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Research & Development

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GIST Market Comes Of Age

Patent expiries, novel pipeline treatments, and more patients are set to shake up the gastrointestinal stromal tumor market, finds Datamonitor Healthcare.

Market Intelligence Research & Development Cancer
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Clinical Trials

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Latest From Clinical Trials

Non-Inhibitor Data Secure Roche's Competitive Position In Hemophilia A

Roche's Genentech reported positive top-line Phase III results for Hemlibra in a second hemophilia A population – patients without inhibitors – just four days after its approval for patients with inhibitors, which will broaden the product's market and may improve its competitive position.

Clinical Trials Business Strategies

Acorda Decides Tozadenant Isn’t Salvageable, Moves Primary Focus To Inbrija

Days after revealing seven cases of sepsis in trial participants receiving tozadenant – including five deaths – Acorda terminates development of the Phase III Parkinson’s candidate.

Research & Development Drug Safety

Roche Causes Stir With Tecentriq/Avastin/Chemo Lung Cancer Win

There are no actual data yet but the news that the closely-watched IMpower 150 study met a goal of progression-free survival and showed 'encouraging' signs on the overall survival endpoint has made IO rivals sit up, especially Merck & Co.

ImmunoOncology Clinical Trials

Capricor's DMD Cell Therapy Has HOPE, But Market Is Unsure

Capricor will start a Phase II trial in the first quarter of 2018 for its regenerative cell therapy CAP-1002 in Duchenne muscular dystrophy following positive results in an early-stage trial – the stem cell product was dropped by Capricor's big pharma partner Johnson & Johnson earlier this year.

Clinical Trials Research & Development

Acorda's Parkinson's Drug Tozadenant May Not Survive Safety Setback

The safety problems reported for tozadenant – including deaths – have not been reported for other A2a receptor inhibitors and the company sees them as "idiosyncratic," stirring doubts about a commercial future.

Drug Safety Neurology

Wider Than AZ’s PACIFIC – Novartis Has Broad NSCLC Plans For Canakinumab

Novartis is taking its unexpected CANTOS cancer findings for canakinumab and running with them to Phase III in an adjuvant lung cancer setting that is broader that AstraZeneca's PACIFIC study.

Clinical Trials Research & Development
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Approvals

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Latest From Approvals

TiGenix CEO Confident Of European Green Light For Lead Asset

TiGenix CEO Eduardo Bravo outlines group's commercialization plans for CPF candidate Cx601 in Europe and the US.

Approvals Business Strategies

Samsung's Ontruzant Becomes First Trastuzumab Biosimilar Approved In EU

Samsung Bioepis is poised to grab the leading position in the trastuzumab biosimilar market in Europe as its biosimilar Ontruzant gets the European Commission's approval ahead of the competition.

Biosimilars EU

Pipeline Watch: LentiGlobin, BMS-986205 Phase III Studies Initiated

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

Roche's Hemlibra Priced And Labeled To Beat Competition, Safety Concern

Genentech/Roche's Hemlibra, now FDA-approved for hemophilia A patients with inhibitors, offers a once-weekly injection, impressive efficacy with a safety concern that appears to be manageable, and a price that's at least half the cost of the established prophylaxis regimen.

Approvals Blood & Coagulation Disorders

GSK's Triple Combo COPD Drug Gets Europe Okay

Europe's regulators have followed their US counterparts and given the green light to GSK's Trelegy. Now the company is hoping that having the first once-daily single inhaler triple therapy for COPD will boost its respiratory business.

Respiratory Approvals

AZ Looks To Lead Severe Asthma Market After US Fasenra OK

Following FDA approval, AstraZeneca believes that despite reaching the market after GlaxoSmithKline’s Nucala and Teva’s Cinqair, Fasenra's strong clinical package, convenient dosing and very competitive pricing will make it the leading biologic for severe asthma.

Respiratory 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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