"Market single bioprocessing systems Asia Pacific rises∨derfield=date∨derval=DESC" News Stories

00:19 EDT 24th July 2019 | BioPortfolio

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Tuesday 23rd July 2019

BY-HEALTH: The Nutrition Exploratorium Launched in China

On July 23th, 2019, BY-HEALTH Nutrition Exploratorium held its opening ceremony in Zhuhai Sanzao District. Many industry experts including Nobel laureate in Physics, Kip Thorne, attended and shared their understanding and expectation for the future of personalized health management plan. This press release features multimedia. View the full release here:

FDAnews Announces — Get Pre-Certified: Software as a Medical Device Webinar, August 1, 2019

Is the software a medical device? Get certified to be ahead of the competition. FALLS CHURCH, Va. (PRWEB) July 23, 2019 Is there some way to bring a software as a medical device (SaMD) product to market faster? The answer is yes, with the Software Precertification Program. The pre-cert pathway regulatory model expedites pre-market approval while assessing the safety and effectiveness of software ...

Bio-Rad to Report Second-Quarter 2019 Financial Results

Bio-Rad Laboratories, Inc. (NYSE: BIO and BIOb), a global leader of life science research and clinical diagnostic products, will report financial results for the second quarter 2019 on Thursday, August 1, 2019, following the close of the market. The company will discuss these results in a conference call scheduled for 2 PM Pacific Time (5 PM Eastern Time) that day. To listen, call 855-779-9068 ...

Drug development on a chip

Scientists of Karlsruhe Institute of Technology (KIT) have found a way to combine the separate steps required for drug development, hence facilitating and accelerating the search for promising new substances. Their work has been published in the journal Nature Communications. The early phase of drug development is traditionally based on three areas of science, beginning when chemists synthesise a...

FDAnews Announces — FDA Data Integrity: For Device and Pharma Firms, and Their Suppliers Workshop Oct. 21-22, 2019 Bethesda, MD

FDA is keeping pressure on device and drug firms with data integrity shortcomings. FALLS CHURCH, Va. (PRWEB) July 23, 2019 FDA gives simple instructions to its investigators: “If initial findings indicate the firm’s electronic records may not be trustworthy and reliable, or when electronic recordkeeping systems inhibit meaningful FDA inspection, a more detailed evaluation may be warranted.”...

Cutera Receives ANVISA Approval of truSculpt® Body Sculpting Systems in Brazil

CUTERA, INC., (Nasdaq: CUTR) ("Cutera" or the "Company") a leading provider of laser, light and other energy-based aesthetic systems for practitioners worldwide, announced today that Brazil's healthcare regulatory authority, Agência Nacional de Vigilância Sanitária ("ANVISA"), recently granted regulatory approval for truSculpt® iD and truSculpt 3D systems. The truSculpt family of devices use ...

MED-EL gets first FDA approval for the use of cochlear implants in single-sided deafness patients

Last week, the FDA approved an expanded indication for single-sided deafness and asymmetric

Interprofessional WesternU team publishes previously unseen discovery of obturator nerve

Two separate teams of WesternU students discovered cases where the cutaneous branch of the obturator nerve (CBO), which usually remains in the thigh, ran into the foot. A few previous reports in the literature describe CBOs passing the knee to innervate portions of the calf, but none show CBOs extending to the ankle and foot. POMONA, Calif. (PRWEB) July 23, 2019 A routine assignment in Western Un...

Veristat Expands Operations into Taiwan to Support Growing Client Demand for Clinical Trial, Biostatistics and Programming Excellence in the Region

Opens office in Taipei, Taiwan Veristat, a scientifically oriented clinical development, and regulatory submission partner, announces the formal launch of its Clinical Trial, Biostatistics and Programming operations in Taipei, Taiwan with the opening of a

Ping An introduces doctor's AI assistant to Singapore

HONG KONG, July 23, 2019 /PRNewswire/ -- Ping An Insurance (Group) Company of China, Ltd. (hereafter "Ping An" or the "Group", HKEX: 2318; SSE: 601318) announced that Ping An Smart Healthcare (PASH) has introduced AskBob, an artificial intelligence (AI)-based medical decision support tool, to Singapore through collaborations with SingHealth and the National University Health Sy...

EZ Weight Loss TX LLC Issues Voluntary Nationwide Recall of Atomic and Xplode Capsules Due to the Presence of Undeclared Sibutramine

Corpus Christi, TX, EZ Weight Loss TX is voluntarily recalling all lots of La Bri's Body Health Atomic and Xplode capsules to the consumer level. FDA analysis has found the products to be tainted with sibutramine. Sibutramine is an appetite suppressant that was withdrawn from the U.S. market in October 2010 for safety reasons. The presence of sibutramine in these products renders it an unapproved ...

ICU Medical Issues a Voluntary Nationwide Recall of One Lot of 0.9% Sodium Chloride Injection Due to the Presence of Particulate Matter

ICU Medical, Inc. is voluntarily recalling one lot of 0.9% Sodium Chloride Injection, USP 1000 mL to the hospital/user level due to a confirmed customer complaint of particulate matter identified as stainless steel within a single flexible container.

