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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 Approvals

BMS Q&A: Hunting For Biomarkers To Improve Treatment Of Autoimmune Diseases

Bristol-Myers R&D leaders Brian Gavin and Sean Connolly offered insight into the company's immunology focus for autoimmune diseases, which increasingly is driven by a search for biomarkers that point to the best use of the big pharma's drugs.

Personalized Medicine Immune Disorders Research and Development 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 Clinical Trials
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Amsterdam wins European Medicines Agency After Milan Loses Coin Toss In Tight Race

London has lost the European Medicines Agency to Amsterdam after the Dutch capital beat Milan in a voting process that ended in the drawing of lots. The Italian pharmaceutical industry was understandably disappointed at losing, but the EMA said the decision “ticked a lot of our boxes” and would help to keep down staff losses and ensure business continuity.

Brexit Regulation Europe


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Mehta Analysis: Race To Harness Data Will Revolutionize PBM System

Data and intelligence will drive revolutionary changes in healthcare, and today's power brokers will need to adapt. Viren Mehta, founding partner of Mehta Partners LLC, considers how business consolidation in the complex US pharma market reflects the race to tap as yet under-exploited data troves, and how the resulting exploitation of those data may benefit a broader set of stakeholders.

Pharmacy Benefit Management Commercial United States

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 Blood & Coagulation Disorders

Celgene's Partnered Pipeline Delivers Successes And Setbacks

Celgene won the first approval for a drug developed under its aggressive deal-making strategy in 2017 and several potential blockbusters in its partnered pipeline are edging closer to the market. Ozanimod will soon face regulatory approval, but the next-in-line acquired asset GED-0301 had a major setback. Scrip considers the contribution externally derived products have made – and will make – to Celgene’s business.

Deals Business Strategies

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

KemPharm Plans To License Out Commercial Rights For Pain, ADHD Candidates

KemPharm hopes a deep-pocketed company with neuroscience experience will want to market its prodrug of Ritalin for ADHD. For acute pain candidate Apadaz, the firm hopes to partner with a PBM that will price it to replace generics on formulary.

Business Strategies Pricing Strategies

While The Money Flows, So Will Biopharma IPOs

US initial public offerings by biopharma firms in 2017 have outpaced the number of IPOs completed in the previous year and as investors continue to see big returns the pace isn't likely to slow in 2018.

Financing Business Strategies

Executive Interview: Building Merck KGaA's Specialty Business In EMEA

It’s an interesting challenge, commercializing in Europe the first novel pharmaceuticals to be developed and launched by Merck KGaA in a decade. The new head of its EMEA region explains his approach to the task.

Business Strategies ImmunoOncology

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

Policy & Regulation Explore this Topic

Political Bargaining Intensifies Before Vote On EMA’s New Home

In the run-up to Monday’s vote on the EMA’s future home, political horse-trading and vote-swapping behind the scenes makes it difficult to predict which EU city will win the prized agency.

Brexit Regulation Europe

Ultragenyx Gets Commercial Feet Wet With Mepsevii Launch In Sly Syndrome

Commercial opportunity for Mepsevii is small, but launch paves way for company's second product burosumab, following on its heels.

Launches Commercial

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

$1M For Luxturna? ICER Says Big Discount Needed To Be Cost Effective

Luxturna, a one-time treatment for a rare inherited form of blindness, would not be cost-effective at the $1m price level that has been suggested as a possibility, based on ICER's thresholds. But the small patient population would keep it from triggering ICER's US budget spending threshold.

Reimbursement Pricing Strategies

Research & Development Explore this Topic

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 Cancer

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

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

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
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