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February 14, 2020___

Editor’s Note: FierceBiotech will not publish on Monday in observance of Presidents Day, but we’ll be back in your inbox on Tuesday, Feb. 18.


Today's Rundown

Featured Story

AstraZeneca cans cancer pipeline efforts

In its fourth-quarter earnings out early Friday morning, U.K.-based Big Pharma AstraZeneca has cut two early-stage experimental meds.

Top Stories

China's CICC Capital raises $229M biologic investment fund

CICC Capital has raised a RMB 1.6 billion ($229 million) biologic investment fund. The fund received money from Chinese organizations inside and outside the biopharma industry, enabling CICC Capital to ease past its financing target. 

Immunomedics nabs J&J veteran for CMO as it presses on with ADC redo

For the last year, biopharma veteran Loretta Itri, M.D. has been helping Immunomedics out with its troubled antibody-drug conjugate, sacituzumab govitecan. Now, she’s signing on with the company full-time as its new chief medical officer. Itri joins from The Medicines Company, where she oversaw global health sciences and medical affairs.

Melinta seeks buyout bids to secure escape from bankruptcy

A U.S. bankruptcy court has given groups interested in buying antibiotic biotech Melinta Therapeutics until March 2 to make an offer. The bidding process creates an opportunity for Melinta’s business to continue as a going concern despite its financial difficulties.

Novimmune unit nabs Takeda milestone payment for hemophilia work

Light Chain Bioscience, a unit of Swiss biotech Novimmune, has been handed a nice royalty milestone check from partner Takeda.

Targeting the 'clock gene' in obesity to slow triple-negative breast cancer

Scientists at City of Hope discovered that prediabetic and obese mice that lacked the BMAL1 protein, which is made by a gene involved in circadian rhythms, suffered from accelerated tumor growth in triple-negative breast cancer. They believe the finding could point to new treatment targets, as well as prevention strategies for overweight people.

EuroBiotech Report—Ipsen's woes, Roche failure, Chiesi, Bayer and Woodford

In this week's EuroBiotech Report, Ipsen takes €669 million hit, Roche Alzheimer's drug fails trial and Chiesi creates rare disease unit.

FiercePharmaAsia—Gilead remdesivir's copy; Enhertu's early launch; Tecentriq's China nod

A Chinese drugmaker has started mass producing a generic to Gilead's remdesivir without any licensing agreement. HER2-targeting Enhertu has got off to a fast start, Daiichi Sankyo U.S. chief said. Roche's Tecentriq won approval in China in first-line small cell lung cancer. And more.

Chutes & Ladders—Ex-Pfizer R&D head Abraham joins Vividion

Vividion nabs ex-Pfizer R&D head Abraham; Lu takes CMO role at Pharvaris; Enterprise taps Morris as medical head.

Resources

[Whitepaper] Regulatory agencies provide insights and concerns for eConsent study

To conduct a successful trial, do you need to understand the global eConsent Regulatory landscape?

[Whitepaper] Computer Software Assurance: What You Need to Know About FDA’s Upcoming Guidance

Details on the FDA’s upcoming Computer System Validation guidance

[Whitepaper] Fusing Specifications and Design for Data Collection Casebooks with Veeva Vault EDC

Learn how data management teams at ICON, Bioforum, and Vertex Pharmaceuticals are creating the spec and casebook in a single step, reducing study build times and effort by over 50%.

[Whitepaper] Assessing the Financial Impact of Translational Pharmaceutics®

Tufts Center for the Study of Drug Development (CSDD) white paper sharing study results that indicate Quotient Sciences’ Translational Pharmaceutics® platform reduces development times by more than 12 months and lowers R&D costs by more than $100 million per approved new drug, compared to traditional multi-vendor development paradigms.

[Presentation] Flexible Manufacturing Strategies

Get expert insights on strategies to implement flexible manufacturing and different technologies that are easily scalable and reproducible.

[Executive Summary] Overcoming Manufacturing Challenges for Accelerated Drug Development

Regardless of the assigned FDA expedited approval designation and approach, the key action items should be: the assurance of a detail-oriented plan and the adaption of a “forward-thinking” approach that will assist in any future challenges and opportunities for growth of each project.

[Executive Summary] Clinical Supplies - Made to Order

Learn how recent innovations in demand-led supply and direct-to-patient distribution are converging to create a next-generation clinical supply chain that is flexible, lean and most importantly patient-centric.

[Whitepaper] Digital Twins: Creating Digital Operations Today to Deliver Business Value Tomorrow

This whitepaper highlights the challenges of implementing the right digital twin strategy while providing key use cases in the manufacturing domain for which a digital twin is extremely useful and several examples of technology trends that will shape the future.

[Q&A] Embarking Upon the Commercial Manufacturing Journey for a Biologic

In this Q&A, four Catalent Biologics experts share how scale-up, regulatory expectations, demand forecasting and process validation all play a role in the success of a biologic when embarking upon the commercial manufacturing journey.

Events