FDA – Page 14

After disappointing 2016, new drug approvals roared back to life in 2017

New drug approvals all but screeched to a halt in 2016, with a measly 22 new OKs after a pair of bountiful years. But the FDA wasted no time in 2017, signing off on 12 drugs in the first quarter alone—besting its record for the same period of any year in recent history.

Source: fiercebiotech
630
January 4, 2018

FDA Approves Angiotensin-II for Septic Shock

The FDA approved angiotensin-II (Giapreza) as a new intravenous vasopressor for septic shock and other forms of distributive shock. The first new FDA-approved vasopressor in decades, angiotensin-II could significantly change the management of severe septic shock.

Source: PulmCCM
529
January 3, 2018

FDA New Approvals sepsis septic shock

Roche snags another Perjeta combo nod, but will ‘weak’ data limit its use?

Analysts and investors think Perjeta’s end-of-the-year indication may not be as lucrative as they once hoped. The FDA green-lighted the drug in tandem with giant Herceptin and chemo for HER2-positive, post-surgery breast cancer patients with a high risk of recurrence. Patients should receive up to 18 cycles of the regimen over the course of one year, according to the indication.

Source: fiercepharma
566
December 28, 2017

breast cancer Company Insight FDA HER2-positive

FDA releases new guidelines for 3D printing devices

The U.S. Food and Drug Administration (FDA) has issued new guidelines related to the 3D printing of medical devices. FDA is now preparing for a significant wave of new technologies that are nearly certain to transform medical practice.

Source: biospectrumasia
577
December 27, 2017

3D printing FDA medical device polices

FDA clears Shire’s dosing software for haemophilia A SHARE

Irish biotechnology firm Shire has received 510(k) marketing clearance for its myPKFiT for ADVATE [Antihemophilic Factor (Recombinant)] software from the US Food and Drug Administration (FDA).

Source: medicaldevice-network
609
December 26, 2017

ADVATE FDA haemophilia A Shire

FDA rolls out an early and historic OK for Spark’s pioneering gene therapy

Spark Therapeutics $ONCE has scored an historic FDA approval of Luxturna, the world’s first such AAV-delivered gene therapy designed to cure a rare eye disease triggered by a genetic mutation. The drug is OK’d for RPE65 mutation linked retinal dystrophy. The treatment uses a viral vector to insert the correct copy of a gene retinal cells need to create a protein that turns light into electric signals which can restore vision lost to the disease. As with the earlier pioneering approval of the world’s first CAR-T, FDA commissioner Scott Gottlieb did the honors in recognizing the importance of this approval. And he says the agency will make sure that the regulatory path is straight and clear for the rest of the field looking to following Spark’s footsteps. “We’re at a turning point when it comes to this novel form of therapy and at the FDA, we’re focused on establishing ...

Source: drugdu
760
December 20, 2017

FDA genetic mutation. Luxturna New Approvals rare eye disease

Ultragenyx Sells Priority Review Voucher for $130 million

“The sale of the PRV provides us with an important source of non-dilutive capital to help advance our pipeline of rare and ultra-rare therapies, and accelerates the availability of these potential therapies to patients,” said Emil D. Kakkis, M.D., Ph.D., Chief Executive Officer and President of Ultragenyx.

Source: finance.yahoo
725
December 20, 2017

FDA Market Views Novartis PRV

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
619
December 19, 2017

AstraZeneca CNS FDA New Approvals NSCLC TAGRISSO®

FDA Accepts Biologics License Application for Fremanezumab with Priority Review for Prevention of Migraine and Grants Fast Track Designation for Cluster Headache Development Program

Teva Pharmaceutical Industries Ltd., (NYSE and TASE: TEVA) today announced the U.S. Food and Drug Administration (FDA) has accepted for review the company’s Biologics License Application (BLA) for fremanezumab, an anti-calcitonin gene-related peptide (anti-CGRP) monoclonal antibody for the preventive treatment of migraine. Additionally, the FDA has granted fast track designation for fremanezumab for the prevention of cluster headache.

Source: finance.yahoo
575
December 19, 2017

cluster headache FDA fremanezumab migraine New Approvals Teva

Surgical Device Company Virtual Incision Raises $18 Million in Series B

Virtual Incision’s RASD weighs just two pounds and is designed to perform the procedure through a smaller incision, potentially reducing recovery time and mitigating the risk of surgical complications.

Source: xtalks
578
December 18, 2017

FDA medical device RASD Series

After disappointing 2016, new drug approvals roared back to life in 2017

FDA Approves Angiotensin-II for Septic Shock

Roche snags another Perjeta combo nod, but will ‘weak’ data limit its use?

FDA releases new guidelines for 3D printing devices

FDA clears Shire’s dosing software for haemophilia A SHARE

FDA rolls out an early and historic OK for Spark’s pioneering gene therapy

Ultragenyx Sells Priority Review Voucher for $130 million

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

FDA Accepts Biologics License Application for Fremanezumab with Priority Review for Prevention of Migraine and Grants Fast Track Designation for Cluster Headache Development Program

Surgical Device Company Virtual Incision Raises $18 Million in Series B

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