Medical Tidbits, FDA Accelerated Approvals

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FDA granted accelerated approval to alectinib (ALECENSA capsules, Hoffmann-La Roche Inc.) for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib.   for more Information:

FDA approves first emergency treatment for overdose of certain types of chemotherapy

The U.S. Food and Drug Administration today approved Vistogard (uridine triacetate) for the emergency treatment of adults and children who receive an overdose of the cancer treatment fluorouracil or capecitabine, or who develop certain severe or life-threatening toxicities within four days of receiving these cancer treatments. read more

FDA approves new oral therapy to treat ALK-positive lung cancer

The U.S. Food and Drug Administration today approved Alecensa (alectinib) to treat people with advanced (metastatic) ALK-positive non-small cell lung cancer (NSCLC) whose disease has worsened after, or who could not tolerate treatment with, another therapy called Xalkori (crizotinib). read more

Chugai’s ALK Inhibitor “Alecensa®” Accelerated Approval in Three Months after Priority Review Designation in the US

TOKYO–(BUSINESS WIRE)–Chugai Pharmaceutical Co., Ltd. (TOKYO:4519) announced today that Genentech Inc., a member of the Roche Group, obtained approval from the U.S. Food and Drug Administration (FDA), for the anti-cancer agent, alectinib hydrochloride (brand name: Alecensa®) for the indication of “anaplastic lymphoma kinase (ALK) positive, metastatic non-small cell lung cancer (NSCLC) who have progressed on or those intolerant to crizotinib.”  read more

Medtronic Announces New High-Tech Facility in Galway; Building on Global Synergies

New facility to manufacture Medtronic’s market- leading drug-coated balloons (DCB) technology

DUBLIN- December 14, 2015 – Medtronic plc (NYSE:MDT), a global leader in medical technology, services and solutions, today announced a new manufacturing facility in Galway, Ireland that will manufacture the market-leading IN.PACT® Admiral® drug-coated balloon (DCB) for the treatment of peripheral artery disease (PAD). PAD is a build-up of plaque in arteries throughout the body leading to reduced blood flow to the limbs, organs, and the brain. Patients with PAD are at higher risk for stroke and heart attack. read more

Medtronic Announces FDA Approval of Infuse® Bone Graft for Three New Spine Surgery Indications

Medtronic plc (NYSE: MDT) today announced U.S. Food and Drug Administration (FDA) approval of additional spine surgery indications for Infuse® Bone Graft. Upon receiving final labeling approval from the FDA, the company expects to begin marketing these expanded indications in early calendar year 2016. With this expanded approval, Medtronic will be able to market Infuse Bone Graft for use with certain spine implants made of polyetheretherketone (PEEK) in oblique lateral interbody fusion (OLIF) and anterior lumbar interbody fusion (ALIF) procedures. read more

Medtronic and Samsung Expand Alliance to Develop Connected Health Solutions for Neuromodulation Patients and Healthcare Providers

Medtronic plc (NYSE:MDT), the global leader in medical technology, and Samsung Electronics America, a global leader in consumer electronics and digital health, today announced a broad-based strategic alliance to accelerate the development of digital health solutions for the millions of people suffering from chronic pain, movement disorders, incontinence, and other conditions who could benefit from neuromodulation therapy. People with these conditions, as well as their healthcare providers, need convenient access to mobile technology to better manage their health. Medtronic is developing a range of future solutions that will enhance and help deliver personalized patient care and improve healthcare outcomes. read more

Invitation to Improve Community Drug Disposal Programs Through Grant Funding

To help support education and awareness of community drug disposal programs, non-profit organizations throughout the U.S. and Puerto Rico are invited to apply for grant funding from the Cardinal Health Foundation.

“The Generation Rx Medication Disposal Grant Program helps support our communities as they strive to prevent the misuse of prescription medications,” said Betsy Walker, director of Community Relations at Cardinal Health. “Proper medication disposal is a simple way adults can help keep their families safe, so it is critical for communities to have the support to offer medication disposal options.” read more

Egalet Signs Agreement with Teva Pharmaceutical Industries to Commercialize SPRIX® (ketorolac tromethamine) Nasal Spray in Select Geographies Outside the United States

WAYNE, Pa., Dec. 14, 2015 /PRNewswire/ — Egalet Corporation (Nasdaq: EGLT) (“Egalet”), a fully integrated specialty pharmaceutical company focused on developing, manufacturing and commercializing innovative treatments for pain and other conditions, today announced a collaboration agreement with Teva Pharmaceutical Industries Ltd. (“Teva”), a leading global pharmaceutical company. With this agreement, Egalet granted Teva exclusive marketing and commercialization rights to SPRIX (ketorolac tromethamine) Nasal Spray in Israel, Gaza and the West Bank. Teva, a leader in the commercialization of central nervous system (CNS) products, including many in pain management, will be responsible for registering, marketing, distributing and selling SPRIX Nasal Spray in these territories. Under the terms of the agreement, Egalet will receive an undisclosed upfront payment, sales-based milestones and will share in the profits from net sales of SPRIX in these territories.  read more

