fierce)
  • GE Healthcare training facility opens in Ireland's 'thriving biopharma' market (BioPharmaReporter)
  • Lonza plugs EU cell and gene therapy manufacturing gap through PharmaCell buy (BioPharmaReporter)
  • Boston Scientific to drop $19m on Irish endoscopy R&D center (MassDevice)
  • Response to Cochrane Collaboration review in to Hepatitis C medicines (ABPI)
  • Pfizer eyes building another plant in Russia (PharmaLetter-$)
  • Rostec inks deal with Arab firm for antiviral drugs in Russia (PharmaLetter-$)
  • Levact (bendamustine) - Important Safety Information from Mundipharma Pharmaceuticals Ltd. as approved by the HPRA (HPRA)


  • China H7N9 bird flu death toll rose to 37 in May: health authority (Reuters)


  • Strides Shasun gets USFDA nod for pain relieving drug (Economic Times)
  • India's Strides Gets 483 for Quality Problems (FDANews-$)
  • India's new medical device regulations: 10 things you need to know (MedCityNews)
  • Pharma market grows 7% in May, beats pre-GST fears (Economic Times) (PharmaBiz)
  • Regulatory challenges to stay with emergence of drug & device as combination products : Expert (PharmaBiz)
  • CDSCO concludes 185 risk based inspections on Sch M units towards GMP compliance (PharmaBiz)

Other International

  • WHO Prequalification: Application of reference-scaled criteria for AUC in bioequivalence studies
  • conducted for submission to PQTm (WHO)
  • Mazor Robotics reveals Israeli regulatory probe (MassDevice)

General Health & Other Interesting Articles

  • Black and Hispanic patients less likely to see neurologists (Reuters)

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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