Recon: Amazon, Berkshire & JPM Team Up to Cut Healthcare Costs

Posted 30 January 2018 | By Michael Mezher 

Recon: Amazon, Berkshire & JPM Team Up to Cut Healthcare Costs

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

In Focus: US

  • Amazon, Berkshire and JPMorgan join forces to shake up healthcare (Financial Times) (WSJ) (Reuters) (NYTimes)
  • Pfizer profit tops estimates as it booked an $11 billion tax gain (Reuters) (CNBC) (WSJ)
  • Pfizer confirms neuro cuts as it swings the ax on a host of other early projects (Fierce)
  • Chemotherapy, a Trusty Weapon Against Cancer, Falls Out of Favor (WSJ)
  • So, Your Board Asked For A Deal This Year? (LifeSciVC)
  • Imodium Swept Up in Opioid Crisis as FDA Seeks Restrictions (Bloomberg) (FDA)
  • Congress eyes FDA and drug compounders (Politico)
  • Corbus cystic fibrosis drug to get FDA review on flare-up data (Reuters)
  • Opioid crisis continues to ravage US as Trump administration dithers (CNBC)
  • Attorney General Sessions Announces New Tool to Fight Online Drug Trafficking (DoJ)
  • Gottlieb Statement on Preventing Opioid Addiction, Curbing Abuse (FDA)
  • New 'Liquid Biopsy' Shows Early Promise in Detecting Cancer (NIH)
  • Sanofi CEO: $16 Billion Deal Binge Does Not Represent A Change In Strategy (Forbes)
  • Faced with failing antibiotics, scientists are using killer viruses to fight superbugs (MIT Technology Review)
  • Chasing Biotech Buyouts? Beware! (Forbes)
  • Nasdaq Exec 'Even More Bullish' On Biotech IPOs As New Entries Soar (Forbes)
  • Donald Trump promised to fight Big Pharma. He never did. (Vox)
  • Southern Illinois University halts herpes research amidst investigation into clinical trial practices (MedCityNews)
  • Cancer drug to treat dwarfism? Abandoned Novartis asset snagged by BridgeBio's QED Therapeutics (Endpoints)

In Focus: International

  • Italy to ask EU to reconsider Milan for drugs agency headquarters (Reuters)
  • EU clears MSD's Prevymis for CMV prevention (PharmaTimes)
  • MHRA cracking down on organised crime worth £200m (MHRA)
  • MHRA, Welsh Health Inspectorate Sign MoU (MHRA)
  • Dr Reddy's Pins Hopes On Complex Drugs Pipeline Amid Weak Q3 (SCRIP-$)
  • EU Extends Deadline For Bayer-Monsanto Review (Law360-$)
  • Scientists use pocket-size device to map human genetic code (Reuters)
  • Philippines' DoH demands full refund of $70m Dengvaxia program from Sanofi (Pharmafile)
  • Puma Biotechnology and Medison Pharma Enter into Exclusive Licensing Agreement to Commercialize NERLYNX® (neratinib) in Israel (Press)
  • Australia Says No to Suffixes in Biologics Names (BioCentury)
  • Pharmacovigilance market value to be worth $8 billion by 2024, says report (PharmaLetter-$)

Pharmaceuticals & Biotechnology

  • How to "Lower Drug Prices" Without Lowering Drug Prices (Harvard Bill of Health)
  • NIH launches partnership to improve success of clinical trials for patients with Parkinson's disease (NIH)
  • Celgene Executive Chairman Bob Hugin to retire (Pharmafile)
  • Opioid Crisis: USP's Comments to the FDA (USP)
  • Pediatric Exclusivity: Court Backs US On When Studies 'Fairly Respond' To Requests (Pink Sheet-$)
  • Shire bags rights to autoimmune drug to target multibillion-dollar IVIg market (Fierce)
  • FDA Clarifies Stance on Clinical Trial Reimbursements for Patient Travel, Lodging (FDANews-$)
  • PTC Gains On Early Data For SMA Candidate (BioCentury)
  • Valeant partner Cosmo turns wannabe IBS-D rival, and it could do some sales damage: analyst (Fierce)
  • Brain insulin resistance in type 2 diabetes and Alzheimer disease: concepts and conundrums (Nature)
  • Severe toxicity in nonhuman primates and piglets following high-dose intravenous administration of an AAV vector expressing  human SMN  (Liebertpub)
  • CRISPR Stocks Add Over $530 Million In Market Cap (BioCentury)
  • CF Foundation Grants Corbus $25m for Phase IIb Study (BioCentury)
  • Bigger in Texas: Fujifilm adds 6,000L and opens gene therapy plant (BioPharmaReporter)
  • A dataset of 200 structured product labels annotated for adverse drug reactions (Nature)
  • Industry awaits FDA on rules for real-world evidence (BioPharmaDevice)
  • Quigley: 'These are medicines people need to live' (Indy Star)
  • Richard Lehman's journal review—29 January 2018 (BMJ)
  • Primus Announces a Voluntary Nationwide Recall of All Lots Within Expiry of Prescription Medical Food Limbrel® Due to Rare But Serious and Reversible Adverse Events While Seeking FDA's Cooperation to Restore Access for Patients with Medical Necessity (FDA)
  • Expiration Date Extension for North American Coral Snake Antivenin (Micrurus fulvius) (Equine Origin) Lot L67530 through January 31, 2019 (FDA)
  • Determination of Regulatory Review Period for Purposes of Patent Extension; KEYTRUDA (FDA)

