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Amgen Plugs Away On Repatha, With Hope For New Monthly Product

In a very strong second-quarter earnings report, Amgen reports just $27m in worldwide sales for cholesterol-busting PCSK9 inhibitor Repatha, as reimbursement continues to present a big hurdle.

Reimbursement Cardiovascular Commercial

Lilly BioMedicines Head Ricks Tasked With Overseeing Growth Phase As Next CEO

Long-time CEO John Lechleiter, who led the company through a challenging period of enormous patent expirations, will step down at year's end.

Leadership Management Issues Companies

Shire Backs Hemophilia Focus With Asset Updates, Irish iPATH Study

Newly enlarged Shire PLC is showcasing its Baxalta component's dynamic hematology portfolio and pipeline at the WFH congress in Orlando, Florida and tells Scrip of its plans for a novel study in Ireland with renowned institutions there using advanced data technology to redefine hemophilia care.

Blood Products Clinical Development & Trials Ireland

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.

Content Marketing
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Commercial Explore this Topic

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 Financial Reports

Strong 2Q And Fresh UK Investment Signal Few Brexit Blues at GSK

GlaxoSmithKline reported a strong second quarter and along with its core EPS guidance upgrade, this adds momentum to its post-Brexit vote boost.

Financial Reports Companies Brexit

Latest From Commercial

Gilead Sees Prospects For Declining HCV Revenues To Stabilize

A confluence of factors, including a higher proportion of patients covered by public payers, has caused Gilead's powerhouse hepatitis C franchise to slow down and now begin showing signs of decline.

Market Access Reimbursement

Teva Embarks On New Phase With FTC Clearance Of Allergan Generics

Teva said the deal will close the first week of August, after agreeing to sell assets related to 79 pharmaceutical products to gain FTC clearance.

Antitrust Regulation Deals

Turmoil In Allergy Market Continues As Merck Ends ALK Partnership

Merck & Co has returned all US marketing rights to ALK-Abello’s sublingual allergy tablets to the Danish company, casting a pall over the sector that has this year been dismayed by late-stage failures of new products and delays in drug development.

Commercial Deals

Dr Reddy's Slumps In Q1 But Will Pressures Ease Soon?

Dr. Reddy’s Laboratories (DRL) has reported a slump in profits for the first quarter, dented by a decline in volume growth and pricing pressure in the US as well as a loss of business in Venezuela. While the firm's long term story appears intact, resolution of compliance issues at its Indian sites and product flows in the US and other markets (DRL expects to participate in a Russian tender for rituximab) could lift investor sentiment significantly.

Financial Reports India

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

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

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

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

Latest From Policy & Regulation

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

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

Clinical / R&D Explore this Topic

Phase III Will Be Real Test For vTv's Resurrected Alzheimer's Drug

Phase IIb data for vTv Therapeutics' lead product azeliragon have demonstrated an effect on cognitive deterioration in mild Alzheimer’s disease patients – but is this evidence enough to get the small biotech back on track after it lost Pfizer Inc. as a partner for the drug in 2012?

Neurology Clinical Trials Clinical R&D

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

Astellas Targets ALS In Expansion Of Cytokinetics Alliance

Astellas and Cytokinetics are expanding their existing alliance to investigate two candidates against amyotrophic lateral sclerosis, as the Japanese firm looks to build its strategic interests in muscle disease.

Clinical R&D BioPharmaceutical

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

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

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

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

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
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