Regulatory Recon: Pfizer's Besponsa Gets EU Approval Roche Buys Diabetes App Firm (30 June 2017)

Posted 30 June 2017 | By Michael Mezher 

Regulatory Recon: Pfizer's Besponsa Gets EU Approval Roche Buys Diabetes App Firm (30 June 2017)

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

In Focus: US

  • High Drug Prices Are Bad. Cutting Them Could Be Worse. (NYTimes)
  • Drug Industry Should Welcome This Effort to Cut Price (WSJ)
  • An FDA drug voucher program needs a reboot (The Hill)
  • FDA, Pfizer, Merck join WHO in Memphis for global drug conference (Memphis Business Journal) (UTHSC)
  • Tight Timeline to Reauthorize FDA User Fee Programs Before FDA Begins Layoffs (Focus)
  • FDA Plots Elimination of the Orphan Drug Designation Request Backlog (Focus)
  • House Bill Would Narrow Orphan Drug Exception (Arnall Golden Gregory)
  • Gilead buy Vertex? A golden oldie in the M&A buzz circuit gets fresh air time (Endpoints)
  • Biotechs stumble as more clouds gather over healthcare reform (Financial Times)
  • Cara tries hard to spin the data, but key PhIIb pain study fails and shares slide south (Endpoints) (Fierce) (Reuters)
  • FDA Reviewing Celltrion's Rituxan Biosimilar (BioCentury)
  • Senate Majority leader cites 'good progress' on healthcare talks (Reuters)
  • Senate bill would cut Medicaid spending 35 percent in 2036: budget analyst (Reuters 1, 2)
  • This Woman Can Make Or Break McConnell's Health Bill (KHN)
  • Drug Pricing Hearing In Senate Postponed, Handing Innovators Another Victory (Pink Sheet-$)
  • When Will Real World Evidence Be Persuasive? FDA's Temple Offers Perspective (Pink Sheet-$)
  • Medical device industry looks to take the lead on cybersecurity standards (Fierce)
  • Hack Attack: Biopharma Cyber Chiefs Fight Back (SCRIP-$)
  • Trump to Senate Republicans: kill Obamacare now, replace later (Reuters)
  • Common pitfalls in preclinical cancer target validation (Nature) (In the Pipeline)
  • Cancer scientists may overestimate reliability of mouse studies (Reuters)
  • Despite FDA rule, teens may struggle to get morning-after-pill (Reuters)

In Focus: International

  • Merck KGaA steps up Hippo pathway cancer pact with CRT (Fierce) (PharmaTimes)
  • Roche buys diabetes app firm in digital health push (Reuters) (Press)
  • NICE backs Lilly's JAK inhibitor Olumiant for RA (PharmaTimes)
  • MHRA Updates Alert on Metal-on-Metal Hip Implants (Focus)
  • European Regulatory Roundup: Swissmedic Proposes Overhaul of Drug Ordinances (29 June 2017) (Focus)
  • Meeting with Heads of Agencies/High level representatives and Heads of Europe of Pharmaceutical Companies (EFPIA)
  • ABPI reveals 10% increase in HCP payment disclosure (Pharmafile) (ABPI 1, 2)
  • Where Europe's 'BeNeLuxA' Joint Pricing Pilot May Have Gone Wrong (Pink Sheet-$)
  • Year's Delay Possible For Europe's Unified Patent Court As German Ratification Is Put On Hold (Pink Sheet-$)
  • Lonza expands in Asia: 8,000L single-use in Singapore, regenerative meds in Japan (BioPharmaReporter)
  • Pfizer says Besponsa approved in the EU for adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (Reuters) (Press)
  • The pharmaceutical research and development challenge (Pharmafile)
  • Homeopathy company investigated in Australia over ebook advocating treatment of babies (The Guardian)

Pharmaceuticals & Biotechnology

  • C. Diff Infections Are Falling, Thanks To Better Cleaning And Fewer Antibiotics (NPR)
  • Experts may disagree on skin cancer diagnoses (Reuters)
  • Arena's PAH play and Astra tries again with tralokinumab (EP Vantage)
  • Incentivizing Brand Pharma Cos. To Manufacture In The US (Law360-$)
  • Takeda shares low-cost vaccine production tech with Biological E (Fierce)
  • ReNeuron Outlines First-To-Market Plans For Stroke Disability Cell Therapy (SCRIP-$)
  • Pharma has 'little appetite' for more anti-counterfeiting (Securing Industry)
  • U.S. Diabetes Patients Reducing, Skipping Medicines (BioCentury)
  • Paper Describes Inducible CRISPR (BioCentury)
  • Common antimicrobials help patients recover from MRSA abscesses (NIH)
  • Authorization of Emergency Use of an Injectable Treatment for Nerve Agent or Certain Insecticide (Organophosphorus and/or Carbamate) Poisoning; Availability (FDA)

