FDA clears investigational new drug application for Calibr's 'switchable' CAR-T therapy
(Scripps Research Institute) Calibr, the drug discovery and development division of Scripps Research, today announced that the US Food and Drug Administration has given clearance to the Investigational New Drug (IND) application for Calibr's 'switchable' CAR-T cell therapy, which is being evaluated for the treatment of certain cancers, including relapsed/refractory B-cell malignancies such as non-Hodgkin lymphoma and chronic lymphocytic leukemia. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - February 3, 2020 Category: International Medicine & Public Health Source Type: news

Hematologic Malignancies: Regulatory Considerations for Use of Minimal Residual Disease in Development of Drug and Biological Products for Treatment
Assist sponsors planning to use minimal residual disease (MRD) as a biomarker in clinical trials conducted under an investigational new drug application (IND) or to 19 support marketing approval of drugs and biological products2 for the treatment of specific 20 hematologic malignancies. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 24, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

INHIBITOR Therapeutics Submits Investigational New Drug Application for Treatment of Patients with Late-Stage Prostate Cancer
SUBA™-Itraconazole to be Tested in Combination with Standard of Care Chemotherapy for Metastatic Castrate Resistant Prostate Cancer FDA Confirms the Proposed Study Adequately Addresses the Objectives Necessary to Support a Regulatory Submission TAMPA... Biopharmaceuticals, Oncology, FDA INHIBITOR Therapeutics, SUBA-Itraconazole, prostate cancer (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - November 25, 2019 Category: Pharmaceuticals Source Type: news

Three UCLA scientists receive grants totaling more than $18 million
Three researchers at the  Eli and Edythe Broad Center of Regenerative Medicine and Stem Cell Research at UCLA have received awards totaling more than $18 million from the California Institute for Regenerative Medicine, the state’s stem cell agency. The recipients areDr. Sophie Deng, professor of ophthalmology at the UCLA Stein Eye Institute;  Yvonne Chen, a UCLA associate professor of microbiology, immunology and molecular genetics; andDr. Caroline Kuo, a UCLA assistant clinical professor of pediatrics. The awards were announced at a CIRM meeting today.Deng ’s four-year, $10.3 million award ...
Source: UCLA Newsroom: Health Sciences - October 31, 2019 Category: Universities & Medical Training Source Type: news

Digital submission of adverse event reports for investigational new drug applications
The U.S. Food and Drug Administration is taking steps towards requiring electronic submission of certain safety reports for products being evaluated by the FDA under an investigational new drug (IND) application into the FDA's Adverse Event Reporting System (FAERS). The planned process for submissions is outlined in a new draft guidance, and the FDA is also making available supporting technical specification documents. (Source: World Pharma News)
Source: World Pharma News - October 29, 2019 Category: Pharmaceuticals Tags: Featured FDA Regulatory Affairs Source Type: news

The Importance of Quality Data and Data Fitness in a Regulatory...
This webinar aims to provide guidance and support for those preparing a submission of their Investigational New Drug (IND) to regulatory bodies by exploring Data Quality Oversight (DQO) combined with...(PRWeb October 15, 2019)Read the full story at https://www.prweb.com/releases/the_importance_of_quality_data_and_data_fitness_in_a_regulatory_submission_upcoming_webinar_hosted_by_xtalks/prweb16643428.htm (Source: PRWeb: Medical Pharmaceuticals)
Source: PRWeb: Medical Pharmaceuticals - October 15, 2019 Category: Pharmaceuticals Source Type: news

Webinar: Submitting IND Safety Reports to FDA Adverse Event Reporting System (FAERS)- Nov. 1, 2019
FDA is establishing a new submission process for investigational new drug (IND) safety reports. Submission of this important safety information as structured data will improve FDA ’s ability to review and track safety signals that occur during the conduct of clinical trials. It will also provide spon (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 24, 2019 Category: Drugs & Pharmacology Authors: FDA Source Type: news

