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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.

China Cancer Approvals

Interview: Novartis Counts On AS and PsA For Cosentyx Growth

Novartis immunology chief Eric Hughes tells Scrip a wealth of data is showing that early treatment with Cosentyx can prevent the structural changes that lead to lack of mobility in ankylosing spondylitis and psoriatic arthritis patients.

Immune Disorders Clinical Trials Dermatology

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.

Research and Development Strategies Neurology Clinical Trials
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Commercial Explore this Topic

Set Alert for Commercial

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.

Financing Business Strategies Liver & Hepatic

Calliditas IPO To Support Phase III Berger's Disease Study

Calliditas is aiming to raise new funding in an IPO and listing on Nasdaq Sweden to support late-stage clinical development and commercialization of its Berger's disease candidate, and studies in additional indications.

 

Financing Renal Research & Development

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. 

Innovation Business Strategies

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.

Japan Neurology

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.

Research and Development Strategies Neurology

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.

Generic Drugs Respiratory

Big Pharma Voluntary List Price Reductions Doubtful, Sen. Warren Says

Companies responding to inquiries from Sens. Elizabeth Warren, D-Mass., and Tina Smith, D-Minn., did not indicate they are planning to reduce list prices, despite promises by President Trump, Warren told a June 12 hearing. 
Pricing Debate Pharmacy Benefit Management

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.

Manufacturing Compliance

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.

Generic Drugs Approvals BioPharmaceutical

Big Pharma Voluntary List Price Reductions Doubtful, Sen. Warren Says

Companies responding to inquiries from Sens. Elizabeth Warren, D-Mass., and Tina Smith, D-Minn., did not indicate they are planning to reduce list prices, despite promises by President Trump, Warren told a June 12 hearing. 
Pricing Debate Pharmacy Benefit Management

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.

Approvals Clinical Trials

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. 

Digital Health ASCO

Research & Development Explore this Topic

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Pipeline Watch Phase III Progress With Trintellix, Ocrevus And Olumiant

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.

Pipeline Watch Approvals BioPharmaceutical

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.

StartUps and SMEs Cancer

Eisai Refocuses AiM As It Builds US Immuno-Dementia Research

Amid multiple industry drug failures in the sector, Eisai is opening a new US research facility to discover innovative therapies for dementia based on a long-standing immunology hypothesis.

Neurology Research and Development Strategies

TMB Biomarker Is A Winding Path Rather Than Straight Road

The tumor mutational burden biomarker had a much higher profile at this year's ASCO meeting, promising to help target treatment to individuals, though practical barriers remain and testing still is not ready for prime time yet.

ASCO ImmunoOncology
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