Drugs
A study in the Journal of the American Medical Association says that there is a correlation between increases in the number of men seeking and taking testosterone and televised direct-to-consumer ads for the drug. An online CardioBrief post says that although testosterone is approved only for men with
Drugs
FDA has given Cornerstone Pharmaceuticals a green light to conduct pivotal trials of its lead compound, CPI-613, in patients with acute myeloid leukemia (AML) and pancreatic cancer. CPI-613 is the company’s first-in-class anticancer compound from its proprietary Altered Energy Metabolism Directed platform. It is designed
Drugs
Sen. Bernie Sanders (I-VT) and Rep. Elijah Cummings (D-MD) have written to PTC Therapeutics CEO Stuart Peltz asking for information on the price the company plans to charge for Emflaza (deflazacort), used in treating Duchenne Muscular Dystrophy. PTC recently acquired rights to the drug from Marathon Pharmaceuticals, which
Drugs
FDA has granted EMD Serono accelerated approval for Bavencio (avelumab) for treating adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (MCC), including those who have not received prior chemotherapy. The therapy works by targeting the PD-1/PD-L1 pathway (proteins found on the body’
Drugs
FDA has sent a Warning Letter to India’s USV Pvt Ltd for CGMP violations and data integrity problems at its Daman drug manufacturing facility. The Economic Times reports the letter also referenced similar CGMP violations at the firm’s other facilities. FDA acknowledged that USV is using a consultant
Drugs
Attorney James Beck (Reed Smith) says that if FDA ends its ban on truthful off-label promotion under incoming commissioner Scott Gottlieb, warnings that drug and medical device companies will face increased liability don’t ring true. Writing in an online blog post, Beck disputes assertions made in a 3/
Drugs
Former FDA commissioner Robert Califf is chairman of the board of the new People-Centered Research Foundation (PCRF) that he says has been created to sustain and expand a national network for clinical research that originated with funding from the Patient-Centered Outcomes Research Institute and studies conducted by the
Drugs
The Combination Products Coalition says that while it agrees with many of the recommendations in an FDA draft guidance on comparative analyses and related comparative use human factor studies for a drug-device combination product submitted in an ANDA, it believes there should be several revisions. The coalition says it
Drugs
Acting on a request from Sens. Orrin Hatch (R-UT), Charles Grassley (R-IA), and Tom Cotton (R-AR), the Government Accountability Office (GAO) will look for possible abuses in FDA’s orphan drug program. Kaiser Health News reports that GAO will take the next few months to determine the
Drugs
FDA has released a draft guidance on “Delayed Graft Function in Kidney Transplantation: Developing Drugs for Prevention,” which addresses the agency’s current thinking on the overall development program and clinical trial designs for systemic drugs administered to kidney transplant recipients to support an indication of prevention of delayed graft
Drugs
A Massachusetts federal court jury has found former New England Compounding Center co-owner Barry Cadden guilty of racketeering and other charges in a 2012 fungal meningitis outbreak that killed more than 60 people and sickened hundreds more nationwide. The Boston Globe reports that the jury returned guilty verdicts on
Drugs
FDA testimony delivered by CDER director Janet Woodcock during a 3/22 House Energy and Commerce Committee health subcommittee hearing on reauthorizing the Prescription Drug User Fee Act (PDUFA 6) indicated that the Trump Administration does not stand behind the agency- and industry-negotiated user fee agreements and that new
Drugs
A 6/1-6/10/16 FDA inspection at USV Private Limited, Daman, India, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to a 3/10 Warning Letter. Specific violations include: * failing to establish laboratory controls that include scientifically sound and appropriate specifications, standards,
Drugs
A 5/30-6/1/16 FDA inspection at Jinan Jinda Pharmaceutical Chemistry Co., Zhangqiu City (Jinan), China, found significant deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients (API), according to a just-released 2/24 Warning Letter. Specific deviations included: * failure of the firm’s quality
Drugs
FDA has approved a Newron Pharmaceuticals NDA for Xadago (safinamide) tablets as an add-on treatment for patients with Parkinson’s disease who are currently taking levodopa/carbidopa and experiencing “off” episodes. An “off” episode is a time when a patient’s therapy is not working well, and thus causing
Drugs
A Health Affairs online post by California Western School of Law professor Robert Bohrer calls for a conditional drug approval system that would accelerate access to new drugs while restraining their price until full approval is granted. Bohrer writes that such an approach would address two major issues roiling the
Drugs
FDA has granted NantKwest an orphan drug designation for the company’s activated natural killer (aNK) cell therapy for treating patients with advanced Merkel cell carcinoma. The therapy is currently in a Phase 2 clinical trial at sites in the U.S. treating subjects with metastatic or locally advanced Merkel
Drugs
Today FDA posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. ARK Bio-Medical Canada Corp. North Milton, Prince Edward Island, Canada (3/7): FDA inspected the firm 7/2015 and determined that the firm is marketing the ARK Bio
Drugs
FDA has denied a 4/7/16 ProbioTech petition asking the agency to amend the definition of “dietary supplement” under the Dietary Supplement Health and Education Act of 1994 so that probiotic suppositories could be treated the same as oral probiotic dietary supplements. The company said that if the definition
Drugs
Former FDA commissioner Robert Califf told a 3/14 Clinical Trials Transformation Initiative webinar that better educational efforts are needed so that everyone in the clinical trial chain understands the entire process and not only their own role during a specific trial segment. In a presentation entitled “A Viewpoint on
Drugs
A Mississippi federal court decision in a prescription drug preemption case has muddied the waters for the legal status of design defect as a claim under state law, according to a blog post by attorney Eric Alexander (Reed Smith). He writes that the judge dismissed without prejudice the design defect
Drugs
Tarrex Biopharma has submitted an IND for TX803, a novel treatment for colorectal cancer. TX803 is a first-in-class small molecule therapeutic that “inhibits the PI3K/AKT pathway through a novel mechanism – by targeting, not the kinase itself, but a PI3K activating onco-protein, the truncated retinoid X receptor