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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Bristol-Myers Squibb has withdrawn its EU application to extend Opdivo’s use to metastatic colorectal cancer (mCRC), following a similar move for liver cancer last year.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.
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.
14 Nov 2022
Disease management and treatment programmes change, as research evolves and new discoveries are made. Your market access strategies must evolve too.
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.
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.
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.
14 Nov 2022
This essential whitepaper looks at how increased drug spending and a rising desire for expenditure controls are influencing access dynamics across key markets. It is available to you now, for free.
By David Wallace 25 Oct 2022
Chirag Patel and Chintu Patel have returned to being co-CEOs of Amneal, just over a year after the firm completed its merger with Impax. Rob Stewart – who was president and CEO of Amneal – and executive chairman Paul Bisaro have resigned from the roles.
Topic Company Analysis
By Jung Won Shin 25 Oct 2022
AstraZeneca plans hefty investment in South Korea’s biomedical sector over next few years, in a signal of multinationals' improved sentiment over the government’s recently announced plans to nurture the bio-health industry as a major growth engine.
Topic Company Analysis Strategy
21 Oct 2022
As biopharma continues to make progress developing novel and more targeted cancer therapies, regulators are responding with innovative and collaborative approaches to reviewing cancer products, aiming to resolve questions earlier and review products more quickly. Pink Sheet closely covers these programs, helping readers understand the expectations, challenges and opportunities, as well as lessons from companies putting policy into practice. This ebook takes some of our recent articles on special review mechanisms and regulators’ data expectations.
20 Oct 2022
Advances in multiple scientific areas will mature into novel therapeutics, often tailored for the individual patient and increasingly curative, making biopharma an exciting place to be in 2020.
By Bridget Silverman 19 Jan 2022
US FDA’s accelerated approvals hit a contemporary high in 2021, accounting for one-third of novel US approvals, but the big story was the agency’s crackdown on delinquent confirmatory trials for oncology AA indications.
By Chloe Kent 18 Jan 2022
Medicines for Ireland has appointed Accord Healthcare Ireland managing director Padraic O’Brien as chairperson and Teva Ireland director of generic products Paul Neill as vice chairperson of the Irish industry association. The changes come just a few weeks after Ireland implemented its new framework agreement on off-patent pricing.
By Vibha Sharma 18 Jan 2022
The EU will make it mandatory for clinical trial sponsors to prepare layperson summaries of their study results. Industry practices around content presentation, translation and dissemination of these documents will be keenly watched.
By David Wallace 18 Jan 2022
WaveData’s compilation of the fastest-rising UK generics prices in December showed several products across multiple presentations more than doubling their average trade prices to independent pharmacists.
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