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AstraZeneca's Imfinzi/Tremelimumab Combo Conquers HIMALAYA

After the combination's success in the non-small cell lung cancer POSEIDON study, AstraZeneca's Imfinzi and tremelimumab could now be on the way to approval as a first-line treatment for hepatocellular carcinoma.

Liver & Hepatic Clinical Trials ImmunoOncology

The Next Big Thing In Gene Therapy Might Not Be Gene Therapy

Gene therapy remains attractive when data show new technologies can advance the field, but gene regulation, editing and RNA therapies are grabbing investors’ attention, panelists said at ARM’s Cell and Gene Meeting on the Mesa.

Gene Therapy Financing Innovation

Pfizer Testing Warranty Offer With Xalkori, May Expand It To ‘Multiple’ Products

Company seeks to avoid Medicaid “best price” implications by administering the program through an insurance policy with AIG, which is handling claims for refunds and processing payments.

Commercial Advertising, Marketing & Sales Value-Added Medicines

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Breast Cancer Trial Enrollment Illustrates Diversity Challenge

INFOGRAPHIC: Data on industry-sponsored breast cancer studies posted on ClinicalTrials.gov shows how much work remains for drug makers to ensure their studies enroll diverse populations.

Diversity & Inclusion Clinical Trials

Alzheimer’s Disease: Many Failures Before One Success

For Biogen/Eisai’s success with Aduhelm, there were 93 failures in the anti-amyloid field. Scrip took a look back at how the pipeline for amyloid-targeting Alzheimer’s drugs progressed over roughly the past decade to showcase exactly how difficult the Alzheimer’s space has been. 

Approvals Clinical Trials

Titans Of Pharma 2021: J&J’s Gorsky Tops Big Pharma Remuneration

INFOGRAPHIC: A snapshot of the compensation packages of CEOs and R&D leaders of the world’s biggest pharmaceutical companies, alongside median employee pay and key company performance metrics.

Leadership Strategy

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Gilead Sees Room For Trodelvy In European Markets

Gilead looks set to expand its lead position in the triple-negative breast cancer (TNBC) market in Europe with a positive opinion for Trodelvy from the CHMP.

Market Access Business Strategies

Can Sarepta Beat Pfizer To A Duchenne Gene Therapy Breakthrough?

As rival Phase III gene therapy trials get underway, Sarepta’s product could have the edge in safety and efficacy over its rival from Pfizer, but the chance of failure remains high.

Companies Gene Therapy

BeiGene/BMS Parting Abraxane Ways As China Supply Woes Continue

The latest development over the licensing arrangement for the anticancer drug may deal a further blow to BeiGene’s oncology commercial efforts in China.

China Commercial

US Vs. EU: Is Cell And Gene Therapy Reimbursement Easier Stateside?

A bluebird executive spoke during ARM’s Cell and Gene Meeting On The Mesa about why the firm pulled Zynteglo out of the EU, but while progress has been made in the US, long-term challenges remain.

Gene Therapy Market Access

Q3 Headwinds For Pharma Could Dampen A Continued Rally

COVID-19 disruptions, less favorable currency and the shadow of drug price reform could mean more headwinds for pharma during this S&E period after a strong Q2.

Sales & Earnings Business Strategies

Asia Deal Watch: Hansoh Teams Up With OliX On SIRNA Therapies

Among other Asia deals, Takeda adds to pair of recent gene therapy tie-ups with a CNS-focused cell therapy partnership with Immusoft; earlier it licensed ex-US rights to JCR’s Hunter syndrome drug.

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GSK Shoulder-To-Shoulder With CureVac Over COVID-19 Vaccine U-Turn

The UK major is delighted with the German biotech's decision to throw in the regulatory towel with CVnCoV and concentrate on the firms' collaboration to development a second-generation COVID-19 vaccine. However, GSK is insisting that the partners look at both modified as well as unmodified mRNA approaches, a significant change of strategy for CureVac.

Vaccines Coronavirus COVID-19

Under The Shadow Of Drug Price Reform, US Tax Policies Still Challenge Pharma

Congress is considering legislation that would reverse some of the Trump administration's friendly corporate tax policies, presenting another challenge to the biopharmaceutical industry.

Politics Policy

Mirum Targets $500m Sales For Just-Approved Rare Liver Disorder Drug

Regulators have approved Mirum's IBAT inhibitor as the first medication for a genetic disorder which affects up to 2,500 children in the US.

Approvals Liver & Hepatic
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Research & Development

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Pipeline Watch: Phase III Readouts in Fabry's Disease And COVID-19

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Pipeline Watch Approvals

Keytruda Cements Cervical Cancer Leadership With First-Line Nod

Although the label’s PD-L1 expression requirement could limit the addressable market, there is also potential for future combination with Seagen’s recently approved Tivdak.

Approvals ImmunoOncology

Exelixis Moves Into RNA-Modifying Cancer Therapy With Storm Pact

Deal Snapshot: In addition to investigating the ADAR1 target with the UK biotech, Exelixis also has optioned a second candidate for non-Hodgkin’s lymphoma under its 2019 deal with Aurigene.

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