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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 Scrip 100

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 Pricing 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 Commercial
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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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Commercial Explore this Topic

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

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

Don’t Miss The Train: Pharma's Future Holds Deeper Digital Deals, Outcome-Based Pacts

Asked by Scrip to name two big changes coming pharma's way, Merck KGAA Healthcare CEO Belén Garijo identified artificial intelligence and outcome-based pacts as 'ways of the future'.

Artificial Intelligence Business Strategies

Piramal Pharma Solutions CEO On Building ‘Symbiotic’ Preferred Partnerships

The Indian contract development and manufacturing organization (CDMO) Piramal Pharma Solutions (PPS) expects to grow its pool of “preferred partnerships” that includes a mix of both biotechs and large pharma. In an interview with Scrip, CEO Vivek Sharma outlined the value of such “symbiotic” relationships and how PPS is focused on quality as a culture rather than purely limiting it to inspection clearance and product approvals.

Commercial Strategy

AZ Sustains Strong China Growth Via Commercial Innovation

AstraZeneca’s strong showing in China in the third quarter was driven by a combination of expanded coverage, investment in patient access efforts and an innovative commercial model. New introductions Tagrisso and Farxiga are also expected to add to the momentum.

Commercial Launches

Deal Watch: Genentech Expands Upon Arvinas PROTAC Collaboration

The Roche affiliate doubles the potential monetary value of partnership focused on PROTAC technology in a range of therapeutic areas. Cardinal sells off Chinese business for $1.2bn, while Novartis licenses Homology’s gene-editing technology.

Deals Business Strategies

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

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 Research & Development

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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