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Policy & Regulation

Teva 'Pay-For-Delay Case Will Keep Courts Busy For Years'

Once again the European Commission has the marketing practices of the pharmaceutical industry in its sights, with Teva the latest company in the spotlight for an alleged 'pay-for-delay' agreement over the sleep disorder drug modafinil.

Legal Issues Generic Drugs Intellectual Property

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 Cancer
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Policy

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Latest From Policy

Hack Attack: Biopharma Cyber Chiefs Fight Back

News that Merck & Co was affected by the recent global ransomware attack hits home the increasing importance of cybersecurity. In Vivo recently hosted a roundtable of information security officers on how to prepare for the growing threat of cyber attack.

Business Strategies Companies

Biopharma Largely Avoids Partisan Bloodbath At US Pricing Hearing

Democrats spent most of their time complaining about Senate Republicans' closed-door process for developing healthcare legislation, leaving little time for the expert witnesses to weigh in on drug pricing.

Pricing Debate Reimbursement

Firms Commit To Local Production As Turkey Seeks Import Cuts

The Turkish government’s drive to increase the local production of medicines has begun to yield results, with companies so far committing to shift over $500m in sales to domestic manufacture, as the country plans to cut around $685m from its drug imports bill in the first year of the program.

Turkey Policy

Dragon Tamer: New Models Needed To Capture China Opportunities

As China enacts reforms to open up to novel drugs, companies must rapidly change their approaches and adopt new business models to seize the window of opportunity, industry insiders tell a recent partnering event in the country.

China Research and Development Strategies

Bayer's Weinand On Broadening Value-Based Pricing Views

Bayer's pharma head Dieter Weinand talks about his biggest issues with current value-based pricing assessments for new drugs and how companion diagnostics will pave the way to easier pricing of oncology therapies.

Pricing Strategies Reimbursement

Scrip Asks… Is The Biosimilar Cost-Saving Theory Sustainable?

Scrip asks industry whether the promise of biosimilars producing substantial cost-savings is a sustainable model to help healthcare systems afford the next wave of expensive biologics. Drug developers and trade associations comment on the caveats still in play when it comes to biosimilars, cost-cutting and market access.

Biosimilars Market Access
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Regulation

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Latest From Regulation

J&J's Symtuza Will Debut In Europe On Cramped HIV Market

Johnson & Johnson's combination HIV therapy Symtuza has secured a greenlight in Europe, marking its first approval worldwide – but will the big pharma be able to catch up with successful HIV opponents from AbbVie and Gilead?

Infectious Diseases Approvals

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

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

Novartis Content With CAR-T Manufacturing Ahead Of Crucial FDA Panel

As crunch time approaches with its eagerly-anticipated CAR-T advisory meeting with FDA advisors on Wednesday, Novartis has been looking to allay fears about the manufacturing of CTL019.

Companies Deals

Ipsen Promotes UK Business; Kidney Cancer Drug Gets NICE Nod

Ipsen's VP of commercial operations for the UK and Ireland outlines how the French company will use managed access programs to get drugs reimbursed on the NHS and describes Ipsen's plans for growth and greater investment in the UK, despite Brexit uncertainties.

Business Strategies Brexit

Antibiotics Pipeline Is Lively, But Sponsors Are Fragile

Regulatory uncertainty could imperil the crop of emerging companies making a go of it in the incentive-laden US anti-infective space.

Infectious Diseases Clinical Trials
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