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After MURANO: Roche/AbbVie Map Venclexta's Expansion Past CLL

Sponsors expect that if Venclexta demonstrates compelling early data in new indications – like acute myeloid leukemia and multiple myeloma – the US FDA will be willing to help speed access for patients.

Cancer Clinical Trials Research and Development Strategies

Interview: GW Pharma Gears Up For Pivotal 2018

The UK group has raised nearly $320m this week which will be used to build commercial organizations in the US and Europe ahead of potential approvals for its cannabinoid epilepsy therapy Epidiolex.

Neurology Pediatrics Strategy

Newly Launched Peptide Specialist Aelin Therapeutics Seeks CEO

Flemish academic spin-off Aelin Therapeutics harnesses the power of protein aggregation to specifically induce functional neutralization or 'knockdown' of a target protein.

Business Strategies Commercial Innovation

Capacity Shortages Unlikely To Hold Back Cell And Gene Therapies

The pharmaceutical industry's manufacturing capacity for cell and gene therapies is under pressure from an ever-increasing number of life sciences companies wanting to exploit rare expertise in the sector, but CMOs and government-backed facilities are rapidly coming on-stream, hoping to develop local clusters of companies to deliver the complete "living medicines" supply chain.

Regenerative Medicine Manufacturing Scrip 100

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Venture Funding Deals: Semma, Arcus Raise $100m-Plus For Cancer, Diabetes Therapies

Semma's $114m Series B round and a $107m Series C for Arcus top November's list of biopharmaceutical venture capital deals. Forty Seven, Medeor and Tricida also closed sizeable rounds.

StartUps and SMEs Financing Deals

NorthSea Raises Cash For NASH Program

NorthSea raises €25m to push icosabutate, its only clinical compound, which was licensed from Pronova BioPharma, into Phase IIb trials for fatty liver disease. The drug has previously been tested in hypertriglyceridemia and dyslipidemia.

Business Strategies Financing Liver & Hepatic

Korea 2017 Review: Biosimilar Advances, R&D Progress Restore Confidence

Strong global advances in biosimilars and progress in new drug development as well as clampdowns on illegal rebate payments have dominated headlines in South Korea in 2017.

Commercial South Korea

Heights And Plights Of Vaccine Development: Tales From The Frontline

Gary Dubin, senior vice president and global medical officer in Takeda Pharmaceutical Co.’s Vaccine Business Unit, talks about the trials and tribulations of vaccine R&D and how it felt to get one of the world's first human papillomavirus injections to market.

Vaccines Scrip 100

2018 Preparation: PD-1 Predictions And Commercialization Challenges

What's next for the PD-1 market, a cancer therapy area that exploded in 2017 as recently launched products secured ever more approvals? Maria Whitman, managing principal at sales and marketing firm ZS Associates, talks about challenges facing the booming immuno-oncology market and shares her predictions for 2018.

ImmunoOncology Business Strategies

How Novartis’ For-Profit Social Business Is Reshaping Healthcare

Amid glaring healthcare gaps in emerging markets like India, Novartis has scaled up its unique for-profit social business; similar initiatives are running in Kenya and Vietnam. Scrip brings you an on the ground report from rural India, where the Swiss multinational is trying to make a difference in a sustainable way.

Commercial Strategy

Arix Shepherds Atox $30m Funding Amid High Hopes For Start-up's Lead Asset

Its investment in Atox Bio's $30m Series F financing round added the 12th company to Arix's portfolio, hitting a target set at its February IPO. Atox’s late-stage peptide is designed to modulate a patient’s response to severe infections.

Business Strategies Clinical Trials

Antikor Takes Aim At Solid Tumors With Antibody-Fragment Conjugates

Emerging Company Profile: The UK's Antikor Biopharma is advancing antibody fragment-drug conjugates (FDCs) closer to the clinic with plans for its first human study in 2019 or 2020.

StartUps and SMEs Cancer

Policy & Regulation Explore this Topic

Brazil’s Spiraling Access Suits And The Potential Impact On Companies

Spending on medicines as a result of litigation against health authorities is soaring in Brazil. Scrip investigates the challenges firms may face in future, including greater pricing pressure, a more NICE-like health technology appraisal system and increased scrutiny over any perceived industry wrongdoing.

Scrip 100 Market Access Brazil

Pharma Lauds Brexit ‘Breakthrough’ But Says Focus Now Must Be On Drug Regulation & Supply

The UK pharmaceutical industry has welcomed the announcement that Brexit talks are to move on to trade deal discussions, but says a regulatory cooperation agreement and a fixed transition period are essential to safeguard European supply chains. Several pharma executives outlined some of their key concerns at a parliamentary committee hearing on Dec. 5.

Brexit Europe

RWE and Clinical Trials To Take Center Stage In UK Sector Deal Prospects

Some of the loudest messages from UK government's Life Science Sector Deal was the importance of using real world evidence - and the uniqueness the British health ecosystem can offer to trail blazing innovation.

Brexit Business Strategies

Novo Nordisk Plans Value-based Contracts For GLP-1 Agonist Ozempic

Company aims to shift gradually away from once-daily GLP-1 Victoza (liraglutide) toward once-weekly Ozempic (semaglutide).

Approvals Metabolic Disorders

Research & Development Explore this Topic

Agios' IDH Inhibitors Show Their Mettle At ASH

Updates for key products from Agios bring comfort for analysts as it forges ahead with a filing and new studies in AML. Another of its investigational products is also showing first-in-class potential in pyruvate kinase deficiency.

Clinical Trials Research & Development Cancer

A Star Is Born? HERCULES Data Shine At ASH For Ablynx's Caplacizumab

Strong Phase III HERCULES data mean Ablynx's caplacizumab is likely to sail through regulatory proceedings next year, becoming the first approved therapy for the rare blood disease, acquired thrombotic thrombocytopenic purpura.

Market Intelligence Business Strategies

Topas To Enter Clinic In 2018

Timm Jessen, CEO of Topas Therapeutics, talks to Scrip's Lucie Ellis about his journey through the pharma and biotech sector and what lies ahead for his current company.

Research and Development Strategies Research & Development

Roche's Neuroscience Franchise Gets Lift From Huntington's Breakthrough

Roche is aiming to bolster its future neuroscience franchise with another potential breakthrough product in neurology to add to its clinical-stage efforts in Alzheimer's disease, and its success in developing the first therapy for primary progressive multiple sclerosis, Ocrevus.

Clinical Trials Neurology