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Policy & Regulation

No Love From US: Senate Bill Deals Blow To Aspiring China Biotechs

In a bipartisan move, the US Senate is moving to impose new rules on companies - including those from China - seeking US initial public offerings, adding further uncertainty over such plans and further stoking trade tensions.

Policy & Regulation Financing China

Intercept’s NASH Approval Timeline Shuffled Again With FDA Delay

The company said a planned 9 June advisory committee to review the NDA for obeticholic acid in NASH has been postponed a second time, which means OCA likely will not be approved by 26 June.

Drug Approval Standards Advisory Committees Liver & Hepatic

Policy

Set Alert for Policy

Latest From Policy

BIO’s New CEO, Michelle McMurry-Heath, Aims To ‘Change The Dialogue’ Around Science

Former senior leader in J&J’s medical devices business will take over the reins from Jim Greenwood in June; an immunologist by training, McMurry-Heath brings a resume that is long on scientific, regulatory and corporate experience, but she also has some political qualifications under her belt.

Policy Leadership

Coronavirus Update: Moderna Scales Up Manufacturing, Sosei Looks To Structure-Based Design, Taking Stock Of India’s Lockdown

Moderna details plans on how it will make enough of its coronavirus vaccine, and Sosei is using structure-based design technology to target a SARS-CoV-2 non-strucural protein. Meanwhile, the industry in India faces up to lockdown. 

Coronavirus COVID-19 Companies

Amarin's Vascepa May Face Generic Competition In US Next Year After Patents Ruled Invalid

Amarin had argued that Vascepa’s sales success showed that its patents were not obvious, but the court found otherwise, even as it concluded that Hikma, Dr. Reddy's and West-Ward has infringed on the fish oil pill's patents.

Legal Issues Intellectual Property

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
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Regulation

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Latest From Regulation

Amivas Bests La Jolla In Race For US Approval Of Antimalarial Artesunate

La Jolla’s formulation appears blocked by Amivas’ seven-year orphan exclusivity, and the company also will miss out on chance for a tropical disease priority review voucher;  Amivas worked with the US Army to bring the severe malaria treatment through final stages of development and regulatory review.

Approvals Rare Diseases

Coronavirus Update: Sinovac Gets $15m Towards CoronaVac Phase II, Remdesivir Early Access In UK

Multiple vaccine and drug developers across the world report progress and partnerships amid volatility in their shares. 

Coronavirus COVID-19 BioPharmaceutical

US Medicare Insulin Demo Could Expand To Other Drugs

Eighty-eight insurers who offer Medicare Part D plans are interested in the demonstration project, which would limit insulin copays to $35.

Medicare Pricing Debate

Kancera Targets COVID-19 With Fractalkine Inhibitor

Sweden-based Kancera hopes to advance its investigative anti-inflammation drug in a Phase II trial to treat severe COVID-19 patients and then build its applications from there.

Clinical Trials Companies

Roche's Tecentriq Notches Approval For First-Line NSCLC Monotherapy

The company is getting more attention these days for its TIGIT inhibitor tiragolumab in combination with Tecentriq for 1L NSCLC, but a new 1L monotherapy indication for Tecentriq helps it compete against Keytruda. 

Approvals ImmunoOncology

Clovis’s Rubraca Is First PARP For Prostate Cancer, But AZ’s Lynparza Coming Soon

The limitations of launching during the pandemic will make it difficult to capitalize on a short window between the approvals.

Approvals Launches
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