Regulatory Recon: Astellas to Buy Ganymed for up to $1.4B Sanofi, Novo Nordisk Fortunes Diverge (28 October 2016)

Posted 28 October 2016 | By Zachary Brennan 

Regulatory Recon: Astellas to Buy Ganymed for up to $1.4B Sanofi, Novo Nordisk Fortunes Diverge (28 October 2016)

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

In Focus: US                                      

  • Drug prices quietly rise as politicians pounce (EP Vantage)
  • Top biotech and pharma firms bring out creativity, growth in their scientists (Science)
  • ASCO star, backed by billionaires, goes to Astellas in $1.4 billion buyout (Endpoints) (Press) (Press)
  • Sanofi, Novo Nordisk Fortunes Diverge Amid Insulin Price Slump (WSJ-$) (Bloomberg) (Bloomberg)
  • FDA flashes red light on Sanofi manufacturing infraction, threatening a looming blockbuster decision (Endpoints)
  • FDA slaps a partial hold on one of AstraZeneca’s crucial durvalumab programs (Endpoints) (Reuters)
  • The Update Continues: FDA’s List of Drugs that May Not Be Compounded Under 503A and 503B (FDA Law Blog)
  • GDUFA Science Priorities for 2017: Postmarket Evaluation and Complex Generics (Focus)
  • J&J pays $70m over cancer allegations (Pharmafile) (Law360-$)
  • EpiPen price hikes add millions to Pentagon costs (Reuters)
  • Mylan Officials Unlikely to Lose Pay Over EpiPen Settlement (WSJ-$)
  • Cures bill in jeopardy amid drug pricing push (The Hill)
  • Examining high prescription drug spending for people with employer sponsored health insurance (Kaiser)
  • FTC seeks review of a court ruling on generic drug competition (Stat)
  • Biosimilars – In The Pipeline or Still a Pipe Dream? (Harvard Bill of Health Blog)
  • Understand Biosimilars Better Before Seeking Approval, FDA Official Says (BNA)
  • Biosimilars in the US: Progress and Promise (FDA Slides)
  • After years of criticism, FDA tries to step up oversight of medical devices (Consumer Affairs)

In Focus: International

  • International Pharmaceutical Regulators Forum Progresses Work (IPRF)
  • Samsung BioLogics Prices Nearly $2 Billion IPO at Top of Range (WSJ-$)
  • Yangon women 'should avoid pregnancy' in next six months due to Zika (Reuters)
  • EMA: Meeting Highlights from the PRAC 24-27 October (EMA)
  • UK Advances Bill to Stop Price Spikes on Generic Drugs (Focus)
  • MHRA Cautions Against Sudden Switches of Insulin Devices (Focus)
  • China to Begin Priority Reviews of Medical Devices in January 2017 (Focus)
  • New WHO Director-General Candidates’ Forum Next Week (WHO)
  • Yemen's suspected cholera cases soar to 1,410 within weeks: WHO (Reuters)

US: Pharmaceuticals and Biotechnology

  • These pricey cholesterol drugs aren’t selling. And that has the biotech industry sweating (Stat) (In the Pipeline)
  • Amgen Unlikely to Launch Humira Biosimilar Before 2018 (Big Molecule Watch)
  • Celgene May Be Ready to Lap Bristol (Bloomberg)
  • The Good (Celgene) and Bad (Biogen) Ways to Deliver Drug Revenue Growth (TheStreet)
  • Key Facts about “Abuse-Deterrent” Opioids (FDA Voice Blog)
  • Pharmaceutical and life sciences deals insights: Q3 2016 update (PwC)
  • Nordic Nanovector ASA signs second ADC deal in a month (BioPharma-Reporter)
  • Approval of Sandoz’s Pegfilgrastim biosimilar may be delayed until 2018 (Big Molecule Watch)
  • Stopping Breast Cancer with Help from AI (MIT Tech Review)
  • Adderall Buyers Deride Objections To $15M Settlement (Law360-$)
  • The New Fee Paradigm of GDUFA II (Lachman Consultants)
  • Parexel looks to new bookings (Outsourcing-Pharma)
  • Pharma supplier Lonza posts strong Q3 results (PharmaLetter-$)
  • Amazon's Bezos, Mayo Clinic back Unity in $116M Series B to slow diseases of aging (FierceBiotech)
  • Myovant bumps IPO to $218M with Pfizer, BB Biotech aid (FierceBiotech)
  • Generic drug maker Lannett making progress on first branded product (Philadelphia Business Journal)
  • Pfizer Fined by EPA for Failing to Disclose Chemicals Used in Puerto Rico Plant (FDANews-$)

