Sentences with phrase «market authorization of»

April 19 (Reuters)- AB SCIENCE SA:

* REG - AB SCIENCE ANNOUNCES THAT THE CHMP HAS ADOPTED A NEGATIVE OPINION FOR THE MARKETING AUTHORIZATION OF MASITINIB IN AMYOTROPHIC LATERAL SCLEROSIS

* AB SCIENCE WILL PROVIDE ADDITIONAL DATA THROUGH A REEXAMINATION PROCEDURE

* RE-EXAMINATION WILL LEAD CHMP TO...

LEAWOOD, Kan. (U.S.)(For EU audience), November 10, 2017 — Elanco Animal Health, a division of Eli Lilly and Company (NYSE: LLY) and Aratana Therapeutics, Inc. (NASDAQ: PETX), today announced the European Medicine Agency's (EMA) Committee for Medicinal Products for Veterinary Use (CVMP) adopted a positive opinion to recommend the marketing authorization of GALLIPRANT ® (grapiprant tablets) in the European Union.

LEAWOOD, Kan. (U.S.)(For EU audience), January 11, 2018 — Elanco Animal Health, a division of Eli Lilly and Company (NYSE: LLY) and Aratana Therapeutics, Inc. (NASDAQ: PETX), today announced the European Commission adopted the decision to grant marketing authorization of GALLIPRANT ® (grapiprant tablets) in the European Union.

Not exact matches

By April 2014, Health Canada will be getting out of the pot business, opening up the market to licensed producers and letting individuals buy it with only a doctor's note (they currently need Health Canada authorization).

The company announced in September that Health Canada granted market authorization to formally transfer the Drug Identification Number (DIN) ownership of Belbuca (buprenorphine) buccal film in Canada to BDSI's commercial partner, Purdue Pharma in Canada.

CLX has an open - market share repurchase authorization of up to $ 750 million, all of which was available as of June 30, 2017.

At current prices, the 250 million share buyback authorization would represent $ 13.2 billion and through 3Q15, Wells Fargo has repurchased $ 6.7 billion of common stock, which represents 2.5 % of WFC's market cap.

For example, a Supplementary Protection Certificate in Europe may be applied for approval to recover some of the time lost between the patent application filing date and the date of first marketing authorization.

This repurchase authorization permits the company to reacquire up to 33.8 % of its shares through open market purchases.

Our areas of expertise are in Investment Banking, Wealth Management and Corporate Advisory and we serve a wide range of clients, including high net worth individuals, family offices and small to medium sized regional businesses.We are valued by clients across the Middle East for our full spectrum capital markets offerings and for the extensive, global experience of our Board and the management team.We are respected for our commitment to building long - standing and successful relationships with our clients and for delivering services that are tailored to their individual needs and requirements.We understand the importance of integrity in promoting and building sustainable businesses and in cultivating personal relationships with all stakeholders, and are committed to generating value for our clients.Morgan Gatsby is regulated by the Dubai Financial Services Authority («DFSA») and is owned by Essel Group ME («EGME»), which is pending authorization.

In response to complaints of a «do - nothing Congress,» Gibson points out votes on a water bill which included aid to victims of Superstorm Sandy, a farm bill that included first - time authorization for an industry - wide marketing campaign for New York's organic farmers, and the first federally authorized budget in five years.

The European Commission recently granted marketing authorization for Cervarix as a two - dose schedule for girls aged 9 - 14 years, and outside of the EU, the Cervarix two - dose schedule is approved in more than ten countries, including Panama, Guatemala, Honduras, El Salvador, Haiti, Suriname, Chile, Guyana, Nigeria, Ghana, Pakistan, and Bangladesh.

«Consequently we are currently in a catch - 22 situation, since only the «owners» of a market authorization can apply for a new indication!»

At the same time, we will also issue a compliance policy that, with the exception of outliers potentially harming public health in a significant way right now, will give current product developers a very reasonable period of time to interact with the FDA in order to determine if they need to submit an application for marketing authorization and to come into the agency and work on a path toward approval.

Sander van Deventer has had a critical role in the development of the first commercial monoclonal antibody (Remicade) and the first gene therapy to be granted market authorization in the Western world (Glybera).

Sander van Deventer has had a critical role in the development of the first commercial monoclonal antibody and the first gene therapy to be granted market authorization in the Western world.

Notably, in May 2016 the European Commission granted marketing authorization for Strimvelis for the treatment of ADA - SCID, a severe form of immunodeficiency.

Many of these products are reaching late - phase trials with the potential to receive final approval and marketing authorization from regulatory agencies such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

We may not use your health information or share it with others outside of True Health for marketing purposes without your prior authorization.

The SpotOption Exchange binary options market maker was fined by the CySEC $ 10 000 for non-compliance with authorization conditions regarding procedures and failure to act honestly and professionally in accordance with the best interest of the clients.

The Cyprus Securities and Exchange Commission (CySEC) announced it has renounced the authorization of Starfish Markets, owner of the New Zealand - based forex broker Starfish FX.

