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Humira Biosimilars Face Complex Asia Outlook As Launches Edge Closer
The Asia Pacific region presents large potential opportunities for the development of biosimilar versions of big-selling original biologics as these come out of protection in the major markets. However the regulatory, reimbursement and commercial situation varies greatly country-by-country, presenting a complex mix of factors affecting the overall market outlook for these up and coming biosimilar products.
Bayer Still Confident Of Future Prospects Post-Xarelto
The German group has been talking up its pharmaceuticals division but analysts are not convinced it has addressed the elephant in the room that is the loss of patent protection for its blockbuster anticoagulant Xarelto in 2024.
Ovarian Cancer Market Snapshot: AstraZeneca's Lynparza Poised To Lead In Niche Space
AstraZeneca's Lynparza, Tesaro's Zejula and Clovis' Rubraca have brought much needed advances to patients with ovarian cancer, but the market is relatively small and the competition intense, while unmet need remains high.
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Recent Tweets from ScripF-star’s Transformation into a Clinical-stage Business
Since its creation in 2006, F-star has pioneered both the creation of bispecific antibodies and the pursuit of an asset-centric approach to partnering. Having seen two partnered programs enter the clinic, F-star is now planning to complete its evolution into a fully-fledged clinical-stage business by putting potential immunotherapies from its proprietary pipeline into the clinic by itself.
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All Downhill: Ranbaxy Singh Brothers Trade Charges, Blows
The Singh brothers' feud has moved from a war of words allegedly to blows, with any efforts at reconciliation looking bleak. The siblings also find themselves in tight spot as Daiichi Sankyo presses ahead to enforce a INR35bn damages award.
Deal Watch: Boehringer Teams Up In CNS Disorders Again, This Time With Domain
Following last December’s partnership in CNS with Autifony, BI undertakes a screening collaboration with Domain. Leo maintains its busy deal-making pace, partnering in dermatology with Evotec.
Cell And Gene Therapy Logistics Requires Early Planning
It has become standard practice for manufacturing to get early attention in the cell and gene therapy development, but logistics is often not considered until closer to commercialization, which could be a strategic mistake given the speed with which new treatments are being approved.
Ovarian Cancer Pipeline Review: Sponsors Plan Frontline Punch, Smart Combinations
Combination studies of drugs for ovarian cancer have heavy focus on PARP, PD-1/L1 and VEGF mechanisms.
Roche's Tecentriq Becomes Second In PD-1/L1 Family To Gain First-Line Lung Cancer Approval
The PD-L1 inhibitor's label excludes NSCLC patients with EGFR or ALK mutations, which could have been an advantage, but the indication largely reflects the registrational IMpower150 clinical trial's population.
Mallinckrodt Creating Two Companies: Generics And Innovative Specialty Drugs
The company, which makes generic opioid products and the controversial Acthar Gel, is looking to chart a new course for the future – or make that two new courses.
Pharma: Be Prepared For Tougher Price Negotiations For IO Combos And Expansions In Europe
Payers are increasingly likely to implement new strategies to manage price negotiations for immuno-oncology combinations, as competition heats up among the drug class. Mechanisms allowing for the negotiation of different prices for combination therapies do not exist at present, but payers insist that new tools must emerge.
Brii Builds China Ops With Hep B Assets, New Partnerships
China-focused Brii Biosciences, formed earlier this year, unveils plans to take its first projects into the clinic by way of deals with VBI and Vir for hepatitis B, and builds other alliances and operations in the country.
Policy & Regulation Explore this Topic
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Brexit And Cooperation: Insights From Danish Medicines Agency Head Thomas Senderovitz
It was inevitable that Brexit would be the key theme of an interview with Danish Medicines Agency head Thomas Senderovitz earlier this year. The senior European regulator oversees one of the agencies that has taken on new staff to help deal with the impact, in drug regulatory terms, of the vote by the UK in June 2016 to leave the European Union. Senderovitz also chairs the management group of the EU Heads of Medicines Agencies network.
Roche's Tecentriq Becomes Second In PD-1/L1 Family To Gain First-Line Lung Cancer Approval
The PD-L1 inhibitor's label excludes NSCLC patients with EGFR or ALK mutations, which could have been an advantage, but the indication largely reflects the registrational IMpower150 clinical trial's population.
Pharma: Be Prepared For Tougher Price Negotiations For IO Combos And Expansions In Europe
Payers are increasingly likely to implement new strategies to manage price negotiations for immuno-oncology combinations, as competition heats up among the drug class. Mechanisms allowing for the negotiation of different prices for combination therapies do not exist at present, but payers insist that new tools must emerge.
Lilly CEO Made New IFPMA President On Health Budget Mandate
David Ricks will lead IFPMA into 2020 with an eye on how to meet the healthcare needs of the world’s aging population, and stepping up the power of private-public partnerships.
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EAGLE Crash Lands: AstraZeneca's Imfinzi/Tremelimumab Continues To Disappoint
The latest failure of the combination of AZ's PD-L1 inhibitor and its CLTA4 inhibitor is in advanced head and neck cancer. It follows recent failures of the MYSTIC and ARCTIC trials in lung cancer.
UK Receives £1bn Confidence Boost From Industry Investment In Life Sciences Sector
The international biopharma industry is backing the UK life sciences sector, with UCB spearheading the charge with a £1bn commitment to R&D in the nation still in a state of flux regarding its exit from the European Union in 2019.
AML Paradigm Shift: Doctors Welcome Many New Approvals And Approaches
This year's ASH meeting reflected a peak of development success, with many new approvals and many more in the pipeline.
AbbVie's Rova-T Disappoints As Second-Line SCLC Trial Halted
Enrolment In the Phase III TAHOE study has been halted due to shorter overall survival in the Rova-T arm compared with the control arm.
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