DEA Moving on MMJ BioPharma Marijuana Cultivation Application for FDA...
Once awarded, the DEA approval will allow MMJ BioPharma Cultivation to cultivate cannabis plants to support MMJ International Holdings investigational new drug (IND) filings with the FDA for Multiple...(PRWeb August 27, 2019)Read the full story at https://www.prweb.com/releases/dea_moving_on_mmj_biopharma_marijuana_cultivation_application_for_fda_study_supply/prweb16530493.htm (Source: PRWeb: Medical Pharmaceuticals)
Source: PRWeb: Medical Pharmaceuticals - August 27, 2019 Category: Pharmaceuticals Source Type: news

"Research Investigational New Drug Applications – What You Need To Know" June 25, 2019 Issue
FDA recently released an update to clarify when ‘Research’ vs. ‘Commercial’ should be selected on FDA Form 1571, and thus when electronic common technical document or “eCTD” requirements would apply for an investigational new drug or “IND” application. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - June 26, 2019 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Incysus Therapeutics receives US patent for its technology
Biopharma company Incysus Therapeutics has been issued a patent by the U.S. Patent and Trademark Office for “Drug Resistant Immunotherapy for treatment of a cancer.”  According to the company, the patent covers the treatment of brain cancer with the combination of certain chemotherapies and a T cell genetically modified to confer chemotherapy resistance.  According to the company, Incysus has two Investigational New Drug applications (INDs) approved by the U.S. Food and Drug Administration… (Source: bizjournals.com Health Care News Headlines)
Source: bizjournals.com Health Care News Headlines - June 21, 2019 Category: Health Management Authors: Tyler Patchen Source Type: news

Incysus Therapeutics receives US patent for its technology
Biopharma company Incysus Therapeutics has been issued a patent by the U.S. Patent and Trademark Office for “Drug Resistant Immunotherapy for treatment of a cancer.”  According to the company, the patent covers the treatment of brain cancer with the combination of certain chemotherapies and a T cell genetically modified to confer chemotherapy resistance.  According to the company, Incysus has two Investigational New Drug applications (INDs) approved by the U.S. Food and Drug Administration… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - June 21, 2019 Category: Biotechnology Authors: Tyler Patchen Source Type: news

Personalized Stem Cells, Inc. Submits Investigational New Drug (IND)...
Personalized Stem Cells, Inc. submits Investigational New Drug (IND) application for the treatment of osteoarthritis with stem cells.(PRWeb June 18, 2019)Read the full story at https://www.prweb.com/releases/personalized_stem_cells_inc_submits_investigational_new_drug_ind_application_for_the_treatment_of_osteoarthritis_with_stem_cells/prweb16384983.htm (Source: PRWeb: Medical Pharmaceuticals)
Source: PRWeb: Medical Pharmaceuticals - June 18, 2019 Category: Pharmaceuticals Source Type: news

Content and Format of INDs for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-Derived Products. Questions and Answers
Clinical/Medical; Investigational New Drug Applications; Pharmacology/Toxicology (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - June 11, 2019 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Rare Diseases: Early Drug Development and the Role of Pre-IND Meetings
The purpose of this guidance is to assist sponsors of drug and biological products for the 19 treatment of rare diseases in early development and in the planning of and participation in formal 20 pre-investigational new drug application (pre-IND) meetings with the Food and Drug 21 Administration (FD (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - June 11, 2019 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-derived Products
Clinical/Medical; Investigational New Drug Applications; Pharmacology/Toxicology (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - June 11, 2019 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Clinical Investigator Inspection List (CLIIL)
The Clinical Investigator Inspection List contains names, addresses, and other pertinent information gathered from inspections of clinical investigators who have performed studies with investigational new drugs. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - June 5, 2019 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Delaware-developed CRISPR cancer therapy edging closer to human testing
Christiana Care Health System ’s Gene Editing Institute is preparing a preliminary investigational new drug (IND) application that, if approved by the Food and Drug Administration, would allow the institute to begin human testing of a CRISPR therapy it is developing to treat non-small cell lung cancer. CRISPR, an acronym for Clustered Regularly Interspaced Short Palindromic Repeats, is a technique that allows researchers to alter DNA sequences and modify gene function. Christiana Care’s Gene… (Source: bizjournals.com Health Care:Physician Practices headlines)
Source: bizjournals.com Health Care:Physician Practices headlines - May 6, 2019 Category: American Health Authors: John George Source Type: news

