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Gilead Trial Pause Adds To Merck & Co’s HIV Concerns

The partners are halting recruitment out of “an abundance of caution,” but Gilead could decide to exit the alliance if islatravir cannot shake off safety concerns.

Infectious Diseases Companies Research & Development

Chinese Biotechs Step Onto World Stage With Innovative Products, Competitive Prices

In a new landmark, Chinese firm BeiGene has posted greater quarterly sales of its cancer drug Brukinsa in the US than in China for the first time. Meanwhile, a growing number of innovative products developed in China are on the cusp of expansion into overseas markets.

China Business Strategies Cancer

New Player Joins Search For Effective Huntington's Therapies

Despite recent setbacks for Roche and Wave's respective antisense offerings, both those two firms and a number of other companies are trying a variety of approaches to find a treatment for Huntington's.

Clinical Trials Financing Rare Diseases

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Scorching COVID-19 Era Returns From India Biotech, Healthcare Funds Outpace The Globe

Early COVID-19 therapies including Gilead’s remdesivir, China-plus procurement policies, vaccine partnerships and a dovish stance by the central bank led to returns on India biotech and healthcare funds outperforming global returns. Meanwhile, funding for e-pharmacies and online consulting firms gathered pace.

Commercial Financing

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. 

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Cambridge Vision Achieved, AstraZeneca Looks To Realize ‘Pipeline 2’ Ambitions

Having achieved a turnaround in its R&D and commercial fortunes, AstraZeneca’s hopes the opening of a new research center will herald its next wave of novel therapies.

Companies Commercial

3D Med, Alphamab Get First SubQ Immuno-Oncology Approval, In China

A landmark approval and domestic tie-up in China mark the fast innovation that is shaping the country’s health sector.

Approvals ImmunoOncology

Tech Transfer Roundup: Athenex, PDS Align With National Cancer Institute On Oncology R&D

Athenex expands its portfolio of T-cell receptor therapy technology under NCI license agreement; PDS Biotechnology accesses institute’s TARP tumor antigen technology.

Tech Transfer Round-Up Deals

Finance Watch: Venture Capital Drives Record-Breaking Year For Cell And Gene Therapies

Private Company Edition: Recent VC financings across biopharma sectors include three major mega-rounds as Generate Biomedicines bringing in $370m, followed by $250m for Acelyrin and $125m for Chroma Medicine. Also, Treadwell raised a $91m series B and Ncardia brought in $60m-plus.

Regenerative Medicine Financing

Takeda's Livtencity Approved For Refractory CMV Infection In Transplant Patients

Maribavir is the first antiviral agent targeting and inhibiting the pUL97 protein kinase, as well as Takeda's second new molecular entity approved by FDA this year.

Approvals Business Strategies

Pharma Will Need To Embrace More Inward-Looking China

The world’s second-largest economy is fast moving away from reforms and open to a "dual circulation" model, focusing on domestic market consumption while reducing export-driven production. Executives and investors shared views at a conference on whether multinational pharma firms are still welcome in China and what opportunities may lie in the drastic policy shift.

China Market Access
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Pfizer/BioNTech’s Comirnaty Supply Agreements Unaffected Despite EU Green Light For Under-12s

Pfizer and BioNTech’s Comirnaty supply under existing agreements will continue as planned despite anticipated expansion into a new child sub-population in Europe.

Vaccines Regulation

Novo Nordisk Braced For China Insulin Scheme Impact

The value-based procurement scheme in China is about to be implemented on insulin products and while most of Novo Nordisk's therapies were included in the tender, price cuts are going to impact global sales growth by 3% next year.

China Market Access

Amryt's Wings Clipped By Delay For Butterfly Skin Drug Decision

The Irish firm needs to give regulators in the US more information on its epidermolysis bullosa therapy but is confident of address those requests from its "existing data within the time periods required," according to CEO Joe Wiley.

Rare Diseases FDA
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Research & Development

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Cambridge Vision Achieved, AstraZeneca Looks To Realize ‘Pipeline 2’ Ambitions

Having achieved a turnaround in its R&D and commercial fortunes, AstraZeneca’s hopes the opening of a new research center will herald its next wave of novel therapies.

Companies Commercial

Pipeline Watch: Six Phase III Trial Starts Plus 19 New Approvals

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

J&J's Next Immunology Act Centers On Nipocalimab For Autoantibody-Driven Diseases

The company has ramped up a broad R&D program for the FcRn inhibitor in 11 autoantibody-driven disease areas.

Immune Disorders Research & Development
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