Positive Phase III data for Aerie's second glaucoma drug candidate Roclatan – which will support a US FDA submission in the first half of 2018 – have boosted the California company's M&A allure.
Bayer's pharma head Dieter Weinand talks about his biggest issues with current value-based pricing assessments for new drugs and how companion diagnostics will pave the way to easier pricing of oncology therapies.
PwC partner Dmitri Drone explained that a deal for an asset with high commercial expectations is best structured with more emphasis on pre-approval than post-approval payments. A post-approval focus on shared risk is more appropriate when an asset is licensed at an earlier stage of development.
Cipla is recalibrating investments in the “resource-intensive” biosimilars business, reinforcing its thrust on the respiratory and specialty products segment. Large biosimilar manufacturing plans in South Africa have been put on hold, with curtains seemingly coming down at an Indian unit.
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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 Teijin.
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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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.
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.
Policy & Regulation Explore this Topic
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?
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.
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.
Research & Development Explore this Topic
Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.
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Stéphane Boissel, CEO of TxCell, discusses the company's plans to advance its lead next-generation regulatory T-cell candidate into human studies, after having switched to a new platform, in a video interview with Scrip.
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.
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