Pharmaceutical and Biotechnology: Study Results, Filings and Designations

  • CardiAMP Cell Therapy Receives FDA Approval for Pivotal Trial in Chronic Myocardial Ischemia (Press)
  • Sunovion Announces Positive Topline Results from Pivotal Study of Apomorphine Sublingual Film (APL-130277) in Patients with Parkinson's Disease (Press)
  • Perrigo Announces Tentative FDA Approval For The Generic Version Of Soolantra Cream, 1% (Press)

Medical Devices

  • Hearing aid maker GN develops device to help soldiers in the din of war (Reuters)
  • How Two Tiny Insulin Devices Won JDRF Support (MDDI)
  • FDA Issues UDI Guidance for Class I and Unclassified Devices (FDA Law Blog)
  • Magnetic Hammer Drives Tiny Medical Robot Through Brain Tissue (IEEE Spectrum)
  • Why Cardiostim is Cancelled This Year (MDDI)
  • Medtronic and Philips Partner to Innovate in Lung Cancer Management (Press)
  • J&J's DePuy Synthes touts anterior-approach results in comparative THA study (MassDevice)
  • Electrocore wins FDA nod for GammaCore acute migraine treatment indication (MassDevice)
  • Stryker touts AHA, ASA updated guidelines based on Dawn thrombectomy trial results (MassDevice)
  • Accuray touts trigeminal neuralgia CyberKnife study results (MassDevice)
  • Medtronic's In.Pact Admiral drug-coated balloon succeeds in two-year study, critical limb ischemia analysis (MassDevice) (Press)
  • Multi Radiance Medical Super Pulsed Lasers Receive FDA Clearance for Neck and Shoulder Pain (Press)

US: Assorted & Government

  • DOJ Says Guidance Documents Can't Drive Enforcement Actions (Bloomberg)
  • Novartis Blasts Attempt To Revive Pay-For-Delay Suit (Law360-$)
  • In re Janssen Biotech, Inc. (Fed. Cir. 2018) (Patent Docs)
  • As If Discovery Were Not Difficult Enough, Now This (Drug & Device Law)
  • Forest Beats Final Cases In Celexa, Lexapro MDL (Law360-$)
  • Patent Deal Clears Actavis' Zohydro Generic For 2029 (Law360-$)
  • FDA, USDA partner to improve coordination, bolster collaboration (FDA)

Upcoming Meetings & Events


  • German court allows pharma company promotional statements about Rx-drug to counter a "shitstorm" – a trend also for the rest of the EU? (National Law Review)
  • Draft qualification opinion on molecular neuroimaging of the dopamine transporter as biomarker to identify patients with early manifest Parkinsonism in Parkinson's disease (EMA)
  • Report From The Commission To The European Parliament And The Council on the Member States' transposition of Article 118a of Directive 2001/83/EC of the European Parliament and the Council of 6 November 2001 on the Community code  relating to medicinal products for human use as amended by Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011 (EC)


  • CFDA and the Ministry of Health of the Czech Republic Signed the Memorandum of Understanding on the Joint Organization 16+1 Drug Regulatory Cooperation Summit (CFDA)


  • Divis to spend Rs 300 crore on expansion plans in 2018 (Economic Times)
  • Top Indian lawyers to argue Ranbaxy-Daiichi appeal in Singapore (Economic Times)


  • Agreement Cuts Common Canadian Generics Prices by Up to 40 Percent (FDANews-$)

General Health & Other Interesting Articles

  • Arno Motulsky, a Founder of Medical Genetics, Dies at 94 (NYTimes)
  • When You Care for Someone With Alzheimer's (WSJ)

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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