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Published on Dec 13, 2018

Meetings Held With FDA Support Mesoblast’s Planned Regulatory Filing for Commercialization of Remestemcel-L in Acute ...

NEW YORK and MELBOURNE, Australia, Dec. 13, 2018 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB) today announced that recent meetings held with the United States Food and Drug Administration (FDA) support its planned regulatory filing for …

Distribution channels: Healthcare & Pharmaceuticals Industry ...
Published on Dec 12, 2018

FDA Approves Tolsura (SUBA®-itraconazole capsules) for the Treatment of Certain Fungal Infections

FDA Approves Tolsura (SUBA®-itraconazole capsules) for the Treatment of Certain Fungal Infections ADELAIDE, Australia, Dec. 11, 2018 /PRNewswire/ -- Mayne Pharma Group Limited (ASX: MYX) is pleased to announce that the US Food and Drug …

Source: Pharmaceutical News
Published on 08:44 GMT

Vertex Pharma gets Health Canada marketing approval for Orkambi for children with CF aged 2 to 5 years

Vertex Pharmaceuticals Incorporated, a global biotechnology company, announced that Health Canada has granted Market Authorization for Orkambi (lumacaftor/ivacaftor) to include use in children ages 2 through 5 years with cystic fibrosis (CF) who have …

Source: Pharmabiz.com
Published on Dec 12, 2018

Mayne Pharma receives FDA approval of Tolsura™ (SUBA®-itraconazole capsules) for the treatment of certain fungal ...

ADELAIDE, Australia, Dec. 11, 2018 /PRNewswire/ -- Mayne Pharma Group Limited (ASX: MYX) is pleased to announce that the US Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for Tolsura™ (SUBA®-itraconazole) 65mg …

Source: Odessa American
Published on Dec 11, 2018

Arch Biopartners Forms New Subsidiary to Pursue a Phase I Trial in Australia for Metablok (LSALT Peptide)

TORONTO, Dec. 11, 2018 (GLOBE NEWSWIRE) -- Arch Biopartners Inc., (Arch or the Company) (TSX Venture: ARCH and OTCQB: ACHFF) today announced it has formed a 100% owned subsidiary in Australia, named Arch Clinical Pty Ltd, to pursue an application to …

Distribution channels: Technology ...
Published on Dec 11, 2018

Non–Cystic Fibrosis Bronchiectasis (NCFB) FDA Grants “Fast-Track” and “QIPD” to Zambon for Colistimethate Sodium Powder ...

Zambon Posted on: 11 Dec 18 Zambon announced that colistimethate sodium powder for nebulizer solution, delivered by the I-neb AAD system obtained QIDP and “Fast Track” designation by the FDA for the indication “prevention of pulmonary exacerbations in …

Source: PharmiWeb.com
Published on Dec 14, 2018

Will money or morality win?

ANALYSIS/OPINION: Recently there was a major breakthrough in the early detection of virtually every kind of cancer (“Researchers develop quick, easy cancer detection test,” Web, Dec. 5). According to the Australian scientists who announced the news, it …

Source: Washington Times
Published on Dec 14, 2018

12-Month Results from Study of NeoTract’s UroLift® System for BPH in Men with an Obstructive Median Lobe Published in ...

WAYNE, Pa.--(BUSINESS WIRE)--Dec 14, 2018--NeoTract, a wholly owned subsidiary of Teleflex Incorporated (NYSE:TFX) focused on addressing unmet needs in the field of urology, today announced the publication of 12-month data from the multi-center prospective …

Source: Odessa American
Published on Dec 7, 2018

Medisca Texas Facility Receives Perfect Score in 2018 FDA GMP Inspection

MEDISCA Posted on: 07 Dec 18 Today MEDISCA, the industry leader for providing high quality compounding solutions and services to pharmacists worldwide, announced that its Irving, Texas repackaging and distribution center received zero observations during …

Source: PharmiWeb.com
Published on Dec 6, 2018

Next generation of biotech food heading for grocery stores

In this July 11, 2018 photo, animal geneticist Alison Van Eenennaam of the University of California, Davis, points to a group of dairy calves that won’t have to be de-horned thanks to gene editing. The calves are descended from a bull genetically altered …

Source: Stamford Advocate
Published on Dec 7, 2018

Olympus' Spiration Valve System receives US FDA approval to treat emphysema

Olympus, a global technology leader in designing and delivering innovative solutions for medical and surgical procedures, among other core businesses, announced FDA approval of its Spiration Valve System (SVS) for the treatment of severe emphysema, a …

