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Lilly/Loxo Deal Came Together Quickly

Lilly's $8bn acquisition of genetics-based cancer specialist Loxo Oncology didn't involve any other bidders and was finalized in just days over the holidays as Lilly sought to make a news splash at the J.P. Morgan Healthcare conference, according to an SEC filing.

Deals Business Strategies Commercial

J&J’s Erleada Gives Chase To Xtandi For Non-Metastatic Prostate Cancer With Approval In Europe

Astellas/Pfizer’s Xtandi and Johnson & Johnson’s Erleada are both now approved for non-metastatic castration-resistant prostate cancer in Europe, while Xtandi benefits from physician familiarity, Erleada has shown greater metastasis-free survival.

Cancer Approvals Europe

Spectrum Reshuffles Focus, Selling Seven Products To Aurobindo

By selling seven approved oncology/hematology products to a US affiliate of Aurobindo, Spectrum gets cash to increase focus on late-stage candidates Rolontis for neutropenia and poziotinib for solid tumors.

Cancer Commercial Deals

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Factoring the "What Ifs" into Supply Forecasting

With the pressure on to deliver new products faster and more efficiently, sponsors are facing a variety of challenges. Download this whitepaper and discover the challenges as well as aspects to consider when developing a supply plan, the influence of early decisions and much more.

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Commercial Explore this Topic

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Finance Watch: VC Deals Keep Up Fast Pace With $1.1bn In Less Than Three Weeks

Finance Watch has noted $1.1bn worth of venture capital deals so far in 2019. Meanwhile, public offerings continue to be muted by the US government shutdown, though Revance and others sold shares. Also, Five Prime and others reveal layoffs and strategic shifts.

Financing StartUps and SMEs Business Strategies

Otsuka, Click ‘Digital Therapeutic’ Alliance Aims At Novel Depression Option

“There’s an app for that” could take on added significance under a new alliance for a digital therapeutic for the treatment of depression, in which the partners hope the novel approach will take its place as an effective option among current drug and other cognitive therapies.

Digital Health Business Strategies Neurology

Q4 Pharma Earnings Preview: J&J, Bristol And AbbVie

Johnson & Johnson has solid growth drivers in pharmaceuticals, but still faces an overhang related to talc controversy; Bristol's call will be dominated by the just-announced Celgene acquisition; and AbbVie will face questions about its cancer plans after expensive failure with Rova-T.

Sales & Earnings Companies

Dark Days For Sun As Governance Saga Escalates

Allegations of corporate governance lapses continued to singe Sun, but there is little clarity on which way things are headed, at least for now.

Commercial Companies

Catalan Biotechs Boosted By International Backers

The number of foreign investors participating in Catalan biotech companies has gone from 0 to 50, and over the past five years alone, the figure has increased tenfold, according to the latest Biocat report.

Spain Financing

Finance Watch: Recent Offerings Show Some Companies Were Ready For The Government Shutdown

Public Company Edition: The usual mid-January surge in public offerings hasn't happened this year, since the SEC can't process new filings, but Alnylam, Acceleron and others apparently were prepared for a lengthy shutdown. Also, ARM reports cell and gene therapy financing data.

Financing Business Strategies

US Army Splashes The Cash On Valneva's JE Vaccine

Valneva’s 2019 guidance has been boosted by the US Army’s Ixiaro vaccine order, as other products flourish in the pipeline.

Vaccines Deals

Biotech Showcase 2019: Takeda Establishes Digital Health Focused Fund

Digital health represents a set of opportunities that can transform all parts of the pharma landscape. Speaking on the sidelines of Biotech Showcase 2019, Stephanie Bova, managing partner at Hatch@Takeda, tells Scrip how the Japanese pharma has established a new group to support the creation and financing of digital health businesses in the US and Europe.

Financing Digital Health

Policy & Regulation Explore this Topic

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Financial Transparency Concerns Over Patient Groups Advising NICE

England and Wales' cost-effectiveness agency has been urged to review its disclosure policy in a BMJ report which calls on NICE to probe the financial transparency of patient organizations that contribute to reimbursement assessments.

Reimbursement United Kingdom Health Technology Assessment

Pharma Industry Holds Tight As Disorderly Brexit Approaches

A worst-case Brexit scenario – a disorderly one – has become more likely, making an already white-knuckled life sciences industry step up its preparations.

Brexit Trade

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

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

Research & Development Explore this Topic

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Biotech Showcase 2019: Harnessing IgE Antibodies To Tackle Solid Cancers

Immuno-oncology is currently one of the hottest spaces for biotechs and so to rise above the noise companies need to be truly differentiated. Speaking on the sidelines of Biotech Showcase 2019, Tim Wilson, CEO of Cambridge, UK-based IGEM Therapeutics, tells Scrip how his company is achieving this by developing IgE antibody drugs to fight cancer, with its lead program against ovarian cancer already in Phase I testing.

ImmunoOncology Innovation Research & Development

Novartis’ Data-Centric R&D Strategy Adds Pact With UK-based Big Data Institute

Novartis and the Big Data Institute have entered a research alliance using artificial intelligence to understand complex diseases and improve drug development.

Artificial Intelligence Deals

Biotech Showcase 2019: Stem Cell Approach Shows Promise In Neurodegeneration

Recent studies have shown that mesenchymal stem cells (MSCs) hold great potential as a cell‐based therapy for a number of neurodegenerative diseases. Speaking on the sidelines of Biotech Showcase 2019, Chaim Lebovitz, President and CEO of Brainstorm Cell Therapeutics, tells Scrip how the New York-based biotech is currently enrolling a multi-dose, double-blind, placebo-controlled Phase III study of its MSC therapy, leveraging the company’s NurOwn platform, in 200 rapid-progressing amyotrophic lateral sclerosis patients.

Clinical Trials Regenerative Medicine

United Neuroscience To Move Forward Alzheimer's Vaccine After Promising Phase IIa

It's early days yet and Alzheimer's is a field littered with failures, but the latest results for the vaccine UB-311 support advancing development.

Clinical Trials Research & Development