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TrialScope Disclose

The State of Global Clinical Trial Disclosure

31 Mar 2023

The coronavirus pandemic put clinical trials in the spotlight — or hot seat, depending on one’s perspective. Around the globe pressure came from multiple fronts: regulatory agencies, the public, patients, advocates, pharmaceutical industry watchdogs and investors all clamored for increased clinical transparency. The push for accountability has not abated for study sponsors to publish results in a timely manner. However, just as there are numerous regulatory agencies and guidelines (approximately 90 countries have requirements related to the disclosure of clinical trial data made publicly available on over 30 clinical trial registries), enforcement of clinical trial disclosure requirements varies greatly.

Scrip

Opdivos EU Colorectal Cancer is a Setback but More Than Offset By Potential Gains

By Ian Schofield 29 Nov 2022

Bristol-Myers Squibb has withdrawn its EU application to extend Opdivo’s use to metastatic colorectal cancer (mCRC), following a similar move for liver cancer last year. But the mCRC withdrawal is likely to have limited commercial impact and the company is more interested in pursuing the product’s use in combination treatment for this indication.

Trial Results Summaries

AstraZeneca takes an innovative approach to trial results summaries

25 Nov 2022

What Are Trial Results Summaries and Why Are They Necessary?

Trial Results Summaries

Trial results transparency starts here

25 Nov 2022

Trial Results Summaries provides an unbiased and non-promotional portal for sponsors to share trial results summaries, also known as plain language summaries (PLS), with participants and the public.

Citeline, Trialtrove

2020 Clinical Trials Roundup: Disruptions to the Trial Landscape

25 Nov 2022

Our annual analysis dissects the data of all Phase I–III clinical trials that started in a year dominated by COVID-19.

5 Top Tips For Generating Successful Content Marketing

18 Nov 2022

From choosing the right audience to measuring campaign results, follow these 5 tips when planning your successful content marketing campaign.  

In Vivo

Bayer’s US Playbook: The Smart Way To Top-Line Growth

By William Looney 14 Nov 2022

The hotly contested US market is central to Bayer’s aspirations to become a global innovation player in pharmaceuticals, especially in key growth segments like oncology. A little more than one year in, Bayer Pharmaceuticals Americas President Dr. Carsten Brunn reflects on his unit’s progress.

Medtech Insight

Inside Toyota's 'Cult' Car-Makers Quality VP Tells Device-Makers How To Adopt 4-Pronged Quality Strategy

By Shawn M. Schmitt 14 Nov 2022

Toyota Motor North America's Kristen Tabar told a roomful of medical device quality and regulatory professionals at a Case for Quality forum that they can infuse quality concepts into every nook and cranny of their firms by adopting the car-maker's quality strategy of reflection, education, celebration and planning. "I don’t want to make it sound like it’s sort of cult-y, but it’s kind of cult-y," Tabar quipped.

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Pfizer Lays Out Multi-Phase COVID-19 Vaccine Commercial Strategy

By Jessica Merrill 14 Nov 2022

The pandemic phase will last through late 2021/early 2022, becoming a more seasonal opportunity for several years after, Pfizer management predicted during the company's second quarter call.

Datamonitor Healthcare

Multiple Myeloma Pricing, Reimbursement, and Access

14 Nov 2022

Disease management and treatment programmes change, as research evolves and new discoveries are made. Your market access strategies must evolve too.

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Sanofi's €10bn Dupixent Plan: 'We're Going To Put The JAKs Properly In Their Place'

By Jessica Merrill 14 Nov 2022

Sanofi's new CEO has ambitious forecasts for Dupixent in atopic dermatitis, asthma and other indications. The French pharma outlined how it plans to reach that goal despite new competition vying to get in.

In Vivo

Critical Insights into Market Access

14 Nov 2022

Your key to refining your market access strategy with essential patient market access mini-mag and infographic from the experts at In Vivo.

In Vivo

From US To EU: Young Biotechs Going It Alone

By Jo Shorthouse 14 Nov 2022

Europe’s patchwork of reimbursement agencies make it a daunting place for a small US biotech to do business. Traditionally large pharma partners or CMSOs have provided an experienced hand to hold, but as a new wave of gene therapies and orphan drugs get the EMA green light, smaller drug developers are applying innovation to commercialization and choosing to go solo.

Scrip

Progress Being Made With Cell And Gene Therapy Market Access, But Challenges Remain

By Mandy Jackson 14 Nov 2022

Drug developers and payers are coming together long before product approvals to work out payment options for high-cost, high-impact cell and gene therapies, but challenges like portability of commercially insured patients and Medicaid best price requirements remain.

Datamonitor Healthcare

Acute Myeloid Leukemia Market Outlook Seminar

By Dominique Fontanilla 14 Nov 2022

There has been little change to standard treatment for AML in recent years; however, 2017 saw a flurry of new targeted drug approvals, sparking significant market growth. Patient age remains the biggest factor in driving treatment decisions for AML. Cases of AML are expected to increase, and prognosis remains poor – especially among older adults. Drug developers are targeting patient segments with high unmet clinical need to gain access to the AML market and the budget impact of AML is expected to grow considerably.