Source: Pharmabiz.com
Published on Dec 5, 2018

Olympus Spiration(R) Valve System Is FDA Approved for the Endobronchial Treatment of Emphysema

Devices FDA News Release - December 5, 2018 Minimally invasive therapy offers non-invasive patient screening with short procedure time and is shown to improve lung function and quality of life CENTER VALLEY, Pa., Dec. 5, 2018 -- (Healthcare Sales & …

Source: salesandmarketingnetwork.com
Published on Dec 13, 2018

Health Canada Grants Market Authorization for ORKAMBI® (lumacaftor/ivacaftor) for Children with Cystic Fibrosis Aged 2 ...

Vertex Pharmaceuticals Incorporated Posted on: 13 Dec 18 Vertex Pharmaceuticals Incorporated (Nasdaq:VRTX) today announced that Health Canada has granted Market Authorization for ORKAMBI® (lumacaftor/ivacaftor) to include use in children ages 2 through …

Source: PharmiWeb.com
Published on Dec 13, 2018

Symphony Health Announces Availability of 340B Drug Discount Program Data

BLUE BELL, Pa., Dec. 13, 2018 (GLOBE NEWSWIRE) -- Symphony Health, a PRA Health Sciences company and a leading provider of data, cloud-based analytics and consulting solutions to life science companies and healthcare organizations, today announces the …

Distribution channels: Healthcare & Pharmaceuticals Industry ...
Published on Dec 3, 2018

Shield Therapeutics' Ferracru to be considered for US market by the FDA

Shield Therapeutics PLC (LON:STX) has received the go-ahead to file for the US approval of Feraccru, its iron deficiency treatment. The AIM-listed company expects to hear shortly from the US Food and Drug Administration the date in 2019 it will complete …

Source: Proactive Investors
Published on Dec 4, 2018

When The FDA Creates A Buying Opportunity: Zafgen

Zafgen (ZFGN) is a biopharmaceutical company developing treatments for type 2 diabetes, Prader-Willi syndrome (PWS) and liver disease. The company's most advanced drug, ZGN-1061 is nearing completion of a Phase 2 study. The development of ZGN-1061 …

Source: Seeking Alpha
Published on Dec 3, 2018

Shield Therapeutics' Ferracru to be considered for US market by FDA

Shield Therapeutics PLC (LON:STX) has received the go-ahead to file for the US approval of Feraccru, its iron deficiency treatment. The AIM-listed company expects to hear shortly from the US Food and Drug Administration the date in 2019 it will complete …

Source: Proactive Investors
Published on Dec 13, 2018

Soldiers have to get flu shots. Civilians? It’s a harder sell.

VICENZA, Italy — Despite decades of studies showing its safety and effectiveness in preventing flu or reducing severity of the disease that killed more than 80,000 Americans last year, the influenza vaccine can be a tough sell among U.S. Army Europe …

Source: Stars and Stripes
Published on Dec 13, 2018

Shield Therapeutics Says PDUFA Date For Feraccru Is 27 July 2019

Dec 3 (Reuters) - Shield Therapeutics PLC ::SHIELD THERAPEUTICS - US FOOD AND DRUG ADMINISTRATION HAS ACCEPTED FOR REVIEW NEW DRUG APPLICATION (NDA) FOR FERACCRU, SHIELD'S LEAD PRODUCT.SHIELD THERAPEUTICS PLC - UNDER TERMS OF PRESCRIPTION DRUG USER FEE …

Source: Reuters

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Published on December 14, 2018 - 20:39 GMT

Dov Bechhofer on the FDA’s Announcement to Explore New Digital Health Avenues

NEW YORK CITY, NEW YORK, USA, December 14, 2018 /⁨EINPresswire.com⁩/ -- Dov Bechhofer is a computer engineer exploring how technology shapes our present and what technological advancements we can expect in the future. Recently, the FDA Commissioner …

Distribution channels: Consumer Goods, Culture, Society & Lifestyle ...
Published on December 14, 2018 - 21:02 GMT

Supernus Announces FDA Approval of sNDA to Expand Oxtellar XR® Label to Include Monotherapy

ROCKVILLE, Md., Dec. 14, 2018 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (NASADQ: SUPN) announced today that the United States Food and Drug Administration (FDA) has approved the Company’s supplemental new drug application (sNDA) for Oxtellar XR®. …

Distribution channels: Healthcare & Pharmaceuticals Industry ...

