Articles By Marcus Johnson
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Shire To Comply With FDA Request To Test ADHD Drug On Preschoolers
6/17/2014
Shire, which produces the ADHD drug Vyvanse, has agreed to test the drug on preschool children at the request of the FDA. The FDA is concerned about the increase in ADHD diagnoses and drug prescriptions for young children and wants to learn if Vyvanse can produce positive outcomes for the young patients that it treats.
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FDA Lifts Partial Hold On Imetelstat Study
6/17/2014
The FDA and Geron Crop have announced that the FDA has lifted the partial hold on the clinical study testing of imetelstat, Geron’s myelofibrosis drug. Myelofibrosis is a rare blood cancer. The Geron Crop early stage imetelstat drug study is sponsored by the Mayo Clinic and it was stopped by the FDA in March because of concerns about liver toxicity issues.
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Sanofi And CQDM Enter Into Drug Discovery Agreement
6/17/2014
Sanofi Canada has announced that it is entering into a drug discovery agreement with the Quebec Consortium for Drug Discovery, or CQDM. The partnership will help to support drug discovery and development efforts in Quebec and other provinces in Canada. Sanofi has already stated that it will be contributing as much as half a million dollars to the agreement, which is set to last for as many as five years. There may also be other financial contributors to the partnership in the future.
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Federal Judge Strikes Down Drug Discount Program
6/17/2014
A new rule included in the Affordable Care Act would have required drug companies to offer certain drugs at discounted prices. However, the rule was struck down by a federal judge who said that the President’s administration does not have the authority to include the rule in the legislation. Judge Contreras said that the Obama administration was “acting beyond the bounds of its statutory authority.” The decision was issued by Judge Rudolph Contreras of the Federal District Court, and the Obama administration has stated that it is currently reviewing the ruling, without noting if it will appeal.
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Xcelience Opens New Packaging And Distribution Facility In UK
6/11/2014
Xcelience has announced that it will be opening a 3,000 square foot facility in Birhmingham, United Kingdom. The facility’s opening makes Xcelience the first small to mid-sized American CDMO to establish an international operation. This facility will allow the company to expand its packaging and distribution business and move into European markets. It will also allow Xcelience to expand its capabilities, including secondary packaging, labeling, and clinical trial distribution operations, as well as qualified person release and lab services.
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TaiGen Signs Deal With ScinoPharm To Use Burixafor APIs
6/10/2014
Drug manufacturer TaiGen Biotechnology has announced that it has signed an agreement to use ScinoPharm Taiwan’s active pharmaceutical ingredients, or APIs, to make stem cell mobilizer, Burixafor. The drug is used in hematopoietic stem cell transplantation, chemotherapy sensitization, and other ischemic diseases. The drug is expected to help TaiGen attain 40 percent of the blood and marrow transplant drug market, earning the company a potential 500 million in addition to $600 million in sales of chemotherapy enhancers, the Taipei Times says. Burixafor sales alone are expected to reach $1.1 billion within a year.
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Merck Agrees To Purchase Idenix For $3.85 Billion
6/10/2014
Drug industry heavyweight Merck has announced that it will be purchasing Idenix Pharmaceuticals, a biopharmaceutical company, for $3.85 billion. Idenix Pharmaceuticals, based out of Cambridge, Massachusetts, develops drugs for human viral diseases, focusing in particular on treatments for hepatitis C virus, or HCV. This move could be a smart one for Merck, considering that the market for HCV treatment is estimated to hit $200 billion worldwide over the next 15 years.
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Study Finds Selecting Cheaper Eye Drug Could Save U.S. Billions
6/9/2014
Researchers at the University of Michigan have found that if eye doctors began to prescribe a less expensive eye drug for the wet form of macular degeneration or those who have diabetic macular edema, the U.S. Medicare system could save as much as $18 billion over 10 years. Patients suffering from these two conditions currently have two treatment options: bevacizumab (branded as Avastin), which costs $55 per treatment, or ranibizumab (branded as Lucentis) which costs $2,023 per treatment. Ranibizumab is almost 40 times more expensive than bevacizumab, and the researchers found that the drugs are very similar in terms of efficacy, safety, and side effects. Both drugs are injected into the patients’ eyes during visits to the doctor.
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Medicenna Therapeutics Chooses CMO Kalon To Manufacture New Drug
6/9/2014
Texas A&M-based Kalon Biotherapeutics has announced that it has been chosen by Medicenna Therapeutics as the contract manufacturer for the development, testing, and commercialization of several new drugs in the Medicenna pipeline.
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TiGenix Sells Dutch Manufacturing Plant To PharmaCell
6/4/2014
TiGenix NV, which is a leader in Europe’s cell therapy sector, has announced that it has come to terms with PharmaCell BV in regards to the sale of its Dutch based manufacturing plant. The sale cost PharmaCell a total of 5.75 million Euros. PharmaCell, which is a European contract manufacturing organization (CMO) that focuses primarily on cell therapy and regenerative medicines, will be receiving shares of TiGenix’s subsidiary, TiGenix BV, as it is TiGenix BV that holds the manufacturing plant.