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Policy & Regulation

Ocrevus Delay As CHMP Continues Assessment?

The CHMP's assessment of Roche's novel multiple sclerosis therapy Ocrevus continues, making a year-end approval unlikely.

Companies Approvals Neurology

Samsung Bioepis’s Biosimilar Trastuzumab First To Take On Roche’s Herceptin In EU

Samsung Bioepis’s Ontruzant is likely to be the first biosimilar to take on Roche’s Herceptin in the EU market after it was recommended for marketing authorization by the EMA’s CHMP on Sept 15.

Biosimilars Approvals Europe


Set Alert for Policy

Latest From Policy

Policy Prescriptions: Kite's CAR-T; Price And Value Scrutiny; Biosimilars; Manufacturing Missteps

Kite's CAR-T application seems to be sailing ahead without US FDA AdComm review; large employers in the US look into value-based contracting while European regulators band together on joint price negotiations; Teva is back at FDA with its EpiPen application. Policy Prescriptions rounds up recent regulatory news and trends reported by sister publication the Pink Sheet.

Reimbursement Advisory Committees

Policy Prescriptions: User Fees, EMA Worries, PBM Strategies, PRIME Milestones

The US has plenty of new pharma legislation, Europe has plenty of worries about EMA's Brexit move, pharmacy benefit managers give plenty more scrutiny to which products earn a place on formulary. Policy Prescriptions rounds up recent regulatory news and trends reported by sister publication the Pink Sheet.

Pharmacy Benefit Management Drug Review

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
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Set Alert for Regulation

Latest From Regulation

Nabriva's Antibiotic Lefamulin Does Well In First Of Two Pivotal Trials

Results from the first Phase III study – LEAP 1 – of the antibiotic lefamulin are positive, and Nabriva still has one trial to go. But the firm believes that regardless of that result, the totality of data could be used to support regulatory filings.

Infectious Diseases Drug Approval Standards

Fosun Tweaks Gland Deal Amid Limbo In India

China’s Fosun group isn’t backing off from its $1bn-plus buyout of Gland Pharma and will now pursue a tweaked version of the original deal that technically qualifies for automatic approval under Indian rules. Whether that means smooth sailing hereon remains unclear.

Commercial Deals

Bayer's Aliqopa Approval Gives PI3K Class A Second Chance in Follicular Lymphoma

Bayer's PI3 kinase inhibitor copanlisib now has accelerated approval in a common type of non-Hodgkin lymphoma, but the drug's competitive profile still awaits Phase III data.

Cancer Approvals

GSK's COPD Triple Combo To Challenge Chiesi's Trimbow In EU

GSK's closed triple combination for COPD, Trelegy, is expected to get a green light for approval in Europe on Friday – but the product will be fighting for market share against Chiesi's triple combination Trimbow, which has a head start.

Approvals Regulation

Novo Nordisk Settles Over US Federal Investigation Of Marketing Practices

Novo Nordisk has settled with the US Federal government over claims it did not comply with communicating safety information on its diabetes drug Victoza.

Legal Issues Companies

Manufacturing Snag May Stall Portola's Bevyxxa Launch

Company has priced its Factor Xa anticoagulant at $15 per capsule, on par with competitors, and is gearing up for a launch, but it first must resolve manufacturing issues with FDA as it scales up to commercial capacity.

Approvals Regulation
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