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FDA Approves AbbVie's Rinvoq, a Potential Successor to Humira

Biospace news - Mon, 08/19/2019 - 02:00
AbbVie’s JAK inhibitor Rinvoq was approved by the U.S. Food and Drug Administration for the treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate.

Data Scandal Threatens to Undermine Trust in Novartis CEO

Biospace news - Mon, 08/19/2019 - 02:00
The data-manipulation scandal with Novartis is widening, undermining investors’ trust in company chief executive officer Vas Narasimhan.

Informational Interviewing for Life Science Professionals

Biospace news - Mon, 08/19/2019 - 02:00
The idea is to have a conversation with someone holding a job like the one you’d like to have and ask all about what the job is like, along with advice about how to attain one like it.

Study: Black and Hispanic Populations Underrepresented in Oncology Clinical Trials

Biospace news - Mon, 08/19/2019 - 02:00
“It’s important to recognize that this problem is there and this problem is persisting over the years,” Kanwal Raghav, author of the study and an oncologist at MD Anderson Cancer Center, told STAT.

Clinical Catch-up for August 12-16

Biospace news - Mon, 08/19/2019 - 02:00
As summer winds its way to an end, biopharmaceutical companies continue to conduct clinical trials and release news related to them. Here’s a look at last week’s clinical trial headlines.

New Insights Could Lead to More Control Over Opioid Addiction

Biospace news - Mon, 08/19/2019 - 02:00
Researchers at The Scripps Research Institute in Florida recently published a study in the journal Science describing a newly discovered biological system that manages how cells respond to exposure to opioids.

SpringWorks Sets Stage for $115 Million IPO

Biospace news - Mon, 08/19/2019 - 02:00
The company is seeking the funds to continue to drive the development of its lead candidates, nirogacestat, a gamma-secretase inhibitor for the treatment of desmoid tumors and PD-0325901, a MEK inhibitor for the treatment of neurofibromatosis type 1-associated plexiform neurofibromas.

Juvenescence Raises $100 Million for Longevity Drug Development

Biospace news - Mon, 08/19/2019 - 02:00
The $100 million tranche brings the company’s total fundraising efforts this over the past 18 months to $165 million.

Roche's first FDA-approved tumour-agnostic medicine

World Pharma News - Fri, 08/16/2019 - 10:00
Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the US Food and Drug Administration (FDA) has approved Rozlytrek™ (entrectinib) for the treatment of adults with ROS1-positive, metastatic non-small cell lung cancer (NSCLC). The FDA has also granted accelerated approval to Rozlytrek for the treatment of adult and paediatric patients 12 years of age and

FDA Approves First Myelofibrosis Drug in Nearly a Decade

Biospace news - Fri, 08/16/2019 - 02:00
The U.S. Food and Drug Administration approved Impact’s Inrebic for the treatment for adult patients with certain types of myelofibrosis, cancers of the bone marrow.

Report: Projected Sales of 10 Top-Selling Drugs Through 2024

Biospace news - Fri, 08/16/2019 - 02:00
Although some of the top-selling drugs in the world are facing patent cliffs between now and then, many of them are still projected to continue being big sellers between now and 2024.

Will Long-Term Post-Marketing Studies Become the Norm for Gene Therapy Companies?

Biospace news - Fri, 08/16/2019 - 02:00
Current rules set by the FDA allow companies to assess whether or not long-term follow-ups are required based on risk factors determined by the company.

New Drug Helps Blood Stem Cells Recover from Chemotherapy and Radiation

Biospace news - Fri, 08/16/2019 - 02:00
The researchers are currently optimizing the drug and similar drugs so they can advance to human clinical trials.

BioSpace Movers & Shakers, Aug. 16

Biospace news - Fri, 08/16/2019 - 02:00
Biopharma companies strengthen their executive ranks and boards with new additions.

FDA Approves Genentech's Rozlytrek for Two Rare Types of Cancer

Biospace news - Fri, 08/16/2019 - 02:00
The FDA approved Rozlytrek for the treatment of adults with ROS1-positive, metastatic non-small cell lung cancer. Also, Rozlytrek secured accelerated approval for the treatment of solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance...

Research Roundup: Radical Insights into Cellular Dark Matter and More

Biospace news - Fri, 08/16/2019 - 02:00
Every week there are numerous scientific studies published. Here’s a look at some of the more interesting ones.

BIO CEO Warns About Government Pricing Measures at CLSA Event

Biospace news - Fri, 08/16/2019 - 02:00
When it comes to potential pricing controls of the pharmaceutical industry, Jim Greenwood, chief executive officer of BIO, grimly stated that “nothing good” was going on in the halls of power in Washington, D.C.

Experimental Endoscope Captures 3D Images Smaller than a Single Cell

Biospace news - Fri, 08/16/2019 - 02:00
The device is most likely to be used in optogenetics, where light is used to stimulate cellar activity. It may also have functionality for monitoring tissues and cells during medical procedures.