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Published on December 13, 2018 - 22:04 GMT

Statement from FDA Commissioner Scott Gottlieb, M.D. and FDA Deputy Commissioner Frank Yiannas on new findings and ...

On Nov. 20, the U.S. Food and Drug Administration and the Centers for Disease Control and Prevention warned the American public of a multi-state outbreak of E. coli O157:H7 linked to romaine lettuce and advised against eating any romaine lettuce on the …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on December 13, 2018 - 21:15 GMT

Agile Therapeutics, Inc. Meets With FDA on Comparative Wear Study of Twirla® and Xulane®

PRINCETON, N.J., Dec. 13, 2018 (GLOBE NEWSWIRE) -- Agile Therapeutics, Inc., (Nasdaq: AGRX), a women’s healthcare company, today announced that on December 11, 2018, it met with the U.S. Food and Drug Administration’s (“FDA”) Division of Bone, Reproductive …

Distribution channels: Healthcare & Pharmaceuticals Industry ...

Published on December 13, 2018 - 11:00 GMT

Meetings Held With FDA Support Mesoblast’s Planned Regulatory Filing for Commercialization of Remestemcel-L in Acute ...

NEW YORK and MELBOURNE, Australia, Dec. 13, 2018 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB) today announced that recent meetings held with the United States Food and Drug Administration (FDA) support its planned regulatory filing for …

Distribution channels: Healthcare & Pharmaceuticals Industry ...
Published on December 13, 2018 - 14:35 GMT

Statement from FDA Commissioner Scott Gottlieb, M.D. and Director of FDA’s Center for Drug Evaluation and Research Janet ...

Protecting patient safety is at the core of the FDA’s mission. All FDA-approved drugs have benefits and risks which must be weighed and balanced by health care providers and patients when making decisions about medical therapy. For our part, the FDA is …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on December 12, 2018 - 13:30 GMT

Zosano Receives Conditional FDA Acceptance of Proposed Brand Name Qtrypta™ for M207

FREMONT, Calif., Dec. 12, 2018 (GLOBE NEWSWIRE) -- Zosano Pharma Corporation (NASDAQ:ZSAN) (“Zosano” or the “Company”), a clinical-stage biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has conditionally accepted …

Distribution channels: Healthcare & Pharmaceuticals Industry ...
Published on December 12, 2018 - 13:30 GMT

Amyris Receives GRAS Notification from FDA for its New, Sugarcane-Derived, Zero Calorie Sweetener

EMERYVILLE, Calif., Dec. 12, 2018 (GLOBE NEWSWIRE) -- Amyris, Inc. (Nasdaq:AMRS), a leader in the development and production of sustainable ingredients for the Health & Wellness, Clean Beauty and Flavors & Fragrances markets, announced today that …

Distribution channels: Chemical Industry, Culture, Society & Lifestyle ...

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Published on December 15, 2018 - 20:47 GMT

Authentic Olive Wood Serving Pieces from Gourmet Living

Looking for last minute holiday gifts for home chefs? Gourmet Living has a delightful assortment of rustic wood olive baskets, olive boats and salad claws. GREENWICH, CT, UNITED STATES, December 15, 2018 /⁨EINPresswire.com⁩/ -- Looking for some …

Distribution channels: Culture, Society & Lifestyle, Food & Beverage Industry ...
Published on December 15, 2018 - 12:20 GMT

Ari Carlson of Arbonne International to be Featured on CUTV News Radio

EAGLE, IDAHO, UNITED STATES, December 15, 2018 /⁨EINPresswire.com⁩/ -- A monthly salary is hardly enough to get by anymore. An extra $500 or $1000 a month can make a big difference. That’s why it has become so important for people to have a …

Distribution channels: Beauty & Hair Care, Culture, Society & Lifestyle ...
Published on December 15, 2018 - 07:15 GMT

ITFirms Tossed Gauntlet for Top Web Development Companies Over Again

Turning plowshares into swords, ITFirms latest listing makes the pressure loom for top contenders in web development. NEW YORK, UNITED STATES, December 15, 2018 /⁨EINPresswire.com⁩/ -- Every entrepreneur/small business has to face certain …

Distribution channels: Business & Economy, Culture, Society & Lifestyle ...
Published on December 14, 2018 - 21:10 GMT

Monolithic Power Systems Announces Fourth Quarter Dividend

KIRKLAND, Wash., Dec. 14, 2018 (GLOBE NEWSWIRE) -- Monolithic Power Systems (MPS) (Nasdaq: MPWR), a leading company in high-performance analog solutions, today announced its fourth quarter dividend of $0.30 per common share to all stockholders of record as …

