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Daiichi's Phase III Quizartinib Data Pave Way In Niche AML Market
Showing an overall survival improvement in the especially hard to treat FLT3-ITD mutated patients is a significant achievement in AML, analysts say.
Roche's Risdiplam Data Stir Up SMA Market
Positive results for the Swiss major's oral therapy suggests that Biogen and Ionis' monopoly of the lucrative spinal muscular atrophy market with Spinraza could soon be under considerable threat.
Opdivo Approval Opens China I-O Doors But Pricing Key
China approves first immuno-oncology drug in the form of BMS’s Opdivo for lung cancer, opening up a new potentially huge market for the class, but much will depend on pricing and reimbursement policies.
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Innovation in the pharmaceutical industry has never been more exciting, and complicated. Disruptive technologies, such as artificial intelligence and digital health tools, and advanced therapeutic modalities including cell and gene therapies and antisense oligonucleotides demand that all health care stakeholders make efforts to move into the next generation of patient care and centricity.
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Deal Watch: BridgeBio To Launch New Subsidiary Around Rare Disease Candidate Obtained From Alexion
Sanofi completes the transition of its infectious disease unit to Evotec. Perhaps not yet done with virology, Gilead licenses technology for HIV/hep B vaccines from Hookipa.
Scrip Asks... What Is The Future Of Biotech?
Scrip asked industry leaders during the BIO 2018 meeting to envision future changes to the rapidly evolving world of biotechnology, predicting what the next five years will bring.
Finance Watch: Investors Go Nuts For NASH As Madrigal Raises $300m, Galmed Skyrockets
Public Company Edition: Madrigal and Galmed shares more than doubled after reporting what were viewed as positive results in mid-stage NASH studies, with Madrigal going on to raise $300m on the back of the data. Not all is well for publicly traded firms, however, as Advaxis and Flex Pharma reveal layoffs.
Shionogi Deal Opens Asia To Sage’s Fast-Acting Antidepressant
Japan’s Shionogi has gained selected Asian rights to Sage’s promising fast-acting depression drug, in a deal worth up to $575m to the US company.
Lilly Stays Committed To Alzheimer's, Including Amyloid Hypothesis, Despite Many Failures
The failure of BACE inhibitor lanabecestat was the latest setback in Lilly's Alzheimer's pipeline, but the company has been working in this area with almost no success for decades, yet still feels a commitment to keep trying, Lilly Research Labs President Daniel Skovronsky tells Scrip.
Branded Advair Breathes Another Day; Mylan Says A CRL Is On The Way For A Generic
FDA alerted Mylan to expect a complete response letter related to its ANDA for generic Advair. The company said it still could receive an approval prior to the standard 90-day time period after responding to the letter, because the application has a priority designation.
Big Pharma Voluntary List Price Reductions Doubtful, Sen. Warren Says
Sun’s Halol Site Out Of Compliance Rut, Could Add Some SPARC Too
Sun's Halol manufacturing facility is over the compliance hump, receiving an EIR [Establishment Inspection Report] from the US FDA. The site, seen as core to India's top ranked firm's promising filings, including injectables, is also expected to lift the prospects of Sun's spin-off R&D arm, SPARC.
Policy & Regulation Explore this Topic
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Dr. Reddy's Launches First Generic Suboxone Film; Indivior May Seek Injunction
Launch comes immediately after FDA approval of Dr. Reddy's and Mylan ANDAs while Indivior appeals district court ruling of non-infringement; Mylan settlement may delay its entry.
Big Pharma Voluntary List Price Reductions Doubtful, Sen. Warren Says
New EU Approval Further Boost For Tagrisso As Threats Recede
Tagrisso's march on the first-line EGFRm NSCLC market looks like it will be unimpeded by any near-term rivals following new data at ASCO as the EU becomes the latest market to approve it in the first-line setting.
Next-Generation Roche: How Data Analytics Will Keep It In The Lead In Oncology
Roche used its ASCO investor briefing to highlight its digital and personalized healthcare strategy, including examples of how it’s facilitating R&D and reimbursement – and how that should position it to be an oncology leader in the future.
Research & Development Explore this Topic
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Bluebird 'Turns A Corner' With Lentiglobin Gene Therapy, Tests Remain
Updated results of studies of its Lentiglobin gene therapy using bluebird's new manufacturing process presented at the EHA meeting are encouraging but the real test will be in the longevity of its effects and the strength of its surrogate marker.
HVIVO Seeks Big Pharma Partner For ‘Phase III-Ready’ Universal Flu Vaccine
Presenting Phase IIb data on FLU-v, specialized CRO hVIVO now hopes to secure a big pharma partner for Phase III studies and commercialization of the universal flu vaccine candidate. The product has been developed in a joint venture with SEEK.
Teva's CGRP Inhibitor Fails In Chronic Cluster Headaches, Continues In Episodic
Unlike the migraine space, there is only one competitor for Teva's CGRP inhibitor in cluster headaches, but that opportunity narrowed with fremanezumab's failure in chronic cluster headaches, though a trial in episodic cluster headaches is ongoing.
IGEM Therapeutics: Pursuing Novel IgE Antibodies For Solid Tumors
Emerging Company Profile: IGEM Therapeutics has been spun out of King's College London to evaluate the use of IgE-based monoclonal antibodies for the treatment of cancer, including difficult-to-reach solid tumors.
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