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Policy & Regulation

Amgen's US Biosimilar Launches Are Off To A Steady Start, With A Big Coverage Decision

United HealthCare agreed to cover Mvasi and Kanjinti in a preferred position. Amgen VP-oncology sales & marketing Susan Logan talked to Scrip about the company's first US biosimilar launches.

Biosimilars Launches Market Access

Sarepta Surprised By CRL For Exon 53-Skipping DMD Drug Golodirsen

The US FDA issued a complete response letter rejecting golodirsen based on risk of infection at intravenous infusion ports and preclinical renal toxicity.

Complete Response Letters Drug Safety Rare Diseases
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Policy

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Latest From Policy

In Search Of Goodwill, Several Pharmas Commit To New Corporate ‘Statement Of Purpose’

The updated business principles may give pharma companies leverage, or at least talking points, as they continue to engage with the Trump administration on policies like the International Pricing Index and with US lawmakers on drug pricing legislation. J&J's Gorsky heads governing committee of multi-industry business group that revised its principles.

Pricing Debate Policy

Pharma Execs Say Senate Drug Pricing Bill Targets Industry, Not The Problem

Industry CEOs expressed reservations about the US drug pricing legislation in the Senate, but said they support reforms that will impact patient affordability, during Q2 calls. 

Pricing Debate Policy

Real-World Reluctance? Despite Guidance, Drug Developers Wary Of RWE-Based Trials

Biopharma companies are reluctant to rely on real-world evidence trials, but while uncertainty remains about how these novel studies will be accepted, US and other regulators are encouraging drug developers to take a chance – and some have taken on the challenge.

Clinical Trials Research and Development Strategies

UK’s O’Neill ‘Frustrated’ By G20’s ‘Paltry’ AMR Message

Jim O’Neill, the British economist who helped put the dangers of antimicrobial resistance firmly on the world stage, says he’s “frustrated” by the G20’s lack of focus on AMR during its Japan summit.

International Policy

Bruised Over Humira Patent Games, AbbVie Sees Smoother Road With Botox

AbbVie’s proposed acquisition of Allergan unites two companies that have gained notoriety for their exhaustive and unconventional efforts, respectively, to extend the patents of key products.

Pricing Strategies Intellectual Property

Bring Them On: China Releases Generics List To Encourage Competition

China's National Health Commission issues list of 34 generic drugs that have 'insufficient' competition, seeking public comments.

China Generic Drugs
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Regulation

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Latest From Regulation

NICE Head Sir Andrew Dillon To Stand Down

Sir Andrew Dillon is leaving his role as CEO of England’s health technology assessment body after 20 years.

United Kingdom Health Technology Assessment

Nabriva Faces Skepticism After Years Of Preparing For Novel Antibiotic Xenleta's Launch

Lefamulin was approved in the US to treat community-acquired bacterial pneumonia, providing a needed IV and oral drug initially in the hospital setting, but new antibiotics have been a tough sell.

Infectious Diseases Approvals

Vanda Not Ready To Give Up On Jet Lag Indication For Hetlioz Despite CRL

Complete response letter follows July deficiencies letter that made approval seem highly unlikely. Vanda called the setback perplexing and said it plans to continue working to get jet lag disorder added to the Hetlioz label.

Commercial Life Cycle Management

AbbVie’s Post-Humira Strategy Continues Taking Shape With Rinvoq Approval

AbbVie now has both of its Humira successors approved in the US, following April’s Skyrizi approval for psoriasis. But Rinvoq faces stiff competition both within the JAK1 class and in rheumatoid arthritis generally.

Approvals Business Strategies

Europe's Biotechs Gathering Steam With Filgotinib Filing

Galapagos is another step closer to commercializing its products with its lead candidate, filgotinib, now under the gaze of EU regulators.

Approvals Inflammation

Gilead’s Marketing Of Descovy For HIV Prevention Should Not Suggest Superiority To Truvada

US FDA advisory committee members urge agency to hold a firm line against labeling, promotional or educational materials that suggest Descovy has better efficacy or is safer than Truvada, which will face generic competition in 2020. Panel backs HIV pre-exposure prophylaxis indication for Descovy but recommends excluding cisgender women due to lack of clinical efficacy data.

Advisory Committees Advertising, Marketing & Sales
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