Distribution channels: Banking, Finance & Investment Industry, Food & Beverage Industry ...
Published on December 14, 2018 - 18:01 GMT

Smithfield Foods Adds 250 Jobs in North Carolina with New Distribution Center

SMITHFIELD, Va., Dec. 14, 2018 (GLOBE NEWSWIRE) -- Smithfield Foods, Inc. is pleased to announce the grand opening of its new distribution center in Tar Heel, North Carolina, which will create approximately 250 new jobs in the state. Smithfield invested …

Distribution channels: Food & Beverage Industry ...
Published on December 14, 2018 - 16:08 GMT

Questrade invests in kindness with donation to Food Banks Canada

TORONTO, Dec. 14, 2018 (GLOBE NEWSWIRE) -- In the spirit of the season, Questrade has announced a donation of the equivalent of 250,000 meals to Food Banks Canada on behalf of Questrade customers and employees, as part of its annual campaign to help …

Distribution channels: Banking, Finance & Investment Industry, Food & Beverage Industry ...
Published on December 14, 2018 - 14:00 GMT

Plastics Can Help Lighten Your Environmental Footprint This Holiday Season

Toronto, ON, Dec. 14, 2018 (GLOBE NEWSWIRE) -- For many of us, the holiday season is the happiest time of year—but it also can be the most wasteful. Canadians generate approximately 25 percent more waste between Thanksgiving and New Year’s Day. But if you …

Distribution channels: Building & Construction Industry, Food & Beverage Industry ...
Published on December 14, 2018 - 13:31 GMT

Is Your Data an Enterprise Asset?

By Doug Baker, Vice President, Industry Relations - Private Brands, Technology for Food Marketing Institute Data has been at the center of many discussions and presentations for years. Big data and small, for many retailers and brands data is not the …

Distribution channels: Food & Beverage Industry
Published on December 13, 2018 - 14:47 GMT

PLM to Deliver FSMA Training and Compliance to the Food Distribution Industry

PLM delivers training and compliance to the food distribution industry by partnering with Iron Apple, a leader in online food safety compliance training. NEWARK, NJ, USA, December 13, 2018 /⁨EINPresswire.com⁩/ -- PLM, the only nationwide fleet …

Distribution channels: Banking, Finance & Investment Industry, Business & Economy ...
Published on December 13, 2018 - 14:00 GMT

Ari Carlson of Arbonne International to be Featured on CUTV News Radio

EAGLE, IDAHO, UNITED STATES, December 13, 2018 /⁨EINPresswire.com⁩/ -- A monthly salary is hardly enough to get by anymore. An extra $500 or $1000 a month can make a big difference That’s why it has become so important for people to have a …

Distribution channels: Beauty & Hair Care, Culture, Society & Lifestyle ...
Published on December 13, 2018 - 22:50 GMT

PLUS Completes Acquisition of Cannabis-Infused Baked Goods Brand GOOD CO-OP

SAN MATEO, Calif., Dec. 13, 2018 (GLOBE NEWSWIRE) -- Plus Products Inc. (the “Company” or “PLUS”) (CSE: PLUS), the leading cannabis edibles brand in California is pleased to announce that further to its press release of December 3, 2018, it has completed …

Distribution channels: Banking, Finance & Investment Industry, Food & Beverage Industry ...
Published on December 13, 2018 - 21:30 GMT

DAVIDsTEA Announces Third Quarter Fiscal 2018 Financial Results

MONTREAL, Dec. 13, 2018 (GLOBE NEWSWIRE) -- DAVIDsTEA Inc. (Nasdaq:DTEA) (DAVIDsTEA or “the Company”), reported consolidated net loss of $ 9.1 million ($0.35 per diluted share) for the third quarter 2018 compared to a net loss of $6.5 million ($0.25 per …

Distribution channels: Banking, Finance & Investment Industry, Food & Beverage Industry ...
Published on December 13, 2018 - 20:34 GMT

SwissX and Convenience Store Empire Launch Luxury CBD Takeover of Southern California

Los Angeles, CA, Dec. 13, 2018 (GLOBE NEWSWIRE) -- Swissx Oil & Confectionary Inc. and Kohanoff Affiliated have launched a partnership to distribute Swissx CBD products in over 500 convenience stores and gas stations across the Southern California …

Distribution channels: Banking, Finance & Investment Industry, Business & Economy ...
Published on December 13, 2018 - 19:33 GMT

President Bio Launches Quality Produce Fair in Kenema

His Excellency President Julius Maada Bio has officially launched the Quality Produce Fair organised by the Sierra Leone Produce Marketing Board (SLPMB) in the eastern district headquarter town of Kenema. The week-long event, the first in more than thirty …

Distribution channels: Agriculture, Farming & Forestry Industry, Business & Economy ...
Published on December 13, 2018 - 17:00 GMT

ChefsFeed Acquires Feastly, Bridging Digital Media and In Real Life (IRL) Experiences to Further Engage Consumers, ...

