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Biosimilar Confidence And Knowledge Needed In Europe, Say Experts

European biosimilar market penetration varies widely across the EU member states and disease groups, with different government policies on promotion, purchasing and communication leading to mistrust. The European Commission is looking to boost confidence in biosimilars to support their uptake on a much wider scale across Europe, and to get a bird's eye view of what is driving or hindering the EU market for biosimilars.

BioPharmaceutical Europe Policy & Regulation

When Will Gilead Make Its M&A Move?

While HCV sales continue to slow due to a lengthy list of factors, Gilead is seeing a strong launch for revised HIV combo therapies incorporating TAF – but most analysts believe that major M&A is needed to offset stagnation.

Commercial Business Strategies Infectious Diseases

Blow For Celgene As Revlimid Trial Miss Removes Blockbuster Indication

Celgene Corp.'s hopes of extending the market reach of its blockbuster oncology therapy Revlimid (lenalidomide) have taken a blow as Phase III data for the drug in elderly diffuse large B-cell lymphoma (DLBCL) patients have failed to show benefit on overall survival.

Clinical Trials Cancer Clinical R&D

Big Data Brings Big Benefits, But Only If Used Properly

Sponsored content by Medidata.

Mobile health is variously described as game-changing and revolutionary in the way it is impacting healthcare.

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Stockwatch: Earnings Season Appears Not At Home To Brexit

On the morning of the vote by the UK to leave the EU, I speculated firstly that the ensuing currency swings would come too late to impact the imminent second-quarter pharma earnings announcements but secondly, that they could have an effect on the guidance of companies for the rest of the year. In the opening week of earnings season I am currently one for two in the prediction stakes as the effects of Brexit barely figured in either the results or the full-year guidance.

Financial Reports Companies Brexit

Lilly Awaits New Rewards For SGLT-2 Diabetes Drug Jardiance

Although Jardiance is supported by outcomes data, it has not yet been incorporated into labeling, nor has it translated into greater sales.

Commercial Companies BioPharmaceutical

Latest From Commercial

Is Bayer Making A Mistake With Monsanto When Pharma Is Its Leading Business?

Second-quarter earnings results have raised questions about Bayer AG's long-term strategy, including over how long the company's pharma unit can continue to come out on top and drive the group based on the performance of just five "recently" marketed drugs.

Sales & Earnings Business Strategies

Ex-Naval Medical Officer & Merck Veteran Vlad Hogenhuis Describes Life In Leadership At GSK

Dr Vlad Hogenhuis, a Merck & Co. Inc. veteran who joined GlaxoSmithKline PLC in 2012, is currently responsible for the UK company's vast speciality franchise – formulating a global strategy for novel drug development and product launches in the areas of cardiovascular, neuroscience, immunology, oncology, infectious disease, dermatology and a small group of additional diseases. These are markets of significant potential and unmet need for patients, comprising over £280bn in total sales for 2015.

Business Strategies Market Intelligence

Syngene Gears For Biologics Build Up

Syngene, one of Asia's largest contract research organizations, has reported strong first quarter numbers and is bolstering its biologics services business with a new viral testing facility. Brexit isn't a "structural event" for Syngene and the CRO's top brass also outlines to Scrip the significant cost advantage that the firm offers over Chinese and Western competitors.

Commercial BioPharmaceutical

New Funding To Give ViroMed ‘Favorable Position’ For Gene Therapy Deal

ViroMed joins a group of South Korean bioventures launching share offerings to fund R&D activities, in its case to beef up the clinical data package for its lead project VM202, which should in turn help with a licensing out deal for the gene therapy.

Commercial Companies

Case Studies: How Three Public Companies Financed R&D In A Tough Market

The market for public offerings by biopharma companies is tough, but Corbus Pharmaceuticals, Loxo Oncology and Novavax used three different strategies to raise cash from new and existing shareholders.

Commercial Financial Strategies

Public Biopharma Financings Plunge In 2016, But Is It A Sign Of Health?

There were far fewer follow-on and other non-IPO public biopharma company financings during the first half of 2016 compared with the same period in 2015, but the more normal level of investment may mean that the market for therapeutic companies' stocks is healthier than in recent years.

Commercial Financial Strategies

Policy & Regulation Explore this Topic

Large Employer Drug Contracting Block Could Challenge Manufacturers, PBMs

Express Scripts has been talking to members of the Health Transformation Alliance about negotiating pricing on behalf of the group, which includes 20 large employers providing health benefits for four million individuals.

Business Models Commercial Formularies

Semler Dirty Data: EMA Suspends Over 200 Products; Stings Indian CROs

Dirty data issues continue to plague Indian contract research organizations, denting the reputation of the beleaguered local industry and piling up challenges for marketing authorization holders. The European Medicines Agency (EMA) has now suspended close to 300 products that relied on flawed bioequivalence studies done by the Bengaluru-based Semler Research.