FDA Warns Against Using Young Blood As Medical Treatment
(CNN) — Wannabe vampires, beware: The US Food and Drug Administration warned Tuesday against using plasma infusions from young blood donors to ward off the effects of normal aging as well as other more serious conditions. Plasma, the liquid portion of the blood, contains proteins that help clot blood. The infusions are promoted to treat a variety of conditions, including normal aging and memory loss as well as serious conditions such as dementia, multiple sclerosis, heart disease and post-traumatic stress disorder. “There is no proven clinical benefit of infusion of plasma from young donors to cure, mitigate, t...
Source: WBZ-TV - Breaking News, Weather and Sports for Boston, Worcester and New Hampshire - February 19, 2019 Category: Consumer Health News Authors: Health – CBS Boston Tags: Health News Offbeat Blood Donations CNN Source Type: news

Spero Therapeutics Announces FDA Acceptance of IND Application for SPR994
Cambridge, Mass., Feb. 04, 2019 (Globe Newswire) -- Spero Therapeutics, Inc. (Nasdaq:SPRO), a multi-asset clinical-stage biopharmaceutical company focused on identifying, developing and commercializing treatments in high unmet need areas involving multi-drug resistant (MDR) bacterial infections, today announced the acceptance by the U.S. Food and Drug Administration (FDA) of its Investigational New Drug (IND) application for SPR994, Spero’s lead product candidate designed to be...This story is related to the following:Pharmaceuticals (Source: Industrial Newsroom - Health, Medical and Dental Supplies)
Source: Industrial Newsroom - Health, Medical and Dental Supplies - February 5, 2019 Category: Medical Devices Source Type: news

Critical impacts of the government shutdown on the FDA and clinical research
Rachel Martukovich, Clinical Research Associate for IMARC Research, Inc. The recent partial government shutdown, which is now the longest in US history, has various stakeholders in the medical device and pharmaceutical industries concerned with the potential impact on the world of clinical research.  The FDA is one of the federal agencies most affected, as the budget for fiscal year 2019 is on hold until the shutdown ends and Congress can appropriate funds. FDA Commissioner Scott Gottlieb recently tweeted that “The lapse in funding represents one of the most significant operational challenges in FDA’s rec...
Source: Mass Device - January 17, 2019 Category: Medical Devices Authors: Danielle Kirsh Tags: Blog IMARC Source Type: news

Partial Government Shutdown's Impact On FDA Drug Approvals
Besides the government shutdown's impact on food inspection, there are also short-term and possibly longer-term implications for drug development. The FDA has suspended reviews of existing Investigational New Drug (IND) and Biologics License Application (BLA) applications not covered by user fees. (Source: Forbes.com Healthcare News)
Source: Forbes.com Healthcare News - January 10, 2019 Category: Pharmaceuticals Authors: Joshua Cohen, Contributor Source Type: news

Nobilis files IND for trial to study drug-device PTSD therapy
Nobilis Therapeutics said yesterday that it filed an investigational new drug application with the FDA to kick off a Phase IIb trial of its NBTX-001 drug-device PTSD therapy. The Portland, Ore.-based company is developing a portable inhalation device designed to deliver a xenon gas mixture. Get the full story at our sister site, Drug Delivery Business News. The post Nobilis files IND for trial to study drug-device PTSD therapy appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - January 8, 2019 Category: Medical Devices Authors: Sarah Faulkner Tags: Clinical Trials Drug-Device Combinations Featured Food & Drug Administration (FDA) Neurological Pharmaceuticals nobilistherapeutics Source Type: news

$5.1 million grant will fund research to develop stem cell-based therapy for blinding eye conditions
Scientists at the UCLA  Eli and Edythe Broad Center of Regenerative Medicine and Stem Cell Research and the Stein Eye Institute have been awarded a $5.1 million grant from the California Institute for Regenerative Medicine to advance the development of a novel therapy for blinding retinal conditions.The award by the California Institute for Regenerative Medicine, or CIRM, will support the development of a treatment that will use patients ’ own skin cells to generate autologous induced pluripotent stem cells to derive retinal pigment epithelium cells, which are lost in many blinding eye conditions....
Source: UCLA Newsroom: Health Sciences - October 19, 2018 Category: Universities & Medical Training Source Type: news

