Sentences with phrase «approval by a regulatory authority»

Recent advances «give us reasonable hope that gene therapy will enter the armamentarium» to treat genetic blood disorders, some cancers, and inherited diseases, Fischer said, adding: «We might be very close to approval by regulatory authorities.»

Not exact matches

These risks and uncertainties include, among others: the unfavorable outcome of litigation, including so - called «Paragraph IV» litigation and other patent litigation, related to any of our products or products using our proprietary technologies, which may lead to competition from generic drug manufacturers; data from clinical trials may be interpreted by the FDA in different ways than we interpret it; the FDA may not agree with our regulatory approval strategies or components of our filings for our products, including our clinical trial designs, conduct and methodologies and, for ALKS 5461, evidence of efficacy and adequacy of bridging to buprenorphine; clinical development activities may not be completed on time or at all; the results of our clinical development activities may not be positive, or predictive of real - world results or of results in subsequent clinical trials; regulatory submissions may not occur or be submitted in a timely manner; the company and its licensees may not be able to continue to successfully commercialize their products; there may be a reduction in payment rate or reimbursement for the company's products or an increase in the company's financial obligations to governmental payers; the FDA or regulatory authorities outside the U.S. may make adverse decisions regarding the company's products; the company's products may prove difficult to manufacture, be precluded from commercialization by the proprietary rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; and those risks and uncertainties described under the heading «Risk Factors» in the company's most recent Annual Report on Form 10 - K and in subsequent filings made by the company with the U.S. Securities and Exchange Commission («SEC»), which are available on the SEC's website at www.sec.gov.

The approval on February 1 by the UK's Human Fertilisation and Embryology Authority (HFEA) represents the world's first endorsement of such research by any national regulatory aAuthority (HFEA) represents the world's first endorsement of such research by any national regulatory authorityauthority.

Completion of the transaction with Elanco is contingent upon approval by European regulatory authorities and other closing conditions.

At this moment, our national economy is under threat by carbon regulation schemes on three fronts: The Copenhagen conference designed to create a world carbon regulatory authority which could undermine our sovereignty; The cap and trade bill thatâ $ ™ s been passed by the House of Representatives and now awaits Senate approval; and the Obama Administrationâ $ ™ s decision that it can regulate carbon dioxide via the EPA even without approval by Congress.

The government has now accommodated those concerns to an extent by providing, in LSA 2007, s 83 (5)(b) that a licensing authority must, in its licensing rules — which are subject both to consultation and to LSB approval — provide for the ways in which it should, when considering an application for an ABS licence, take account of the regulatory objective of improving access to justice.

Since all farm - outs generally require formal approval by the designated host state authority, Hesse says that host states «will want to make sure that the transaction complies with its regulatory and fiscal regime in all respects», making them «a source of disputes where the return from the farm - out is treated as capital gains or windfall profits by the host state».

The sale purchase agreement is subject to regulatory approval by the Romanian competition authorities.

The hard cases involve grants of regulatory authority subject to further approval by a subpart of Congress like a committee, as opposed to a full fledged act of law (something called a «legislative veto») which has dubious constitutional status despite being common.

The buyer was advised by Eversheds on the January 2018 deal, which remains subject to regulatory approval by the Romanian competition authorities.

Although, the auto insurance companies may be looking forward to increase the auto insurance premiums in order to recover the losses they had to suffer due to the damages caused by natural disasters like earthquake, fire, floods, hurricanes, winter storms, tornados, etc but it is essential for them to get the approval from the regulatory authorities before implementing the increase of auto insurance rate in any state lawfully.