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Bristol Should Have Opdivo First-Line Lung Cancer Data In Weeks

With Opdivo sales up to $840m in the second quarter, Bristol execs once again make the case for trial strategy in the all-important first-line lung cancer indication and say they look forward to the CheckMate 026 data “in weeks not months.”

Cancer Clinical R&D Business Strategies

Bristol's HCV Bump Catalyzes Strong Quarter, But Not Expected To Last

Daklinza has been part of the standard of care in genotype 3 HCV, but the launch of Gilead's Epclusa and an EU ramp-up of Merck's Zepatier are expected to erode that over time.

Commercial Life Cycle Management Infectious Diseases

TauRx’s Data Massage Can't Work Out The Kinks Of Failed LMTX Study

While the company is hyping the benefit seen in a subgroup analysis of the first Phase III trial of the tau aggregation inhibitor, which failed to show an overall benefit in mild-to-moderate Alzheimer's disease, Datamonitor Healthcare analyst Maha Elsayed raises some questions.

Clinical Development & Trials Neurology 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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AstraZeneca CEO Says Post-Crestor Future On Track As Pipeline Builds

AstraZeneca's first-half results presentation highlighted its growing early pipeline, notably in oncology, but also the increasing pain of generic erosion on its Crestor sales – underlining again the importance new drugs will play in the group's turnaround strategy.

United Kingdom Brexit Business Strategies

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 Commercial

Latest From Commercial

Another Strong Quarter For AbbVie, But How Long Will Good Times Last?

With continued strong growth for Humira, AbbVie doubles down on confidence to protect the franchise with IP strategy. Imbruvica and Viekira Pak show growth, although the latter is flourishing only ex-US.

Life Cycle Management Immune Disorders

'Challenging Quarter' For Sanofi As Questions Hang Over Diabetes Franchise

"A somewhat challenging quarter," was how Sanofi CEO Olivier Brandicourt described the second three months of 2016, but analysts say there were no surprises in the downward trajectory of Sanofi's fortunes. There was also little news on Sanofi's pursuit of Medivation.

Commercial Financial Reports

Anavex Stock Price Crash: A Fault By Trial Design?

Anavex Life Sciences' unabashed self-promotion since late-2015 for its leading pipeline product ANAVEX 2-73, which is being studied as a treatment for Alzheimer's disease, may have been one reason the firm's stock crashed down this week following the presentation of Phase IIa data at the Alzheimer's Association International Conference. But the study with no control arm and only 32 patients for a neurological disorder also has some analysts questioning how robust the data are.

Commercial Neurology

Chinese Stamp On Indian Pharma; All Eyes On Regulatory Flow

The Fosun group led by its billionaire chair Guo Guangchang has snapped up the injectables firm Gland for around $1.26bn, the first mega Chinese buy in the Indian pharmaceutical space. The deal opens up many potential collaborative opportunities, though it remains to be seen how smoothly it sails through in the Indian regulatory maze.

Commercial BioPharmaceutical

Yuhan, Luoxin Deal Underscores Asian NSCLC Therapy Needs

Yuhan and Luoxin's licensing agreement for a third generation EGFR inhibitor, the second such deal between South Korea and China, suggests robust demand for novel drugs for non-small cell lung cancer in Asia.

Commercial Deals

Sun Builds On Tildrakizumab Hopes With Almirall Pact

Sun Pharma has struck a licensing deal with Almirall for its late-stage psoriasis asset tildrakizumab, building on its recent clinical advancement and raising hopes of significant upsides for the Indian firm. The IL-23p19 inhibitor also adds to Almirall's broad derma portfolio amid the Spanish firm's acquisitive interest in the space.

Commercial BioPharmaceutical

Policy & Regulation Explore this Topic

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 Commercial

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

No Fanfare For US Approval Of Sanofi's GLP-1 Adlyxin

Sanofi has secured US approval for its a once-daily mealtime GLP-1 injection Adlyxin (lixisenatide) as an adjunct to diet and exercise for the treatment of adults with type 2 diabetes, but as the sixth GLP-1 product to enter this market the drug is unlikely to gain a strong foothold.

Approvals Metabolic Disorders

PDUFA VI: A Machine To Speed R&D Time, Cut Costs

The biopharmaceutical industry is hoping the terms set under the negotiations with the FDA for the sixth round of the Prescription Drug User Fee Act will help reduce the time and money spent on developing medicines, allowing companies to get their products into the commercial setting quicker and maximize those therapies' potential.

Commercial Companies

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

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

Clinical / R&D Explore this Topic

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

Pipeline Watch: Three Approvals, Five Filings And One Launch

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

Anavex Stock Price Crash: A Fault By Trial Design?

Anavex Life Sciences' unabashed self-promotion since late-2015 for its leading pipeline product ANAVEX 2-73, which is being studied as a treatment for Alzheimer's disease, may have been one reason the firm's stock crashed down this week following the presentation of Phase IIa data at the Alzheimer's Association International Conference. But the study with no control arm and only 32 patients for a neurological disorder also has some analysts questioning how robust the data are.

Commercial Neurology

PDUFA VI: A Machine To Speed R&D Time, Cut Costs

The biopharmaceutical industry is hoping the terms set under the negotiations with the FDA for the sixth round of the Prescription Drug User Fee Act will help reduce the time and money spent on developing medicines, allowing companies to get their products into the commercial setting quicker and maximize those therapies' potential.

Commercial Companies

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

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

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
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