June 13, 2017

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Today's Rundown

  1. J&J's Invokana matches Jardiance's 14% reduction in major CV events—but doubles amputation risk, too

  2. Novo's Tresiba matches Sanofi rival Lantus in CV safety study—and cuts down the rate of severe hypoglycemia, too

  3. What helps Lilly, BI's Jardiance slash CV death risk? Not blood pressure, lipid or HbA1c reductions: study

  4. Merck, Pfizer trot out more support for latecomer SGLT2 candidate ertugliflozin

  5. Sanofi and Regeneron's Praluent safely smacks LDL in high-risk diabetics

  6. Novo's Xultophy beats basal-bolus insulin at cutting hypoglycemia, spurring weight loss

  7. Lilly and BI, following their SGLT2 rivals, plan kidney disease study for Jardiance

  8. Sanofi plots real-world data push as Toujeo slashes hypoglycemia risks in seniors

  9. Lexicon diabetes pill hits endpoint in another phase 3, teeing up regulatory filings by partner Sanofi

  10. Special Report—Top 10 diabetes drugs by 2016 sales

Featured Story

J&J's Invokana matches Jardiance's 14% reduction in major CV events—but doubles amputation risk, too

There’s officially another heart-helping SGLT2 on the block. But this one brings some varied benefits—and amputation risks—along with it.

Top Stories

Novo's Tresiba matches Sanofi rival Lantus in CV safety study—and cuts down the rate of severe hypoglycemia, too

Competing with Sanofi blockbuster Lantus is no easy task, but that's exactly what Novo Nordisk's long-acting insulin Tresiba has to do. Thanks to new data, though, the drugmaker can safely say its newcomer poses no increased heart risks—and it has some advantages over its rival, too.

What helps Lilly, BI's Jardiance slash CV death risk? Not blood pressure, lipid or HbA1c reductions: study

Boehringer Ingelheim and Eli Lilly still don’t know what’s responsible for the dramatic reduction in cardiovascular death risk that their diabetes med Jardiance (empagliflozin) posted in its outcomes trial. But they know what isn’t.

Merck, Pfizer trot out more support for latecomer SGLT2 candidate ertugliflozin

At last year’s American Diabetes Association annual meeting, Merck & Co. and Pfizer rolled out positive results from two phase 3 studies they hoped would buoy SGLT2 candidate ertugliflozin once it got to market. And this year, they’re doing it again.

Sanofi and Regeneron's Praluent safely smacks LDL in high-risk diabetics

Sanofi and Regeneron still have months to wait for final data from a key cardiovascular outcomes study of their PCSK9 therapy Praluent. But the pair now has results in hand suggesting the med can safely cut "bad" cholesterol in Type 2 diabetes patients at high risk of CV problems.

Novo's Xultophy beats basal-bolus insulin at cutting hypoglycemia, spurring weight loss

Novo Nordisk is in a tough market race against Sanofi with combo product Xultophy, which hit the market after the French drugmaker’s Soliqua. New basal-bolus-topping data could give the med a leg up.

Lilly and BI, following their SGLT2 rivals, plan kidney disease study for Jardiance

Eli Lilly and Boehringer Ingelheim have reason to believe their SGLT2 inhibitor, Jardiance, may be able to improve outcomes for chronic kidney disease patients—so they’re putting the med to the test.

Sanofi plots real-world data push as Toujeo slashes hypoglycemia risks in seniors

Sanofi’s Toujeo has plenty of competition in the basal insulin market, but new real-world data shows it may outdo its peers at cutting the risk of hypoglycemia for older patients. And Sanofi's planning three real-world follow-ups, a "major shift" from its usual data approach.

Lexicon diabetes pill hits endpoint in another phase 3, teeing up regulatory filings by partner Sanofi

Lexicon Pharmaceuticals has posted upbeat data from another phase 3 trial of its Sanofi-partnered dual SGLT1 and SGLT2 inhibitor sotagliflozin. More patients in the treatment arm hit an established target for glycemic control than did in the control cohort, resulting in Lexicon chalking up its third phase 3 success for the diabetes tablet.

Special Report—Top 10 diabetes drugs by 2016 sales

Formulary exclusions, pricing, biosimilars and cardiovascular outcomes data have impacted the U.S. diabetes space. We’ve compiled last year’s U.S. sales rankings for you, along with some insight into what to expect for each of the top meds going forward.

Resources

[Webinar] Going Digital: Connecting Submission Documents and Regulatory Data

Hear three innovative leaders explain how regulatory can “go digital” in their operations by leveraging the data-handling capabilities in their RIM systems.

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[Whitepaper] Make Your Clinical Trials a Success

Gain critical insights into how to design and implement pragmatic trials and generate relevant, high-level real-world evidence. Learn when to conduct PTs, design considerations, ethical regulatory issues — and more.

[Webinar] Leveraging Medical Insights for Better Healthcare Engagement

Join this global webinar to learn a new approach for demonstrating medical affairs' impact with better metrics - beyond reach and frequency, enabling launch success and better engagement with strategic KOL insights, and increasing your organization's share of voice in the healthcare landscape.

[Marketplace] Halo Pharmaceuticals: See us at CPhl North America Booth 3132

Agile. Flexible. Collaborative. Proven. That’s Halo Pharma – making contract clinical development and commercial manufacturing go smoothly.

[Whitepaper] Addressing Immunotherapy Drug Development Challenges: An Evidence-Based Approach

Discover how you can successfully mitigate risks and maximize trial success by creating a comprehensive strategy that plans for the difference in immunotherapy development and proactively monitors execution.

[Whitepaper] The Paperless Future of Healthcare and Life Sciences

DocuSign’s eSignature solutions modernize healthcare and life science organizations by eliminating paper and antiquated signature processes while meeting compliance requirements and reducing costs and errors.

[Whitepaper] DocuSign Life Sciences eBook: Reducing Cycle Time with Digital Transaction Management

The patients who rely on your scientific leadership are expecting more.

[Whitepaper] Streamline Regulatory Compliance in Life Sciences with Digital Transaction Management

The U.S. Department of Justice has collected upwards of $17 billion in settlements from the healthcare industry since 2009, including more than $2 billion from a single life sciences company.

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