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Novel Antibody Products Ring The Treatment Changes In HIV

Two Canadian companies – Theratechnologies and CytoDyn – exploring the use of monoclonal antibodies in the fight against HIV presented data for their novel late-stage candidates at the recent CROI meeting in Seattle. They are aimed at patients experiencing multi-drug resistance and represent a change in this mature therapy area dominated by small-molecule oral products.

Clinical Trials Companies Research & Development

AbbVie 'Disagrees' With NICE's Draft Rejection Of Venclyxto For CLL

NICE has rejected AbbVie's BCL-2 inhibitor on grounds that evidence presented by the drug maker didn't adequately prove Venclyxto's clinical effectiveness, nor that the cancer product would be value for money.

Health Technology Assessment Market Access Commercial
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Companies

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Latest From Companies

Novartis Combo On Track To Be First Targeted BRAF NSCLC Therapy

The EU's CHMP has granted a positive opinion for Novartis' combo of MEK inhibitor Mekinist and BRAF inhibitor Tafinlar for BRAF-positive non-small cell lung cancer patients.

Approvals Commercial

UCB Predicts Briviact Sales Of €450m by 2026; Plans New Partnerships

UCB says its early to mid-stage pipeline contains 10 promising breakthrough molecules, some of which it aims to partner with other pharma players as part of its open innovation strategy.

Companies Sales & Earnings

Viking Flexes Its Muscles Ahead Of Partnering Talks

The mid-stage company is approaching Phase II data read outs for two lead assets. It is looking to partner with larger pharmas, but is also pursuing orphan indications that it could develop independently.

Business Strategies Rare Diseases

Busy In-Tray Awaits New EFPIA Boss Nathalie Moll

Nathalie Moll is moving on from leading the biotech industry body EuropaBio to be the next director general of EFPIA, the federation that represents the R&D-based pharmaceutical industry in Europe. With issues such as the forthcoming Brexit negotiations, the EU’s inquiry into medicines access and pricing, and the implementation of the new Clinical Trials Regulation on the agenda, Moll will have a lot of weighty dossiers to deal with.

Policy & Regulation Leadership

Ocular Therapeutix Gets Lead Product Back On Track

The long-acting eye insert Dextenza has been accepted for review by the US FDA, a piece of good news for Ocular Therapeutix that had previously received a complete response letter on manufacturing issues and a mixed bag of late-stage clinical trial results.

Companies Ophthalmic

Celltrion's Truxima First Biosimilar MAB In Oncology To Win EU Approval

Celltrion's version of Roche’s MabThera (rituximab), Truxima, has become the first biosimilar anticancer to win marketing authorization in Europe.

Approvals Biosimilars
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Deals

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Merck's Write-Down Of Phase II Nuc Illustrates Current Reality In HCV

While a dwindling patient base and pricing pressures are depleting the market opportunity in hepatitis C, Merck's decision also may result from regulatory dialogue potentially delaying the start of a Phase III study.

Business Strategies Commercial

Deal Watch: Teva's Sol Barer Leads Buyout Of IO Start-up NexImmune

Instead of helping raise a Series A, the Teva chairman and others acquire the preclinical company, convinced of its synthetic nanotech promise in immuno-oncology. Vifor and ChemoCentryx expand their orphan and renal disease collaboration, while Gilead out-licenses an addiction drug candidate.

Commercial Deals

Gilead, With Two PRVs In Hand, Holds Options For Accelerating Late-Stage Pipeline

Likely candidates for use of Gilead's priority review vouchers include GS-4997, a Phase III candidate for NASH, and bictegravir, its second-generation integrase inhibitor for HIV. The virology specialist previously used a PRV successfully to accelerate approval of Odefsey.

Business Strategies Research and Development Strategies

M&A Analysis Reveals Mid Pharma Purchase Preferences

Immunology- and inflammation-focused biotech companies wondering if a trade exit is in their future will be interested to read that, according to a report from Datamonitor Healthcare, their demographic is the most popular acquisition target of the mid-size pharma cohort.

Commercial Deals

Takeda Extends PRA Alliance To Japan With New JV

Takeda is setting up a new joint venture in Japan to extend its global clinical development partnership with PRA, as part of an ongoing R&D overhaul.

