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Policy & Regulation

Billions At Stake As Generic Approvals Open Up Japan Big Sellers

Japan has approved a new batch of first-time and other generic drugs that will be reimbursed and launched in June, putting at risk several billion dollars’ worth of combined sales of some major branded products.

Generic Drugs Japan Policy & Regulation

NICE Move On Cabometyx Gives BMS Longer To Make Opdivo Case In Second Line RCC

A NICE knock-back for Ipsen's Cabometyx in renal cell carcinoma (RCC) means less pressure on BMS's embattled Opdivo, but not for long if Ipsen is willing to compromise on price, warn analysts.

Reimbursement Commercial Cancer
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Policy

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Latest From Policy

Rosalind Franklin Institute May Calm Industry’s Brexit Fears

The setting up of the Rosalind Franklin Institute to link up with one of the world’s largest electron microscopy centers in Harwell, Oxford, could bolster company sentiment towards UK R&D investment in a post-Brexit world.

Innovation Policy

Pharma Earnings Calls Reveal US/EU Trump Divide

Less than a month after his inauguration, President Donald Trump has both unnerved and empowered industry sectors with his immediate actions or divulged potential reforms. Execs offered measured reaction and some speculation during recent earnings calls.

Policy US Election 2016

Turkish Govt Using Purchasing To Foster Local Generic Production

Facing difficulties in attracting greenfield pharma investments in the production of original and high-tech drugs, the Turkish Government is leveraging its purchasing power for generics to encourage local manufacture in this sector. Faced with the threat of exclusion from reimbursement, some multinationals are now building up their capacity in the country.

Turkey Manufacturing

Need To Redefine Recipe For Success In Korean Biotech?

In South Korea, success and failure in the bioventure sector seems to be measured differently to elsewhere, while other legal and investment hurdles remain, and some experts are now pointing to the need for change if the industry is to move on to the next phase.

South Korea Financing

Big Pharma Subdued In Its Response To Trump's Travel EO

Big pharma has been muted in its response to President Trump's executive order imposing severe travel restrictions on nationals from seven Muslim-majority countries for 90 days. Small biotech, however, has no reservations about speaking out against the so-called 'immigration ban'.

Companies Leadership

2017 Preview: Give And Take Marks Mixed Japan, Korea Outlook

As much of Asia celebrates the Lunar New Year holidays, the pharma sector in Japan and South Korea is looking ahead to the Year of the Rooster with a mixture of uncertainty and hope, providing the industry with much to crow about either in support or opposition.

Japan South Korea
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Regulation

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Latest From Regulation

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

Parsabiv Could Allow Amgen To Maintain Control Of Calcimimetics Market

Amgen's oral calcimimetic Sensipar faces generic competition in 2018, but the new intravenuous Parsabiv has advantages that could make it the more popular alternative.

Reimbursement Approvals

Marathon's High-Priced Window May Not Stay Open Long

Ongoing trial is intended to compare the newly approved steroid Emflaza with prednisone in DMD for efficacy and safety.

Approvals Launches

Amid Pricing Criticism, Marathon 'Pausing' Emflaza Launch

Company plans to meet with caregivers and consider other options before moving forward.

Pricing Strategies Approvals

Marathon Gets Long-Known Duchenne Treatment On-Label, But Will Payers Respond?

Steroid treatment like Emflaza is considered standard of care and availability of other products may make payer discussions difficult.

Approvals Rare Diseases

Pressure On Tecentriq: Bladder Cancer Heats Up With Opdivo Approval, Keytruda Filing

Merck's filings in bladder cancer span first-line and second-line treatment and include overall survival data. Roche also is getting ready to move Tecentriq to the frontline setting.

ImmunoOncology Cancer
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