Sentences with phrase «breakthrough therapies»

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.

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

«All - star» researchers intend to develop breakthrough therapies for the viral liver infection within 3 years

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

Our translational research approach means that every day you'll be able to work alongside clinicians, collaborating in the laboratory and at the bedside, to develop breakthrough therapies that will help patients feel better, sooner.

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

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.

«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.»

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

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.

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.

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.

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.

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.

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

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.

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.

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

«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.

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 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.

He noted that the panel played a big role in shepherding into law a 2012 measure — the FDA Safety and Innovation Act (FDASIA)-- which created a new «breakthrough therapy» designation to speed the approval process for certain treatments for seriously ill patients.

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

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

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

Based in part on these promising findings, the FDA granted MPDL3280A a «Breakthrough Therapy» designation.

«We are encouraged to have received Breakthrough Therapy Designation for AVXS - 101, and look forward to collaborating with the FDA to determine next steps in the development pathway for AVXS - 101,» said Sean P. Nolan, president and chief executive officer, AveXis.

Chicago, Ill., July 20, 2016 — AveXis, Inc., a clinical - stage gene therapy company developing treatments for patients suffering from rare and life - threatening neurological genetic diseases, today announced the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for AVXS - 101, the company's lead development candidate for the treatment of spinal muscular atrophy (SMA) Type 1 in pediatric patients.

The Breakthrough Therapy Designation is based on preliminary clinical results from the ongoing trial of AVXS - 101, conducted in collaboration with The Research Institute at Nationwide Children's Hospital and The Ohio State University.

«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.

Belle appreciates work where the body's wisdom can be incorporated and has training in EMDR, a breakthrough therapy used to overcome the effects of psychological trauma.

Trauma Counseling and EMDR I thought this week we would look at trauma counseling by reviewing the book entitled «EMDR: The Breakthrough Therapy for Overcoming Anxiety, Stress, and Trauma» by Francine Shapiro, and Margot Silk Forrest.

EMDR is considered a breakthrough therapy because of its simplicity and the fact that it can bring quick and lasting relief for most types of emotional distress.

EMDR is considered a breakthrough therapy because of its ability to bring quick and lasting relief for most types of emotional distress.

Not exact matches

Medical breakthroughs in 2018 range from new devices for sleep apnea to gene therapy for blindness, according to the Cleveland Clinic.

Genetic engineering promises breakthrough medical therapies, plus more nutritious and resilient crops and livestock.

«Today's approval marks another first in the field of gene therapy — both in how the therapy works and in expanding the use of gene therapy beyond the treatment of cancer to the treatment of vision loss — and this milestone reinforces the potential of this breakthrough approach in treating a wide - range of challenging diseases,» FDA Commissioner Scott Gottlieb said in a statement.

In a rare appearance Dr. Chandan Sen, Director, OSU Center for Regenerative Medicine & Cell - Based Therapies will explain how this breakthrough came about and how the technology is leading to other medical discoveries and how the principle can be used to generate any tissue out of skin or fat which is abundant in human body.

IDEAYA Biosciences, Inc., an oncology - focused biotechnology company committed to the discovery of breakthrough synthetic lethality medicines and immuno - oncology therapies, announced today the successful completion of a $ 94 million crossover Series B financing.

TORONTO, October 7, 2014 — MyndMove, a breakthrough medical therapy that significantly improves recovery of voluntary movement in patients with arm and hand paralysis following stroke or spinal cord injury (SCI), will be accessible to more Ontarians with the assistance of a unique program at MaRS Discovery District.

MyndMove, a breakthrough medical therapy that significantly improves recovery of voluntary movement in patients with arm and hand paralysis following stroke or spinal cord injury (SCI), will be accessible to more Ontarians with the assistance of a unique program at MaRS Discovery District.

The hyperbaric oxygen therapy he received could be a major breakthrough in the treatment of athletes (or anyone) suffering from concussions or concussion - related issues, and Bryan continuing to receive therapy while successfully keeping his career as a wrestler going would only add to that breakthrough.

The concept of oral rehydration therapy (ORT) has made a real breakthrough in reducing mortality from acute gastroenteritis.

These organizations are developing new medical and pharmaceutical breakthroughs that have the potential to save lives, whether through new therapies or the early detection of diseases like autism and cancer.

Since the breakthrough in 2010 with the first curative therapy for melanoma, funding became widely available from government, industry and philanthropic organizations.

Ian Wilmut talks about serendipity, shared credit and the messy — and very human — story behind the breakthrough that paved the way for stem cell therapies

The breakthrough could produce new cancer therapies, aid infertility and help us to understand why we reproduce sexually

Fong, a physician and astrophysicist who trained in part at NASA, weaves firsthand, nail - biting ER experiences with gripping historical narrative as he recounts 100 years of breakthroughs, such as inducing hypothermia as life - saving therapy and pioneering facial reconstruction for burn victims.