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

  • Sanofi Lifts Profit Outlook (WSJ-$)
  • Amgen Sees Profit Increase, Raises Guidance (WSJ-$)
  • Adaptimmune signs Keytruda/T-cell therapy myeloma tie-up with Merck (FierceBiotech)
  • GSK posts 23% hike in third-quarter sales (PharmaTimes)
  • Opdivo drives gain in BMS sales, but business revamp coming (PMLive)
  • New Cancer Therapy: Food Poisoning? (GEN)
  • Sugar Pill Beats Two Drugs in Migraine Trial for Children (NY Times-$) (NEJM)
  • FDA approval could be delayed for Sanofi Genzyme’s next blockbuster (Boston Business Journal)
  • AbbVie stock sinks 5% after slight third-quarter earnings beat, revenue miss (MarketWatch)
  • Sanofi will accept epilepsy drug blame if court rules that way (Reuters)
  • Biogen’s Regulatory Applications for Nusinersen as a Treatment for Spinal Muscular Atrophy Accepted by FDA and EMA (Press)
  • Eisai to initiate two Phase III trials for antiepileptic drug (Press)

Medical Devices

  • St. Jude Medical shareholders grudgingly approve executive tax breaks ahead of Abbott merger (Mass Device)
  • Zimmer Biomet Digs Deeper into Digital Health with RespondWell Deal (Xconomy)
  • Corindus wins FDA nod for 2nd-gen CorPath GRX vascular robot-assisted surgery system (Mass Device)
  • Titan Medical adds $900k to $8m overnight offering (Mass Device)
  • Abiomed shares dip on Q1 release, despite FDA IDE win (Mass Device)
  • Comparing drug and medical device clinical trials (Mass Device)
  • Skin Patch Helps Control Peanut Allergies in Year-Long Study (MedGadget)
  • 3D-printed device controls ultrasound waves for surgical procedures (Medical Design & Outsourcing)

US: Assorted and Government

  • Senate Finance Committee Floats Chronic Care Discussion Draft (InsideHealthPolicy-$)
  • Draft Guidance for Industry: Describing a Hazard That Needs Control in Documents Accompanying the Food, as Required by Four Rules Implementing FSMA (FDA)

Upcoming Meetings and Events             


  • Commission continues fight against Antimicrobial Resistance with announcement of second Action Plan (EC)
  • Tesaro’s PARP accepted for review in EU as Astra makes case for Lynparza (FierceBiotech)
  • Promethera boosts Series C to €30M to join NASH race (FierceBiotech)


  • Infections associated with heater-cooler devices (Australia’s TGA)
  • Australian Businesses Worried U.S. Will Ask For Biologics Changes In TPP Certification (InsideHealthPolicy-$)
  • India better placed to reap benefit of biologics patent expiry: say experts (PharmaBiz)

General Health and Other Interesting Articles

  • Does the Flu Provide Better Immunity Than a Flu Shot? (NY Times-$)
  • The Cure for UTIs? It’s Not Cranberries (NY Times-$) (JAMA)
  • Chlorine gas released in Kansas distillery chemical mix-up (C&EN)
  • As record number of states vote on marijuana, public health questions remain (Stat)

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? Send him an email at
A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.

Categories: Recon, Regulatory News

Regulatory Focus newsletters

All the biggest regulatory news and happenings.


Most Viewed Articles