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.
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.
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.
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.
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Commercial Explore this Topic
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.
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.
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.
TiGenix CEO Eduardo Bravo outlines group's commercialization plans for CPF candidate Cx601 in Europe and the US.
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.
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.
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.
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.
Policy & Regulation Explore this Topic
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.
Commercial opportunity for Mepsevii is small, but launch paves way for company's second product burosumab, following on its heels.
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.
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.
Research & Development Explore this Topic
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.
Patent expiries, novel pipeline treatments, and more patients are set to shake up the gastrointestinal stromal tumor market, finds Datamonitor Healthcare.
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.
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.
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