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Policy & Regulation

BMS Gets US Approval Of Ozanimod For Relapsing MS, But Launch Delayed

Zeposia, one of three Celgene candidates central to last year’s merger with BMS, obtains US FDA approval in relapsing MS. BMS, however, will delay the launch due to the COVID-19 pandemic.

Approvals Business Strategies Research and Development Strategies

China 'No' For Celgene's Paclitaxel A Major Blow To BeiGene

After winning a major procurement contract, BeiGene now may need to find an alternative manufacturing site for  Celgene's Abraxane to supply China.

Manufacturing Compliance China

Policy

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Amgen Sees A Vibrant Biosimilars Market As Its Business Pushes Into Blockbuster Territory

Biosimilar executives Leah Christl and Chad Pettit see reasons for optimism in the US market as new launches and sales begin to add up. Amgen’s portfolio is annualizing at $1bn as of the fourth quarter.

Biosimilars Business Strategies

Both US List And Net Drug Price Increases Have Been Substantial, JAMA Study Finds

A new study looks at list drug price increases and manufacturer discounts over 11 years and finds that despite significant rebates, net price increases still grew 3.5 times more than inflation.

Pricing Debate Policy

How The Coronavirus Could Bolster Innovation Arguments Against US Price Controls

The Trump administration does not believe its partnership with industry on therapeutics for COVID-19 should include conditions on pricing, US Health Secretary Alex Azar tells Congress.

Vaccines Pricing Debate

Indian Pharma Monitoring Coronavirus Fallout On Production

With several Chinese manufacturing facilities shut at least till 10 February, Indian pharma companies are keeping a close watch on the evolving coronavirus situation. API inventory can last for a while, but if intermediates supplies don’t resume soon the fallout could be grim.

Commercial Manufacturing

Biogen's Tecfidera Safe Following IPR Decision – For Now

Tecfidera accounts for nearly one-third of Biogen's revenues, so the patent decision relieves one overhang for the company. However, other ANDA challenges are ongoing.

Intellectual Property Legal Issues

NICE Rejects Janssen’s Treatment-Resistant Depression Drug Spravato

Draft guidance questions lack of evidence comparing new nasal treatment with older therapies.

United Kingdom Neurology
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Regulation

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Novartis Close To EU Approval For Zolgensma At Last

Novartis’s AveXis unit has received a CHMP nod for the spinal muscular atrophy gene therapy at its latest meeting, sending it on the final steps to market in the EU.

Approvals Companies

UK Experimental AMR Payment Program “On Track”

Designers of the UK’s experimental antibiotic payment system aim to identify two drugs later this year which will then undergo a novel technology assessment in 2021.

Market Access Infectious Diseases

'Get Your Skates On', UK Firms Planning M&A Warned

UK pharma groups planning M&A deals ‘must get their skates on’ and begin filing now if they want to benefit from the EU’s review process before the Brexit transition period ends on 31 December.

Companies Regulation

Could Postponement of Intercept’s Expected NASH Panel Impact Its PDUFA Date?

CDER’s postponing of meetings planned through the end of April likely means a later advisory committee date to review OCA in NASH. The US PDUFA date previously was pushed back to late June.

Advisory Committees Drug Approval Standards

Stockwatch: Lax Approval Requirements Yield Blockbusters That Don’t Work

With the backdrop of Biogen’s BLA filing, and the FDA’s expected response for aducanumab in Alzheimer’s disease in 2020, the link between efficacy and approval seems to have broken. Conditional FDA approvals can’t help when the conditions are ignored.

Stockwatch Clinical Trials

Interview: Acacia Seeks Access All Areas For PONV Drug Barhemsys

Acacia's bids to get the thumbs-up in the US for its post-operative nausea and vomiting therapy have finally borne fruit. CEO Mile Bolinder tells Scrip that his experienced team is now firmly focused on gaining as many hospital formulary approvals as possible for Barhemsys.

Market Access Approvals
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