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Research & Development

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Biogen Spooks With Phase III Aducanumab Changes

Recruiting more patients into a trial to retain statistical power is standard practice, but with other companies discontinuing late-stage investigational Alzheimer's therapies, the difficulty in maintaining confidence in the development of new therapies for the condition has been underlined by investor responses to Biogen's alterations.

Neurology Clinical Trials Research & Development
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Clinical Trials

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Latest From Clinical Trials

Novo Nordisk's Oral Semaglutide Succeeds In First Phase III, But Prompts Questions

In PIONEER 1, weight loss results for the oral version of the GLP-1 agonist were somewhat disappointing and lack of detail in the top-line release prompts concerns about compliance.

Clinical Trials Metabolic Disorders

AbbVie's Got A Competitive Edge With Elagolix For Women With Uterine Fibroids

AbbVie announced positive data from the first of two pivotal Phase III studies testing the GnRH receptor antagonist, but Allergan and Myovant are among the companies also looking to bring new drugs to market.

Gynecology & Urology Clinical Trials

AAD Roundup: More Data Emerges In Atopic Dermatitis, But Dupixent Maintains Big Lead

Atopic dermatitis (AD) was a hot topic at the AAD meeting based on last year's Dupixent approval and the growing array of new systemic and topical therapies for the skin condition – and the large market those products may address.

Clinical Trials Research and Development Strategies

Aimmune Accelerates Commercial Planning For Peanut Allergy Drug

Even better than expected efficacy and safety in the Phase III PALISADE trial puts Aimmune on track to file its BLA for peanut protein capsule AR101 by the end of 2018.

Clinical Trials Immune Disorders

Waking Up Market To US Obstructive Sleep Apnea Epidemic

RespireRx president & CEO James Manuso explained to Scrip during the 2018 Biotech Showcase how the company is repurposing an existing drug to tackle the problem of sleep apnea.

Clinical Trials Companies

Lilly Halts Hanmi BTK Inhibitor Trial For RA, Mulls Other Indications

Hanmi Pharmaceutical shares fell sharply on the news Lilly has halted Phase II trials of the South  Korean firm’s BTK inhibitor for rheumatoid arthritis. But Hanmi says its license contract remains intact and that the two firms are discussing the potential development of the molecule for other indications.

Research & Development South Korea
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Approvals

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Latest From Approvals

Pipeline Watch: Phase III Starts With Atezolizumab, CNTX-4975 And WTX101

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

EU Delays For Portola As CHMP Trend Votes Go Good And Bad

Portola will have to rein in its European sales ambitions as the CHMP gives early verdicts on its Factor Xa inhibitor betrixaban and its reversal agent andexanet. 

Approvals Policy & Regulation

Think Positive: Clovis Confident Of CHMP Okay For Rubraca

The US biotech expects to finally get its PARP inhibitor for ovarian cancer onto the European market in the next few months to compete with rivals AstraZeneca and Tesaro after the CHMP "communicated a positive trend vote" ahead of an opinion being issued next month.

Cancer Drug Review

AstraZeneca's Imfinzi Scores First Early Lung Cancer Approval

Unlike other indications PD-1/L1 inhibitors are shooting for, Stage III non-small cell lung cancer is an untapped market and AstraZeneca will have the space to itself for a while.
ImmunoOncology Cancer

Pipeline Watch: Phase III Progress With Avelumab, Ixekizumab And Eravacycline

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

Celltrion's Trastuzumab Biosimilar Gets EC Nod

With the latest EC approval, Celltrion's trastuzumab biosimilar Herzuma is set to compete with Samsung's Ontruzant, which received approval late last year.

Commercial Approvals
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Post Marketing Regulation & Studies

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Latest From 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

Off-Label Communication: Pfizer Highlights Burdens Of FDA Policy

Seeking relaxation of US agency restrictions, Pfizer cites three examples where company delayed or decided against distributing medically relevant information beyond the product labeling; PhRMA survey shows almost half of all requests for information by prescribers and payers relate to off-label use.

Regulation Advertising, Marketing & Sales

Orexigen Begins Slow Climb Up Slippery Slope Of Obesity Drug Sales

Orexigen has a tough climb ahead as it sets out without a US partner to boost sales for its obesity drug Contrave with the goal of profitability by 2019, but it appears that doctors, patients and payers are becoming more open to pharmaceutical treatment.

Advertising, Marketing & Sales Strategy

Investors Relieved As Mylan Settlement Avoids Investigation

Mylan shares rallied on Oct. 7 following the company’s late-day Oct. 10 announcement that it agreed to settlement terms with the Department of Justice related to Epipen rebates for Medicaid prescriptions, but separate investigations and competition are looming.

Commercial Companies
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