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The Gene Therapies Are Coming – And So Are New Ways To Pay For Them

Annual payment plans for gene therapies appear closer to becoming reality now that bluebird bio detailed plans at J.P. Morgan. Novartis, Sarepta and others are also talking to payers about alternative payment models. Harvard Pilgrim's Michael Sherman applauded the effort in an interview.

Market Access Pricing Strategies Regenerative Medicine

Scrip Asks...What Does 2019 Hold For Biopharma? Part 3: Pricing, Reimbursement And Market Access

How much therapies should cost and how they should be reimbursed are questions that are expected to dominate in 2019, according to industry experts and participants surveyed by Scrip on their expectations for the coming year. This is the focus for the final installment of our three-part Scrip Asks series.

Pricing Debate Pricing Strategies Reimbursement

How Lilly Aims To Make Sure Good Drugs Don't Get Lost In Translation

SVP/CSO Daniel Skovronsky says the company has invested in technology and biotech-like teams to speed up the process of translating targets identified in house into human data for novel drugs.

Business Strategies Research and Development Strategies Companies
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Loxo Links And Colorectal Cancer Data Put Array In M&A Spotlight

Following Lilly's proposed acquisition of Loxo, other possible takeover targets in the precision medicine field have emerged and Array, armed with more positive data on its colorectal cancer triplet, is near the top of the list.

M & A Cancer Clinical Trials

Video: Novo Seeds Describes Company-Building Aspirations

With a focus on innovative early stage European biotechs, Novo Seeds senior partner Stephan Christgau explains to Scrip how the investor picks opportunities and creates companies.

Financing Companies Europe

Tech Transfer Roundup: GE Healthcare, Vanderbilt Partner To Optimize Precision Cancer Immunotherapy

Five-year collaboration will analyze data from thousands of cancer patients to optimize immunotherapy treatment and develop PET imaging tracers to stratify clinical trial participants. Also, MD Anderson starts 2019 with three new agreements.

Deals Commercial

AZ Management Shake-Up Sees CMO Bohen Exit

Sean Bohen is to join Bahija Jallal, Mark Mallon and Ludovic Helfgott in leaving AstraZeneca as the company transitions to a new organizational structure announced last week by CEO Pascal Soriot.

Leadership Strategy

J.P. Morgan 2019: Biopharma Sentiment Soars As Deal And Financing Optimism Abounds

Biopharma investor sentiment plunged at the end 2018, but soared as the J.P. Morgan Healthcare Conference kicked off with another big company acquisition and as industry participants indicated their optimism about financing and deal-making opportunities in 2019.

Deals Financing

Glenmark, Yuhan Partner for Ryaltris, Eyes On US Trajectory

Glenmark has kicked off 2019 with more regional deal-making, sealing an alliance for its investigational rhinitis asset with Yuhan in South Korea. But the outlook for the fixed-dose combination nasal spray also hinges on its US approval.
Commercial Deals

Deal Watch: Denali Partners With Sirion To Take On The Blood-Brain Barrier

Denali will collaborate with Sirion in Parkinson’s and Alzheimer’s diseases. Meanwhile, Lundbeck and Elevian unveil drug development partnerships with technology firms at the J.P. Morgan meeting.

Deals Business Strategies

Rovi and Recordati Deemed Top Picks By Analyst

The team at Jefferies believe that the Spanish and Italian firms, as well as Hikma, are looking like good bets for the year ahead.

Market Intelligence Europe

Policy & Regulation Explore this Topic

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Roche Calls For Harmonized Regulation As Subcutaneous Herceptin Is Denied Trial Waiver In India

Roche’s subcutaneous (SC) Herceptin (trastuzumab) has been declined a trial waiver in India, at least for now, stretching potential launch timelines for the product significantly. The company emphasizes that a harmonized regulatory approach could best serve patient interests for therapies like Herceptin that come with a ‘long history of proven efficacy’.

Policy & Regulation Clinical Trials Biosimilars

In A Record Year For US FDA Approvals, Pfizer Came Out On Top

FDA’s approval teams cleared a total of 65 new molecular entities and novel biologics in 2018, blowing past previous records. Scrip looks at how that breaks down for industry leaders. 
Approvals Drug Review

All Gifts Out As IFPMA New Code Of Practice Raises Ethical Bar

The international drug industry group's new code of practice bans gifts and promotional aids and moves from a rules-based approach to a so-called 'values-based' code in IFPMA's dealings with the overall healthcare community.

Commercial Companies

Anticancers, Orphans & The First CAR-Ts: New EU Drug Approvals In 2018

New approvals in the EU were again dominated by oncology drugs in 2018, although medicines for infectious diseases were a close second. The number of orphan drugs more than doubled over the previous year, to 17. There were also some star arrivals in multiple sclerosis, genetic disorders, metabolism and migraine.

Approvals Europe

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Merck’s Keytruda Misses OS Endpoint, But Shows Utility In Subset Of Esophageal Cancer

A Phase III study testing Keytruda monotherapy in second-line esophageal cancer versus physician’s choice of chemotherapy shows a 31% reduction in risk of death for patients expressing PD-L1.

Clinical Trials ImmunoOncology Research & Development

Can Vivus Get Away Without Outcomes Study Of Obesity Drug Qsymia?

Fixed-dose combination of phentermine and topiramate is FDA-approved for chronic, long-term use, but the average duration in the real world is only about 2.1 months, which is reassuring for Qsymia’s cardiovascular safety, according to a new retrospective claims study.

Clinical Trials Cardiovascular

Takeda's Investments In Data Science Seek Improved Trial Outcomes, R&D Efficiency

President of R&D Andrew Plump notes that much of the work to rationalize Takeda's pipeline after its Shire acquisition took place years ago when the Japanese pharma streamlined its R&D organization, but investments in data science to improve clinical trial outcomes and R&D efficiency are ongoing.

Research and Development Strategies Artificial Intelligence

Verona Investors Gasp As Lead Asset Misses Main Endpoint In COPD Trial

Verona’s shares sank after a brief three-day Phase II trial using lead asset RPL554 in patients already maximally bronchodilated on both a LAMA and LABA missed the primary endpoint.

Clinical Trials Respiratory
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