Why International Regulations On Clinical Trials Can Actually Reduce Costs And Shorten Time To Market

Palm Beach, FL – April 11, 2019 – Every business or industry strives to improve quality, reduce costs and improve their products time to market. This, surprisingly, is true for the biotechnology industry as well. Usually regulations increase costs and create hurdles for these companies, but in the worldwide clinical trial theatre, the domestic and international governments are actually providing a faster, safer and less costly path to getting new products to market.  Recent upgrades in international and domestic regulations regarding clinical trials, are both designed to protect patients, but also to upgrade the ‘new normal’ procedures in clinical trial quality and more efficient approaches to clinical trial design, conduct, oversight, recording and reporting.   Internationally, the key regulation is Good Clinical Practice, which is: “Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve human subjects.   Active biotech and pharma companies in the markets this week include Moleculin Biotech, Inc. (NASDAQ:MBRX), Teva Pharmaceutical Industries Limited (NYSE: TEVA), OPKO Health, Inc. (NASDAQ: OPK), Geron Corporation (NASDAQ: GERN), Gilead Sciences, Inc. (NASDAQ: GILD).


In the U.S. this marriage of the FDA and private sector in the Orphans Grants Programs has been quite effective: “The number of new FDA approvals in oncology continues at a rapid pace. From November 2017 through October 2018, the FDA approved 11 new cancer therapies and 39 new uses of cancer therapies. In the same time frame in the previous year, there were 18 new cancer therapies and 13 new uses approved.   The FDA prides itself on what this partnership has wrought: “The program has successfully enabled the development and marketing of over 600 drugs and biologic products for rare diseases since 1983. In contrast, fewer than 10 such products supported by industry came to market between 1973 and 1983. The Orphan Grants Program has been used to bring more than 60 products to marketing approval.”


Moleculin Biotech, Inc. (NASDAQ:MBRX) BREAKING NEWS:  Moleculin Biotech, a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors, today announced it has entered into an agreement with Emory University to conduct a Phase 1 clinical trial of WP1066 in children with recurrent or refractory malignant brain tumors. The study will be conducted at the Aflac Cancer & Blood Disorders Center at Children’s Healthcare of Atlanta.


“Given the exciting data Emory University researchers presented at the recent Society for Neuro Oncology conference, we have been working closely with them to begin a trial in pediatric brain tumors,” commented Walter Klemp, Moleculin’s Chairman and CEO.  “WP1066 was shown to have a significant anti-tumor effect on medulloblastoma cell lines, so there is a lot of encouragement regarding the opportunity to provide new hope for treating this rare condition.  This will also give us yet another opportunity to develop human proof of concept data, bringing our total number of clinical trials to five.  This clinical trial is expected to begin recruitment in the second half of this year.”    Read this and more news for MBRX athttps://financialnewsmedia.com/news-mbrx/


Other recent developments in the biotech industry include:


Teva Pharmaceutical Industries Limited (NYSE: TEVA) recently announced  that it has entered into a new $2.3 billion unsecured revolving credit facility, which replaces its existing $3.0 billion credit facility.


“By signing this new revolving credit facility, with its extended and flexible terms, we took another step on our financial strategy and secured ample contingent liquidity to support Teva’s financing needs in the coming years,” stated Mike McClellan, Executive Vice President and Chief Financial Officer of Teva. “We achieved all goals we set to ourselves in this refinancing exercise, particularly optimizing the overall size of the facility, and we were very pleased to see the significant demand to commit, demonstrating the strong support from our existing relationship banks as well as from additional new banks.”


OPKO Health, Inc. (NASDAQ: OPK) recently announced positive topline results from a Phase 2 dose escalation trial of OPK88003 to treat type 2 diabetes and obesity.  OPK88003 is a once-weekly injectable oxyntomodulin compound with glucagon-like-peptide 1 (GLP-1) and glucagon dual agonist activity.  Based on data from a previous 420 patient Phase 2 study, an optimized dosing regimen for OPK88003 was evaluated to improve glucose control and increase weight loss.  Topline analysis of results of the study demonstrated that OPK88003 met the primary objective with a statistically significant lowering of hemoglobin A1c (HbA1c) after 30 weeks of treatment versus placebo as well as an important secondary endpoint, statistically significant weight loss versus placebo.


Geron Corporation (NASDAQ: GERN) recently announced the appointments of Dawn C. Bir and Elizabeth G. O’Farrell as independent members of its Board of Directors. In addition, Ms. Bir will serve as a member of the Board’s Nominating and Corporate Governance Committee, and Ms. O’Farrell will serve as a member of the Board’s Audit Committee.


“We enthusiastically welcome two accomplished biopharmaceutical executives to Geron’s Board, both of whom have deep experience with guiding the growth of companies from clinical to commercial stage,” said John A. Scarlett, M.D., Chairman and Chief Executive Officer. “We believe their contributions will be invaluable as we advance our lead indication for imetelstat in lower risk MDS to Phase 3 clinical development and, in the future, begin preparations for the potential commercialization of imetelstat.”


Gilead Sciences, Inc. (NASDAQ: GILD) recently announced the launch of five new global grants programs to continue to support investigator-sponsored research in chronic hepatitis C virus (HCV) and hepatitis B virus (HBV), HCV and HIV co-infection, nonalcoholic steatohepatitis (NASH) and primary sclerosing cholangitis (PSC). The programs will accept applications from around the world for projects that seek to address pressing unmet patient needs in liver disease, including improving screening and linkage to care, simplifying HCV testing and treatment, developing innovative referral pathways to help patients with NASH access care, addressing gaps in HBV care for special populations and understanding PSC epidemiology.


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