Sentences with phrase «breakthrough therapy»

I have successfully integrated laboratory and clinical teams to better understand immune responses to cancer and develop breakthrough therapies based on this knowledge.

AveXis, Inc., a clinical - stage gene therapy company developing treatments for patients suffering from rare and life - threatening neurological genetic diseases, announced in July 2016 that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for the treatment based on preliminary clinical results from the trial of AVXS - 101.

The company prides itself on making a meaningful difference in the lives of patients — which it does by developing breakthrough therapies for autoimmune disorders, neurogenerative diseases, and hemophilia.

From 2002 to 2010, Yujiro served as Vice President, Senior Vice President, and Chief Business Officer at Enanta Pharmaceuticals (NASDAQ: ENTA), which he joined as a startup and helped build to a public company that discovered the protease inhibitors contained in Viekira Pak and Mavyret ™, both of which received Breakthrough Therapy designation by the U.S. FDA.

Based on previous results, the Food and Drug Administration has given MDMA breakthrough therapy status, which could speed approval.

Hutchison China Meditech (HCM)- The stock offers investors a strong pipeline of differentiated candidates (up to 15 possible Breakthrough Therapy Designations), China exposure (via its sales team of over 3,200 employees and 1,900 medical professionals), validating partnerships and several upcoming catalysts.

«We must continue to be relentless in our fight to end cancer, and harness the best scientific minds in the world to develop new breakthrough therapies to conquer one of the most devastating diseases facing humanity,» says Hunter.

• Rallybio, a biotechnology company focused on the development of transformative breakthrough therapies for patients with severe and rare disorders, raised $ 37 million in Series A funding.

Cambridge, MA — March 5, 2015 — Aura Biosciences, a biotech company developing highly tumor - targeted breakthrough therapies for rare cancers, has secured a $ 21M Series B round of funding.

Drs. Lazaridis and LaRusso say that collaboration is essential for translating scientific discoveries into breakthrough therapies to address the unmet needs of patients with PSC.

Ensuring patient access to said breakthrough therapies through lower cost sharing is key.

«We will continue to provide input to the FDA as the agency works to bring breakthrough therapies to patients that are clinically appropriate and effective, without compromising patients» health or safety.»

«There is no obvious breakthrough therapy emerging in the coming years.

«Expedited approaches can be used without compromising efficacy standards for drugs that demonstrate breakthrough therapy potential.»

«Achieving Breakthrough Therapy designation for enfortumab vedotin is another step forward in our goal to bring an additional option to patients who need it most,» said Steven Benner, MD, the senior vice president of oncology development at Astellas.

«The FDA Breakthrough Therapy designation underscores the potential of enfortumab vedotin as a meaningful treatment for patients with locally advanced or metastatic urothelial cancer,» said Robert Lechleider, MD, the vice president of clinical development at Seattle Genetics, according to a press release.

TCG is about the bold pursuit of big ideas using innovative science to generate breakthrough therapies that address significant diseases.

CDER designated 41 % as fast track, 22 % as breakthrough therapies, 61 % as priority review and 20 % under FDA's Accelerated Approval program.

Based on these promising early results, brigatinib, developed by Ariad Pharmaceuticals, Inc., recently received Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA) for the treatment of patients with ALK + metastatic NSCLC whose tumors are resistant to crizotinib.

Our lead product candidate, entinostat, which was granted Breakthrough Therapy designation by the FDA following positive results from our Phase 2b clinical trial, ENCORE 301, is currently being evaluated in a Phase 3 clinical trial for advanced hormone receptor positive, human epidermal growth factor receptor 2 negative breast cancer.

AbbVie, which partnered with Enanta Pharmaceuticals, disclosed positive results for the remaining phase III studies tied to its all - oral regimen, which also has breakthrough therapy status.

«Two decades of discoveries in the fields of stem cell biology, cortical brain development, and cell transplantation have revealed the potential for particular types of neurons to repair the nervous system, representing a possible breakthrough therapy for patients with devastating neurological diseases,» said Cory Nicholas, Co-Founder, VP of Research at Neurona.

