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Menarini And Radius Skip Into SERD Lead With Elacestrant Success

Elacestrant has become the first oral SERD to generate positive topline results in a pivotal study as a monotherapy versus standard of care for ER+/HER2- advanced or metastatic breast cancer.

Acceleron Investors Want Merck To Pay More, Ask Company To Wait For Better Offer

Avoro Capital, Holocene Advisors and Darwin Global say that Acceleron should sell later for a higher price based on forthcoming data or Merck should raise its bid above $180 per share.

Deals M & A Cardiovascular

Deal Watch: J&J Partners On Bispecific Antibody R&D With F-Star, Xencor

Janssen Biotech adds to its bispecific antibody pipeline for cancer via pair of collaborations. Ipsen and Accent pair up to investigate new target for acute myeloid leukemia.

Deal Watch Business Strategies Deals

Coronavirus Spotlight

China Hits Two Billion COVID Jabs But More Effective mRNA Shots Elude

Despite administering a total of 2.2 billion COVID-19 shots, China as the first country to experience the coronavirus outbreak has yet to open its borders, while more effective mRNA vaccines are still nowhere to be found amid apparent delays for the licensed-in lead candidate.

China Coronavirus COVID-19

Rolling Coverage Of The Coronavirus Outbreak And The Biopharma Industry's Response Is Here.

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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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High Stakes: Boehringer Faces Pre-Expiry India Jardiance Challenge

Indian firms debut empagliflozin copies ahead of expected patent expiry for diabetes blockbuster Jardiance in the country. Spotlight now on how swiftly Boehringer Ingelheim can fend off the entrants and whether the local challenge goes well beyond “inspiration” from the goings-on in the case of another SGLT2 inhibitor dapagliflozin.

Commercial Intellectual Property

Leucid Bio Unveils ‘Parallel CAR-T’ Platform Targeting Solid Tumors

The King's College London spin-out has gained £11.5m backing to take its ‘parallel CAR-T’ into the clinic.

Commercial Clinical Trials

Emerging Biopharma’s Next First Launch Market: China?

Despite multiple challenges including pricing pressures and slowing general economic growth, China offers attractive opportunities for emerging biopharma firms, helped by an encouraging regulatory environment. But weighing up options around challenging areas including partnering is essential, a new report states. 

China Commercial

Biogen’s Q3 Aduhelm Sales Even Worse Than Expected

Analysts expected at least $12m in third quarter sales, but the Alzheimer’s therapy brought in just $300,000. The company says educating doctors and procuring a coverage determination from CMS – not lower pricing – are key to growth.  

Launches Market Access

Semglee's Boost On Express Scripts Formulary Reflects Interchangeability – And Rebates

First interchangeable insulin biosimilar gains preferred status on one of the largest national formularies in the US.

Biosimilars Commercial

Failure Brings Atea and Roche’s COVID-19 Pill Moonshot Down To Earth

An attempt to show efficacy even in younger people with mild COVID-19 symptoms has fallen flat in Phase II, and AT-527 will now lag behind rivals Merck and Pfizer.

Commercial Companies
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Policy & Regulation Explore this Topic

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Latest From Policy & Regulation

UCB Frustrated By FDA Failure To Inspect Facility For Psoriasis Drug

The Belgian group is the latest to be hit by the FDA's difficulties in address the growing backlog of facility inspections, leaving bimekizumab in limbo in the US, despite having just been approved as Bimzelx in Europe.

Drug Review Immune Disorders

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
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Research & Development

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Latest From Research & Development

Leucid Bio Unveils ‘Parallel CAR-T’ Platform Targeting Solid Tumors

The King's College London spin-out has gained £11.5m backing to take its ‘parallel CAR-T’ into the clinic.

Commercial Clinical Trials

Entasis Anticipates First FDA Approval Of Pathogen-Specific Antibacterial

With Phase III data showing non-inferiority to colistin, as well as nephrotoxicity superiority, Entasis thinks sulbactam/durlobactam will provide a new standard of care and succeed where Achaogen’s Zemdri failed.

Clinical Trials Drug Approval Standards

Sage/Biogen Delay Zuralone Filing, Commercial Path Remains Unclear

The companies will seek approval for zuranolone in MDD second-half 2022 and in PPD in first-half 2023, but that also means launch will probably happen second-half 2023.

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