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Ranbaxy Brothers Arrested, Downward Spiral Intensifies

$131.00

With the Singh brothers of Ranbaxy being arrested over allegations of financial fraud, Scrip looks at the history of issues at the company and how things appear headed even further downhill with Daiichi Sankyo also separately pursuing enforcement of damages against the brothers.
September 2, 2019
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Amarin CEO Thero On Gearing Up For Success Ahead Of The Big Vascepa Ad Comm

$131.00

Speaking with Scrip recently, Amarin CEO, John Thero talked about the upcoming US advisory committee meeting for Vascepa and commercial expansion plans and deflected questions about a big pharma buyout. What he did say was that, “We’re planning for success.
September 2, 2019
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The Case For Agile Innovation In Health Care

$131.00

According to a recent Bain & Company survey, while nearly 80% of health care executives said they needed to be more agile, more than half said they were not familiar with formal agile methodologies and tools and were not using them in their companies.
September 2, 2019
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Defying FDA: Shanghai Lab Gets Warning Letter But Won’t Relent

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A Shanghai testing laboratory has been handed an FDA warning letter for refusing a GMP inspection but told the agency it rightfully did so. Pink Sheet shares the exact working of the FDA letter as well as the highly unusual response from the laboratory.
September 2, 2019
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What Does It Take To Launch And Lead An Oncology Biotech Today?

$200.00

Oncolytic virus company Theolytics has emerged ready to raise a series A round and get its preclinical assets into human trials by 2021. CEO Charlotte Casebourne talks to In Vivo about the challenge of standing out from the crowd in oncology, how viruses have evolved as a treatment approach in cancer, and how oncolytic viruses might be the answer to the cancer drug pricing conundrum. Learn what this young CEO (at age 26) has to say about the skills required to be a biotech CEO today, the concerning issue of access to novel personalized cancer treatments, and the biggest challenges she sees in cancer drug development today.
August 12, 2019
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Novartis’ Zolgensma Had Manipulated Data In Application, US FDA Says

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The gene therapy Zolgensma will remain on the market, but Novartis and subsidiary AveXis Inc. may face civil or criminal action after revelations by the FDA that data used for approval had been manipulated. In fact, the drug giant knew about the problem months before Zolgensma was approved and said nothing. Learn what happened, why the FDA still asserts confidence in its approval of Zolgensma, and what these events could mean to Novartis and the gene therapy industry moving forward.
August 3, 2019
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Novartis CEO Explains Delay In Telling US FDA About Zolgensma Data Fraud: We Wanted To Understand It First

$200.00

Novartis AG tried to squash any murmurings that it had a disreputable intent in not disclosing the data fraud it knew about before approval of its gene therapy Zolgensma, saying the company wanted a full understanding of the issue first before bringing it to the attention of regulators. In a recent conference call with analysts, Novartis execs were bombarded with questions about their “prescribed process” of internal investigation, and when exactly they knew about the fraud. Find out how the pharma giant is handling such close scrutiny, how they are dealing with the AveXis scientists involved in the “data inaccuracies,” and the recent EMA decision to downgrade Zolgensma’s accelerated assessment.
August 2, 2019
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Sanofi Offloads Two German OTC Brands, New CEO Prepares To Make Mark

$200.00

Sanofi signaled earlier this year it would continue to rationalize its Consumer Healthcare portfolio and focus on several priority brands and categories. Now they have divested two brands in Germany and Austria. HBW covers the details including plans of the firm’s CEO.
August 2, 2019
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Reckitt Invests In AI Symptom Checker To ‘Unlock Self-Care’

$131.00

Reckitt Benckiser has invested in ‘doctor in your pocket’ app Your.MD in response to consumers’ increasing demand for “personal, always-on mobile and data-driven” digital healthcare – that according to Aditya Sehgal, RB Health’s chief operating officer. The app’s AI-powered symptom checker claims to diagnose with high accuracy a range of medical conditions. For its part, Your.MD believes the tie-up with RB will be a game-changer for the firm. Will the new infusion of capital fulfill the goal of Your.MD to put a doctor in the pocket of every citizen in the world?
August 2, 2019
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GSK And Pfizer Assemble Consumer Healthcare Leadership Team As JV Closes

$131.00

GlaxoSmithKline PLC and Pfizer Inc. have closed their consumer health joint venture to create the “global leader in OTC products.” Operating under the GSK Consumer Healthcare name, the joint venture – announced in December last year – has around a 7.3% share of the global consumer health market, well ahead of the next competitor, Johnson & Johnson, at 4.1%. Under the leadership of Brian McNamara, the new company has begun to assemble a management team that combines talent from both GSK and Pfizer. Who’s on the dream team, and what’s on the horizon for this new superpower?
August 2, 2019
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IXICO Targets Go-To Status In Neuro Data Analytics Space

$131.00

IXICO is a neuroscience data specialist that wants to partner with large and small pharmas to help them develop better-targeted clinical trials using imaging and digital biomarkers data. In Vivo looks at the CEO’s activity planning review and subsequent leadership restructuring.
August 2, 2019
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FDA Announces More Actions On Drug-Coated Devices

$131.00

Based on a meta-analysis of randomized trials for paclitaxel-coated devices, the FDA is concerned that they may not be safe to use, as they may be linked to mortality. Until further information is available, the FDA is recommending doctors prescribe these devices on a case-by-case basis only.
August 2, 2019
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Novo Nordisk’s Oral Rybelsus Priced On Par With Injectable GLP-1s, But Big Discounts May Be Needed

$200.00

While a 30-day supply of the first oral GLP-1 agonist will cost $772.43, similar to the injectable version, this is still steeper than oral diabetes medicines and Scrip looks at how deep discounts may be needed to secure market access.
August 2, 2019
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Why Deals Fail: The Reasons May Be Clinical, Economic Or Strategic

$131.00

Acquisitions and licensing are core to pharma and big biotech growth as pipelines thin and assets lose patent protection. Looking back at significantly sized acquisitions over just five years reveals that half of 2014’s acquisitions can already be judged as outright failures or, at best, questionable. But some lessons can be learned from dud deals. This article from In Vivo
Examines deal failures, from the most surprising to the most expected, given the level of risk at stake. If past Is prologue, dealmakers would be wise to look back and consider these lessons of the past.
August 1, 2019
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Biotech CEOs: Can Scientist-Founders Remain In Charge?

$200.00

Founder-CEOs do not typically remain at the helm as biotechs mature, as the majority of scientist-founders lack the skills to lead a company beyond discovery and early development. Exceptions to that rule are multiplying, though, especially in Europe as companies aim directly for Nasdaq. In this fascinating read, In Vivo reviews the many, varied paths toward biotech CEO, and what it takes to lead a company to IPO and beyond.
May 20, 2019
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