Fueling the growth of the drug industry is billions of dollars in spending on research and development, which is producing new breakthrough therapies and discovering treatments for diseases that were formerly untreatable.

Under Dr. High's leadership, Spark has received Breakthrough Therapy designation for two clinical programs, and has recently filed the first BLA for an AAV - based gene therapy in the US.

A breakthrough therapy designation means the treatment shows marked improvement over more traditional drugs for life - threatening diseases.

But for all of the attention paid to its cancer drug pipeline, Bristol just scored a breakthrough therapy designation from the Food and Drug Administration for a treatment that targets hepatitis C.

The FDA, for its part, seems excited, too; shortly after the study presentation, it granted patisiran «Breakthrough Therapy Designation» status — a promise that the agency will expedite its review of the drug if and when it's submitted for approval.

Such a breakthrough therapy could reduce the cost of care for Alzheimer's patients in 2050 by $ 447 billion.

Now, the first thing to understand about oliceridine's ongoing studies is that the primary endpoint for both trials is the drug's ability to outperform placebo as a pain reliever — a feat it has performed in spades in its mid-stage trials that even led to a breakthrough therapy designation from the FDA last February.

Psychotherapy that incorporates MDMA, the primary ingredient of ecstasy, was designated in August as a Food and Drug Administration «breakthrough therapy» for severe post-traumatic stress disorder.

Because so many of the patients in the early testing showed significant long - lasting responses, the study was continued and the FDA granted the drug «breakthrough therapy» status, allowing it to be fast - tracked for approval.

The success of the agent, nivolumab, in this study has prompted the U.S. Food and Drug Administration to designate it a «breakthrough therapy» for treating relapsed HL, and a large, multinational Phase 2 trial is now under way.

Now, a pair of studies suggests why two breakthrough therapies might not help many patients as much as hoped.

Baker, however, plans to test the most promising products in his lab with the hope that some organic origami master out there will stumble upon the key component for an AIDS vaccine or another breakthrough therapy.

Nonprofit seeks funding for phase III trials after Food and Drug Administration grants MDMA «breakthrough therapy» status

In July 2014, the U.S. Food and Drug Administration granted CTL019 its Breakthrough Therapy designation for the treatment of relapsed and refractory adult and pediatric ALL, a step which is intended to expedite the development and review of new medicines that treat serious or life - threatening conditions, if a therapy has demonstrated substantial advantages over available treatments.

«I think it's very easy to read into that that «breakthrough therapy» means a proven benefit — there's no uncertainty about how it works,» Schwartz said.

Last year, the U.S. Food and Drug Administration recognized the promise of both drugs, designating them «breakthrough therapies» — ibrutinib for chronic GVHD and ruxolitinib for the acute disease.

Nonetheless, an FDA press release described Zykadia as «a breakthrough therapy drug approved four months ahead of review completion goal date,» a message that was reflected in reporting by the Washington Post.

For example, Zykadia, a drug for metastatic lung cancer, received a «breakthrough therapy» designation that allows expedited approval based on preliminary evidence for certain drugs that treat serious conditions.

In April 2015, it received a U.S. Food and Drug Administration (FDA) Breakthrough Therapy designation.

Oliceridine received «breakthrough therapy» status from the FDA, a designation aimed to help speed development of medicines that have shown evidence of clinical promise in treating serious or life - threatening conditions.

Breakthrough Therapies are those that are intended to treat a serious or life - threatening disease or condition, and that have preliminary clinical evidence indicating a substantial improvement over existing therapies.

The Breakthrough Therapy designation was granted based on interim results of a phase I trial, which the companies developing the agent have not yet released.

The US Food and Drug Administration (FDA) has granted a Breakthrough Therapy designation to an antibody - drug conjugate known as enfortumab vedotin.

We are leaders in cancer medicine providing patients with access to clinical trials and new, breakthrough therapies.

Drugmaker company, Roche has been granted FDA approval for its breakthrough therapy designation for Balovaptan to treat Autism Spectrum Disorder (ASD), potentially accelerating its development and approval.