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'Potential Blockbuster' Dupixent Set For EU Eczema OK

While Dupixent looks set for use in Europe for treating moderate-to-severe atopic dermatitis, analysts believe the biologic has a great future in other indications and could eventually become a blockbuster.

Approvals Biologics Commercial

Merck KGaA/Pfizer's Bavencio Set To Enter Europe's Crowded I-O Market

The highly-competitive PD-1 field in Europe is very likely to have a new player as Bavencio gets a CHMP recommendation for Merkel cell carcinoma, but the success of Merck KGaA and Pfizer's checkpoint inhibitor will be gauged on how it competes with the competition already on the market in wider, more valuable indications.

Cancer ImmunoOncology Approvals

Roche's Tecentriq Gets The Double At The EU CHMP

Roche's checkpoint inhibitor Tecentriq clears the EU approval hurdle in locally advanced or metastatic urothelial carcinoma and locally advanced or metastatic non-small cell lung cancer.

Approvals Policy & Regulation ImmunoOncology

Pipeline Watch: Phase III Starts For Itacitinib And AXS-05

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Pipeline Watch Approvals Research & Development

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Commercial Explore this Topic

2Q Pharma Results Preview: Lilly, Biogen, Amgen, GSK And Gilead

Part two of Scrip's preview of first quarter earnings: product launches, management priorities, pricing strategies and biosimilar competition are key themes at the half-year mark.

Sales & Earnings Business Strategies Commercial

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 Commercial

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

Finance Watch Public Company Edition: Akcea, Kala Launch IPOs While FOPOs Keep Busy Pace

Kala follows July's first biopharma IPO from Ionis spinout Akcea into the stock market. Amicus, Arena and othera go high with major offerings, while Inovio and Regulus go low. Also, Galena, Neothetics provide updates on their hunts for "strategic alternatives."

Financing Business Strategies

Ironwood Hits Endpoints In GERD, But Analysts Unimpressed With Treatment Effect

The GI specialty firm hopes it has a future blockbuster with the bile acid sequestrant after hitting multiple endpoints in Phase IIb, but the treatment effect compared to PPI therapy alone was below what was previously anticipated.

Clinical Trials Gastrointestinal

Finance Watch VC Edition: Biopharma Venture Investment Rises In Second Quarter

Venture capital investment in biopharmaceutical firms for the first half of 2017 show that this year is on track to exceed 2016 levels. Recent financings include two $50m Series C rounds for two different companies developing later-stage drugs for itching: Trevi and Menlo Therapeutics.

Financing Business Strategies

Merck's Lantus Copy Lusduna Poised For US Market Pending Litigation

The Merck and Samsung Bioepis formulation of Sanofi's insulin glargine was tentatively approved by FDA, a designation that permits the drug to enter the market pending the resolution of ongoing patent litigation.

Biosimilars Approvals

Indian Tax Turbulence Dents Alembic In Q1 - Portends Industry Trend?

Alembic Pharmaceuticals’ first quarter earnings were weighed down by transitional disturbances pertaining to India’s new goods and services tax (GST) regime, potentially signaling an industry-wide trend, although likely temporary.

Companies Commercial

Policy & Regulation Explore this Topic

Radius's Tymlos Dawdles At CHMP, No EU Opinion Yet

Radius Health has a new CEO, but the company's path to the EU market for its novel osteoporosis therapy Tymlos looks still subject to questions at this week's meeting of the European Medicines Agency’s CHMP.

Companies Regulation Policy & Regulation

Merck's Lantus Copy Lusduna Poised For US Market Pending Litigation

The Merck and Samsung Bioepis formulation of Sanofi's insulin glargine was tentatively approved by FDA, a designation that permits the drug to enter the market pending the resolution of ongoing patent litigation.

Biosimilars Approvals

J&J's Quad HIV Combo Likely To Pass CHMP; EU Market Uptake Is Trickier

Johnson & Johnson's quadruple HIV combination is likely to win a positive recommendation for approval in Europe this week – but clever positioning will be required to secure strong uptake for the combination considering its late entry onto a competitive market place.

Approvals Regulation

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

Research & Development Explore this Topic

UCB's Bimekizumab Could Struggle With Saturated Psoriasis Market

UCB's has reported strong Phase IIb data for its novel psoriasis therapy bimekizumab, but the drug is unlikely to launch before 2022 and is at risk of being redundant on a crowded market.

Clinical Trials Immune Disorders Business Strategies