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Amicus Makes Its Gene Therapy Move, Focusing On CNS Lysosomal Storage Disorders

The rare disease specialist gained 10 gene therapy programs with the acquisition of Celenex, including two in clinical-stage development for Batten disease, in exchange for $100m up front. President Bradley Campbell talked to Scrip about the process that led to the deal and next steps for development.

Deals Rare Diseases Regenerative Medicine

Novo Nordisk CSO Says R&D Revamp Reflects New Stem Cell And AI Focus

Mads Krogsgaard Thomsen tells Scrip that recent successes in stem cell research and the on-going advances in artificial intelligence helped prompt the Danish group to revamp its R&D activities.

Business Strategies Commercial Companies

Deal Watch: Takeda Teams With Molecular Templates On Anti-CD38 Approach To Multiple Myeloma

Takeda and Molecular Templates will work to develop targeted engineered toxin bodies for multiple myeloma. Celgene decides against optioning OncoMed’s navicixizumab for ovarian cancer, while CRISPR and ViaCyte team up on type 1 diabetes.

Deals Business Strategies Commercial
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Case Study: Broad Thinking Yields Big Results

There are numerous details when considering product packaging that require both creative thinking and feature prioritization. Rather than developing a standard solution for the current need, it’s imperative to think broadly and design options that are cost-effective, simplify operations and save time and/or resources.

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Commercial Explore this Topic

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Garland Takes Helm Of Portola At A Crucial Time

Portola touts exec's commercial management experience with Genentech success stories Avastin and Tarceva.

Commercial Sales & Earnings Cardiovascular

Spanish Biotechs Prepare To Seek Partners In Seville

Start-ups in Spain will descend on the Andalusian city next week for the BioSpain meeting in search of national and international investors and collaborators to boost their respective R&D pipelines.

Spain Financing StartUps and SMEs

Clinuvel Is Planning For US Commercialization Of Ultra-Orphan Drug Scenesse

Clinuvel's Scenesse for the ultra-rare, light-induced disease erythoropoietic protoporphyria (EPP) is already approved in Europe and the company is hopeful that a rolling NDA submission could pave the way for a US launch.

Rare Diseases Business Strategies

Ipsen Sees First Mover Advantage In EU For Cabometyx In Liver Cancer

Ipsen CSO says CHMP recommendation for TKI Cabometyx should give it first mover advantage globally in liver cancer.

Approvals Business Strategies

Biosimilar Tipping Point: Five Questions For Henlius CEO

Now valued at close to $3bn, Henlius is one of the largest biotech unicorns in China. CEO Scott Liu sat down with Scrip in an exclusive interview to discuss biosimilar development in China, emerging market expansion plans, and its venture into immuno-oncology combo strategy.

China Biosimilars

Interview: DKSH Building Healthcare Services In Changing Asian Markets

Market expansion services provider has its headquarters in Switzerland but a long history and most of its business in Southeast Asia, where the global head of its Business Unit Healthcare tells Scrip it continues to build a broad range of services based around knowledge and penetration of local markets.

Asia Pacific Business Strategies

Galera Raises $150m To Take Lead Drug From Phase III To NDA Submission

Galera garnered $70m in Series C venture capital and $80m through a royalty deal tied to GC4419 and a follow-up drug for the treatment of severe oral mucositis caused by radiation therapy with an initial focus on head and neck cancer patients.

Financing Business Strategies

Clovis, CEO Mahaffy Settle SEC Investor Fraud Charges Over Rociletinib Efficacy Claims

Clovis, CEO Patrick Mahaffy and former CFO Erie Mast will pay more than $20m to settle charges by the SEC that the company misled investors on the efficacy of rociletinib. Clovis raised $298m in a public stock offering during the timeframe SEC says it misled investors.

Legal Issues Leadership

Policy & Regulation Explore this Topic

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AbbVie Deployed Nurses As 'Runners And Cappers' In Humira Kickback Scheme, Suit Alleges

California Insurance Commissioner claims AbbVie gave kickbacks for healthcare providers to prescribe Humira and had nurse 'ambassadors' insert themselves between patients and physicians.

Advertising, Marketing & Sales Legal Issues Immune Disorders

Merck & Co Needs To Go Low On Price For New HIV Drugs In EU

Pifeltro and Delstrigo have been backed for approval by the CHMP but how well they will fare on the market depends on a competitive pricing strategy and continuing to benefit from current European guidelines which recommend NNRTI-containing regimens for HIV.

Infectious Diseases Pricing Strategies

Roche To Set Right Avastin Post-Marketing Surveillance Delay In India

Roche is working towards implementing PMS studies for Avastin (bevacizumab) and ensuring that a suspension of marketing authorization for the product in first line ovarian cancer is lifted in India.

Policy & Regulation Regulation

Fix Antibiotic Payment Models To Spur R&D Investment, US FDA’s Gottlieb Says

Citing need for more ‘pull’ incentives to overcome commercial hurdles, FDA commissioner says a subscription-based fee reimbursement system would provide a foundation for return on investment of new antimicrobials targeting multi-drug resistant pathogens.

Infectious Diseases Reimbursement

Research & Development Explore this Topic

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Phase III Roxadustat ALPS Data Positive For New Class Of Anemia Therapies

Positive top-line data from the ALPS study confirms the efficacy and safety of roxadustat, a Phase III-stage product which could be the first a new class of orally active agents with potential in the treatment of anemia associated with chronic kidney disease.

 

Clinical Trials Renal Research & Development

Pipeline Watch: Phase III Readouts For Oral Semaglutide, Roxadustat, Dasiglucagon

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events 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

Spectrum To Test Poziotinib's Potential As First Line Treatment Of Exon 20 Mutant NSCLC

Spectrum is expanding a clinical trial with its novel, oral pan-HER inhibitor poziotinib into the first-line treatment of NSCLC with EGFR or HER2 exon 20 insertion mutations, which could provide a much-needed new option for these patients. The move also marks further positive development progress for the drug, which the US firm licensed in from Hanmi.

Clinical Trials Cancer

ASLAN, Sosei Pipeline Assets Hit By Development Delays

Two Asia-based companies disclose delays to important clinical pipeline assets, one in oncology driven by apparent ethnic differences in response to prior therapy and the other a CNS molecule hit by an unexpected toxicity finding in an animal study.

Asia Pacific China
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