AltheaDx Completes $30M Series C Financing

Among the firms joining WXHV are new investors WuXi PharmaTech, Ally Bridge Group and ALMA Life Sciences. This investment will enable the company to invest in prospective outcome trials for its IDgenetix® testing portfolio and expand its commercial capabilities. The IDgenetix® pharmacogenetics (PGx) testing portfolio enables personalized therapeutic decisions for patients suffering from some of the most prevalent clinical conditions, including: cardiovascular disease, neuropsychiatric disorders and pain. The Series C financing will also provide capital for product enhancements, international opportunities as well as other investments in long-term growth. read more

Initiation of first multinational study to evaluate safety of OFEV® (nintedanib) with add-on of pirfenidone in patients with IPF

INGELHEIM, Germany–(BUSINESS WIRE)–Boehringer Ingelheim today announces the initiation of trial 1199.222 (ClinicalTrials.gov Identifier: NCT02579603), a new 12 week study to assess the safety, tolerability and pharmacokinetics of add-on treatment with pirfenidone to background therapy with OFEV® in patients with Idiopathic Pulmonary Fibrosis (IPF).1 The trial’s primary endpoint is the percentage of patients with on-treatment gastrointestinal (GI) adverse events from baseline to week 12.1 read more

AltheaDx Completes $30M Series C Financing

Among the firms joining WXHV are new investors WuXi PharmaTech, Ally Bridge Group and ALMA Life Sciences. This investment will enable the company to invest in prospective outcome trials for its IDgenetix® testing portfolio and expand its commercial capabilities. The IDgenetix® pharmacogenetics (PGx) testing portfolio enables personalized therapeutic decisions for patients suffering from some of the most prevalent clinical conditions, including: cardiovascular disease, neuropsychiatric disorders and pain. The Series C financing will also provide capital for product enhancements, international opportunities as well as other investments in long-term growth. read more

Poxel Announces Imeglimin Phase 2b Initiation in Japan

LYON, France–(BUSINESS WIRE)–POXEL SA (Euronext – POXEL – FR0012432516), a biopharmaceutical company focused on the development of innovative drugs to treat type 2 diabetes, today provided an update on the clinical development of its two lead pipeline assets: Imeglimin, the first in a new class of oral anti-diabetic agents, and PXL770, a direct activator of the adenosine monophosphate-activated kinase (AMPK). The first Phase 2b clinical trial site for Imeglimin has been opened in Japan, starting the planned rapid late-stage clinical development program for Imeglimin in the Japanese market. For PXL770, preparations for the start of a Phase 1 trial in Germany are on track to obtain first clinical data by mid-2016. read more

Premaitha Health PLC Premaitha Health signs Investment Agreement with Thermo Fisher Scientific

Premaitha’s CE-marked, non-invasive prenatal screening (NIPT) product, the IONA® test, runs on Thermo Fisher’s two sequencing instruments, the Ion Proton and Ion Chef. Thermo Fisher is the world leader in serving science, with revenues of $17 billion and approximately 50,000 employees in 50 countries. read more

AcelRx Pharmaceuticals Conducts Pre-NDA Meeting with U.S. Food and Drug Administration for ARX-04

PRNewswire/ — AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies designed for the treatment of acute pain, today reported on the outcome of the ARX-04 (sufentanil sublingual tablet, 30 mcg) pre-NDA meeting held recently with the U.S. Food and Drug Administration (FDA).  The Company intends to pursue an ARX-04 indication for moderate-to-severe pain in a medically supervised setting. To support this indication, based on feedback from the FDA, the Company will expand the clinical program by approximately 165 patients to include individuals from specific populations and settings. Enrollment in the ongoing SAP302 open-label study in the emergency room will be increased, and a new study known as SAP303 is expected to be initiated in the first quarter of 2016 in postoperative patients with moderate-to-severe pain. SAP303 will focus on enrolling patients greater than 40 years of age and will allow for administration of ARX-04 for up to 12 hours. With these modifications, assuming successful completion of the studies, AcelRx anticipates submitting the NDA for ARX-04 in the second half of 2016 read more

Telesta Therapeutics Inc. (TSX:TST; PNK:BNHLF) today provided an update on the Biologics License Application (BLA) for their drug MCNA[1] that the US Food and Drug Administration (FDA) is currently reviewing under Priority Review.  

On December 10, 2015, Telesta and the FDA conducted a scheduled late-cycle teleconference with the objective of discussing any substantive review issues identified to date by the FDA.  The review issues discussed were related to Chemistry, Manufacturing and Control issues (CMC) and Telesta’s manufacturing facility.  As part of the meeting, the FDA briefly discussed the recent Advisory Committee and provided answers to several questions posed by the sponsor.  A late-cycle meeting is not a decisional meeting and is used by the FDA to   share information, identify deficiencies, and discuss any substantive review issues identified to date by the FDA and plan the rest of the review.

 

 

 

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