The circular from the ESMA concluded that if the instruments feel under the EU's Markets In Financial Instrustments Directive (MiFID) then social trading networks would require regulatory authorization as they would count as a form of portfolio management.

In the group of patents issued before market authorization, all patents are accorded equal priority and in such instances challenges must be made to the Federal Court for determination as to whether a disputed SPC has complied with threshold requirements (ie.

it pertains to a medicinal ingredient, an SPC has not previously been granted in respect of the same first market authorization etc.).

The priority of SPC applications depends on whether patents are issued before or after «market authorization».

A patent issued before market authorization has priority over patents issued after market authorization (as would be expected, given that earlier issued patents have had more of their patent monopoly wasted during government approval).

Secondly, even if enhanced cooperation was permissible, it argued that the authorizing decision violated the treaty requirements for its use viz: the authorization was not a «last resort» and was in an area of exclusive EU competence (Article 20 TEU); the authorization violated the principle of non-discrimination and undermined the single market by creating discrimination in trade and distortions to competition within the single market (Article 326 TFEU); and, did not respect the rights of the non-participating states (Article 327 TFEU).

In this particular case, it was of course not very hard to obtain the consent of the first marketing authorization holder, as Novartis was the sponsor for both drugs.

However, if the EMA has already granted authorization to a similar orphan product of a third party which independently enjoys period of exclusivity, then the provisions of Article 8 (1) and 8 (3) will be in conflict since in such a scenario the marketing authorization holder of the first orphan product would be denied the express statutory authority to grant consent with respect to approval of another similar product while that of third party would be needed for such approval.

This market exclusivity protects the orphan medicinal product from market competition with similar products with same indication for a certain period of time from the date of first marketing authorization.

Specifically, Teva contended that a marketing authorization granted pursuant to Article 8 (3) can not confer exclusivity under Article 8 (1) of the Orphan Drug Regulation since the provisions under Article 8 (3) constitute derogations and must be interpreted narrowly.

The Commissioner may seek ex parte judicial authorization to intercept private communications (wiretapping) to assist the Commissioner in investigating conspiracies with respect to prices, markets or customers, quantity or quality of production, or channels or methods of distribution, and in investigations of bid - rigging and deceptive telemarketing.

In particular, the Council of State found that patients may be enrolled in compassionate use programmes or supplied with a medicine listed in the so - called 648 List after the product has obtained a marketing authorization, at least until the company starts to commercialize it in Italy.

Overseeing the proper work authorization process for international workers entering the Canadian labour market either on behalf of a foreign company or under the employment of a Canadian company.

(6) Business management activities and general administrative functions, such as management activities relating to implementation of and compliance with the requirements of this subchapter, fundraising for the benefit of the covered entity to the extent permitted without authorization under § 164.514 (f), and marketing of certain services to individuals served by the covered entity, to the extent permitted without authorization under § 164.514 (e)(see discussion in the preamble to that section, below).

In the final rule we add a definition of marketing and clarify when certain activities that would otherwise fall within that definition can be accomplished without authorization.

The definition of health care operations includes those marketing communications that may be made without an authorization pursuant to § 164.514.

Some of these commenters suggested that individuals should have an opportunity to opt out of these types of marketing activities rather than requiring authorization.

Finally, many commenters argued we should not require authorization for the use or disclosure of protected health information to market any health - related goods and services, even if those goods and services are offered by a third party.

Comment: A few commenters suggested we prohibit health care clearinghouses from seeking authorization for the use or disclosure of protected health information for marketing purposes.

the Secretary of State for Health's decision not to grant a marketing authorization for a medicinal product.

Many asked that the definition of disease management be clarified to identify those functions that, although some might consider them to be subsumed by the term, are not permitted under this regulation without authorization, such as marketing and disclosures of protected health information to employers.

They suggested retaining the language in proposed § 164.508 (a)(2)(A), which would permit a broader range of uses and disclosures without authorization, in order to engage in health promotion activities that might otherwise be considered marketing.

In the final rule, we retain the general rule that covered entities must obtain the individual's authorization before making uses or disclosures of protected health information for marketing.

Section 164.514 contains provisions governing use or disclosure of protected health information in marketing communications, including a description of certain marketing communications that may use or include protected health information but that may be made by a covered entity without individual authorization.

Second, we permit a covered entity to use or disclose protected health information without individual authorization to make marketing communications involving products or services of only nominal value.

The following are examples of valid compound authorizations: an authorization for the disclosure of information created for clinical research combined with a consent for the use or disclosure of other protected health information to carry out treatment, payment, and health care operations, and the informed consent to participate in the clinical research; an authorization for disclosure of psychotherapy notes for both treatment and research purposes; and an authorization for the disclosure of the individual's demographic information for both marketing and fundraising purposes.

Comment: Some commenters complained that the absence of a definition for disease management created uncertainty, in view of the proposed rule's requirement to get authorization for marketing.

Other commenters complained that the absence of a definition for disease management created uncertainty in view of the proposed rule's requirement to get authorization for marketing.

Other types of activities, such as the sale of a patient list to a marketing firm, would not be permitted under this rule without authorization from the individual.