Regulatory Focus™ > News Articles > 2 > Recon: Amgen's Q4 Earnings Fall Short of Expectations; AstraZeneca Sued by Array Over Royalties

Recon: Amgen's Q4 Earnings Fall Short of Expectations; AstraZeneca Sued by Array Over Royalties

Posted 02 February 2018 | By Michael Mezher 

Recon: Amgen's Q4 Earnings Fall Short of Expectations; AstraZeneca Sued by Array Over Royalties

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

In Focus: US

  • AstraZeneca is sued by Array BioPharma over cancer drug royalties (Reuters)
  • AstraZeneca stops monotherapy study of centerpiece of $500M buyout (Fierce)
  • Despite Doubters, Moderna Raises $500 Million, Is Now Worth $7 Billion (Forbes) (Fierce) (Financial Times)
  • US FDA Taps Pfizer Executive For CDER Deputy Director Slot (Pink Sheet-$)
  • We Saw It Coming In Pharma: Now Gene Therapy Is Biotech 2.0 For Rare Diseases (LifeSciVC)
  • New York accuses Insys of deceptively marketing opioid (Reuters)
  • Purdue's Oxycontin Targeted at Judge's Opioid Summit (Bloomberg)
  • CDC employees are delighted that their acting director is back in charge (Washington Post)
  • This new group is angry about high drug prices — and plans to make candidates pay attention in 2018 elections (CNBC)
  • AstraZeneca logs fall in 2017 revenues on lower product sales (Financial Times)
  • Merck results mixed, plans $8bn in US capital spending (Financial Times) (Fierce)
  • Drugmakers highlight US pricing pressure in results (Financial Times)
  • Amgen reports profit below analyst views, but beats expectations on earnings outlook (CNBC) (Fierce) (Financial Times) (Endpoints)
  • A Good Health Care Deal, but Only for Some (NYTimes)

In Focus: International

  • PRIME Dry Spell Continues At EMA (Pink Sheet-$)
  • Health campaigners decry global HIV fund's deal with Heineken (Reuters)
  • AstraZeneca links with Alibaba and Tencent in China push (Reuters) (Financial Times)
  • UK and China sign Memorandum of Understanding on Medicine and Device Regulation (MHRA)
  • Philippines says anti-dengue vaccine may be connected to three deaths (Reuters)
  • Billion-dollar biosim maker mulls $500M Hong Kong IPO (Endpoints)
  • Venezuela's Health Care System Ready To Collapse Amid Economic Crisis (NPR)
  • India's 'Modicare' to cost about $1.7 billion a year: sources (Reuters) (Economic Times 1, 2)
  • Cardinal Health closes $1B China biz sale (MassDevice)
  • After EMA flop, Puma takes Nerlynx to China in new out-licensing deal (Endpoints)
  • Hard-hit Novo Nordisk still has M&A 'on the radar' post-Ablynx setback, CEO says (Fierce)
  • Settling a post-buyout hangover, Allergan gives Teva a $700M remedy (Fierce)
  • Faslodex rejected by NICE for NHS breast cancer use (Pharmafile)
  • Japan urged to act on "opaque and under-regulated" regenerative medicine field (PharmaLetter-$)

Pharmaceuticals & Biotechnology

  • Trump's 'Right To Try' Push Would Only Punish The Seriously Ill (Forbes)
  • A search for insomnia genes involving 1.3 million people is the largest genetic study ever (MIT Technology Review)
  • Pfizer Mum On Consumer Business Plans As Analysts Say Spin-off (Pink Sheet-$)
  • RNA biotech Arcturus boots CEO Joseph Payne (Endpoints)
  • Kenji Yasukawa takes the reins at Astellas; Voyager hunts for new CEO as Steven Paul goes back to research (Endpoints)
  • Flu vaccine provided dismal protection against this winter's virus, early data suggest (STAT)
  • Profit-turning Samsung BioLogics wins $105m contract extension (BioPharmaReporter)
  • Boehringer US CEO Fonteyne Retiring, Baiker To Succeed (BioCentury)
  • Zika vaccine development: two years on from the outbreak (Pharmaceutical Journal)
  • The CEO, reporter, and short seller: The story behind the MiMedx viral video at JPM18 (MedCity)

Pharmaceutical and Biotechnology: Study Results, Filings and Designations

  • Priority Review For Alnylam's Patisiran (BioCentury) (Press)
  • FDA Approves AVYCAZ® (ceftazidime and avibactam) for the Treatment of Patients with Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia (Press)
  • Pivotal SAKURA Phase 3 Clinical Data to be Presented at IMCAS World Congress 2018 (Press)

Medical Devices

  • Stranger Things in Medtech (MDDI)
  • Titans Unite: Medtronic, Philips Partner to Treat Lung Cancer (MDDI)
  • Edwards Lifesciences shares up after Q4, 2017 earnings beat The Street (MassDevice)
  • Boston Scientific confirms Lotus valve off the market until 2019 (MassDevice)
  • Heart Study app could be Apple's first FDA-cleared product (mobihealthnews)
  • FDA recall of Vyaire AirLife humidification chambers is Class I (MassDevice) (FDA)
  • Adhesys Medical wins FDA EAP designation for Vivo surgical sealant (MassDevice)
  • Siemens Healthineers Receives FDA Clearance for Blood Urea Nitrogen and Total C02 Point-of-Care Testing (Press)

US: Assorted & Government

  • Eleventh Circuit Affirms Summary Judgment for Defendants in Embrel Case (Drug & Device Law)
  • Insurers Sue Pfizer To Avoid Covering $400M Settlement (Law360-$)
  • Azar to announce Indiana's Medicaid work requirements today (Politico)
  • Vape Shops Challenge Constitutionality of FDA's Deeming Rule (FDA Law Blog)
  • PTAB Releases Another Update to Its Motions to Amend Study (Patent Docs)
  • Justice Department requests more information on CVS-Aetna merger (CNBC)
  • US government proposes 1.84 percent hike in 2019 payments to Medicare insurers (Reuters)
  • Schedules of Controlled Substances: Temporary Placement of Seven Fentanyl-related Substances in Schedule I (DEA)

Upcoming Meetings & Events

Asia

  • Making the World Safe from the Threats of Emerging Infectious Diseases Prince Mahidol Award Conference, Bangkok, Thailand (WHO)
  • FiercePharmaAsia—Lantus biosimilar, Takeda's Zika vaccine, Celltrion warning letter (Fierce)

Other International

  • Cancer Surpasses Malaria as Top Public Health Threat in Africa (BIO)

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 news@raps.org.

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.


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