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February 28, 2020___

Today's Rundown

Featured Story

Biogen puts down massive $350M upfront for Sangamo preclinical assets

A year ago, Sangamo’s shares sank after it posted lackluster data for its genome-editing therapy; 12 months down the line, and it’s a complete reversal for the biotech as Biogen lays down a major upfront and biobucks pact for several of its CNS meds.

Top Stories

Gilead hungry for 'don't eat me' cancer biotech: reports

A new decade, the same old game: It’s time to play, who will Gilead buy? Sources now says it’s Forty Seven, a cancer-focused startup with a unique MOA.

Boehringer taps Trutino to bag safer, more efficacious cytokines

Boehringer Ingelheim has struck a deal with Trutino Biosciences to develop three cytokine therapies. The deal tasks Trutino with applying a platform designed to yield safer, more effective cytokines to the discovery of three oncology drugs for Boehringer.

Trial sponsors set to report a decade of old data after judge finds FDA rule unlawful

A federal judge has ruled that sponsors need to share results from a decade’s worth of clinical trials. The ruling reflects the judge’s belief that the FDA’s interpretation of the law on clinical trial reporting “is unlawful and must be set aside.”

Passage Bio pulls off $216M IPO, blowing past original goal

Passage Bio finished 2019 with nearly $160 million in the bank but wasted no time coming back for more, filing earlier this month to raise $125 million in its IPO. Now, the gene therapy player has outraised that goal by $91 million with its $216 million Wall Street debut.

Insilico Medicine taps GSK alum for a six-month AI sprint aimed at brain cancer

Digital molecule designer Insilico Medicine has launched a new preclinical research program focused on treatments for brain cancer, and has brought on the former global program head of GlaxoSmithKline’s computer-aided drug discovery unit to help run it.

Thwarting coronaviruses by preventing them from copying themselves

Scientists at the University of Lubeck are targeting a protein-cutting enzyme that many viruses, including the coronavirus COVID-19, need to replicate. They developed a molecule that in cell studies shows potential in blocking coronaviruses, including COVID-19, they reported, and they're planning to move to animal trials soon.

Biohaven set to take on Allergan, Lilly with new migraine med and 500-plus reps

Biohaven will challenge much larger companies with its new migraine med Nurtec ODT. But the med scored a strong FDA label and will have a field sales team of more than 500 reps, execs said Friday. On the market, Nurtec ODT will go up against Allergan's Ubrelvy and Eli Lilly's Reyvow, both brand new options, plus older medicines.

EuroBiotech Report—Roche-Bicycle, GSK-COVID-19, Grifols acquisition, Kahr round and Genfit delay

In this week's EuroBiotech Report, Bicycle lands Genentech collaboration, GSK inks COVOD-19 adjuvant deal and Grifols buys antibiotic assets.

FiercePharmaAsia—Harvard-GIRH, GSK-Clover, Vir-WuXi coronavirus collabs; Takeda’s PvP buy

Harvard University and Guangzhou Institute of Respiratory Health, GlaxoSmithKline and Clover Biopharmaceuticals, and Vir Biotechnology and WuXi Biologics have formed R&D collaborations focused on COVID-19. Takeda is buying its celiac disease partner PvP Biologics for $330 million. And more.

Chutes & Ladders—Viatris appoints Pfizer CFO Narula to C-suite

Pfizer, Mylan vets move over to generics merger Viatris; Spark CMO Reape steps down; Eloxx cuts CEO Ward in shakeup.

Resources

[Whitepaper] The ROI of Document Delivery

3 ways you may be overspending on scientific literature access, and how to fix them.

[Whitepaper] Strategies for Improving Software Deployments and Business Processes Adoption Rates

Mediocre adoption rates aren’t due to poorly designed software or lazy users. They’re the result of how skills are trained. Achieve high adoption rates by implementing the right methodology with a focus on behavior change.

[Whitepaper] Navigating Today’s Healthcare Transformation: The Evolution of Payers

Read about the innovative ways payers are making smart moves in the healthcare game.

[Whitepaper] One-step Specs and Design 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%.

[Video] FierceBiotech Sits Down With H1

Biopharma companies don't want to go to market with a product no one knows about. H1 has homed in on the often time-consuming research and engagement phases that companies must ace for a successful launch, said Ariel Katz, co-founder of H1.

[Whitepaper] Successful BYOD in Any Phase

Download this free white paper to learn how a BYOD ePRO approach is beneficial to your trial.

[Executive Summary] Strategies for Flexible Manufacturing

This whitepaper discusses the benefits of end-to-end solutions and share case studies on how flexible manufacturing strategies can accommodate the changing landscape of pharmaceutical products and help bring a drug to market.

[Video] FierceBiotech Sits Down With Accenture

Kevin Julian, senior managing director of Accenture’s life sciences practice, recently sat down with FierceBiotech to discuss market trends and Accenture’s new technology platform, INTIENT. 

[Whitepaper] Achieving Differentiation in the Complex Oncology Market

White paper describing how a biopharma company can successfully differentiate an oncology product when the clinical profile alone is not enough to get the job done.

[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?

[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