Regulatory Recon: BMS to Acquire IFM Therapeutics in $2.3B Deal FDA Approves AbbVie's 8-Week Pan-Genotypic Hep C Drug (4 August 2017)

Posted 04 August 2017 | By

Regulatory Recon: BMS to Acquire IFM Therapeutics in $2.3B Deal FDA Approves AbbVie's 8-Week Pan-Genotypic Hep C Drug (4 August 2017)

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

In Focus: US

  • Trump to Sign FDA User Fee Reauthorization Bill (Focus)
  • Senate Passes 'Right-to-Try' Bill (Focus)
  • Siemens, DHS warn of "low skill" exploits against CT and PET Scanners (Ars Technica) (DHS 1, 2)
  • Lilly's acute migraine drug succeeds in late-stage study (Reuters) (Endpoints) (Press)
  • Bristol-Myers beefs up big cancer drug pipeline, buying IFM drugs in $2.3B-plus deal (Endpoints) (Reuters) (LifeSciVC) (Fierce) (Press)
  • Duke-Margolis Proposes Value-Based Pricing Model For Antimicrobials (BioCentury) (JAMA)
  • AbbVie's pan-genotypic hep C therapy cleared in the US (PharmaTimes) (Endpoints)  (Reuters) (Press)
  • Dynavax shares dip after FDA asks for more time to sort out Heplisav post-marketing plan (Endpoints)
  • Is the new Dynavax hepatitis vaccine safe? I couldn't tell — and I was advising the FDA (STAT)
  • Is Pharma hiding 'dark money' to fight an Ohio measure to lower drug prices? (STAT)
  • Shire may spin off hyperactivity drugs, raises forecasts (Reuters)
  • FDA to step up fentanyl targeting at postal facilities (Washington Post)
  • Wal-Mart, Walgreens, CVS turn up the heat on generic drugmaker deals (Reuters)
  • FDA Panel Says Yes to Xeljanz for PsA (Press)

Sponsored Content: IVDR/MDR Challenges Top Roadshow Agenda

  • BSI's 6th Annual, full-day medical device Roadshow will guide participants to new EU Medical Device/In-Vitro Device Regulation compliance. The program examines key issues facing Med Dev Manufacturers under the new MDR/IVDR starting with an overview, then analyzing legacy products and transitional provisions. Implementation issues including conformity assessments, essential/clinical requirements, SPR, labeling and QMS impacts of these standards will be detailed.
  • Check here for specific dates, locations and the program agenda.

In Focus: International

  • Teva to cut 7000 jobs, close 15 manufacturing sites (PMLive) (EP Vantage)
  • Ebola scare shows that the world is still not ready for a major disease outbreak (STAT)
  • Drugmakers Hunt for Patients in India's Remote Corners (Bloomberg) (Economic Times)
  • India Health ministry's mini drug testing lab project got stuck with no staff to start operations (PharmaBiz)
  • Dr. Reddy's struggles to meet FDA concerns (C&EN)
  • NICE greenlights Celgene pancreatic cancer drug as first-line combination treatment (Pharmafile) (PharmaTimes) (NICE)
  • NICE leans towards a 'no' for Keytruda in urothelial cancer (PharmaTimes)
  • Celltrion Healthcare $890m IPO to up biosimilar inventory and broaden portfolio (BioPharmaReporter)
  • Irish Regulator Prepares For Brexit-Related Problems, Offers To Take On More EU Work (Pink Sheet-$)
  • Delayed Medicines To Hit Irish Market, But Uncertainty Remains For Future (Pink Sheet-$)
  • Quarterly sales edge up for Merck KGaA, but 2017 outlook hit by exchange rate changes (PharmaLetter-$)

Pharmaceuticals & Biotechnology

  • Big Pharma veterans at Pfizer, AstraZeneca join the great migration to biotech (Endpoints)
  • Q&A with Ubl: Accelerate competition to slow drug price increases (Modern Healthcare)
  • NIH Centers for Accelerated Innovations Program: principles, practices, successes and challenges (Nature)
  • Regulators Promote Early Process Understanding As Key To Success In Cell Therapy Manufacturing (Pink Sheet-$)
  • National Kidney Foundation Holding Patient-Focused Meeting With FDA (BioCentury)
  • Florida Law Will Let Patients Get All Their Drug Renewals At The Same Time (KHN)
  • Aeterna Zentaris claims it booted CEO and then discovered a plot to grab control of its lead asset (Endpoints)
  • Stopping Epidemics At The Source: Applying Lessons From Cholera To The Opioid Crisis (Health Affairs Blog)
  • Cardiovascular Imaging: Not Just for Cardiovascular Trials (BioClinicaBlogs)
  • Diocto Liquid and Diocto Syrup by Rugby Laboratories: Recall - Possible Product Contamination (FDA)
  • NCI study shows feasibility of cancer screening protocol for patients with Li-Fraumeni syndrome (NIH)
  • GSK adds Chief Digital and Technology Officer and more digital health hires (MobiHealthNews)

Pharmaceuticals and Biotechnology: Study Results, Filings and Designations

  • Nexus Pharmaceuticals Receives FDA Approval for Isoproterenol Hydrochloride Injection USP (Press)

Medical Devices

US: Assorted & Government

  • DOJ subpoenas Mallinckrodt over opioids (Drug Delivery)
  • AbbVie files another Humira patent suit, this time against Boehringer Ingelheim (Fierce)
  • Adams Confirmed as Surgeon General (Medpage)
  • Senate Panel Gives HHS Nominees Warm Reception (Medpage)
  • Accreditors Can Keep Their Hospital Inspection Reports Secret, Feds Decide (ProPublica)
  • Opioid Users Are Filling Jails. Why Don't Jails Treat Them? (NYTImes)
  • Under Trump, Hospitals Face Same Penalties Embraced By Obama (KHN)
  • Health insurer Aetna profit rises as Obamacare business shrinks (Reuters)
  • Comment K and Non-Implanted Medical Devices (Drug & Device Law)
  • How Much Detail do You Want? First Circuit Holds that Identifying One Fraudulent Medicaid claim, with Projections, is Sufficient to Survive Motion to Dismiss in FCA Case (FDA Law Blog)

Upcoming Meetings & Events


  • Medicines Manufacturing Industry Partnership fiscal paper (ABPI)
  • Draft tadalafil film-coated tablets 2.5 mg, 5 mg, 10 mg and 20 mg product-specific bioequivalence guidance - Revision 1 (EMA)
  • Draft prasugrel hydrochloride film-coated tablets 5 mg and 10 mg product-specific bioequivalence guidance - Revision 1 (EMA)
  • Draft dimethyl fumarate gastro-resistant capsules 120 mg and 240 mg product-specific bioequivalence guidance (EMA)


  • Syngene plans to scale up for biologics (Economic Times)
  • NPPA moves to prevent distributors from taking higher cuts on stents (Economic Times)
  • Writ petition against 38 hospitals for stent price violation to be admitted in Delhi HC next week (PharmaBiz)


  • TGA GMP Clearance information sessions (TGA)
  • TGA updates licencing & certification guidance (TGA)

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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