DURECT Corporation (NasdaqGM:DRRX) is an emerging specialty pharmaceutical company developing innovative drugs for pain and other chronic diseases, with late-stage development programs including REMOXY®, POSIDUR™, ELADUR™, and TRANSDUR™-Sufentanil.  DURECT’s proprietary oral, transdermal and injectable depot delivery technologies enable new indications and superior clinical/commercial attributes such as abuse deterrence, improved convenience, compliance, efficacy and safety for small molecule and biologic drugs

Changes in regulatory requirements or guidance or unanticipated events during our clinical trials may result in the need for us to amend clinical trial protocols. Amendments may require review and approval by regulators and/or IRBs, and re-consent subjects, which may adversely affect the cost, timing or successful completion of a clinical trial. If we experience delays in the completion of, or if we terminate, any of our clinical trials, the commercial prospects for Aramchol would be harmed and our ability to generate product revenue would be delayed, possibly materially.

        In the E.U., pricing and reimbursement schemes vary widely from country to country. Some countries provide that drug products may be marketed only after a reimbursement price has been agreed. Some countries may require the completion of additional studies that compare the cost-effectiveness of a particular drug candidate to currently available therapies. For example, the E.U. provides options for its member states to restrict the range of drug products for which their national health insurance systems provide reimbursement and to control the prices of medicinal products for human use. E.U. member states may approve a specific price for a drug product or it may instead adopt a system of direct or indirect controls on the profitability of the company placing the

“The possible formation of nitrosamines from nitrites and secondary amines in acidic conditions was already well-known to the food industry,” says André. “The use of sodium nitrite should have been a red flag prompting a check of possible presence of secondary amines, but it was not,” he says.

Dewachter, L. et al. Bone morphogenetic protein signalling in heritable versus idiopathic pulmonary hypertension. Eur. Respir. J. 34, 1100–1110 (2009).

The following table summarizes the Company’s marketable debt securities as of December 31, 2018 and 2017.

In addition to any healthcare reform measures that may affect reimbursement, the market acceptance and sales of Aramchol will depend on the reimbursement policies of government authorities and third-party payors. It will be difficult for us to profitably sell Aramchol if reimbursement for the product is limited by government authorities or third-party payors. Government authorities and third-party payors, such as private health insurers and health maintenance organizations, decide which medications they will pay for and establish reimbursement levels. A primary trend in the U.S. healthcare industry and elsewhere is cost containment. Government authorities and these third-party payors have attempted to control costs by limiting coverage and the amount of reimbursement for particular medications. We cannot be sure that coverage or reimbursement will be available for Aramchol and, if coverage and reimbursement are available, of the extent of coverage and the level of reimbursement. Reimbursement may affect the demand for, or the price of, any product for which we obtain marketing approval. In addition, third-party payors are likely to impose strict requirements for reimbursement in order to limit off-label use of a higher priced drug. Reimbursement by a third-party payor may depend upon a number of factors including the third-party payor’s determination that use of a product is: 

Preventing situations like this from occurring in the future will be complex, Fuglsang notes, given the different players involved—from the pharmacopeias, which set standards for the APIs and excipients, to the regulatory agencies, whose guidelines refer to the pharmacopeias and standards for development, to finished drug manufacturers who buy API and excipients from subcontractors, to subcontractors who make the API, and the national testing labs, which test products to ensure that they meet standards.

(a)      Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the Company, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

The contractual maturity of the aforementioned marketable securities varies between less than one year to two years.

CombinatoRx Inc. (NasdaqGM: CRXX ) CombinatoRx, Incorporated (CRXX) is pioneering the new field of synergistic combination pharmaceuticals and has a broad product portfolio in phase 2 clinical development. Going beyond traditional combinations, CombinatoRx creates product candidates with novel mechanisms of action striking at the biological complexities of human disease. This product portfolio is internally generated from the CombinatoRx proprietary drug discovery technology which provides a renewable and previously untapped source of novel drug candidat.

皮质类固醇偶尔对乳腺癌有效，并且是乳腺癌转移导致肾上腺切除后必须的替代激素。其抗炎功效有可能有助于减少癌症后遗症。有助于降低脑肿瘤生长或放射治疗导致的脑水肿。对癌症患者常见的衰弱、发烧、食欲不振有效。