Regulatory Focus™ > News Articles > Regulatory Recon: Early Looks at Trial Results Giving Investors Whiplash; Biosimilars Still Hard to

Regulatory Recon: Early Looks at Trial Results Giving Investors Whiplash Biosimilars Still Hard to Sell Against Rivals (15 August 2017)

Posted 15 August 2017 | By Michael Mezher 

Regulatory Recon: Early Looks at Trial Results Giving Investors Whiplash Biosimilars Still Hard to Sell Against Rivals (15 August 2017)

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

In Focus: US

  • Trump's renewed broadsides on drug pricing didn't even dent biopharma this time (Endpoints) (Forbes)
  • Will more pharmas defy Trump after Merck CEO's council exit? Don't count on it (Fierce)
  • What's Harder Than Making Copycat Biotech Drugs? Selling Them (Bloomberg)
  • Why Early Peeks at Drug Trials Are Giving Investors Whiplash (WSJ) (Endpoints)
  • Is Amazon planning to disrupt the $560B prescription drug market? (Endpoints) (MedCityNews)
  • How a drug company fighting depression and schizophrenia avoids 'ripoff' drug prices (CNBC)
  • What's worth $500M-plus? The Big 6 deals of Q2 show you where the money is — and isn't (Endpoints)
  • With an eye on the FDA, Lexicon and Sanofi line up more positive data on diabetes drug (Endpoints) (Fierce)
  • After a slow start, Novartis finally gains market traction with heart drug Entresto (Fierce)
  • Gilead set to open $250m, 23-acre campus (Pharmafile)
  • Novartis, Lilly-backed Cavion poaches Teva exec as R&D head (Fierce)
  • GOP senator meeting with White House on new ObamaCare plan (The Hill) (The Advocate)
  • Apple Continues Push Into Device Industry With New Patent Filing (Focus)
  • Report: Aetna in talks to get Apple Watches to its customers (The Hill)
  • Medical device tax repeal push through recess (Politico)

Sponsored Content: RWS Acquires LUZ

In Focus: International                         

  • Teva Falls Hard, Loses Title as Israel's Biggest Firm (The Street)
  • EMA's CHMP Adopts Updated Guideline on Manufacture of Finished Dosage Form (Focus)
  • Shire files dry eye drug lifitegrast in Europe (PharmaTimes) (Pharmafile)
  • EU ADR Reporting Guidance Remains Complex, But Addresses Some Of Industry's Concerns (Pink Sheet-$)
  • China's HitGen bags new drug discovery deal with Aduro (Fierce)
  • China's High Court Pushes for Severe Penalties for Falsifying Clinical Trial Documents (FDA News-$)
  • Will biosimilars revolutionise the future of health? (ABPI)
  • Rare fungus found in 200 patients in 55 UK hospitals (Reuters)
  • MHRA advises health professionals on supply of clobazam for epilepsy (Pharmaceutical Journal)

Pharmaceuticals & Biotechnology

  • FDA Sends Dear Colleague Letter to Industry Ahead of PDUFA VI (FDA)
  • The New Conundrum About When to Stop Antibiotics (WSJ)
  • New FDA security rules will bar agency from hiring some foreign nationals (Science)
  • The key to innovation is balancing risk and rigour (Financial Times)
  • Breakthrough Requests Keep Climbing (Pink Sheet-$)
  • As Zytiga's importance grows, so does that of generics (EP Vantage)
  • As federal efforts slow, states take up drug pricing pushback (BioPharmaDive)
  • In Ohio, tension brews over who's funding a drug price-control ballot measure (STAT)
  • The secret recipe behind the launch price of a drug (BioPharmaDive)
  • Biogen, Merck use predictive modeling to better negotiate value-based contracts (MM&M)
  • ROS1 cancer patients set out to create disease models (Fierce)
  • Cerecor CEO retires after scoring J&J license deal (Fierce)
  • Dipeptidyl peptidase-4 inhibitors and cancer risk in patients with type 2 diabetes: a meta-analysis of randomized clinical trials (Nature)
  • Five Reasons Biotech Entrepreneurs Absolutely, Positively Need Neil Young, Miles Davis And Liszt (Forbes)
  • Amneal Pharmaceuticals issues voluntary recall of lorazepam droppers (MassDevice)
  • Upsher-Smith Laboratories, Inc.; Withdrawal of Approval of an Abbreviated New Drug (FDA)

Pharmaceuticals and Biotechnology: Study Results, Filings and Designations

Medical Devices

  • Abbott's new contact ablation catheter: Here's what you need to know (Medical Design & Outsourcing)
  • Manufacturing drug device products: challenges and best practices (Drug Delivery)
  • FDA Pre-Cert Pilot for Medical Software: Key Questions and Eligibility Criteria (Emergo)
  • Medtronic, Halyard Health's Corpak to lay off 266 in Illinois (MassDevice)
  • Report: Olympus study of next-gen power morcellator draws criticism (MassDevice)
  • Senseonics expects FDA panel to consider Eversense CGM clearance (MassDevice)
  • BioStable Science & Engineering wins FDA nod for Haart 200 aortic annuloplasty device (MassDevice)
  • Medtronic Announces Randomized Global Resolute Onyx(TM) DES One-Month Dual Antiplatelet Therapy Study to Address Critical Unanswered Question in Interventional Cardiology (Press)
  • FDA approves pivotal study of Vascular Dynamics MobiusHD high blood pressure device (MassDevice)
  • Camber Spine Technologies Announces FDA Clearance And Nationopthea
  • al Launch Of SPIRA™ Open Matrix ALIF (Press)
  • Tandem Diabetes Care Begins Enrollment in Pivotal Trial for First Touchscreen Insulin Pump with Predictive Low Glucose Suspend (PLGS) (Press)
  • BioStable Science & Engineering Announces FDA Clearance of the HAART™ 200 Aortic Annuloplasty Device for Bicuspid Aortic Valve Repair (Press)
  • ImpediMed shares rise on FDA nod for Sozo system (MassDevice)
  • FDA Grants EUA for Columbia University's Zika Test (GenomeWeb)

US: Assorted & Government

  • CBO report on pulling Obamacare payments due today (Politico)
  • Trump administration could zap Obamacare enrollment by dropping outreach deals (CNBC)
  • FDA Action Against Outsourcing Facility, the Sequel (FDA Law Blog)
  • Causation Testimony Excluded in Heart-Lung Bypass Machine Death Case – Again (Drug & Device Law)
  • AIA America, Inc. v. Avid Radiopharmaceuticals (Fed. Cir. 2017) (Patent Docs)

Upcoming Meetings & Events

Europe

  • Atlas awarded £2m grant for infectious disease test (PharmaTimes)
  • Making safer polio vaccines with plants (MHRA)
  • Data shows 'dramatic drop' in UK bowel cancer deaths (PharmaTimes)

Australia

  • Planned process improvements for GMP Clearance (TGA) (Pink Sheet-$)

Other International

  • Zika Tied to Sharp Rise in Adult Neurological Syndromes in Brazil (Medpage)
  • Director-General leads WHO delegation to the Belt and Road Forum for Health Cooperation (WHO)

General Health & Other Interesting Articles

  • Fleas Found To Be Carrying Plague In Arizona (Forbes)
  • Little evidence shows cannabis helps chronic pain or PTSD (Reuters)

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.


Categories: Recon, Regulatory News

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