Search Results for “ oncology” – Page 63

Two Former Receptos Execs Launch New San Diego Biotech Startup With $100M

Gossamer Bio is launching with $100 million in seed financing and two biotech heavy hitters as leadership.

Source: drugdu
486
January 10, 2018

Ionis’ Inotersen NDA Accepted for Priority Review by the FDA

Ionis Pharmaceuticals, Inc. (NASDAQ: IONS) announced that its New Drug Application (NDA) for inotersen has been accepted for Priority Review by the U.S. Food and Drug Administration (FDA). Inotersen is an investigational drug for the treatment of patients with hereditary TTR amyloidosis (hATTR). Priority Review is granted by the FDA to drugs with the potential to address a serious condition and, if approved, would provide a significant improvement in safety or effectiveness of the treatment, prevention, or diagnosis of a serious condition. The FDA has set a Prescription Drug User Fee Act (PDUFA) date of July 6, 2018. “TTR amyloidosis is a progressive, fatal disease with very limited treatment options. Receiving Priority Review in the U.S. and Accelerated Assessment in the EU for inotersen shows that the regulatory agencies recognize the high unmet need and the urgency to identify effective therapies to treat patients with this devastating disease,” said Sarah ...

Source: Prnewswire;
477
January 10, 2018

FDA hATTR New Approvals TTR amyloidosis

How doctors and bots can work together

The fear that machines will replace humans in the workplace is not a new one. In 1930, economist John Maynard Keynes conjectured that in the years to come, modern economies would face a new kind of affliction: what Keynes called “technological unemployment.”

Source: Venturebeat
540
January 10, 2018

AI digital health Market Views

The Healthcare Technology Winners of 2017

It’s been a big year in healthcare technology. Healthcare Analytics News™ reached out to experts across our 8 coverage areas to determine which companies, people, and projects made the biggest waves. The winners of 2017 ushered in advances that have turned heads, resulted in measurable improvements, and given reason to believe that this high-speed sector is not built on hype alone.

Source: hcanews
492
January 1, 2018

healthcare technology Market Views

Google-Backed FLX Bio Scores $60M Financing

FLX Bio, Inc., a biopharmaceutical company focused on the discovery and development of oral small-molecule drugs to activate the immune system against cancer, today announced the completion of a $60 million Series C private financing. The financing included new investments from GV (formerly Google Ventures) and other undisclosed investors as well as existing investors including The Column Group, Kleiner Perkins, Topspin Partners and Celgene Corporation.

Source: Flxbio
422
December 27, 2017

Market Views oral small-molecule drugs

Janssen buys into Legend’s CART therapy

Janssen has entered into a global collaboration and license agreement with Legend Biotech USA and Legend Biotech Ireland to develop, manufacture and commercialise experimental CART-cell therapy LCAR-B38M.

Source: Pharmatimes
412
December 26, 2017

CAR-T therapy Company Insight Market Views

Roche and Ignyta Reach Definitive Merger Agreement

Roche (SIX: RO, ROG; OTCQX: RHHBY) and Ignyta, Inc. (NASDAQ: RXDX) today announced they have entered into a definitive merger agreement for Roche to fully acquire Ignyta at a price of US$ 27.00 per share in an all-cash transaction. This corresponds to a total transaction value of US$ 1.7 billion on a fully diluted basis. This price represents a premium of 74% to Ignyta’s closing price on 21 December 2017 and a premium of 71% and 89% to Ignyta’s 30-day and 90-day volume weighted average share price on 21 December 2017, respectively. The merger agreement has been unanimously approved by the boards of Ignyta and Roche.

Source: Roche
529
December 25, 2017

Ignyta Market Views Roche

U.S. FDA Grants Priority Review to Janssen for Apalutamide as a Treatment for Non-Metastatic Castration-Resistant Prostate Cancer

Janssen Biotech, Inc. (Janssen) announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review designation for the New Drug Application (NDA) for apalutamide, an investigational, next-generation oral androgen receptor (AR) inhibitor for the treatment of men with non-metastatic castration-resistant prostate cancer (CRPC). Currently, there are no FDA-approved treatments for patients with non-metastatic CRPC.

Source: Janssen
489
December 25, 2017

CRPC inhibitor New Approvals

US FDA Accepts Regulatory Submission for TAGRISSO (Osimertinib) in 1st-Line EGFR-Mutated Non-Small Cell Lung Cancer

AstraZeneca today announced that the US Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) for the use of TAGRISSO® (osimertinib), a third-generation, irreversible epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) with clinical activity against central nervous system (CNS) metastases, in the 1st-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have EGFR mutations (exon 19 deletions or exon 21 (L858R) substitution mutations). The FDA has granted TAGRISSO Priority Review status, and previously granted Breakthrough Therapy Designation for TAGRISSO in the 1st-line treatment of patients with metastatic EGFR mutation-positive (EGFRm) NSCLC.

Source: finance.yahoo
613
December 19, 2017

AstraZeneca CNS FDA New Approvals NSCLC TAGRISSO®

Atlas and OrbiMed back Boston’s Kyn in $49M round to pursue immunometabolism therapies

Kyn is led by an Atlas entrepreneur-in-residence Mark Manfredi, who was previously chief scientific officer at Raze Therapeutics (also an Atlas-funded startup). Raze raised a $24 million Series A in 2014, but the company appears to have wound down pretty quickly. The website is no longer active, and Manfredi said Raze still has some assets and collaborations, but no longer employs anyone. Atlas’ Bruce Booth says the underlying cancer metabolism biology was too complicated to warrant further investment. Before Raze, Manfredi was VP of oncology biology at Takeda.

Source: Endpts
508
December 18, 2017

cancer immunometabolism Market Views Series

Two Former Receptos Execs Launch New San Diego Biotech Startup With $100M

Ionis’ Inotersen NDA Accepted for Priority Review by the FDA

How doctors and bots can work together

The Healthcare Technology Winners of 2017

Google-Backed FLX Bio Scores $60M Financing

Janssen buys into Legend’s CART therapy

Roche and Ignyta Reach Definitive Merger Agreement

U.S. FDA Grants Priority Review to Janssen for Apalutamide as a Treatment for Non-Metastatic Castration-Resistant Prostate Cancer

US FDA Accepts Regulatory Submission for TAGRISSO (Osimertinib) in 1st-Line EGFR-Mutated Non-Small Cell Lung Cancer

Atlas and OrbiMed back Boston’s Kyn in $49M round to pursue immunometabolism therapies

Trending Topics

Hot Tags

Subscribe

more

more

Customer Services

About Us

Buy on Drugdu.com

Sell on Drugdu.com

Blogroll

Free APP

Follow Us