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Neurocrine Blames Sub-Par Dosing For Ingrezza Study Failure

Neurocrine's stock fell 9% on May 24 after the company said a closely-watched Phase II study for Ingrezza in pediatric Tourette's syndrome failed, but blamed a sub-therapeutic dose for the disappointing results. Most analysts gave the prospects for a higher dose study the benefit of the doubt.

Clinical Trials Neurology Research & Development

Keytruda Approval Opens New Routes For Immuno-Oncology

Merck's PD-1 inhibitor holds the first cancer indication based on biomarkers rather than tumor location. The most significant market will be colorectal cancer, but Bristol-Myers Squibb's Opdivo is pending for the same subgroup and Roche's Tecentriq could eventually gain a broader approval.

Approvals Drug Approval Standards Research and Development Strategies

Scrip Asks… Is The Biosimilar Cost-Saving Theory Sustainable?

Scrip asks industry whether the promise of biosimilars producing substantial cost-savings is a sustainable model to help healthcare systems afford the next wave of expensive biologics. Drug developers and trade associations comment on the caveats still in play when it comes to biosimilars, cost-cutting and market access.

Biosimilars Market Access Pricing Strategies

Mehta Analysis: Biopharma's 10% Myth

Viren Mehta, founder of Mehta Partners, LLC, considers the oft-repeated statement that the cost of drugs represents only 10% of US healthcare expenditure. Does it matter that the figure excludes a large and growing segment of medicine spending?

United States Pricing Debate Government Payers
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All Change At Alexion, But Will It Boost Investor Confidence?

The US rare diseases company Alexion appoints a new COO and is now looking for a new CFO, head of R&D, and head of human resources, as leadership changes leaves its CEO searching for a new executive team.

Appointments Business Strategies Rare Diseases

Shanghai Henilus Biotech Has Blockbuster Biologics In Biosimilars Crosshairs

Dr. Cheni Kwok, a business development and strategy consultant, caught up with Scrip’s Mike Ward to outline how Shanghai Henilus Biotech is positioning itself to provide affordable healthcare globally.

Asia Pacific Biosimilars Commercial

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Deal Watch: Takeda Signs Broad Cancer Collaboration With Nektar

Takeda will pair five cancer candidates with different mechanisms of action with Nektar's NKTR-214 and Merck follows up its Phase III disappointment verubecestat by licensing a preclinical Alzheimer's drug from Teijen.

Deals M & A

PML Case With Roche's Ocrevus, Link Unlikely

A German case of PML in a patient treated with Ocrevus, but who was also previously treated with Tysabri, threatens to take the gloss off Roche’s new multiple sclerosis therapy.

Drug Safety Neurology

Three CHMP Negative Opinions ‒ But Who Got A Boon?

The European Medicines Agency's advisory committee, the CHMP, unusually issued three negative opinions at its recent monthly meeting. Which companies received an unexpected boon at the news?

Commercial Therapy Areas

Korean Pharma Spawns US Cancer Biotech Startup

Dr. Benjamin R Cowen, COO of ImmunoMet Therapeutics, reveals how the Houston-based startup is developing OXPHOS inhibitors to treat drug resistant and relapse cancers.

Companies StartUps and SMEs

Celltrion Gets Go-Ahead For Remsima Trials In China, Mulls JV

Celltrion has received approval to begin clinical trials of its biosimilar infliximab in China and also filed IND applications for other biosimilar products with the CFDA, accelerating plans to enter the world’s second biggest pharma market as it propels efforts for global leadership in the biosimilar space.

Commercial Companies

US Price Pressure Clouds Lupin Outlook – Can Its Pipeline Deliver?

Lupin reported a sharp decline in its fourth quarter profits, dented by heightened price pressure and competition in the US for its key products. The management sees a ‘challenging’ 2018, but underscored the strength of the firm’s ANDA pipeline and enhanced investments in the biosimilars, inhalation and injectables space.

Commercial Strategy

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Merck & Co Accused Of Anti-Competitive Biosimilar Pricing

The UK's anti-competition authority has accused Merck & Co of anti-competitive behavior in its UK pricing strategy for its infliximab product Remicade.

Commercial Biosimilars Pricing Strategies

Sickle Cell Innovators Required: Emmaus' Pending Approval Highlights Rare Disease Void

FDA approval is likely for Emmaus' sickle cell drug L-glutamine this summer, representing the first new product for the disease since 1998 – a decision FDA advisory committee panelists hope will spur more innovation.

Approvals Research and Development Strategies

Three CHMP Negative Opinions ‒ But Who Got A Boon?

The European Medicines Agency's advisory committee, the CHMP, unusually issued three negative opinions at its recent monthly meeting. Which companies received an unexpected boon at the news?

Commercial Therapy Areas

Contrave Rxs Jump In Q1, But TV Commercial Runs Afoul Of FDA

Orexigen touts 39% growth in US sales of its obesity drug; agency objects to advertisement for excluding risk information.

FDA Advertising, Marketing & Sales

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The Pharma Pipeline Report Card 2017, An Infographic

The Pharmaceutical and Biotech industries’ R&D performance can be measured in a number of ways. Here is a look at its worldwide output of novel drug launches for 2016 and total pipeline size in 2017.

Research & Development Market Intelligence Launches

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Disappointing Bydureon EXSCEL Outcomes Data May Raise Stakes For Victoza

AstraZeneca's EXSCEL study could have created confidence in a GLP-1 class-wide outcomes benefit, but instead it has raised questions about whether differences in trial results boil down to trial design.

Research & Development Metabolic Disorders

NeuroVive To Take Traumatic Brain Injury Drug Into Mid-Stage Studies

Protecting the function of mitochondria may be key to developing medicines to reduce the nerve damage caused by traumatic brain injuries. NeuroVive Pharmaceutical is moving its cyclosporine candidate into Phase IIb studies.

Clinical Trials Research & Development

Shire Discontinues Development Of Once-Weekly SHP656 For Hemophilia A

Shire's cash-strapped partner Xenetic, whose technology enabled the long-acting Factor VIII, said on May 22 that SHP656 could not achieve once-weekly dosing in a Phase I/II clinical trial. The market for such a product may be limited anyway given current competition and payer preferences.

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