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.
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.
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.
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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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.
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.
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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.
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.
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.
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.
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.
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.
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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.
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.
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”.
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.
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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.
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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.
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.
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.
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