| 03.15.18 | Alexion’s Solir is 2.0 matches but doesn’t be at original; Ionis turns to own subsidiary for sales deal

Klicken Sie hier, um Fiercebiotech.com zu abonnieren

Laden...

6 jahre vor

Html
Text

To view this email as a web page, click here

This week's sponsor is Premier Research.
	Can You Boost Your Odds in Early-Phase Oncology Trials? Find Out! Despite advances in molecular targeting, developing new cancer drugs remains a long shot. Download our white paper for insights on maximizing early-phase trial success. Premier Research. It's what we do. Best.

Today's Rundown

Alexion hits endpoints in ALXN1210-Soliris test as it plots filings After GSK snub, Ionis finds new commercialization partner—its own spinout GV, Roche help Ideaya to $94M crossover round, setting stage for synthetic lethality, I-O trials Solid Bio's DMD gene therapy graduates from partial FDA hold to full-on clinical hold MorphoSys eyes MOR208 approval after midphase DLBCL data impress SEC hits Theranos’ Elizabeth Holmes with fraud charges Boehringer, Vanderbilt U to develop cancer MCL1 inhibitors in third team-up

Featured Story

Alexion hits endpoints in ALXN1210-Soliris test as it plots filings

Thursday, March 15, 2018

Alexion hit key endpoints for its experimental phase 3 drug ALXN1210 in patients with a life-threatening ultrarare blood disorder.

This week's sponsor is Catalent.

[Webinar] Unparalleled Success With Parallel Screening: A Data-Driven Approach to Transitioning Your Challenging Drug to Phase I
Wednesday, March 28 | 11am ET / 8am PT
Join this free webinar and hear an overview of a rapid science driven approach using molecule characterization, DMPK analysis and parallel formulation feasibility assessment that is designed to accelerate early phase development. Register now!

After GSK snub, Ionis finds new commercialization partner—its own spinout

Thursday, March 15, 2018

Ionis Pharma is licensing two antisense drugs to Akcea Therapeutics, picking up a $150 million upfront fee. It will also increase its stake in Akcea to 75% from 68%.

GV, Roche help Ideaya to $94M crossover round, setting stage for synthetic lethality, I-O trials

Thursday, March 15, 2018

Ideaya Biosciences has raised a $94 million crossover round to take its synthetic lethality and cancer immunotherapy programs into the clinic. Riding high on enthusiasm for both its chosen fields, Ideaya has added Alphabet’s GV and Roche to a list of investors already dotted with big names such as 5AM Ventures and Celgene.

Solid Bio's DMD gene therapy graduates from partial FDA hold to full-on clinical hold

Wednesday, March 14, 2018

Solid Biosciences downsized its IPO in January after disclosing that its DMD candidate SGT-001 was under a partial clinical hold from the FDA. The biotech pressed on, but the hospitalization of a patient has led the agency to place a full hold on the phase 1/2 trial.

MorphoSys eyes MOR208 approval after midphase DLBCL data impress

Thursday, March 15, 2018

MorphoSys is hoping to hustle MOR208 through an early, speedy regulatory filing after posting an upbeat look at phase 2 data. Median progression-free survival is still ticking up in the trial of the CD19 monoclonal antibody, adding weight to MorphoSys’ claims MOR208 can hold its own against CAR-T therapies.

SEC hits Theranos’ Elizabeth Holmes with fraud charges

Wednesday, March 14, 2018

Elizabeth Holmes' day of reckoning has arrived, more than two years after reports exposed problems with Theranos' blood-testing technology.

Boehringer, Vanderbilt U to develop cancer MCL1 inhibitors in third team-up

Thursday, March 15, 2018

Cancer cells are different from normal cells in that they can avoid naturally programmed cell death known as apoptosis and grow almost indefinitely. In their third collaboration, Boehringer Ingelheim and Vanderbilt University have their eyes on a target that helps cancer cells evade death.

This week's sponsor is Eurofins Advinus.

Resources

[Whitepaper] Medical Device Innovation: Are You Outrunning The Competition?

[Webinar] Driving Market Access through Patient Advocacy: Trends & Opportunities

[Whitepaper] CFO's, Is This Part Of Your Corporate TO DO List?

[Whitepaper] Choosing the Right Solution: Improving the Site Feasibility Process

[Whitepaper] How Do Sponsors Ensure Quality in Global Clinical Trials?

Presented by: Covance

Global clinical trials are the trend and gaining in popularity, but running a global trial is not a straightforward process. This white paper explores some of the challenges associated with global clinical trials and considerations for ensuring that the collected data comply with the trial's overall objectives.