FDA lifts hold on CRISPR, Vertex sickle cell trial
CRISPR Therapeutics and Vertex Pharmaceuticals announced that the U.S. FDA has lifted the clinical hold and accepted the Investigational New Drug application for a new treatment for sickle cell disease. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - October 11, 2018 Category: Pharmaceuticals Source Type: news

OSE Immunotherapeutics and Oncology Physician Network GERCOR Announce Submission of Investigational New Drug Application to Evaluate Tedopi(R) in Combination with Nivolumab in Pancreatic Cancer
The Phase 2 clinical trial of Tedopi® in pancreatic cancer will be sponsored by the oncology group GERCOR The study will explore Tedopi®’s potential in an additional oncology indication NANTES, France, Oct. 10, 2018 -- (Healthcare Sales & Mar... Biopharmaceuticals, Oncology, Regulatory OSE Immunotherapeutics, Tedopi, pancreatic cancer (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - October 10, 2018 Category: Pharmaceuticals Source Type: news

JAK Inhibitors Promising for Alopecia Areata JAK Inhibitors Promising for Alopecia Areata
Two investigational new drugs are emerging for patients with moderate to severe hair loss, for whom there are currently no reliable treatments.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - September 17, 2018 Category: Consumer Health News Tags: Dermatology News Source Type: news

Experimental drug eases effects of gluten for celiac patients on gluten-free diet
(Digestive Disease Week) An investigational new drug offers hope of relief for celiac disease patients who are inadvertently exposed to gluten while on a gluten-free diet. Findings of the first phase 2 study of a biologic immune modulator in celiac disease will be presented at the upcoming Digestive Disease Week ® (DDW) 2018. Inadvertent exposure to gluten can be a frequent occurrence for celiac patients that triggers symptoms, such as pain in the gut and diarrhea, due to intestinal damage. (Source: EurekAlert! - Biology)
Source: EurekAlert! - Biology - May 22, 2018 Category: Biology Source Type: news

FDA is asking for more information on application forms: Here ’s why that’s good for innovation and improving health
Christopher Leptak, M.D., Ph.D., is Director, Office of New Drug’s Regulatory Science Program in the FDA’s Center for Drug Evaluation and Research. By: Dr. Christopher Leptak To be most effective, electronic health records (EHRs) use a systematized and standardized nomenclature for the hundreds of thousands of clinical terms that characterize patient care. This helps to ensure consistency from EHR to EHR and allows these records to be usable from healthcare entity to health care entity, a concept known as interoperability. This nomenclature, used by both industry and the federal government, is called SNOMED CT....
Source: Mass Device - May 17, 2018 Category: Medical Devices Authors: Danielle Kirsh Tags: Blog FDA Voice Source Type: news

Mesothelioma Clinical Trial Evaluating Selecta ’ s SEL-403 Begins
A clinical trial testing a new therapeutic modality on patients with pleural and peritoneal mesothelioma is officially underway. Selecta Biosciences, a clinical-stage biopharmaceutical company, and the National Cancer Institute (NCI) teamed up for the phase 1 clinical trial under the Cooperative Research and Development Agreement. The trial will evaluate safety and tolerability of SEL-403, Selecta’s investigational new drug combination consisting of a potent anti-tumor agent (LMB-100) and a drug that prevents an immune response (SVP-Rapamycin). LMB-100 and SVP-Rapamycin have been studied separately in clinical trials...
Source: Asbestos and Mesothelioma News - March 29, 2018 Category: Environmental Health Authors: Daniel King Source Type: news

