Articles By Marcus Johnson

  1. Relypsa Enters Into Manufacturing Deal With DSM Fine Chemicals 5/22/2014

    Relypsa Inc. has announced that it has entered into a manufacturing contract with DSM Fine Chemicals. The multi-year commercial manufacturing and supply contract will be for the production of the active pharmaceutical ingredient, or API, of patiromer, which will be used in the development of hyperkalemia treatment.

  2. Could Pine Bark Substance Be New Melanoma Treatment? 5/21/2014

    Researchers at the Penn State College of Medicine believe that a substance derived from pine bark could potentially help treat patients suffering from melanoma. The substance, leelamine, was discovered during a screening of 480 different natural compounds and has since undergone tests at the university on mice.

  3. FDA Says More Studies Needed For Osteoporosis Drug 5/21/2014

    The FDA says that more research is necessary for bisphosphonates, which are a class of drugs used to treat patients with osteoporosis. Bisphosphonates have been used since 1995 to treat patients with osteoporosis, and it is estimated that as many as 44 million Americans are at risk for the condition. While the drugs have proven effective, regulators are looking into the long term effects of regular usage of the drugs.

  4. Shire Reports Positive Phase 3 Trial Results For Lifitegrast Drug 5/2/2014

    Specialty biopharmaceutical company Shire has announced positive results from a Phase 3 OPUS-2 study on its lifitegrast ophthalmic solution. The study measuring the safety and effectiveness of lifitegrast being administered twice a day was randomized, double-masked, placebo-controlled, and lasted a year. The clinical trial met one of its primary endpoints of reduced dry eye symptoms in comparison to the placebo. However, the study did not meet its second co-primary endpoint of the sign of inferior corneal staining.

  5. Amicus Therapeutics Releases Positive Trial Results For Experimental Fabry Disease Drug 5/2/2014

    Amicus Therapeutics issued a press release announcing that its experimental Fabry disease drug, migalastat, has performed well in its late stage clinical trial. The 24-month double blind study proceeded with a 6-month placebo-controlled treatment period and was followed by another six months, during which patients were treated with migalastat. This was followed by a 12-month open-label extension phase.

  6. FDA Grants Approval To U.S. Phase-II Trials For ALS Disease Treatment 4/29/2014

    On Monday, the FDA announced that it had approved Phase II clinical trials for BrainStorm Cell Therapeutics’ stem cell treatment for patients with amyotrophic lateral sclerosis, or ALS.

  7. Erdosteine Given Orphan Drug Status By FDA 4/29/2014

    Edmond Pharma’s drug Erdosteine has been given orphan drug status by the FDA for the treatment of bronchiectasis. Orphan status is typically given to drugs that affect less than 200,000 people within the United States; in turn, the drug producer receives various benefits in return, such as longer exclusivity periods.

  8. Sylvant Approved For Treatment Of Castleman's Disease 4/28/2014

    Sylvant (siltuximab), Janssen Biotech’s Castleman’s disease drug, has been approved by the FDA for use in adults that do not have HIV or the human herpes virus 8. To date, it is the first drug to have been approved for the treatment of multicentric Castleman’s disease, or MCD. The drug underwent an expedited review process, which is reserved for drugs that show the potential to help patients who are suffering from diseases with few current options for treatment. In both the US and in the EU, the drug has been granted orphan drug designation. It was also recently recommended for approval in the EU.

  9. Parkinson's Drug Could Help Prevent Breast Cancer 4/28/2014

    Early research suggests that benserazide, a drug that is currently being used to treat patients with Parkinson’s disease for their symptoms, can prevent breast cancer in women with mutations in the BRCA1 gene. Women with BRCA1 gene mutations are at higher risks for both breast and ovarian cancer. There are not any drugs currently on the market that have been shown to reduce this risk.

  10. TB Drug Could Be Answer To Antibiotic Development In Age Of Drug Resistance 4/24/2014

    University of Illinois researchers have studied the SQ109 tuberculosis drug and determined that it could also be the basis for a class of broad-spectrum drugs that can fight a variety of bacteria, fungal infections, and parasites, and evade resistance. SQ109 is manufactured by Sequella.