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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 Companies

ICON CEO: CROs Must Be Aware Of Threat Posed By Big Tech

ICON’s CEO Steve Cutler talks candidly about the impact of biotech funding, disruptive tech providers, and the constant pressure of running one of the industry’s largest CROs.

Clinical Trials Leadership Research and Development Strategies

Tildrakizumab Set For Europe Debut - Can It Make A Dent?

Almirall's Ilumetri, licensed from Sun Pharma, has been cleared by the European Commission, upping the competition quotient in the psoriasis market and pitting the product directly against Johnson & Johnson's Tremfya.

Europe Commercial Strategy
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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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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 StartUps and SMEs

Novo Nordisk Cuts 400 Jobs In R&D Reshuffle As It Broadens Its Horizons

Novo, which is under pressure to diversify and signaled plans to cut jobs back in August, will lay off 400 people as it reallocates resources to more efficiently bring in novel products through both R&D and business development, continuing a deal-making spree that's already under way.

Business Strategies Research and Development Strategies 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

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

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

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

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

Pfizer Eyes First-To-Market Opportunity In Alopecia

Inflammation and Immunology Chief Scientific Officer Michael Vincent talked to Scrip about the first positive Phase II data testing a JAK inhibitor for hair loss caused by alopecia areata, next steps for development and the broader I&I portfolio.

Immune Disorders Research & Development

Policy & Regulation Explore this Topic

Set Alert for Policy & Regulation

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

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

Timing Is Everything – Unfortunately For Acorda, Timing Couldn't Be Worse

Acorda can't seem to catch a break. The Federal Circuit slapped down the company's last ditch effort to uphold its Ampyra patents and three days later the FDA postponed a decision on Inbrija, widening the gap between the entry of Ampyra generics and the launch of Acorda's new drug.

Neurology Business Strategies

Shire Snags EU Okay For Von Willebrand Drug Veyvondi

Although noises are still being made in Japan concerning the benefits of Shire's merger with Takeda, the former is going about the business of getting marketing green lights with the latest being for its inherited bleeding disorder treatment Veyvondi in Europe.

Blood & Coagulation Disorders Approvals

Research & Development Explore this Topic

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Phase III Data Put Zealand's Dasiglucagon On Track, But Behind Others, For Hypoglycemia Rescue

Zealand Pharma stresses fast onset of dasiglucagon, which it plans to file on its own but develop commercially through partnership.

Metabolic Disorders Clinical Trials Commercial

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

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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