Therapix Biosciences Announces FDA Clearance of Investigational New Drug (IND) for Phase IIa Clinical Trial of THX-110 in the Treatment of Chronic Low Back Pain
TEL AVIV, Israel, March 20, 2018 -- (Healthcare Sales & Marketing Network) -- Therapix Biosciences Ltd. (NASDAQ: TRPX) ("Therapix" or the "Company"), a biopharmaceutical company focused on discovering, developing, and commercializing n... Biopharmaceuticals, FDA Therapix Biosciences, cannabinoid, THX-110, Low Back Pain (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - March 20, 2018 Category: Pharmaceuticals Source Type: news

Terminally Ill People Want More Access to Experimental Treatments. Here ’s Why Doctors Are Pushing Back
Doctors and medical ethicists are criticizing a bill supported by President Donald Trump that would allow people with fatal illnesses to have access to drugs not yet approved by federal authorities. “Right to Try” is a policy that Trump mentioned during his State of the Union Address on Jan. 30. “People who are terminally ill should not have to go from country to country to seek a cure — I want to give them a chance right here at home,” he said. “It is time for the Congress to give these wonderful Americans the ‘right to try.'” Right-to-try laws have passed in some 38 states...
Source: TIME: Health - February 5, 2018 Category: Consumer Health News Authors: Alexandra Sifferlin Tags: Uncategorized compassionate use compassionate use act compassionate use drug experimental treatment FDA Food and Drug Administration Goldwater Institute healthytime medicine right to try right to try act right to try bill right t Source Type: news

FDA Clears Oricula Therapeutics Investigational New Drug Application for Clinical Trials
ORC-13661 Could be the First Medicine Approved Specifically to Prevent Hearing Loss of Patients Using Certain Antibiotics SEATTLE, Feb. 5, 2018 -- (Healthcare Sales & Marketing Network) -- ORICULA THERAPEUTICS, LLC., a biotech company introducing medic... Biopharmaceuticals, FDA Oricula Therapeutics, ORC-13661, hearing loss (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - February 5, 2018 Category: Pharmaceuticals Source Type: news

Trethera Corporation Announces FDA Clearance of Investigational New Drug Application for TRE-515
LOS ANGELES, Feb. 5, 2018 -- (Healthcare Sales & Marketing Network) -- Trethera Corporation, a biopharmaceutical company committed to developing novel drugs targeting cellular nucleotide metabolism for the treatment of cancer, today announced that the U.S... Biopharmaceuticals, Oncology, FDA Trethera, TRE-515, deoxycytidine kinase, myelodysplastic syndrome (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - February 5, 2018 Category: Pharmaceuticals Source Type: news

Morphotek Announces FDA Acceptance Of Investigational New Drug Application For Next-Generation Farletuzumab Antibody-Drug Conjugate MORAb-202
EXTON, Pa., Jan. 10, 2018 -- (Healthcare Sales & Marketing Network) -- Morphotek®, Inc., a subsidiary of Eisai Inc., announced today that the U.S. Food and Drug Administration (FDA) accepted an Investigational New Drug (IND) Application for MORAb-202,... Biopharmaceuticals, Oncology, FDA Morphotek, Eisai, Farletuzumab, eribulin (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - January 10, 2018 Category: Pharmaceuticals Source Type: news

Athenex gets closer to clinical trials in China
Athenex Inc. (Nasdaq:ATNX) has taken another step forward in its efforts to bring an oral breast cancer drug to market in Asia.   The Buffalo-based biopharmaceutical firm received an acceptance from the Chinese Food& Drug Administration for an investigational new drug (IND) application for Oraxol, an oral version of its oral formulation of the chemotherapy formulation paclitaxel. It’s the next in a series of okays from FDA groups across the world, including the United States, South America,… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - January 8, 2018 Category: Biotechnology Authors: Tracey Drury Source Type: news

MiMedx settles former employee breach of contract suit
MiMedx (NSDQ:MDXG) said today it agreed to a confidential lawsuit settlement with former employee William Mills, who the company previously alleged broke contract by selling another company’s medical products while employed at MiMedx. The Marietta, Ga.-based company said that Mills voluntarily resigned from his position in January this year, and that the lawsuit was a “dispute solely over Mr. Mills’ MiMedx employment agreemnt, and no other allegations have been made by either party,” according to a press release. The settlement included an undisclosed monetary award and an agreement in whi...
Source: Mass Device - December 19, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News MiMedx Group Inc. Source Type: news

