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Research & Development

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Historic Mapping Of Deadly Pathogens Allows PacBio To Showcase Its Platform

PacBio and Wellcome Sanger Institute tell Scrip why they've teamed up to decode genomes of more than 3,000 bacteria, including some of the world's most dangerous, and how it will help fight AMR and bioterrorism.

Platform Technologies Strategy Infectious Diseases
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Clinical Trials

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Latest From Clinical Trials

Incyte Will File Jakafi For Acute GVHD In US Based On Phase II Success

The JAK1/2 inhibitor may add an indication for acute graft-versus-host disease, though based on a single, open-label Phase II trial that showed a 55% response rate in a high-mortality indication.

Research & Development Clinical Trials

ViiV CEO: "We Aim To Be Top HIV Player By Mid-2020s"

ViiV CEO predicts strong pipeline and two-drug strategy will reinforces group's HIV market position and put it ahead of Gilead by the mid-2020s.

Analysis Business Strategies

Alexion Gets Speedy Review For Soliris Successor

Switching patients from the very expensive ultra rare disorder drug to ravulizumab will be a key strategy for Alexion if the latter is approved. Recent compelling data in paroxysmal nocturnal hemoglobinuria patients suggests the long-acting C5 complement inhibitor could offer more benefit than its predecessor with more convenient dosing.

Rare Diseases Business Strategies

ADA Meeting's Around The Corner: Five Things To Watch For

Among other debates at the American Diabetes Association annual meeting, clinicians will discuss the future of cardiovascular outcomes studies for diabetes drugs – whether they should maintain course or are due for an overhaul.

Clinical Trials Research & Development

Kala Hopes To Stride Into Dry Eye Market This Year

Kala Pharmaceuticals is hoping to shake up the dry eye market with a NDA filing this year for its steroid eye drop KPI-121 0.25%.

Ophthalmic Commercial

iTeos Says Adios To IDO And Eyes US IPO

An oversubscribed financing round led by new US investor MPM Capital has brought in $75m for the Belgian company. Much of it will be used to advance its potential best-in-class adenosine A2A receptor now that its IDO1 drug has been shelved.

Financing ImmunoOncology
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Approvals

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Latest From Approvals

Opdivo Approval Opens China I-O Doors But Pricing Key

China approves first immuno-oncology drug in the form of BMS’s Opdivo for lung cancer, opening up a new potentially huge market for the class, but much will depend on pricing and reimbursement policies.

China Cancer

Dr. Reddy's Launches First Generic Suboxone Film; Indivior May Seek Injunction

Launch comes immediately after FDA approval of Dr. Reddy's and Mylan ANDAs while Indivior appeals district court ruling of non-infringement; Mylan settlement may delay its entry.

Generic Drugs Approvals

Pipeline Watch Phase III Progress With Trintellix, Ocrevus And Olumiant

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Pipeline Watch Approvals

Pipeline Watch: Phase III Progress With Nimotuzumab, Solriamfetol, And Upadacitinib

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

 

Approvals Research & Development

New EU Approval Further Boost For Tagrisso As Threats Recede

Tagrisso's march on the first-line EGFRm NSCLC market looks like it will be unimpeded by any near-term rivals following new data at ASCO as the EU becomes the latest market to approve it in the first-line setting.

Approvals Clinical Trials

Lilly Prices Olumiant For JAK Battle, But Misses Approval For Higher Dose

Lilly priced its now-approved Olumiant (baricitinib) to fight for US market share versus well-known rheumatoid arthritis therapies, undercutting Humira by 60% and Pfizer's established JAK inhibitor Xeljanz by 50%.

Approvals Pricing Strategies
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Post Marketing Regulation & Studies

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Latest From Post Market Regulation & Studies

Real World Data Helping To Drive Rise Of Novartis' Entresto

Patients with heart failure on Entresto say they have fewer symptoms and greater quality of life, according to a registry study and Novartis is hoping that this and other real world data will propel the drug towards its peak sales target of $5bn.

Cardiovascular Life Cycle Management

Repatha Inroads Build Gradually As EU Extension Nears

Europe is expected to follow where the US led in expanding the label for Amgen's PCSK9 inhibitor Repatha to include a prevention indication for heart attacks and strokes. But growth will be hard-won.

Approvals Cardiovascular

Biogen, AbbVie Withdraw Struggling MS Drug Zinbryta Due To Safety Issues

Antibody was approved in the US with a liver safety warning while EU regulators recently limited the drug's use. Now, EMA has begun an urgent review of reports of inflammatory brain disorders related to Zinbryta.
Drug Safety Post Market Regulation & Studies

Siliq Probably Isn't The Light At The End Of Valeant's Tunnel

Valeant is touting Siliq to lead new product growth, but the drug's significant safety concerns in a competitive psoriasis market likely will offset efficacy advantages it could offer.

Drug Safety Risk Management

Nearing Finish Line, HCV Race Focuses On Salvage Therapy

With few remaining unmet needs in hepatitis C, Gilead, Merck and AbbVie are focusing on tough-to-treat niches with their next-gen combination regimens, especially treatment-experienced patients who failed on prior direct-acting antiviral therapy. Merck also is studying injectable drug users in an effort to eradicate HCV entirely.

Infectious Diseases Liver & Hepatic

Intercept Seeks Long-Term Data To Build Ocaliva Market In PBC

The FXR agonist is the first new drug approved for primary biliary cholangitis in 19 years, but the lack of long-term outcomes data leaves a perceived opportunity for a host of mid-stage candidates also pursuing the indication. Intercept is conducting a Phase IV study to obtain such data with Ocaliva.

Commercial Business Strategies
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