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Novartis Pursues Disease-Modifying Differentiator For Cosentyx In Psoriasis

New extension data suggesting that Novartis's IL-17A inhibitor Cosentyx could alter the course of disease in its lead indication of psoriasis could position the drug earlier in the treatment paradigm and please payers; the company has launched a new prospective study to see if the results hold true.

Clinical Trials Research & Development Dermatology

Cardiovascular Benefits of SGLT2 Inhibitors: A Class Effect?

The first large real-world evidence study has found SGLT2 inhibitors cut the rate of hospitalizations for heart failure and all-cause mortality in patients at low risk of cardiovascular events, but the results of CV outcomes studies are awaited to confirm the findings.

Clinical Trials Comparative Effectiveness Research & Development

China VC Roundup: Investors Flock To Rising Innovation, Expertise

The past few months have seen frenzied venture capital and other investment in the Chinese pharma and biotech space, driven by increasingly innovative startups run by big pharma veterans, while corporate ventures have been joining with private equity to build up specialist investment and M&A funds.

China Financing Companies

The Decline And Fall Of The Pharma Pipeline

2016 saw a drop in the growth rates for both number of products in active development and in the number of companies in active R&D. The data from a new report from Pharmaprojects seem to point to an end to recent years of accelerated growth in the pipeline that followed five years of stagnation.

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As MS Space Awaits Ocrevus, MedDay Sees 'Synergistic' Positioning Opportunity

With Roche's Ocrevus expected to be given the green light at any moment for the underserved progressive multiple sclerosis market, a tiny French biotech with a "synergistic" product for the same indication also believes it could soon have a commercial success on its hands.

Commercial Neurology BioPharmaceutical

Which Pharma Firm Increases US Prices The Most?

Transparency reports from companies aim to change conversation from prices to discounts, but also invite comparisons. Lilly, for example, saw a higher average list price increase in 2016 than Merck and Janssen, but its net prices grew by less than the others.

Pricing Debate Policy Pricing Strategies

Latest From Commercial

Deal Watch: Success Nets CytomX Another $200m From BMS, Up To $3.6bn For Milestones

Bristol-Myers Squibb expanded its collaboration with CytomX for $200m up front and up to $3.6bn in milestone fees. Also, Takeda spun out eight non-core molecules into a new joint venture and X-Chem executed two deals with Japanese partners, among other recent deals.

Commercial Deals

Gilead Cites 'More Sophisticated' Process As Pressure For A Major Deal Increases

CEO John Milligan offered few details about Gilead's deal strategy during an investor conference last week, but analysts think internal pressure for a major deal is beginning to equal the external sentiment, including an analyst who sees Incyte as a likely target, but not a quick fix for Gilead's declining HCV drug sales.

Commercial Business Strategies

Inhaled Anti-Infectives With Extended Lung Retention: Pulmocide Secures Cash To Fund Trials

When tackling pulmonary infections, getting therapeutics into the lungs that stay there long enough to be effective is the key challenge. Pulmocide has just persuaded investors it is up to the task, raising $30m to fund two clinical programs.

Commercial Companies

Finance Watch: Two New VC Funds Raise $500m; One New US IPO; And Galena's 'Strategic Review'

Pivotal and Biomatics launch new VC funds totaling $300m and $200m, respectively; Spero raises a $51.7m Series C round; BeyondSpring is March's only US IPO, so far; Aurinia and TG Therapeutics capitalize on positive data with secondary offerings; and Galena hires a "strategic review" advisor.

Commercial Financing

Threshold And Molecular Templates Merge To Test The Power Of Two

Although a vehicle for Molecular Templates to take its Engineered Toxin Bodies oncology platform public, the combined company also will seek a pathway to approval for Threshold's evofosfamide for pancreatic cancer in Japan.

Commercial Deals

Circassia Builds US Respiratory Presence with AstraZeneca Deal

Circassia has put memories of last year's Cat-SPIRE disappointment firmly behind it with a new deal with AstraZeneca for Tudorza and Duaklir in COPD that will allow it to concentrate on boosting its respiratory franchise.

Deals Companies

Policy & Regulation Explore this Topic

Parkinson’s Niche To Expand With New Drugs, More Patients

Newron’s new Parkinson’s disease therapy, Xadago, approved in the US after a regulatory delay, is expected to be the first of several new products to be introduced in this long-neglected therapeutic sector.

Approvals Commercial Neurology

Biogen Secures First-Round Patent Win For Tecfidera; One More To Go

PTAB rejected an inter partes review challenge to a key patent protecting the oral multiple sclerosis blockbuster to 2028 in the US, but another challenge remains outstanding.

Intellectual Property Legal Issues

Now Is The Time! Rule Changes To Open Up China To Foreign New Drugs?

The China FDA has outlined a raft of new measures to streamline the development and approval process for foreign new drugs, in changes that are likely to bolster multinationals’ interest and activity in China, and to quicken the pace of launches to potentially overcome the country’s “drug lag”.

China Drug Approval Standards

AstraZeneca’s ZS-9 Delay In US Gives Veltassa An Edge

FDA issued a second complete response letter to AstraZeneca’s NDA for ZS-9 for hyperkalaemia, a potential blockbuster that would compete against Vifor Pharma’s Veltassa.

Complete Response Letters Manufacturing

Research & Development Explore this Topic

GSK, Regeneron and UK Biobank In Gene Sequencing Initiative

GlaxoSmithKline and the Regeneron Genetics Center have joined forces with the UK Biobank to sequence genes from its 500,000 participants in an effort to improve drug discovery and disease diagnosis. The first data are due within a year.

Deals Companies Research & Development

Latest From Research & Development

Heartache For Novartis As Serelaxin Failure Ups Pressure On Entresto

Novartis's latest Phase III study of serelaxin has failed, deleting a significant chunk of forecasted revenue that analysts had attributed to the heart failure drug candidate.

Research & Development Clinical Trials

Intercept Hopes Statin Trial Will Lessen Ocaliva's Perceived CV Risk

After otherwise successful Phase II NASH trial showed Ocaliva can increase a patient's LDL cholesterol levels, Intercept hopes a study in NASH patients who use atorvastatin will show this effect is manageable.

Drug Safety Clinical Trials

Minoryx Preps For Tough Pricing Regime As CNS Orphan Drug Enters Phase II/III

Orphan drug development used to be considered a license to print money, with high price tags and a focused customer base. With the development of an increasingly tough orphan drug pricing environment in the US and Europe, biotechs are adopting new strategies. CNS drug developer Minoryx will introduce endpoints into its Phase II/III studies for rare brain disease X-ALD that should help demonstrate both efficacy and value for future pricing discussions.

Rare Diseases Research and Development Strategies
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