Every industry or sector has pioneers that worked at the forefront of the field to shepherd new technologies into the mainstream. Oncology, for example, took huge steps forward as a result of the efforts of Dr. Sidney Farber, earning him the titles of “the father of the modern era of chemotherapy” and “father of modern pediatric pathology”. What Dr. Farber was doing seventy years ago changed the landscape of cancer therapies. Fast forwarding to today, there are leaders in the regenerative medicine (sometimes called “tissue engineering”) field that one day may be referenced in the same manner as Farber. Henri Termeer, who retired from his post as CEO at Genzyme last year when the biotech leader was bought by Sanofi-Aventis (NYSE: SNY) for $20.1 billion; Geoff MacKay, CEO at privately-held Organogenesis, Inc.; and Gil Van Bokkelen, CEO at Athersys, Inc. (NASDAQ: ATHX) are each recognized as innovators in regenerative medicines that demonstrate the skill, tenacity and Read More

Fibrocell Science, Inc. (OTCBB: FCSC), an autologous cellular therapeutic company focused on the development of innovative products for aesthetic, medical and scientific applications, announced this morning that is has submitted to the U.S. Food & Drug Administration (FDA) the company’s Phase II clinical study protocol to evaluate the safety and efficacy of Fibrocell’s lead therapy, azficel-T, in improving the range of motion, function and flexibility, in patients with existing restrictive burn Read More

An article released yesterday by Reuters titled, “U.S. may speed approval of ‘breakthrough’ drugs” could prove extremely valuable for biotechs of all sizes.  According to the article,

Experimental drugs that show a big effect early in development for treating serious or life-threatening diseases would get a faster and cheaper path to U.S. approval, under a proposal likely to become law this year.

U.S. drug regulators would be able to label such treatments ‘breakthrough’ therapies, and work with companies to speed up clinical trials, for example by testing the drugs for a shorter time or enrolling fewer patients.

The U.S. Food and Drug Administration has said it supports the proposal, which is included in both versions of an FDA ‘must-pass’ funding bill currently working its way through Congress and set to be passed by the end of the summer.

Cellceutix (CTIX) Stock Quote and News:

A letter from the Food and Drug Administration can send a stock flying or crush the dreams of shareholders like ocean waves on a rock.  Falling somewhere in the middle, Guided Therapeutics, Inc. (OTCBB: GTHP) received word from the FDA in November 2011 that it was not planning a panel review to render a decision on the Premarket Approval (PMA) application of the company’s LuViva™ Advanced Cervical Scan.  The regulatory agency saying that it understood the technology and the clinical application was positively received with shares heading on a steady upward trek from around 75 cents to $1.84 over the next couple months as investors awaited official approval.  But, when Read More

Graft versus Host Disease (GvHD) is an area of great unmet medical that represents a significant risk to cancer patients throughout the world.  The condition occurs when patients receive a bone marrow transplant following radiation and/or chemotherapy, and the transplanted immune cells begin to attack the patient, causing significant pain and disability, or even death. Read More

Supplemental New Drug Applications (sNDA) are in the news quite a bit recently.  Gilead Sciences Inc. (NASDAQ: GILD) has filed a sNDA with the U.S. Food and Drug Administration to allow the use of Truvada (tenofoviremtricitabine) for preventative purposes of HIV (human immunodeficiency virus) after studies have shown a great reduction in risk of spreading the disease.  Johnson & Johnson (NYSE:JNJ) and Bayer AG (Pink Sheets: BAYRY) have plans this quarter to file Read More

There’s no arguing that stem cells therapies have been a hot button topic of controversy for years.  The days are few and far between where there isn’t something in the media that highlights some aspect of the debate, whether it’s promising research results; a new clinical study being authorized by the FDA; a high-profile athlete heading overseas for some type of stem cell therapy through the practice of Read More

Expanding its footprint in the cancer treatment space, Access Pharmaceuticals, Inc. (OTCBB: ACCP) said today that Memorial Sloan-Kettering Cancer Center (MSKCC), one of the world’s premier cancer centers, has added MuGard to its cancer supportive care pharmacy formulary.  Patients undergoing cancer treatment will now have direct access to MuGard from the first day of cancer treatment to manage oral mucositis, Read More

Company on Schedule for Filing Amended IND -

Cellceutix Corporation (OTCBB: CTIX) (the “Company”), a biopharmaceutical company developing small molecule drugs to treat severe medical conditions, including drug-resistant cancers, is pleased to provide shareholders an update on developments with its novel anti-cancer compound Kevetrin™. Read More

San Diego, California-based Optimer Pharmaceuticals, Inc. (NASDAQ: OPTR) and Tokyo-based Astelllas Pharma Inc. (Pink Sheets: ALPMY, Tokyo: 4503) reported this morning that the execution of an exclusive collaboration and license agreement to develop and commercialize fidaxomicin tablets in Japan for the treatment of Clostridium difficile Infection (CDI). Read More