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Mortality Signal For Pfizer's Xeljanz In Rheumatoid Arthritis Puts A Damper On JAK Class
Analyst speculates that risk of pulmonary embolism for a higher unapproved of Xeljanz in arthritis could trigger a label change for the same regimen in the drug's ulcerative colitis indication.
Merck's Keytruda Loss In Liver Cancer Could Be Gain For Rivals
The drug demonstrates improvements in overall survival and progression-free survival, but not enough for success in KEYNOTE-240.
Reata Expands Options For Bardoxolone With New CKD Data
Once suspended due to safety issues, bardoxolone now has completed a Phase II study that showed kidney function benefit in four rare types of CKD. A pivotal study is underway, with another planned and more possible.
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Recent Tweets from ScripPulse Of The Industry 2018: How Medtechs Will Create Value In The New Health Ecosystem
In the 12th edition of EY’s medtech report, The Pulse of the Industry, they examine the annual performance of the medical device industry in the context of the technological advances and rising customer expectations associated with the Fourth Industrial Revolution. To thrive in this transformative age, medtechs must adapt their business models to meet the increased expectations of consumers and other health care stakeholders.
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Commercial Explore this Topic
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Evotec Extends Anti-Infectives Footprint With Helmholtz Collaboration
Building on a leading position in anti-infectives research, Evotec aims to develop a new class of antibacterials based on cystobactamids, which are found in slime bacteria and have potent activity against serious bacterial pathogens.
Novo Nordisk CSO: Hemophilia Treatment ‘Segmenting’ Much Like In Diabetes
Novo Nodisk's CSO says FDA approval of extended half-life Factor VIII Esperoct treatment for people with hemophilia A will give more choice to those patients and "effectively completes" the Danish group's hitherto R&D efforts based on clotting factor deficiencies.
GSK’s Terrell On ‘Relentless’ Digital Consumption Across the Spectrum
Tough Going Forces Chinese Biotechs To Form Domestic Alliances
Deals among domestic Chinese biotechs are growing fast, reflecting a need to huddle up amid tightening scrutiny over biotech deal-making and an unusually competitive immuno-oncology market.
Cipla Backs Start-Up As It Builds Digital Health Strategy
Facing Up To A Patent Cliff: Indivior Plans For Loss of Suboxone Film Exclusivity
With sales of its largest-selling product under threat from generic competition, a couple of new products and cost cuts are put forward to reinvigorate Indivior, a leader in addiction therapies.
IQVIA Could Be CRO Bellwether As Tech Offering Outperforms Expectations
IQVIA has impressed industry observers with its Q4 results, which show the potential of the freshly merged company, especially in its technology division. With biotech money and strategic outsourcing as prevalent as it has been in recent memory, could the rest of the CRO industry follow suit?
Bayer Bags Full Vitrakvi Rights As Lilly Signs Off Loxo Buy
When buying Loxo, Lilly highlighted the importance of LOXO-292, a first-in-class oral RET inhibitor, rather than the already-approved Vitrakvi, perhaps knowing that partner Bayer was going to be exercising an option to take full control of the TRK inhibitor.
Policy & Regulation Explore this Topic
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Money Too Tight To Mention At Motif After Iclaprim 'No' From FDA
Hit with a complete response letter from the US FDA for its antibiotic to treat ABSSSI, Motif needs to raise funds and fast to stay afloat and prepare a meeting package to discuss the next steps for iclaprim with the agency.
Commercial, Reimbursement Hurdles Need To Be Addressed By Antimicrobial Resistance Efforts
Melinta describes difficulties launching its new antibiotics at BIO CEO & Investor Conference; companies and other stakeholders urge Congress to enact package of incentives to reinvigorate antibiotic pipeline.
AZ And Ipsen Outline Brexit Contingency Plans
With the UK no nearer to deciding how hard or soft its exit from the EU will be on March 29, AstraZeneca and Ipsen have given updates on their efforts to cope with the chaos that could ensue on the medicines supply front.
Janssen’s Esketamine Gets US FDA Panel Endorsement, But With Pricing, Access And Diversion Concerns
Committee overwhelmingly supports approval for treatment-resistant depression but warns that pricing and combination therapy indication could hinder patient access. Esketamine’s risks of sedation and dissociative effects, and its abuse potential, will necessitate a strict risk management strategy.
Research & Development Explore this Topic
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Tanezumab Dances Through Back Pain Studies With “Acceptable” Safety Answers
In its latest TANGO trial for chronic lower back pain, Eli Lilly and Pfizer’s tanezumab has shown efficacy at 10 mg, but its 5 mg dose missed the statistically significant mark. Vitally, analysts are encouraged by safety data.
Nektar/Bristol Show Promise With Double IO Combo, But Numbers Are Small
Updated data from PIVOT-02 at the ASCO GU meeting suggest a path for accelerated approval of the NKTR-214/Opdivo combination as first-line treatment of patients with PD-L1-negative urothelial cancers.
Intercept Retakes The Lead In NASH
A week after Gilead missed its primary endpoint in the first Phase III NASH trial, Intercept shows a statistically significant fibrosis benefit in Phase III with OCA. It plans to file for approval later this year.
Facing Up To A Patent Cliff: Indivior Plans For Loss of Suboxone Film Exclusivity
With sales of its largest-selling product under threat from generic competition, a couple of new products and cost cuts are put forward to reinvigorate Indivior, a leader in addiction therapies.
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