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Featured Stories


The Healthcare World According To Andrew Witty

The former GlaxoSmithKline CEO has given his views on the prospects for healthcare systems, saying that intelligently applying digital technologies can lead to simpler, more cost-effective health systems.

Leadership Healthcare Systems Digital Health

Five Companies To Watch At The Jefferies Conference

Novartis and Roche will present alongside up-and-coming biotechs and microcaps.

Companies Leadership Strategy

Takeda: 12 NMEs Poised To Launch In Five Years, And Deliver $10 Bn In Peak Sales

The Japanese pharma held its first investor day in New York, outlining the company's strategy to deliver long-term growth through a newly energized oncology, gastrointestinal and rare disease pipeline.

Business Strategies Cancer ImmunoOncology

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Astellas Beats Rivals To Japan HIF-PHI Market As Roxadustat Launched

Astellas becomes first to market in Japan in new class of oral anemia drugs, beating multiple rivals in a sector set to see strong growth but also fierce competition.

Japan Launches

Novo Nordisk Enters Its First Strategic RNAi Pact

Novo Nordisk’s head of global drug discovery tells Scrip he hopes the strategic collaboration with Dicerna Pharmaceuticals will generate clinical candidates within three years.

Commercial Companies

Content Personalization Scores As Pharma Ups Digital Ante

Pharma’s digital spend is expected to spurt in the coming years and firms are deploying a range of initiatives to deliver personalized content to physicians via preferred channels. KOL webinars feature among the top three approaches for marketers across the Americas, Europe and Asia, a new survey shows.

Commercial Strategy

FDA Approval For Novartis’s Sickle Cell Treatment Adakveo

One of a new wave of treatments, Novartis has focused on proving its drug cuts vaso-occlusive crises (VOCs), or pain crises.

Approvals Commercial

Monroe Site Commercialization ‘Critical’ For Glenmark’s US Step-Up

Glenmark expects its first US manufacturing site to go commercial next year, accelerating growth in that market, while it sets right certain compliance blips back home. The Indian firm is also on course to divest certain non-core assets but notes that bringing in a minority partner for its API unit is not a priority.

Commercial Sales & Earnings

Roche Paying $390m Up Front For Fibrosis-Fighting Promedior

The deal, which includes up to $1bn for milestones, gives Roche Promedior’s PRM-151, a Phase III-ready asset for IPF that has also completed a Phase II study in myelofibrosis and could be effective in a broad range of fibrotic diseases.

Deals M & A
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Policy & Regulation Explore this Topic

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Gene And Cell Therapies In Asia: Can China Deliver Despite Murky Regulations?

The first country ever to approve a gene therapy, China has been lagging in the area since due to a lack of clear regulatory pathways and insufficient financial incentives. Now a new crop of developers are aiming to revitalize ambitions and make the country a major power for promising novel treatments for rare neurodegenerative conditions, retinal dystrophy, HIV and cancer.

China Gene Therapy

Amarin Heads Into Vascepa Expansion Labeling Talks After Positive US FDA Panel Review

Focus of negotiations with agency will be on breadth of population encompassed by a cardiovascular risk reduction indication; most advisory committee members favored a broad claim for secondary and primary prevention reflecting the REDUCE-IT trial population, but some strongly opposed an indication that includes patients without established CV disease.

Advisory Committees Drug Review

Double Delight For Novartis At The CHMP

Novartis has received two positive opinions in Europe, the most important being for Mayzent, its active secondary progressive multiple sclerosis drug which is key to the company's ambitions for growth in the neurology space.

Drug Review Europe
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Research & Development Explore this Topic

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Myovant Ready To File Relugolix For Prostate Cancer

Secondary endpoint assessing cardiovascular risk may offer important differentiation from AbbVie’s Lupron. Myovant accelerated the prostate cancer filing soon after slowing the planned relugolix submission for uterine fibroids.

Clinical Trials Drug Approval Standards

Karuna Upbeat On New Antipsychotic Mechanism Data

Karuna Therapeutics’ top-line Phase II data for a combination of a centrally acting muscarinic agonist, xanomeline, and a peripherally acting muscarinic antagonist, trospium, were greeted with enthusiasm by investors and the Boston, MA-based biotech.

 

Neurology Clinical Trials

After US Approval, BeiGene Set To Gain Sixth PD-1 Green Light In China

Beijing-based BeiGene is set to score two big wins in a row as it pursues innovation. After securing US approval for its BTK inhibitor zanubrutinib for mantle cell lymphoma, its PD-1 inhibitor has sailed through a technical review in China.
China Research & Development
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