Pharmaceuticals and Biotechnology: Study Results, Filings and Designations

  • Alkermes claims a success in PhIII schizophrenia head-to-head, but where's the benefit for patients? (Endpoints) (Fierce) (Press)
  • Far from the big hubs, Apellis is steering its rival to Alexion's Soliris into a PhIII program (Endpoints) (BioCentury)
  • AMPHORA® (L-lactic Acid, citric acid, and potassium bitartrate) Receives "Qualified Infectious Disease Product" (QIDP) Designation from the FDA (Press)
  • Acorda Submits New Drug Application to U.S. Food and Drug Administration for INBRIJATM (CVT-301, Levodopa Inhalation Powder) (Press)
  • Aeterna Zentaris Resubmits NDA for Macrilen™ for the Evaluation of Growth Hormone Deficiency in Adults (Press)
  • Sunovion Announces FDA Acceptance for Review of Supplemental New Drug Application for Latuda® (lurasidone HCI) for the Treatment of Bipolar Depression in Children and Adolescents (Press)
  • Sunovion Announces FDA Acceptance for Review of New Drug Application Resubmission for SUN-101/eFlow® (glycopyrrolate) for the Treatment of Chronic Obstructive Pulmonary Disease (COPD) (Press)
  • Daiichi drug hits mark in shingles pain, but misses in other indications (PMLive)
  • Astellas Submits Supplemental New Drug Application for mirabegron for Use in Combination with solifenacin succinate 5 mg for the Treatment of Overactive Bladder (Press)
  • Arbor Pharmaceuticals, LLC and Debiopharm International SA Announce U.S. FDA Approval for Triptodur™, Triptorelin 6-month Formulation, in the Treatment of Central Precocious Puberty (CPP) (Press)
  • FDA Approves Vectibix® (Panitumumab) For Use In Wild-Type RAS Metastatic Colorectal Cancer (Press)
  • Sorrento Therapeutics Announced FDA Authorization of IND to Commence Clinical Trial of RTX in Intractable Cancer Pain (Press)

Medical Devices

  • The FDA Owes Patients Improved Medical Device Regulation After Dr. Amy Reed's Death (Forbes)
  • Medtech M&A: The 10 biggest deals so far in 2017 (MassDevice)
  • SciBase wins FDA PMA nod for Nevisense malignant melanoma detector (MassDevice)
  • Could dogs be better than medical devices at detecting cancer? (Medical Design & Outsourcing)
  • Revocation of Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection of Zika Virus (FDA)
  • Spineology wins FDA nod for Rampart One lumbar interbody fusion system (MassDevice)
  • LivaNova wins FDA nod for VNS therapy neurostim for young epilepsy patients (MassDevice) (Press)
  • Illumina Receives FDA Approval for Companion Dx to Run on MiSeqDx (GenomeWeb) (Press)
  • Tumor Test Helps Identify Which Breast Cancers Don't Require Extra Treatment (NPR)

US: Assorted & Government

  • Medicare Halts Release of Much-Anticipated Data (ProPublica)
  • Shkreli Had No Trouble Courting Investors, Financier Says at Trial (NYTimes)
  • Kaleo fires back at Express Scripts, claiming it's owed at least $5.3 million (Fierce)
  • Eleventh Circuit Gets It Wrong on Preemption (Drug & Device Law)
  • Trump Nominates Jerome Adams as Surgeon General (Medpage) (NYTimes)
  • FDA Grants 30-Day Extension for Comments to Menu Labeling Rule (FDA Law Blog)
  • GMO Labeling And The ANPRM That Wasn't (FDA Law Blog)

Upcoming Meetings & Events


  • European healthcare—a golden opportunity for private equity (McKinsey)
  • Hologic Receives CE Mark for Panther System Upgrade, Flu and Respiratory Assays (GenomeWeb)
  • Agena Receives CE-IVD Marking for MassArray With New Module (GenomeWeb)
  • GenMark Receives CE Mark for ePlex BCID Gram-Positive and Gram-Negative Panels (GenomeWeb)
  • Channel Medsystems' Cerene Cryotherapy Device for Menstrual Bleeding Cleared in Europe (MedGadget)


  • AstraZeneca Pharma India appoints Gagan Singh Bedi as MD (Economic Times)
  • Drug retailers and distributors threaten to sue government over GST rates on old stock (Economic Times)
  • Pharma companies to vendors: Be GST-ready to avoid delay in payments(Economic Times)
  • DCGI asks industry to provide feedback on issues falling under drug regulatory regime to streamline regulatory process further (PharmaBiz)
  • Veg & gelatin capsules can coexist with affordability driving demand: Kaushik Desai (PharmaBiz)
  • Zydus Cadila gets USFDA nod to market anti-obesity drug (Economic Times)
  • Unichem Labs gets EIR from USFDA for Goa facility (Economic Times)


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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