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Policy & Regulation

Hope For Price Flexibility After India Pretomanid Go-Ahead

Mylan gets approval in India for pretomanid as part of a combination regimen with bedaquiline and linezolid, providing new hope to patients with drug-resistant tuberculosis. Volume changes may provide opportunities to tweak prices.

Policy & Regulation India Approvals

Policy

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IQVIA: US Out-Of-Pocket Drug Costs Stable, But Overall Spending Is Higher

New report shows average out-of-pocket cost per prescription of $10.67 in 2019 was unchanged from 2018. But while the number of dispensed drugs barely increased, sales jumped more than 5%.

Pricing Debate Pricing Strategies

Sanofi/GSK Working With The US To Increase COVID-19 Vaccine Capacity

The $2.1bn investment under the US’ Operation Warp Speed will fund development, scale-up of US manufacturing and the first 100 million doses. 

Coronavirus COVID-19 Vaccines

Coronavirus Update: Warp Speed Companies Grilled On Vaccine Safety, Price And Timelines

House committee seeks reassurances on a range of issues, including the security of a US vaccines supply chain against a background of rising tensions with China.

Coronavirus COVID-19 Policy

Coronavirus Update: Vaccine Companies To Update Lawmakers As Crisis Deepens In US

Executives from Moderna, Pfizer and AstraZeneca and others will give politicians in Washington DC an update on the progress of their vaccine - but will resist pressure to make promises of a breakthrough in 2020.

Coronavirus COVID-19 Policy

UK Is First To Sign Up Pfizer For COVID-19 Vaccine, AstraZeneca For Antibodies

The UK's vaccine strategy spread its bets over three candidates so far, as the country also looks to prove its world-class status in life sciences research and manufacturing.

Coronavirus COVID-19 United Kingdom

Big Pharma’s $1Bn Antibiotic Development Fund Offers ‘Breathing Room’ For Reimbursement Fix

Companies developing antibiotics to get financial and technical support from more than 20 firms contributing to new AMR Action Fund. Initiative is also pushing for reimbursement reform and other policies to support commercial marketing.

Infectious Diseases Reimbursement
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Regulation

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Roche’s Evrysdi Approved For SMA, Priced Below Competitors

Risdiplam’s efficacy across two clinical trials and oral dosing made it a credible threat before its US FDA approval, but its weight-based pricing falls below Biogen’s Spinraza and Novartis’s Zolgensma. 

Approvals Launches

Morphosys/Incyte’s Monjuvi Wins Early US FDA Approval In Second-Line DLBCL

Monjuvi’s good efficacy and safety profile should enable its broad adoption in the second line DLBCL space and help it compete well against rival CAR-T therapies, analysts said.

Approvals Cancer

Gilead/Kite Gain Second CAR-T Approval With Tecartus, Price On Par With Their First

As the first company with two approved chimeric antigen receptor T-cell therapies, Gilead’s Kite subsidiary has set a precedent by keeping the pricing the same as its first approved CAR-T, Yescarta. 

Approvals ImmunoOncology

Acadia Hit By Two Surprise Disappointments With Nuplazid

A couple of unexpected events for pimavanserin mean that Acadia will drop its development for major depressive disorder and have to wait a little longer to hear if it can launch the product for dementia-related psychosis, a large potential indication.

Clinical Trials Companies

Biogen/Eisai Hit ‘Send’ On High Stakes BLA For Aducanumab In Alzheimer’s Disease

Some analysts see a 50-50 chance of US FDA approval despite the controversial dataset for the anti-amyloid antibody, but at least one expects an eventual CRL requesting a third Phase III trial.

FDA Neurology

US Approval For ViiV’s ‘Last Resort’ HIV Drug Rukobia

The US FDA has given the go-ahead for marketing of ViiV healthcare’s novel HIV drug just as the EMA removes the accelerated assessment status from its application there.

Approvals Infectious Diseases
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