Guidance for Industry: Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation to Treat Clostridium difficile Infection Not Responsive to Standard Therapies
(Source: What's New at CBER)
Source: What's New at CBER - December 15, 2017 Category: Biomedical Science Source Type: news

MMJ BioScience Files Pre Investigational New Drug (IND) Application...
MMJ BioScience's FDA application to initiate clinical trials assessing the company's cannabinoid pharmaceutical compounds for treating and/or preventing symptoms associated with multiple...(PRWeb December 09, 2017)Read the full story at http://www.prweb.com/releases/2017/12/prweb15000381.htm (Source: PRWeb: Medical Pharmaceuticals)
Source: PRWeb: Medical Pharmaceuticals - December 9, 2017 Category: Pharmaceuticals Source Type: news

Triphase Accelerator to Present Investigational New Drug Enabling Data...
Triphase Accelerator Corporation, a company dedicated to acquiring and developing novel therapeutics for the treatment of cancer, and Catalent, the leading global provider of advanced delivery...(PRWeb December 04, 2017)Read the full story at http://www.prweb.com/releases/2017/12/prweb14977095.htm (Source: PRWeb: Medical Pharmaceuticals)
Source: PRWeb: Medical Pharmaceuticals - December 4, 2017 Category: Pharmaceuticals Source Type: news

Capricor Therapeutics Announces FDA Clearance of Investigational New Drug (IND) Application for CAP-1002
Potential Registration Trial in Duchenne Muscular Dystrophy on Track to Initiate in First Quarter of 2018 Company to Host Conference Call and Webcast at 4:30 p.m. ET Today LOS ANGELES, Nov. 29, 2017 -- (Healthcare Sales & Marketing Network) -- Capri... Biopharmaceuticals, FDA Capricor Therapeutics, Duchenne muscular dystrophy (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - November 29, 2017 Category: Pharmaceuticals Source Type: news

Cerveau inks licensing deal with AbbVie for tau imaging agent
Cerveau Technologies has inked a deal to license and supply AbbVie (NYSE:ABBV) with its [F-18]MK-6240 investigational tau imaging agent, the company said today. After the FDA cleared the investigational new drug application for Cerveau’s imaging agent in June, the company said it planned to work with pharmaceutical partners to evaluate the product’s use in positron emission tomography scans to assess neurofibrillary tangles in the brain. Get the full story at our sister site, Drug Delivery Business News. The post Cerveau inks licensing deal with AbbVie for tau imaging agent appeared fir...
Source: Mass Device - October 23, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Clinical Trials Imaging Pharmaceuticals Wall Street Beat AbbVie Cerveau Technologies Source Type: news

FDA OKs trial for MiMedx AmnioFix knee treatment, prelims
MiMedx (NSDQ:MDXG) saw shares rise today after announcing 3rd quarter revenue that beat consensus on The Street alongside FDA approval to proceed with the Investigational New Drug phase 2B study of its AmnioFix injectable product. The Marietta, Ga.-based company said it expects to post sales of $84.6 million for its 3rd quarter, well ahead of both its guidance of between $70 and $80 million and Wall Street consensus of $80.1 million. Revenue for MiMedx grew 31% compared to sales from the 3rd quarter of the previous year, according to an SEC filing. “Our third quarter revenue performance was very strong, and we a...
Source: Mass Device - October 17, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Clinical Trials MiMedx Group Inc. Source Type: news

America & #039;s Blood Supply Can Now Be Screened for Zika
America’s blood supply is better protected from the Zika virus, now that FDA has approved the first test designed to detect the virus in blood donations. Learn about the IVD market at BIOMEDevice San Jose, Dec. 6-7, 2017.  The cobas Zika test from Roche has already been used by several U.S. blood collection establishments under an investigational new drug application (IND). The test can also screen for the virus RNA in specimens collected from living organ donors. “Screening blood donations for the Zika virus is critical to preventing infected donations from entering the U.S. blood supply,” said Pet...
Source: MDDI - October 10, 2017 Category: Medical Devices Authors: Amanda Pedersen Tags: IVD Regulatory and Compliance Source Type: news

