Clinical Research Pathways Organization Unveils New Patients' Guide to Clinical Trials and Expanded Access
Monday, August 13, 2018 09:41 AM

When someone is diagnosed with a serious or life-threatening illness and they have exhausted standard treatments, it's important to know that there are still options. Two important options are clinical trials and expanded access to experimental products. At Clinical Research Pathways, our role is to help individuals learn about clinical trials and help guide them through FDA's Expanded Access program. The path to these options can feel overwhelming, but it does not need to be so difficult. We have put together a document that provides a simple, concise overview of these options. It also answers frequently asked questions and offers guidance for navigating the process. At the end, we have included a glossary with definitions of terms with which patients or their families may be unfamiliar.

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Celtaxsys Announces Results of Phase 2 Trial Showing Clinically Meaningful Improvement in Pulmonary Exacerbations in Cystic Fibrosis Patients
Thursday, August 02, 2018 02:16 PM

Celtaxsys, Inc., a clinical stage pharmaceutical development company focused on advancing treatments for patients with rare inflammatory diseases, today announced top line results of its Phase 2 EMPIRE-CF trial evaluating oral, once daily antiinflammatory molecule, acebilustat, for the treatment of cystic fibrosis (CF), irrespective of the causative genotype. In the 200 patient, double-blind, placebo controlled study, acebilustat demonstrated clinically meaningful improvements in pulmonary exacerbations, both reducing the frequency of pulmonary exacerbations (PEx) and increasing time to next exacerbation over 48 weeks of therapy. Full results from the trial will be presented this fall at the North American Cystic Fibrosis Foundation annual meeting.

“The trial data provide credible evidence to advance the development of this novel antiinflammatory molecule,” said Steven M. Rowe, M.D. MSPH, professor of medicine and director of the Gregory Fleming James Cystic Fibrosis Research Center at the University of Alabama at Birmingham. “Patients in key prospectively-identified sub-groups, including those with mild obstruction at baseline or taking CFTR modulator therapy, derived the most benefit in pulmonary exacerbations. That benefit, when used in combination with a CFTR modulator, is an important consideration given the likelihood of an increase in the number of CF patients who are eligible to be treated with new CFTR modulators over the coming years. This supports the unmet need to address lung inflammation adequately for the optimal treatment of patients with cystic fibrosis.”

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GeoVax and Emory University to Collaborate on HPV Therapeutic Program for Head and Neck Cancers
Tuesday, July 31, 2018 10:51 AM

GeoVax Labs, Inc. (OTCQB: GOVX), a biotechnology company developing human vaccines, announced today that it is collaborating with Emory University on the development of a therapeutic vaccine for human papillomavirus (HPV) infection, with a specific focus on head and neck cancer (HNC).

The GeoVax/Emory collaboration will include testing GeoVax’s MVA-VLP-HPV vaccine candidates in therapeutic animal models of HPV in the laboratory of Dr. Rafi Ahmed, Director of the Emory Vaccine Center. Dr. Ahmed, a member of the National Academy of Sciences, is a world-renowned immunologist whose work during the past decade has been highly influential in shaping understanding of memory T cell differentiation and T and B cell-mediated antiviral immunity. 

GeoVax’s vaccine technology is based on its Modified Vaccinia Ankara (MVA) Virus-Like Particle (VLP) platform, which generates noninfectious VLPs in the individual being vaccinated. Gene sequences of target antigens are inserted into the MVA genome which drives their expression in infected cells. In addition, GeoVax introduces into the viral genome matrix sequences that incorporate antigens into VLPs and simultaneously facilitate their budding from the membranes of infected cells. In this way, vaccination induces two pools of antigens as targets for the immune response – virus-infected cells and released VLPs. This strategy mimics a natural viral infection, triggering the body to produce a robust and durable immune response with involvement of both antibodies and T cells.

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Novartis announces intention to seek shareholder approval for 100% spinoff of Alcon eye care devices business; initiates share buyback of up to USD 5 bn
Thursday, July 26, 2018 11:38 AM
  • Alcon strategic review concludes that 100% spinoff in best interest of shareholders and consistent with the Novartis strategy of focusing as a medicines company 
      
  • Planned spinoff would create world leading eye care devices company
      
  • The Alcon ophthalmology pharmaceuticals portfolio will remain with Novartis, further strengthening its leading ophthalmology pharmaceuticals business
      
  • Transaction expected to be tax neutral to Novartis and subject to general market conditions, tax rulings and opinions, final Board endorsement and shareholder approval at the AGM in February 2019; completion expected in H1 2019
      
  • Alcon CEO Mike Ball to become Chairman-designate; COO, David Endicott promoted to Alcon CEO, both appointments effective July 1, 2018
      
  • Alcon would be incorporated in Switzerland; with Fort Worth continuing to be a key location. Listings planned on SIX Swiss Exchange and New York Stock Exchange
      
  • Share buyback of up to USD 5 bn planned to be executed by end 2019, in line with capital allocation priorities highlighting confidence in top line growth and margin expansion

Basel, June 29, 2018 - Novartis today announced its intention to spinoff Alcon, its eye care division, into a separately-traded standalone company. The planned spinoff would enable Novartis and Alcon to focus fully on their respective growth strategies. Completion of the transaction is subject to general market conditions, tax rulings and opinions, final Board of Directors endorsement and shareholder approval at the 2019 AGM in line with Swiss corporate law.

Novartis also announced that it will initiate a share buyback of up to USD 5 billion to be executed by the end of 2019[1]. This action is planned to be largely funded through the proceeds of the divestment to GSK of the consumer health joint venture stake, net of the AveXis acquisition payments.

Joerg Reinhardt, Chairman of Novartis, said: "Our strategic review examined all options for Alcon ranging from retention, sale, IPO to spinoff. The review concluded that a spinoff would be in the best interests of Novartis shareholders and the Board of Directors intends to seek shareholder approval for a spinoff at the 2019 AGM. This transaction would allow our shareholders to benefit from potential future successes of a more focused Novartis and a standalone Alcon, which would become a publicly traded global medtech leader based here in Switzerland."

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MiMedx Appoints Mark Graves Chief Compliance Officer To Strengthen Corporate Compliance Practices
Friday, July 20, 2018 04:44 PM

MiMedx Group, Inc., a leading developer and marketer of regenerative and therapeutic biologics, announced that it has appointed Mark P. Graves to the position of Chief Compliance Officer.  Mr. Graves will be responsible for providing direction and oversight of MiMedx's compliance program, including the Company's regulatory and legal compliance matters related to the Company's risk management, sales operations and financial reporting. Mr. Graves will report to Ed Borkowski, the Company's Executive Vice President and Interim Chief Financial Offficer on a day-to-day basis. He will also report directly to the newly formed Ethics and Compliance Committee of the Board of Directors.

"We are implementing plans to improve our corporate compliance practices in order to ensure our Company adheres to policies with the highest integrity, ethics and legal standards," said David Coles, interim Chief Executive Officer, MiMedx. "Mark has a strong background in driving compliance strategy, risk awareness, training, and crafting effective policy. He will help MiMedx apply and execute on best-in-class compliance standards that reflect our commitment to enhancing value for all stakeholders. We are pleased to welcome him to our organization."

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