Safety and efficacy in study published in New England Journal of Medicine bode well for cannabinoid therapy Epidiolex, which is headed to FDA mid-year.
Companies doing groundbreaking work in cell and gene therapies should look to how rare disease drug developers partnered with patient advocacy groups and disease foundations to advance their shared goals, suggested speakers at the Cell & Gene Exchange conference.
FDA approval is likely for Emmaus' sickle cell drug L-glutamine this summer, representing the first new product for the disease since 1998 – a decision FDA advisory committee panelists hope will spur more innovation.
A German case of PML in a patient treated with Ocrevus, but who was also previously treated with Tysabri, threatens to take the gloss off Roche’s new multiple sclerosis therapy.
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Takeda will pair five cancer candidates with different mechanisms of action with Nektar's NKTR-214 and Merck follows up its Phase III disappointment verubecestat by licensing a preclinical Alzheimer's drug from Teijen.
Celltrion has received approval to begin clinical trials of its biosimilar infliximab in China and also filed IND applications for other biosimilar products with the CFDA, accelerating plans to enter the world’s second biggest pharma market as it propels efforts for global leadership in the biosimilar space.
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Dr. Benjamin R Cowen, COO of ImmunoMet Therapeutics, reveals how the Houston-based startup is developing OXPHOS inhibitors to treat drug resistant and relapse cancers.
Lupin reported a sharp decline in its fourth quarter profits, dented by heightened price pressure and competition in the US for its key products. The management sees a ‘challenging’ 2018, but underscored the strength of the firm’s ANDA pipeline and enhanced investments in the biosimilars, inhalation and injectables space.
The US rare diseases company Alexion appoints a new COO and is now looking for a new CFO, head of R&D, and head of human resources, as leadership changes leaves its CEO searching for a new executive team.
Dr. Cheni Kwok, a business development and strategy consultant, caught up with Scrip’s Mike Ward to outline how Shanghai Henilus Biotech is positioning itself to provide affordable healthcare globally.
Bioverativ revealed its first transaction since spinning out from Biogen with the acquisition of True North for $400m plus up to $425m in milestone payments. The deal gives Bioverativ a clinical asset, helping to fill the gap between preclinical programs and commercial products in its R&D pipeline.
The partners are looking to create a compelling value proposition for the interleukin-6 inhibitor, approved by FDA to treat moderate to severe RA, by pricing it below the market-leading anti-TNFs.
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The European Medicines Agency's advisory committee, the CHMP, unusually issued three negative opinions at its recent monthly meeting. Which companies received an unexpected boon at the news?
Orexigen touts 39% growth in US sales of its obesity drug; agency objects to advertisement for excluding risk information.
Merck's PD-1 inhibitor holds the first cancer indication based on biomarkers rather than tumor location. The most significant market will be colorectal cancer, but Bristol-Myers Squibb's Opdivo is pending for the same subgroup and Roche's Tecentriq could eventually gain a broader approval.
Viren Mehta, founder of Mehta Partners, LLC, considers the oft-repeated statement that the cost of drugs represents only 10% of US healthcare expenditure. Does it matter that the figure excludes a large and growing segment of medicine spending?
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The Pharmaceutical and Biotech industries’ R&D performance can be measured in a number of ways. Here is a look at its worldwide output of novel drug launches for 2016 and total pipeline size in 2017.
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Neurocrine's stock fell 9% on May 24 after the company said a closely-watched Phase II study for Ingrezza in pediatric Tourette's syndrome failed, but blamed a sub-therapeutic dose for the disappointing results. Most analysts gave the prospects for a higher dose study the benefit of the doubt.
AstraZeneca's EXSCEL study could have created confidence in a GLP-1 class-wide outcomes benefit, but instead it has raised questions about whether differences in trial results boil down to trial design.
Protecting the function of mitochondria may be key to developing medicines to reduce the nerve damage caused by traumatic brain injuries. NeuroVive Pharmaceutical is moving its cyclosporine candidate into Phase IIb studies.
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