FDA cancels panel review of $ITCI schizophrenia drug, causing shares to tumble … There's a third possible explanation, too: FD

FDA cancels panel review of $ITCI schizophrenia drug, causing shares to tumble … There's a third possible explanation, too: FDA already decided to approve the drug. Could the market be mis-reading?

USANA Health Sciences Reports Second Quarter 2019 Results

Second quarter net sales of $256.0 million Second quarter net earnings of $21.4 million, or $0.91 per diluted share Company reiterates 2019 Net Sales and EPS outlook provided on July 2, 2019 Conference call on July 24, 2019 at 11 a.m. ET USANA Health Sciences, Inc. (NYSE: USNA) today announced financial results for its fiscal second quarter ended June 29, 2019. Financial Performance ...

Seattle Genetics Announces Proposed Public Offering of Common Stock

Seattle Genetics, Inc. (Nasdaq: SGEN) today announced that it has commenced an underwritten public offering of 6,000,000 shares of its common stock. All of the shares are being offered by Seattle Genetics. In addition, Seattle Genetics expects to grant the underwriters of the offering a 30-day option to purchase up to an additional 900,000 shares of its common stock solely to cover overallotments...

Apollo Endosurgery, Inc. Reports Second Quarter 2019 Results

Conference Call to Discuss Results Today at 3:30 p.m. CT / 4:30 p.m. ET Apollo Endosurgery, Inc. ("Apollo") (Nasdaq: APEN), a global leader in less invasive medical devices for gastrointestinal and bariatric procedures, today announced financial results for the second quarter ended June 30, 2019. Second Quarter 2019 Highlights OverStitch, or ESS, sales increased 40% to $7.7 million, repres...

AngioDynamics to Present at the Canaccord Genuity Growth Conference

AngioDynamics, Inc. (NASDAQ: ANGO), a leading provider of innovative, minimally invasive medical devices for vascular access, peripheral vascular disease, and oncology, today announced that Jim Clemmer, President and Chief Executive Officer, will present at the 39th Annual Canaccord Genuity Growth Conference at 10:30 a.m. ET on Wednesday, August 7, 2019 in Boston, MA. A live webcast of the pres...

Diener Implants Announces Strategic Partnership with 3dpac

Diener Implants GmbH, a contract manufacturer for medical devices, today announced their strategic partnership with 3dpac by steripac, a German specialist for medical device packaging, to offer implants sterile packed to their customers. TUTTLINGEN, Germany (PRWEB) July 23, 2019 Diener Implants GmbH, a contract manufacturer for medical devices, today announced their strategic partnership with 3dp...

Antibe Therapeutics Announces Offering of Units

NOT FOR DISTRIBUTION OR DISSEMINATION INTO THE UNITED STATES OR THROUGH U.S. NEWSWIRE SERVICES Antibe Therapeutics Inc. (“Antibe” or the “Company”) (TSXV: ATE, OTCQB: ATBPF), a leader in developing safer therapeutics for pain and inflammation, today announced that it has filed a preliminary short form prospectus (the “Preliminary Prospectus”) in connection with a proposed marketed of...

Invacare Corporation to Host Conference Call and Webcast to Discuss Second Quarter 2019 Financial Results

Invacare Corporation (NYSE: IVC) (“Invacare” or the “company”) announces that it will release its financial results for the second quarter ended June 30, 2019, after the market closes on Monday, August 5, 2019. The company will provide a live conference call and webcast to discuss these financial results on Tuesday, August 6, 2019 at 8:30 AM ET. Investors and other interested parties ma...

Capricor Therapeutics (CAPR) Update - PPMD Webinar Commentary (HOPE-2 Results) & Raising Funds

AbstractOn Wednesday, July 17, 2019, CEO Linda Marban of Capricor Therapeutics (CAPR) held a webinar for the Parent Project Muscular Dystrophy (PPMD) to discuss the positive interim results from its HOPE-2 Trial. The webinar provided additional color as Dr. Marban fielded questions regarding: an FDA approval path; and additional context on the results.At the end of last week, CAPR appeared to sett...

Finn Sheds Light on Single-Agent Pembrolizumab Data in Advanced HCC

Richard S. Finn, MD, discusses results from the KEYNOTE-240 trial and explained how they are still clinically meaningful for patients with hepatocellular carcinoma.

Drug resistant #malaria spreads in South East Asia  #pharma

Drug resistant #malaria spreads in South East Asia  #pharma #globalhealth

Evolutionary gene loss may help explain why only humans are prone to heart attacks

Scientists say the loss of a single gene two to three million years ago in our ancestors may have resulted in a heightened risk of cardiovascular disease in all humans as a species, while also setting up a further risk for red meat-eating humans.

FDA Approves Rituximab Biosimilar for CD20+ B-Cell Non-Hodgkin Lymphoma and CLL

The FDA has approved PF-05280586, a biosimilar for rituximab, for the treatment of adult patients with CD20-positive B-cell non-Hodgkin lymphoma as a single agent or in combination with chemotherapy, or for patients with CD20-positive chronic lymphocytic leukemia in combination with chemotherapy.

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