Swissmedic

Type: Organization
Name: Swissmedic
First reported Aug 29 2014 - Updated Aug 29 2014 - 1 reports

What You Missed From Regulatory Agencies Recently – August 18-28, 2014

By , associate editorNICE Gives Nod Of Approval To Celgene’s RevlimidNICE has published final draft guidance stating that Celgene’s Revlimid for myelodysplastic syndromes will be available on the NHS in England. The recommendation applied to people with ... [Published Pharmaceutical Online - Aug 29 2014]
First reported Aug 20 2014 - Updated Aug 21 2014 - 1 reports

Market snaps six-day winning streak

Caution ahead of the release of minutes from the US Federal Reserve's latest meeting pulled key Indian benchmark indices lower. After remaining in red almost throughout the trading session, key indices extended losses in late trade. The barometer index, ... [Published Business Standard India - Aug 20 2014]
First reported Aug 21 2014 - Updated Aug 21 2014 - 1 reports

Venus Remedies extends Wednesday`s gain

Venus Remedies has extended Wednesday's gain on Thursday. The company has secured approval for marketing of Gemcitabine from Swiss Agency for Therapeutic Products (Swissmedic).Shares of the company are trading at Rs 267.55, up Rs 4.45, or 1.69% at the ... [Published MyIris - Aug 21 2014]
First reported Aug 20 2014 - Updated Aug 21 2014 - 6 reports

Venus Remedies up 3% on Swiss marketing approval

NEW DELHI: Venus Remedies Ltd surged as much as 3.02 per cent in trade on Thursday, after the pharma major said that it has secured its first marketing authorisation in Switzerland from Swiss drug authority 'Swissmedic' for its oncology drug 'Gemcita ... [Published Economic Times - Aug 21 2014]
First reported Aug 19 2014 - Updated Aug 20 2014 - 1 reports

Stemedica International Announces Pre-clinical Data of Its Alzheimer’s Study

., a Stemedica Cell Technologies Inc. subsidiary developing stem cell therapies for Alzheimer’s disease and dementia, revealed the first results of an intravenous administration of allogeneic, human, ischemia-tolerant mesenchymal stem cells (itMSCs) in ... [Published Wall Street Select - Aug 19 2014]
First reported Aug 14 2014 - Updated Aug 15 2014 - 1 reports

WHO Alarmed Over Spread of Deadly Ebola Virus

The World Health Organization (WHO) has declared the Ebola Outbreak in West Africa as a Public Health Emergency International Concern (PHEIC).World Health Organization (WHO) representative Dr Custodia Mandlhate, make her remarks on the response to Ebola ... [Published Kenya News Agency - Aug 14 2014]
First reported Aug 06 2014 - Updated Aug 06 2014 - 1 reports

Carbogen Amcis expands operations in Switzerland

6-Aug-2014Containment | Europe | Ingredients | ManufacturingCarbogen Amcis, a Swiss pharmaceutical process development and Active Pharmaceutical Ingredient (API) manufacturing company, plans to take over the operation of a high-containment facility in ... [Published Manufacturing Chemist - Aug 06 2014]
First reported Aug 05 2014 - Updated Aug 05 2014 - 1 reports

Sucampo Reports Second Quarter 2014 Financial Results and Corporate Update

Positive Net Income Driven by Strong Revenue Growth in Product Royalty and Product SalesCEO Peter Greenleaf to Discuss Results of Sucampo's Strategic ReviewCompany Raises Full Year 2014 Earnings GuidanceCompany to host conference call today at 8:30 am ... [Published BioSpace - Aug 05 2014]
First reported Jul 08 2014 - Updated Jul 08 2014 - 1 reports

Swissmedic approves Amitiza for opioidinduced constipation

US biopharma firm Sucampo Pharmaceuticals has received approval from Swissmedic, Switzerland’s Agency for Therapeutic Products, for Amitiza (lubiprostone) 24mcg for the treatment of opioid-induced constipation in adults with chronic, non-cancer pai.. ... [Published BioPortfolio - Jul 08 2014]
First reported Jul 01 2014 - Updated Jul 01 2014 - 1 reports

CHMP recommends approval of Vertex's Kalydeco for people with cystic fibrosis

The European Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending the approval of Vertex Pharmaceuticals' Kalydeco (ivacaftor) for people with cystic fibrosis (CF) ages 6 and older who have one of eight non-G551D ... [Published PharmaBiz - Jul 01 2014]
First reported Apr 09 2014 - Updated Apr 09 2014 - 1 reports