Prometic to conduct PBI-4050 ’s Phase II/III trial for IPF in US
Canada-based Prometic Life Sciences has secured investigational new drug (IND) approval from the US Food and Drug Administration (FDA) to evaluate its drug candidate PBI-4050 in a Phase II/III clinical trial to treat idiopathic pulmonary fibrosis (IP … (Source: Drug Development Technology)
Source: Drug Development Technology - September 26, 2017 Category: Pharmaceuticals Source Type: news

Realm Therapeutics to initiate Phase II trial for allergic conjunctivitis
Realm Therapeutics is set to initiate a Phase II clinical trial of PR013 to treat allergic conjunctivitis (AC), following approval of its investigational new drug (IND) application by the US Food and Drug Administration (FDA). (Source: Drug Development Technology)
Source: Drug Development Technology - September 12, 2017 Category: Pharmaceuticals Source Type: news

MiMedx Notified By FDA That It Can Proceed With Phase 3 Investigational New Drug Clinical Trial For Achilles Tendonitis
MARIETTA, Ga., Sept. 7, 2017 -- (Healthcare Sales & Marketing Network) -- MiMedx Group, Inc. (NASDAQ: MDXG), the leading biopharmaceutical company developing and marketing regenerative and therapeutic biologics utilizing human placental tissue allografts ... Biopharmaceuticals, Regenerative Medicine, Orthopaedic, FDA MiMedx Group, AmnioFix, achilles tendonitis (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - September 7, 2017 Category: Pharmaceuticals Source Type: news

MassDevice.com +5 | The top 5 medtech stories for August 24, 2017
Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry. Get this in your inbox everyday by subscribing to our newsletters.   5. Soft, water-powered robot makes endoscopic surgery easier Harvard researchers have created a rigid-soft robotic arm for endoscopes that can sense, flex and has multiple degrees of freedom. Flexible endoscopes fit through narrow...
Source: Mass Device - August 24, 2017 Category: Medical Devices Authors: MassDevice Tags: News Well Plus 5 Source Type: news

Titan wins FDA nod to study Parkinson ’ s implant
Titan Pharmaceuticals (NSDQ:TTNP) said today that the FDA cleared the investigational new drug application for its ropinirole implant designed to treat the symptoms of Parkinson’s disease. The Phase I/II trial, which is slated to enroll 20 patients with idiopathic Parkinson’s disease, will transition patients taking oral ropinirole to Titan’s ropinirole implant for three months of treatment, according to the South San Francisco, Calif.-based company. Get the full story at our sister site, Drug Delivery Business News. The post Titan wins FDA nod to study Parkinson’s implant appeared first on Mas...
Source: Mass Device - August 24, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Clinical Trials Drug-Device Combinations Food & Drug Administration (FDA) Implants Neurological Pharmaceuticals Wall Street Beat Titan Pharmaceuticals Source Type: news

MiMedx divests Stable Biologics subsidiary in transition to focus on biopharma
MiMedx (NSDQ:MDXG) said today it inked a definitive agreement with the former shareholders of Stability Inc. to divest itself of Stability Biologics, which it acquired last January. The Marietta, Ga.-based company said the divestiture is part of its plan to transition back into a biopharmaceutical-focused company. “The transaction is expected to be completed in the 3rd quarter of 2017, and the consideration will include a promissory note issued by Stability Biologics in the principal amount of $3.5 million in favor of MiMedx and a waiver by the former stockholders of Stability, Inc. ...
Source: Mass Device - August 18, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Mergers & Acquisitions Regenerative Medicine MiMedx Group Inc. Stability Biologics Source Type: news

Update: Temporary Total Depletion of U.S. Licensed Yellow Fever Vaccine for Civilian Travelers Addressed by Investigational New Drug Use of Imported Stamaril Vaccine
(Source: CDC Morbidity and Mortality Weekly Report)
Source: CDC Morbidity and Mortality Weekly Report - July 27, 2017 Category: American Health Source Type: news