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Featured Stories


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.

FDA Immune Disorders Regulation

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.

Clinical Trials Research & Development ImmunoOncology

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.

Clinical Trials Research & Development Renal
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Pulse 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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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.

 

Infectious Diseases Research and Development Strategies Research & Development

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. 

Approvals Blood & Coagulation Disorders Research and Development Strategies

GSK’s Terrell On ‘Relentless’ Digital Consumption Across the Spectrum

GSK’s first chief digital and technology officer shares with Scrip her views on things digital that could potentially transform the pharmaceutical business, the ex-Walmart executive noting how digital touch points with physicians are improving “in every single geography and every single product.” 
Commercial Strategy

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.

Deals Research and Development Strategies

Cipla Backs Start-Up As It Builds Digital Health Strategy

Cipla has picked up a minority holding in the Indian digital therapeutics firm Wellthy, and the duo will combine forces to improve patient outcomes in specific chronic therapies.
Commercial 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.

   

Neurology Business Strategies

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? 

Commercial Sales & Earnings

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.

Deals Personalized Medicine

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.

Financing Infectious Diseases Companies

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.

Infectious Diseases Commercial

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.

United Kingdom Brexit

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.

Advisory Committees Drug Review

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.

Clinical Trials Research & Development Neurology

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.

Clinical Trials Research & Development

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.

Clinical Trials Liver & Hepatic

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.

   

Neurology Business Strategies
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