San Francisco, Dec. 13, 2018 (GLOBE NEWSWIRE) -- Credible Inc., parent company of ChefsFeed, the only expert-powered food media company, announced it has acquired Feastly, a marketplace platform for food and dining experiences ranging from pop-up dinners …

Distribution channels: Banking, Finance & Investment Industry, Culture, Society & Lifestyle ...
Published on December 13, 2018 - 16:09 GMT

It’s Time! MariVanna NYC Brings Christmas Magic and Holiday Cheer to Life through a Wide Selection of Chef-curated Menu ...

NEW YORK, Dec. 13, 2018 (GLOBE NEWSWIRE) -- A true holiday magic, not to mention a mouthwatering selection of chef-curated menu, are waiting for you this December in MariVanna. This booming Flatiron restaurant unveils a true soul of Russian hospitality …

Distribution channels: Culture, Society & Lifestyle, Food & Beverage Industry ...
Published on December 13, 2018 - 15:46 GMT

San Joes Marriott Launches Group-Wellness Program, “RejuveMeet”

San Jose, California , Dec. 13, 2018 (GLOBE NEWSWIRE) -- Located in the nation’s healthiest city, San Jose Marriott has launched RejuveMeet – a holistic approach to group wellness that encompasses everything from nutritious banquet menus to revitalizing …

Distribution channels: Culture, Society & Lifestyle, Food & Beverage Industry ...
Published on December 13, 2018 - 14:55 GMT

LOCAL CRATE ANNOUNCES PARTNERSHIP WITH JAMES BEARD AWARD-WINNING COMMUNITY FOOD52; LAUNCHES FALL/WINTER MENU

Minneapolis, MN and San Mateo, CA, Dec. 13, 2018 (GLOBE NEWSWIRE) -- Local-first food company Local Crate announced today that it has partnered with the James Beard Award-Winning kitchen and home site Food52 to bring regional, Food52 community–inspired …

Distribution channels: Banking, Finance & Investment Industry, Culture, Society & Lifestyle ...
Published on December 13, 2018 - 14:50 GMT

Robert Irvine Adds Sizzle to Stir it Up!

By: Sue Borra, RD, Executive Director, FMI Foundation, Chief Health and Wellness Officer, Food Marketing Institute It’s hard to imagine how the most exciting fundraising event in our industry could become even more sensational, but it is about to happen. …

Distribution channels: Food & Beverage Industry
Published on December 13, 2018 - 14:17 GMT

Contaminants update: first of two opinions on PFAS in food

EFSA has proposed to revise the tolerable intakes of two chemical contaminants to which humans are exposed through the food chain as a result of environmental pollution. This is the first of two assessments of substances collectively known as …

Distribution channels: Food & Beverage Industry

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Catering Equipment & Services Forum

Date: 25-Mar-19 to 26-Mar-19

Location: United Kingdom

The Catering Equipment & Services Forum is a unique event for senior catering procurement professionals, and the suppliers who service them. It is focused around connecting buyers with suppliers covering all areas of the sector – from Bar Equipment & Supplies to Workwear & Clothing; Fixtures & Fittings to Refrigeration & Cold Storage; Food Preparation, Cookware & Kitchen Gadgets to Table Management; and beyond. Benefits include: • Free for catering professionals to attend. • Catering procurement executives are matched with suppliers for a series of face-to-face, pre-arranged meetings based on mutual requirements. • Insightful and inspirational seminars hosted throughout the two days. • Opportunity to network with like-minded peers. • All hospitality – ...

Euro Belgium Craft Beer and Food Science Summit

Date: 13-May-19 to 15-May-19

Location: Brussels / Belgium

It gives us great pleasure to warmly welcome you all to “Conference on Craft Beer and Food Science” which will be held in Brussels, BelgiumEurope during May 13-15, 2019.

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