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Regional Coverage

Asia Pacific

Set Alert for Asia Pacific

Latest From Asia Pacific

Cipla Cuts Down In-House Biosimilars Plans

Cipla is recalibrating investments in the “resource-intensive” biosimilars business, reinforcing its thrust on the respiratory and specialty products segment. Large biosimilar manufacturing plans in South Africa have been put on hold, with curtains seemingly coming down at an Indian unit.

Commercial Strategy

US Price Pressure Clouds Lupin Outlook – Can Its Pipeline Deliver?

Lupin reported a sharp decline in its fourth quarter profits, dented by heightened price pressure and competition in the US for its key products. The management sees a ‘challenging’ 2018, but underscored the strength of the firm’s ANDA pipeline and enhanced investments in the biosimilars, inhalation and injectables space.

Commercial Strategy

Shanghai Henilus Biotech Has Blockbuster Biologics In Biosimilars Crosshairs

Dr. Cheni Kwok, a business development and strategy consultant, caught up with Scrip’s Mike Ward to outline how Shanghai Henilus Biotech is positioning itself to provide affordable healthcare globally.

Asia Pacific Biosimilars

Come Flood Or High Water – How BioNet Is Shaping Its Vaccine Ambitions

Emerging Company Profile: Thailand-based BioNet stuck it out despite widespread flooding at its site and now expects to take its pertussis vaccine to key Western markets.

StartUps and SMEs Vaccines

Dr Reddy’s Gears Biologics Expansion With GE Platform

Dr Reddy’s Laboratories hopes GE Healthcare’s FlexFactory biomanufacturing platform can deliver multiple operational gains, including a potentially more fail-safe compliance system at its site. The Indian company expects to roll out its first biosimilar MAb from the new set-up next year.

Commercial Companies

Lilly-Lupin Bolster India Alliance But Cialis Faces Crowded Market

Eli Lilly and Lupin are building on their alliance in India, with Lupin introducing Lilly’s Cialis (tadalafil) – a teeming market awaits the product, however.

Commercial Generic Drugs
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Europe

Set Alert for Europe

Latest From Europe

‘Excessive Pricing’ Inquiry Widens As EC’s First Antitrust Price Probe Targets Aspen Pharma

The litany of complaints against pharmaceutical companies for imposing “excessive” prices on generic drugs is growing after the European Commission decided to pursue Aspen Pharma over price rises imposed on a range of anticancer products it acquired from GSK.

Europe Generic Drugs

‘World First’ CCHF Vaccine To Invigorate Turkey’s Vaccine Ambitions?

Turkey’s health ministry has disclosed that a local university is close to successfully developing what it believes is the world’s first vaccine against Crimean-Congo hemorrhagic fever, under a 2015 collaboration with the Cuban government. But other efforts to build domestic vaccine production capacity are largely stalled over tender concerns.

Vaccines Turkey

Sarilumab Set To Clear EU Hurdle In RA But Actemra Specter Remains

While Sanofi/Regeneron's sarilumab is set to be the first of the newer IL-6 products to be cleared for rheumatoid arthritis treatment in Europe and the US, its commercial success is under doubt with physicians trying anti-TNF treatments first, followed by Roche's established IL-6 drug Actemra (tocilizumab).

Inflammation Drug Review

BioMarin Could Launch Brineura Concurrently In US And Europe

The EU’s top advisory panel, the CHMP, has given a green light to BioMarin’s late-infantile Batten disease therapy, Brineura, one of the first therapies for the ultra-rare and fatal disease, a decision that comes just days before a US FDA decision is expected on the replacement enzyme therapy.

Advisory Committees Approvals

Pfizer Gets First Regulatory Nod For Besponsa

Pfizer's acute lymphocytic leukemia therapy Besponsa has received a positive recommendation in Europe, which should lead to the drug's first approval worldwide and will add to the high expectations for its regulatory outcome in the US later this year.

Approvals Policy & Regulation

Turkish Industry Group Builds New Platform To Support Biotech

A major local pharmaceutical industry group in Turkey is leading the formation of a new biotechnology platform that will focus on lobbying the government to create a more friendly investment environment, and promote joint projects and training. Given ongoing official moves to attract investments in the pharma and biotech field, the initiative appears to align well with broader existing policies.

Turkey Biologics
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United States

Set Alert for United States

Latest From United States

US Price Pressure Clouds Lupin Outlook – Can Its Pipeline Deliver?

Lupin reported a sharp decline in its fourth quarter profits, dented by heightened price pressure and competition in the US for its key products. The management sees a ‘challenging’ 2018, but underscored the strength of the firm’s ANDA pipeline and enhanced investments in the biosimilars, inhalation and injectables space.

Commercial Strategy

Contrave Rxs Jump In Q1, But TV Commercial Runs Afoul Of FDA

Orexigen touts 39% growth in US sales of its obesity drug; agency objects to advertisement for excluding risk information.

FDA Advertising, Marketing & Sales

Mehta Analysis: Biopharma's 10% Myth

Viren Mehta, founder of Mehta Partners, LLC, considers the oft-repeated statement that the cost of drugs represents only 10% of US healthcare expenditure. Does it matter that the figure excludes a large and growing segment of medicine spending?

United States Pricing Debate

Drug Promotion: FDA Loosens Reins But Industry Wants More Room To Run

Agency proposes a safe harbor for certain communications with payers about approved uses and investigational drugs, but drug manufacturers ask the US agency to expressly protect from enforcement manufacturer communications about off-label uses.

Advertising, Marketing & Sales Reimbursement

More Pressure On Pradaxa? US Payers May Narrow Coverage Of NOACs

US payers may increasingly look to leverage the competition among the novel oral anticoagulants by contracting for preferred coverage with two of the leading drugs in the field, rather than all three.

Research & Development Reimbursement

Glenmark Chief Bullish Despite Generic Zetia's Poor US Start

Glenmark Pharmaceuticals reported overall growth in the fourth quarter of 2016-17, but investors bludgeoned the company’s shares on concerns around the slow traction of generic Zetia in the US and a sharp decline in earnings on a sequential basis.

Sales & Earnings Generic Drugs
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