Drugs
PhRMA (Pharmaceutical Research and Manufacturers of America) president Stephen Ubl says that when drug industry leaders met with president Donald Trump, they found that he was focused on policy changes that would allow the U.S. to continue to lead the world in drug development. “We had a positive, productive
FDA Policy/General
Former CDRH Division of Cardiovascular, Respiratory, and Neurological Devices acting deputy director Daniel Spyker has joined NDA Partners as an expert consultant. The product development and regulatory strategy firm says Spkyer’s “knowledge and expertise of cardiovascular, respiratory, and neurological devices at FDA and in the Industry, in addition to
Devices
Cybersecurity firm TrapX says it has found malware on medical devices at major healthcare providers across the globe. The company says the infected devices “create a backdoor security breech that puts tens of thousands of patient records at risk.” Company president Greg Enriquez tells a San Mateo, CA, television station
Drugs
CDER oncology drug senior staffers Richard Pazdur and Gideon Blumenthal review FDA’s 2016 oncology drug approvals in a Clinical Oncology commentary. They note the approval of five new molecular entities and 17 efficacy supplements, including six accelerated approvals, 17 priority reviews, and 11 approvals of breakthrough-designated therapies. The
Drugs
FDA has accepted for priority review an NDA from the Medicines Co. for Carbavance (meropenem-vaborbactam) for treating complicated urinary tract infections (cUTIs). The submission is based on results from the pivotal Phase 3 TANGO 1 clinical trial in patients with cUTIs, which met both FDA and European Medicines Agency
FDA Policy/General
The Trump Administration is planning to submit its budget plan to Congress on 3/14. Capitol Hill Republicans told the Associated Press that they are expecting a skinny Trump blueprint with fewer details than usual because of the new administration changeover and short time new Office of Management and Budget
Devices
Molecular diagnostic company Immunexpress has received 510(k) clearance for the use of SeptiCyte LAB as an aid in differentiating infection-positive (sepsis) from infection-negative (SIRS) systemic inflammation in critically ill patients on their first day of intensive care unit admission. “It is the first RNA-based clinical diagnostic
Drugs
FDA has awarded contract research organization ICON a contract to validate three patient reported outcomes (PRO) instruments that will measure clinical endpoints in antibacterial drug trials. The conditions in which the endpoints will be validated are acute bacterial skin and skin structure infections, community-acquired bacterial pneumonia and hospital-acquired
Devices
Responding to an FDA notice of proposed medical device guidance development for Fiscal Year 2017, AdvaMed has submitted its priorities for the items on the agency’s lists, marking them either “high,” “medium,” or “low” priority to its member companies. The association also recommends that the agency finalize all of
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Fenwal, Inc. Lake Zurich, IL (10/14/2016): CBER’s Advertising and Promotional Labeling Branch has reviewed Presentation slides to introduce InterSol Solution to blood collection facility staff submitted
Devices
InRange Systems says FDA should detain the Life Integrating Technologies and Experiences Lumma remote medication management system which has not been cleared or approved by the agency and is misbranded. The InRange petition says the Lumma device does not (1) conform to the general controls of the Federal Food, Drug,
FDA Policy/General
Federal Register Notice: FDA has made available a draft guidance entitled “Q11 Development and Manufacture of Drug Substances — Questions and Answers (regarding the selection and justification of starting materials).” The International Council for Harmonization guidance is intended to clarify the principles for selecting starting materials. It focuses on chemical entity
FDA Policy/General
Faster drug approvals and more medical device apps might be among the first issues tackled by former FDA deputy commissioner Scott Gottlieb if he is named commissioner, according to an Endpoints News analysis. The online post says that while other names are also being floated as possible commissioner candidates, Gottlieb
Drugs
Attorney Jeffrey Shapiro (Hyman, Phelps & McNamara) says that the FDA “intended use” regulation is a root cause of the agency’s 1st Amendment problems. Writing in his firm’s FDA Law Blog, Shapiro says the issues created by an FDA 1/9 final rule that created a new “totality
FDA Policy/General
Federal Register Notice: FDA has established a public docket to collect comments related to pediatric postmarketing pharmacovigilance and drug utilization reviews of products posted between 9/17/2016 and 2/24/2017 on the agency’s Web site, but will not be presented at a 3/6-7 Pediatric Advisory
Drugs
Genentech filed suit in Delaware federal court 2/20 seeking a declaratory judgment that Amgen is violating the patent dance provisions of the Biologics Price Competition and Innovation Act in connection with its proposed biosimilar of Genentech’s Avastin (bevacizumab). The complaint says that Amgen opted to participate in the
Drugs
A 6/25-7/1/15 FDA inspection at Humco Holding Group, Texarkana, TX, found significant violations of current good manufacturing practice regulations for finished pharmaceuticals, according to a 1/26 Warning Letter from the agency’s Dallas District Office. The inspection also found that the firm manufactures and distributes
Drugs
Momenta says that a Pfizer facility that is a key fill/finish supply chain partner for the company’s Glatopa (glatiramer acetate injection) products has received an FDA Warning Letter that will likely delay agency approval of a Glatopa 40 mg ANDA. The Warning Letter does not restrict production or
Drugs
Four Dechert attorneys say that life sciences companies continued to be popular targets of securities fraud class action lawsuits in 2016. In a white paper, the four report that in 2016, plaintiffs filed a total of 67 class action securities suits against life sciences companies, an increase of more than
Drugs
Vertice Pharma says FDA should not file for review any NDA or receive any ANDA for potassium chloride oral drug products unless the application includes summaries of completed risk assessment in according with an International Conference on Harmonization (ICH) Q3D guidance and appropriate controls as need for several elemental impurities
Biologics
FDA has accepted for priority review a Pfizer BLA for inotuzumab ozogamicin for treating adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). Inotuzumab ozogamicin received a Breakthrough Therapy designation from the agency 10/2015. The user fee review target date is expected in August. The
Drugs
Sarepta Therapeutics has entered into an agreement to sell to Gilead its FDA Rare Pediatric Disease Priority Review Voucher (PRV) for $125 million. Sarepta was awarded the PRV when it gained approval last year for its Duchenne muscular dystrophy drug Exondys 51. The voucher was awarded under a provision that