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Shire CEO Says Lanadelumab Results Vindicate Dyax Buy, M&A Strategy

Shire's CEO is savoring a personal victory after Phase III data for lanadelumab in acute HAE replicated impressive Phase Ib trial results that underpinned his 2015 decision to buy Dyax.

Business Strategies Clinical Trials Commercial

Chiesi Wins EU Nod For COPD Triple Combo, But Partner Is Predicted For Launch

Chiesi's triple combination therapy for COPD, Trimbow, has secured its first approval globally after winning a positive recommendation from the CHMP for its use in Europe – but analysts expect a respiratory partner will be required to launch the product.

Approvals Respiratory Business Strategies

It's Not All About IO: Seven Drugs To Watch At ASCO

Biomedtracker's review of ASCO abstracts revealed several drugs to watch outside of the immuno-oncology space at the annual cancer conference in Chicago, including market-expanding data for Roche's Perjeta and J&J's Zytiga, and Phase III data for AstraZeneca's PARP inhibitor Lynparza in breast cancer.

Clinical Trials Commercial ImmunoOncology

Scrip's Rough Guide To IDO

IDO has emerged at the lead suitor among new cancer immunotherapy targets to partner with PD-1/L1 inhibitors; the early data help show why big pharmas are so much on board.

ImmunoOncology Research & Development Clinical Trials
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Dr Reddy’s Gears Biologics Expansion With GE Platform

Dr Reddy’s Laboratories hopes GE Healthcare’s FlexFactory biomanufacturing platform can deliver multiple operational gains, including a potentially more fail-safe compliance system at its site. The Indian company expects to roll out its first biosimilar MAb from the new set-up next year.

Commercial Companies Manufacturing

Keep In Touch: Communication Maintains Ongoing Purdue/Shionogi Pact

The private US pain specialist and Japanese pharma have partnered for more than a decade to develop novel pain candidates, but despite perhaps slow progress, the level of collaboration has grown with strong communication.

Leadership Business Strategies Deals

Latest From Commercial

Celgene's Positive Ozanimod Data Puts Focus On MS Commercialization

A second Phase III multiple sclerosis trial testing the S1P1 modulator was positive, turning attention to whether or not Celgene will market the drug independently for the indication and how the drug might be positioned against an eventual generic Gilenya.

Research & Development Neurology

The Future's Bright For Microbiome Investing, Says VC

Seventure Partners’ Eric de la Fortelle explains how the venture capitalist’s €160bn fund will prosper from the increased understanding of human and microbe interactions.

Innovation Financing

Finance Watch: Two More US Biopharma IPOs And Two New European VC Funds

Two biopharma IPOs in the US continue streak of (mostly) positive returns; two new European VC funds launch as Irish antibiotic developer raises $65m; and Halozyme, Ziopharm price offerings.

Business Strategies Commercial

Mitochondrial Medicine Focus Drives NeuroVive Orphan Ambitions

Erik Kinnman, CEO of NeuroVive Pharmaceutical, spoke to Scrip about the company's work in mitochondrial medicine. The company aims to develop orphan drugs to treat rare genetic conditions and seek partners for its NASH and liver cancer projects.

Rare Diseases StartUps and SMEs

J&J Forges Ahead In Immunology Despite Competitive Dynamics

The diversified pharma has two NMEs and three sNDAs pending at FDA in immunology, as well as six more anticipated sNDA filings. Immunology Therapeutic Head Susan Dillon told investors why there is still plenty of opportunity for growth in key autoimmune diseases.

Business Strategies Launches

Avir BD Execs On Innovative Meds For Canadians

Avir Pharma's business development associate Vanessa Fortin and VP of business development Kaled Kadri talk to Scrip about the company's business model and strategy for bringing innovative medicines to Canada.

StartUps and SMEs Business Strategies

Policy & Regulation Explore this Topic

Drug Promotion: FDA Loosens Reins But Industry Wants More Room To Run

Agency proposes a safe harbor for certain communications with payers about approved uses and investigational drugs, but drug manufacturers ask the US agency to expressly protect from enforcement manufacturer communications about off-label uses.

Advertising, Marketing & Sales Reimbursement Regulation

LEO Pharma Gets EU Go-Ahead For Psoriasis Latecomer Brodalumab

The Danish speciality dermatology company LEO Pharma has achieved a key plank in its plans to provide products for the range of psoriasis patients with an EU go-ahead for brodalumab.

Drug Review Approvals

NOAC Costs Weigh Heavy In Europe, Unmet Needs Remain

Makers of novel oral anticoagulants need to work on gaining real world data to prove their worth to European payers, as their INR testing benefit gets lost in administration.

Reimbursement Blood & Coagulation Disorders

‘Excessive Pricing’ Inquiry Widens As EC’s First Antitrust Price Probe Targets Aspen Pharma

The litany of complaints against pharmaceutical companies for imposing “excessive” prices on generic drugs is growing after the European Commission decided to pursue Aspen Pharma over price rises imposed on a range of anticancer products it acquired from GSK.

Europe Generic Drugs

Research & Development Explore this Topic

Merck Expands Aduro Collaboration In Keytruda Tie-Up

Aduro Biotech's scientists have a long association with Merck & Co's Keytruda, and things have come full circle as the small biotech's lead anticancer shows promise in combination with the high-profile checkpoint inhibitor.

Research & Development ImmunoOncology Cancer

Latest From Research & Development

Celgene's Positive Ozanimod Data Puts Focus On MS Commercialization

A second Phase III multiple sclerosis trial testing the S1P1 modulator was positive, turning attention to whether or not Celgene will market the drug independently for the indication and how the drug might be positioned against an eventual generic Gilenya.

Research & Development Neurology

Phase III Data For La Jolla's Angiotensin II Drug Leave Questions About Clinical Benefit

La Jolla's LJPC-501 meets primary blood pressure endpoint in the Phase III ATHOS-3 vasodilatory shock trial, but data suggest benefits may not translate into clinically meaningful improvements.

Clinical Trials Cardiovascular

ARCH CV Signal Scuppers Blockbuster Hopes For Amgen/UCB's Evenity

New Phase III data for the novel osteoporosis therapy romosozumab are set to delay its approval, reduce its commercial potential and open the market to rivals.

Companies Clinical Trials
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