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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 Life Cycle Management

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 Companies

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 Commercial
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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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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 Neurology

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 Europe

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

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

Samsung BioLogics Faces Penalties As Authorities Conclude 'Intentional' Accounting Violation

Things have turned for the worse for Samsung BioLogics after a second review by financial authorities in South Korea over its accounting related to corporate control over Samsung Bioepis, resulting in fines, a recommendation for dismissal of its CEO, and a suspension in trading in its stock. The company is poised to face tough times ahead, although it reiterates it hasn’t violated any accounting rules and has vowed again to seek legal steps.

South Korea Companies

Pfizer's Epogen Biosimilar Retacrit Launches At 33% Off In A US Market Where Amgen's Already Competitive

Retacrit – a biosimilar of Amgen's Epogen and J&J's Procrit – will launch at aggressive discounts to the original anemia products in a market where Amgen's already proven there's a tough fight for market share.

Biosimilars Launches

Venture Funding Deals: Gotham Raises $54m To Advance Epitranscriptomics

Derived from Strategic Transactions, Informa’s premium source for tracking life sciences deal activity, the Venture Funding Deals column provides a comprehensive monthly review of emerging biopharmaceutical companies that have received venture funding. This month’s column covers deals announced September and October 2018.
Deals Financing

Glenmark Re-Evaluates Complex Generics Basket, Won’t Be Part Of The 'Crowd'

Glenmark has ended development of certain in-licensed complex generic assets including generic versions of Abraxane and Suboxone in view of the extremely competitive landscape in the US. The Indian firm says it would rather focus on products where it is an early entrant.

India Commercial

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

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

INFOGRAPHIC: Sweden's Vibrant And Growing Life Sciences Landscape

Sweden's life science industry is a key component of the Scandinavian country's economy. New life science companies emerge there every year. Growing shipments to China and Japan by Swedish companies reflect the duo’s increasing importance as export markets, especially in relation to the US and the European Union. And while the UK has hitherto been regarded as a stepping stone to foreign markets, worries over what Brexit will mean for future business and opportunities is prompting players to increasingly look to the US to set up operations.

Sweden Europe
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