Research and Development Strategies Deals

Five Golden Rules For Post M&A Leadership Success

Four consultants from pharma and further afield discuss their golden rules for the soft aspects of M&A. They outline best practice guidelines for managing people through mergers or takeovers and highlight the most common errors made by transitioning companies when it comes to careers, communication and customers.

Leadership Business Strategies
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Strategy

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Can Pharma Keep Up With The Challenges Of Digital Healthcare?

The digital revolution is transforming the world of healthcare, which is awash with new technologies and floods of data. In this thought leadership article written in partnership with CMS, Scrip considers the opportunities and challenges for pharma, in light of progress to date.

BioPharmaceutical Strategy

Janssen Strives For Simplicity In HIV R&D, While Hunting For A Cure

HIV may be effectively treated and managed with available therapies, but there is still great unmet need for a functional cure and better prevention to stop the epidemic.

Clinical Trials Infectious Diseases

Stockwatch: Limited Acquisition Headroom At Specialty Pharma

Debt-fueled acquisitions helped Teva, Shire and Allergan report well-received fourth-quarter earnings. But sector circumstances have changed since 2016 and the ability to grow by debt-funded acquisition is now severely restricted.

M & A Sales & Earnings

Tepid Q3 For Sun But Momentum In Specialty Build-Up

Sun Pharma reported a decline in profits for the third quarter amid dull US and India growth and ongoing investments to prepare for a larger play in the specialty segment, where it hopes to scale up with a mix of organic and inorganic additions to its portfolio.

Commercial Generic Drugs

J&J’s Stoffels On Actelion’s ‘Exquisite’ Researchers, India TB R&D Plans

J&J’s chief scientific officer Dr. Paul Stoffels tells Scrip that flexibility is a hallmark of how the company goes about its collaborations, including the new $30bn deal with Actelion. Stoffels is also hoping to progress the science for a new TB medicine via a unique collaboration in India.

Commercial Strategy

COMPASS Success Reinforces J&J/Bayer's Broad Labeling Strategy For Xarelto

J&J will be talking to FDA regarding expanded approval for peripheral arterial disease and coronary artery disease following early stop of COMPASS outcomes study; strong data will be needed if asymptomatic patients are targeted.

Clinical Trials Research and Development Strategies
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Market Access

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Latest From Market Access

Gilead, With Two PRVs In Hand, Holds Options For Accelerating Late-Stage Pipeline

Likely candidates for use of Gilead's priority review vouchers include GS-4997, a Phase III candidate for NASH, and bictegravir, its second-generation integrase inhibitor for HIV. The virology specialist previously used a PRV successfully to accelerate approval of Odefsey.

Business Strategies Research and Development Strategies

Express Scripts Projects Higher Spending In Inflammation, Diabetes, Cancer

The three most expensive drug categories, on a per-member/per-year basis for the PBM's clients, increased by 19% or more in 2016, and similar growth is expected in the next three years. Per-patient spending on HCV drugs, however, declined by 34% last year.

Pharmacy Benefit Management Pricing Strategies

Laying The Groundwork For Value-Based Healthcare In Europe

Elisabeth Aloy and David Pistor, healthcare and life sciences advisors at Monitor Deloitte, outline five design principles to create a value-based care project.

Market Access Reimbursement
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Market Intelligence

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Latest From Market Intelligence

Merck's Write-Down Of Phase II Nuc Illustrates Current Reality In HCV

While a dwindling patient base and pricing pressures are depleting the market opportunity in hepatitis C, Merck's decision also may result from regulatory dialogue potentially delaying the start of a Phase III study.

Business Strategies Commercial

AZ’s ZS-9 Targets Hyperkalemia Sector As It Nears EU Market

A potential near-blockbuster drug, AstraZeneca’s Lokelma (ZS-9), has received a positive opinion from Europe’s CHMP and, if approved, will soon have to justify best-in-class plaudits and a hefty acquisition price.

Approvals Market Intelligence

Pharma's Orphan Drug Activity, An Infographic

More than two-fifths of new drugs approved in the US last year were orphan drugs, and there are more than 4,500 drugs in active development for rare diseases. Effective orphan drug legislation and incentivization programs introduced gradually around the world since the 1980s mean rare diseases are no longer a rare sighting in the pharma industry pipeline, as this infographic illustrates.

Rare Diseases Market Intelligence
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