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Regional Coverage

Asia Pacific

Set Alert for Asia Pacific

Latest From Asia Pacific

Will Eurofins Deal See Advinus Turn The Corner?

Eurofins Scientific has snapped up the contract research business of Advinus Therapeutics, continuing its ongoing acquisition momentum. The deal also ends long-running speculation around a potential sale of Advinus, amid its rocky recent run.

Commercial Deals

Celltrion Healthcare IPO To Accelerate Celltrion's Global Biosimilar Expansion

Celltrion Healthcare's initial public offering, which is seen as the most anticipated biotech IPO in South Korea's Kosdaq market this year, is set to speed up Celltrion's expansion of its global market presence as well as the development of biosimilars and novel drugs.

Commercial Biosimilars

Interview: Beigene Bursts Onto World IO Scene With Celgene Onboard (Part 2)

Howard Liang comes from an investment background with years of experience honed being the former managing director and head of biotech equity research at Leerink Partners. He became Beigene's CFO and Chief Strategy Officer in 2015 as the biotech prepared for its initial public offering (IPO) on Nasdaq, and has since seen the Beijing-based firm leap onto the world stage with differentiated immuno-oncology and BTK inhibitor assets.

Commercial BioPharmaceutical

Hetero Set To Join Indian Humira Biosimilar Line-Up

Hetero’s biosimilar version of AbbVie's Humira (adalimumab) appears on course to a debut in India and is set to follow peers like Zydus Cadila and Torrent, signaling the build-up of more competition for the blockbuster biologic across markets.

Commercial Companies

An Infographic Look At Trends In Korean Gene And Stem Cell Therapies

South Korea has opened a new era with the recent granting of approval to the country's first gene therapy, for Kolon Life Science's osteoarthritis drug Invossa. (Also see "First Approval For Kolon's Invossa But No Disease-Modifying Status" - Scrip, 14 Jul, 2017.) Scrip takes a graphical look at the current state of the country's wider gene and stem cell therapy sector, one of the key biotech areas the government is nurturing.

Commercial South Korea

First Approval For Kolon's Invossa But No Disease-Modifying Status

Kolon Life Science's Invossa gets regulatory approval in South Korea as the world's first allogeneic cell-mediated gene therapy for degenerative osteoarthritis, but misses out on disease-modifying status, although the company hopes a large-scale Phase III study can rectify this in the US.

Commercial Approvals
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Europe

Set Alert for Europe

Latest From Europe

Norgine Builds Specialty Business In Europe From Canada's Merus Labs

Merus Labs' portfolio of well-established products are mainly marketed in Europe, and will drive the growth and diversification of Norgine’s specialty business in the region.

M & A Europe

Speedy EU Assessment On Cards For AZ’s Durvalumab

AstraZeneca is hoping that when it files for approval in the EU of its PD-L1 blocker, Imfinzi (durvalumab), for Stage III lung cancer, it will be given accelerated assessment on the back of the PACIFIC data.

ImmunoOncology Regulation

TR-PHARM Sees Early Success In Mediterranean Fever Antibody

TR-PHARM, a Turkish affiliate of the leading Russian pharma company R-PHARM, has disclosed promising early results for clinical trials with a potential new biologic treatment for familial Mediterranean fever.

Turkey Research & Development

Roche Supply Decision Under Investigation In Turkey

The Competition Authority of Turkey has decided to start an investigation into Roche’s refusal to supply products to a local pharmaceutical depot over worries about parallel trade, but a decision could take some time.

Policy & Regulation Legal Issues

ImCheck Therapeutics Pursues Immuno-Oncology Antibodies

Emerging Company Profile: The new anticancer antibody developer ImCheck Therapeutics has set up in Marseille, France, a location that is becoming increasingly attractive to biotech start-ups that could rival more established areas in coming years.

ImmunoOncology StartUps and SMEs

Bio Boost For Benelux As BioGeneration Ventures Beats Fund Target

Dutch life sciences venture capital firm BioGeneration Ventures has exceeded the €50m target in a third closing of its BGV III fund, raising €66m. It intends to focus its investments on firms in the Netherlands, Belgium, Luxembourg and Germany, and expects to secure further funds, reaching the maximum fund size of €75m by the end of 2017.

Financing StartUps and SMEs
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United States

Set Alert for United States

Latest From United States

Spark Sets Sights On Bringing First Gene Therapy To Market In 2018

A BLA for a potential gene therapy to correct vision loss due to certain inherited retinal disease has been accepted by FDA with a Jan. 12 PDUFA date. The proposed trade name is Luxturna.

Drug Review Pricing Strategies

Generic Drug Market Has Gaps, FDA Tells Firms In Solicitation For ANDAs

US agency unveils plans to speed reviews of generic applications in areas with limited competition and offers a list of potential targets, but threat to brands may be limited.

Pricing Debate FDA

Mehta Analysis: Shaming Biopharma Managers

Shame has historically been used as an effective tool in bringing about a change in pricing policy within an industry. But could it be wielded against the pharma industry today? Viren Mehta, founding partner of Mehta Partners, LLC, considers.

Pricing Debate United States

Novo Readies For Victoza CV Benefit Claim With US FDA Panel Nod

HeartofType2 unbranded campaign is aimed at increasing awareness of CV disease in type 2 diabetics. FDA advisory committee strongly endorses new claim for the GLP-1 agonist but recommends limiting it to diabetics with established CV or chronic kidney disease.

Advisory Committees Advertising, Marketing & Sales

Generic Manufacturers Try To Up Their Game As US Pressure Persists

With US generic drug price erosion running at double digits, 2017 is expected to be a challenging year for the generic drug sector. Manufacturers are looking increasingly to complex generics, injectables and biosimilars as an offset, but it's unclear if wins in those areas will be enough to bridge the growth divide.

Generic Drugs Business Strategies

Will Epoetin Biosimilar Serve As Non-Medical Switching Case Study?

Analysts expect potential broad uptake of biosimilars in chronic kidney disease treated at dialysis centers, which could lead to patients being switched off Amgen's Epogen.

Biosimilars Advisory Committees
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