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Featured Stories


Mystic Miss Not Make Or Break For Imfinzi

While the failure of AstraZeneca's Imfinzi in the MYSTIC trial for stage IV lung cancer is a blow, it is not going to have much of an effect on the potential for the company which has carved out a sizeable niche for the drug in stage III NSCLC.

Clinical Trials Companies ImmunoOncology

UniQure Hemophilia B Gene Therapy AMT-061 Has Early Phase IIb Success

Early positive data from a Phase IIb dose-confirmation study showed AMT-061 achieved and sustained therapeutic levels of Factor IX (FIX) activity in all three participating patients at six weeks after a single administration of the investigational AAV5-based gene therapy.

Clinical Trials Companies Rare Diseases

Finance Watch: Biomatics Closes Second VC Fund; SVB Buys Leerink To Expand Life Science Services

Scrip spoke with Managing Director Julie Sunderland about Biomatics' new $300m fund. Also, Silicon Valley Bank reveals its surprising Leerink buy, Perceptive Advisors raises $675m, Roivant brings in another $200m, and cell and gene therapy financings surge in the third quarter.

Financing StartUps and SMEs Neurology
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Case Study: Broad Thinking Yields Big Results

There are numerous details when considering product packaging that require both creative thinking and feature prioritization. Rather than developing a standard solution for the current need, it’s imperative to think broadly and design options that are cost-effective, simplify operations and save time and/or resources.

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Commercial Explore this Topic

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Asia Deal Watch: MEI Partners ME-401 With Japan’s Kyowa Hakko Kirin, Following Chinese Deal With BeiGene

About a month after signing a development and commercialization partnership in China for its PI3K delta inhibitor, MEI signs a deal for Japanese rights to the compound with Kyowa Hakko Kirin. Cue and LG Chem partner to develop targeted T-cell therapies for cancer.

Deals Asia Pacific Commercial

Bridging The Gap: Cyclenium Pharma

Emerging Company Profile: Cyclenium Pharma spoke with Scrip about macrocyclic drug discovery, which covers the molecular space between traditional small molecules and large bio-molecules, to capture the pharmacological properties of larger peptides/proteins in metabolically stable small molecules and proven in a broad range of target classes.

Infectious Diseases StartUps and SMEs Platform Technologies

As AbbVie's Risankizumab Looms, Sun Pushes To 'Maximize Time' Of Ilumya

Sun says that it is "excited" with Ilumya’ s initial launch uptake in the crowded US psoriasis segment, but is pushing ahead with "speedy execution" of plans for the product before the potential arrival of new rivals such as AbbVie’s same-class therapy risankizumab.
Commercial Strategy

Arena To Advance GI, Derm Ambitions With $800m From United For PAH Candidate

With $800m in upfront cash from United Therapeutics and $400m pegged to approvals for ralinepag, Arena gets capital for its R&D ambitions and a partner of choice to advance its Phase III PAH compound.

Deals Commercial

Finance Watch: Not Everyone Can Go Public, But Biopharma IPOs Are Using Multiple Markets

Not every drug developer can go public, but biopharma IPOs are launching in multiple markets, including Moderna's prospective $500m US offering and Innovent's $421m Hong Kong IPO. Also, Sarepta prices a $500m FOPO and Omeros sells $210m in notes.

Financing Asia Pacific

R&D Heads At GSK & AZ Say Key To Success Lies In Smart Risk Taking

AZ's Mene Pangalos and GSK's Hal Barron are at different stages of overseeing culture changes in their respective R&D workforces - but both agreed at a recent conference that such transformations are key for the future viability of their drug companies.

Business Strategies Commercial

A Grunenthal First: Establishing A US Presence With A Tailored Marketing Strategy

Germany's pain-focused specialty pharmaceutical firm is adding America to its commercial reach, through acquiring New York's Averitas Pharma to jumpstart its push to commercialize products on its own account, via a niche approach.

 

Deals Rare Diseases

China 'Bay Area' Calling: Merck KgAA Chooses Guangzhou For New Innovation Center

Thinking all about scale, China opens the world’s longest sea bridge linking the Pearl River Delta area with Hong Kong and Macao, and the newly-formed 'Bay Area' is already attracting drug makers to look further afield than the traditional Beijing and Shanghai locations.

China Innovation

Policy & Regulation Explore this Topic

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ICER On Asthma Biologics: 50%-79% Price Discounts Needed To Meet Value Assessment Metrics

The independent value assessment organization’s draft assessment found that the prices for all five marketed biologics for severe asthma – Xolair, Nucala, Cinqair, Fasenra and Dupixent – far exceed standard cost-effectiveness thresholds.

Pricing Strategies Respiratory Cost Effectiveness

AZ's Lynparza PARP Lead Likely To Lengthen With FDA Priority Review

Despite suffering a setback at the hands of NICE, AstraZeneca's ambitious plans for Lynparza have been boosted by the FDA agreeing to speed up a review of the recent SOLO-1 data which took ESMO by storm last month.

Cancer FDA

‘Drastic’ Japan Price Reforms Hitting R&D Incentives, Plans - EFPIA

European research-based pharma group proposes reconsideration of Japan’s revised pricing system, warning it is already affecting corporate R&D decisions and will stifle industry investment, innovation and patient access to new therapies if incentives are not improved.

Japan Business Strategies

Speedy NICE Support For Eisai's Lenvima In Liver Cancer

It took NICE nearly three years to offer routine access to Lenvima for thyroid cancer but it has taken just three months from European approval to recommend the drug for advanced or unresectable hepatocellular carcinoma.

Reimbursement Cancer

Research & Development Explore this Topic

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Mersana Back On Track After Speedy Changes To ADC Program

Following a clinical hold for its lead product, Mersana explains how it re-engineered the program and how it is developing its ADC platform further.

Clinical Trials Research and Development Strategies Platform Technologies

AbbVie Explores Uncharted Territory With DUB Inhibitor Neuroscience Deal

AbbVie has added Mission Therapeutics to its preclinical partnership roster with a neurology deal to develop DUB inhibitors in Alzheimer’s and Parkinson’s disease. 

Platform Technologies Deals

AstraZeneca: DECLARE-TIMI Outcomes May Support Competitive Claim For Farxiga In Heart Failure

Lack of significant reduction on cardiovascular deaths or a composite of major events may have been due to enrollment of a healthier population relative to other studies, said investigators from the DECLARE-TIMI 58 outcomes study, which was reported at the AHA meeting.

Research & Development Cardiovascular

Madrigal Cements Case For Hepatic Fat Reduction, Other NASH Benefits With MGL-3196

Madrigal’s selective THR beta agonist continues to demonstrate hepatic fat-lowering abilities in 36-week data, along with lipid-lowering characteristics. The company hopes to initiate a Phase III study in early 2019.

Liver & Hepatic Clinical Trials
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