Newron, Zambon seek marketing nod for Parkinson’s disease drug, safinamide from Swissmedic

Newron Pharmaceuticals, a research and development company focused on novel CNS and pain therapies, and its partner Zambon S.p.A., a pharmaceutical company strongly committed to the respiratory, primary care and CNS therapeutic areas, announced that the ... [Published PharmaBiz - Apr 09 2014]
First reported Mar 20 2014 - Updated Mar 20 2014 - 1 reports

Swissmedic approves ThromboGenics' Jetrea for vitreomacular traction treatment

ThromboGenics NV, an integrated biopharmaceutical company focused on developing and commercializing innovative ophthalmic medicines, announced that Swissmedic has approved Jetrea (ocriplasmin) for the treatment of adults with vitreomacular traction (VMT), ... [Published PharmaBiz - Mar 20 2014]

Quotes

"The launch of this product will add to the company's top line and bottom line in the coming quarters" it said
"Venus has achieved yet another landmark by receiving its first marketing authorisation in Switzerland from Swiss drug authority (SWISSMEDIC) for Gemcitabine 200 mg and 1 g injection through Venus Pharma GmbH, the German subsidiary" said the company in its filing
...our resources on value-enhancing activities, and strengthening our management team," said Peter Greenleaf, Chief Executive Officer of Sucampo. "During this morning's call, I look forward to sharing the results of our strategic review and my views of how we will focus Sucampo on our core capabilities of scientific innovation to accelerate patient, healthcare provider, and shareholder value."
...cause of the disease for people with these mutations," said Jeffrey Chodakewitz, M D , senior vice president and chief medical officer at Vertex. "Today's recommendation for the use of ivacaftor in people with eight additional gating mutations represents an important step toward our goal of helping more people with CF."

More Content

All (23) | News (22) | Reports (0) | Blogs (0) | Audio/Video (0) | Fact Sheets (0) | Press Releases (1)
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What You Missed From Regulatory Agencies Recent... [Published Pharmaceutical Online - Aug 29 2014]
Venus Remedies extends Wednesday`s gain [Published MyIris - Aug 21 2014]
Venus Remedies extends Wednesday's gains [Published Business Standard India - Aug 21 2014]
Venus Remedies up 3% on Swiss marketing approval [Published Economic Times - Aug 21 2014]
Venus Remedies jumps on Swissmedic approval for... [Published MyIris - Aug 20 2014]
Venus gets first Swiss marketing approval for G... [Published Express Pharma - Aug 20 2014]
Market snaps six-day winning streak [Published Business Standard India - Aug 20 2014]
Venus gets mkt authorisation from Swiss drug au... [Published Business Standard India - Aug 20 2014]
Venus Remedies secures marketing authorization ... [Published Business Standard India - Aug 20 2014]
Venus Remedies jumps on Swiss nod for anti-canc... [Published Business Standard India - Aug 20 2014]
Venus Remedies soars 10% on Swiss nod for anti-... [Published Moneycontrol.com - Aug 20 2014]
Venus Remedies gets first marketing authorisati... [Published Moneycontrol.com - Aug 20 2014]
Stemedica International Announces Pre-clinical ... [Published Wall Street Select - Aug 19 2014]
WHO Alarmed Over Spread of Deadly Ebola Virus [Published Kenya News Agency - Aug 14 2014]
Carbogen Amcis expands operations in Switzerland [Published Manufacturing Chemist - Aug 06 2014]
Sucampo Reports Second Quarter 2014 Financial R... [Published BioSpace - Aug 05 2014]
Swissmedic approves Amitiza for opioidinduced c... [Published BioPortfolio - Jul 08 2014]
Swissmedic Approves AMITIZA(R) (Lubiprostone) f... [Published GlobeNewswire: Acquisitions News - Jul 07 2014]
CHMP recommends approval of Vertex's Kalydeco f... [Published PharmaBiz - Jul 01 2014]
Newron, Zambon seek marketing nod for Parkinson... [Published PharmaBiz - Apr 09 2014]
Swissmedic approves ThromboGenics' Jetrea for v... [Published PharmaBiz - Mar 20 2014]
Swiss Agency approves ThromboGenics' Jetrea to ... [Published Pharmaceutical Business Review - Mar 19 2014]
GW Pharma's Sativex receives Swiss approval [Published PharmaBiz - Nov 28 2013]
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Swissmedic Approves AMITIZA(R) (Lubiprostone) f... [Published GlobeNewswire: Acquisitions News - Jul 07 2014]
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