Policy & Regulation BioPharmaceutical Europe

Latest From Policy & Regulation

Turkey Fighting Uphill Battle In Pitch For Pharma, Medtech Investment

Hoping to bring in more foreign investment and local production, Turkey is working hard to convince pharma and medtech companies of its attractions, but this effort is set to become even more challenging in the wake of the recent unsuccessful coup attempt and corporate worries over political instability.

Policy & Regulation Turkey

Another Black Cloud Douses Valeant's Sunlight

Valeant Pharmaceuticals International Inc. started the week out strong – winning approval to market an oral formulation of Relistor and gaining an FDA advisory committee's backing to sell the company's plaque psoriasis drug brodalumab. But that winning streak came to an abrupt halt with the agency's rejection of the firm's eye treatment latanoprostene bunod.

Companies Commercial

Suicide Warnings For Valeant’s Siliq Could Hinder Access To Psoriasis Treatment

While an FDA advisory committee unanimously supported approval of the plaque psoriasis drug brodalumab, several recommended a black box warning on suicide risk that could limit sales of the drug.

Advisory Committees Policy & Regulation

A Peek Into Korean Bioventures’ Success Factors, Challenges

Amid a boom in IPOs and valuations, experts at a recent forum in Seoul took a look at some of the success factors and challenges behind the rapid growth of South Korea’s bioventure sector.

Policy & Regulation Asia Pacific

Valeant’s Oral Relistor Poised To Face-Off Against AstraZeneca’s Movantik

FDA approval of the first oral form of Valeant’s mu-opioid receptor antagonist Relistor will pit the franchise against Movantik for the treatment of patients with opioid-induced constipation with non-cancer pain.

Approvals Commercial

Sandoz's Biosimilar Rejection Ups Risks, But Won't Kill Market

The FDA's rejection of Sandoz Inc.'s version of Amgen's Neulasta (pegfilgrastim) has revealed the hard truth that chasing the biosimilar market may be a riskier and more costly endeavor than companies anticipated.

Companies Biosimilars

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China Surprises With First CRISPR Trial Despite Regulatory Lag, Concerns

The lack of a comprehensive regulatory pathway has not hindered Chinese researchers from forging ahead with the world's first human clinical study using CRISPR-Cas9 gene editing technology, which will be used to treat advanced lung cancer.

Clinical R&D Asia Pacific China

Key Clinical Data And Drug Approvals Expected In 2H 2016

As July is already upon us, Scrip takes a look at some of the more interesting clinical trial read-outs and drug approvals expected clinical trials due to report in the second half of the year.

Clinical Trials Approvals BioPharmaceutical

Latest From Clinical R&D

Japan Phase III Start Cements Roxadustat’s Lead

Astellas/FibroGen's oral candidate for anemia in chronic kidney disease has moved into Phase III in Japan on the basis of promising Phase II results, cementing the global development lead for the first-in-class product and taking it closer to a potentially big market.

Clinical R&D Japan

Full Monty On Pfizer’s Failed 5-HT6 Alzheimer’s Drug Leaves Hope For Class

Presentation of data at Alzheimer’s Association International Conference highlights failure of Pfizer’s 5HT6 antagonist PF-05212377, while still leaving room to hope for others in class like Lundbeck’s idalopirdine and Axovant’s RVT-101

Clinical R&D Clinical Development & Trials

ContraVir Hopes To Establish Backbone For Hepatitis B Combo Therapy

Two deals have resulted in the formerly shingles-focused biotech beginning to build an HBV pipeline and look ahead to therapeutic advances similar to those seen in HIV and hepatitis C. But the New Jersey biotech will be competing with some deep-pocketed competitors in the space.

Commercial Clinical R&D

Kidney Cancer Gets A Double Uplift From Latest CHMP Meeting

During its July 2016 meeting, the EU's top scientific advisory panel, the Committee for Medicinal Products for Human Use, recommended approval for two anticancers, cabozantinib and lenvatinib, that will likely shake up the advanced kidney cancer sector, and a new therapy for pancreatic cancer, liposomal and pegylated irinotecan.

Approvals Cancer

PIPELINE WATCH: Eight Approvals, Seven Filings And Three Launches

This week's Pipeline Watch, a snapshot of all the late-stage R&D and regulatory events in the pharma and biotech industries, is now available to view.

Clinical R&D Pipeline Watch

Huapont Taps US Partner To Ride China Precision Medicine Wave

2016 is the year for precision medicine therapies to be included in China’s National Major Project for Innovation. Looking to seize market opportunity in the newly funded area, Huapont Life Sciences has linked up with and invested in a US bioventure partner for a gene therapy for refractory angina.

Clinical R&D Companies
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