In a speech at a University of Southern California-Brookings Institution event, Seema Verma pointed to 2016 figures showing more than $1 billion in missed savings.
The FDA last week issued the draft guidance, under which it would publicly state if it denied branded drugmakers' citizen petitions because they were designed to delay generic market entry.
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
Civica Rx, announced earlier this year, formally established with $30 million in philanthropy money, a former Amgen exec as CEO and a focus on 14 drugs facing shortages.
The FDA commissioner is singling out companies that he says have blocked access to product samples needed to make generics.
Four health systems — Intermountain Healthcare, Ascension, SSM Health and Trinity Health — and the U.S. Department of Veterans Affairs will launch a nonprofit generic drug company, which will either directly manufacture generic drugs or sub-contract the manufacturing work.
The high prices Americans pay for generic drugs may have been cooked up by pharmaceutical salespeople on golf courses, at a New Jersey steakhouse or over martinis at a “Girls Nights Out” in Minnesota.
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
Attorneys general in 20 states have filed an anti-trust lawsuit against Heritage, Mylan, Teva and three other generic drug companies, alleging price-fixing and market-splitting tactics between the competition.
Critics say getting generic alternatives to the U.S. market for products like EpiPen is still taking far too long.
This will be a year in which generic drugmakers will have plenty of fodder - more than two dozen major drugs are going off-patent in 2016.
Bionpharma just raised $6.5 million, according to a regulatory filing - on top of about $31 million raised last year.
Gabby Everett, the site director for BioLabs Pegasus Park, offered a tour of the space and shared some examples of why early-stage life science companies should choose North Texas.
Also, the narrative shifts for FDA nominee Robert Califf, good news on Merck's c. diff treatment, and here's one part of Obamacare everyone hates.
A cadre of former execs at Indian generic drugmaker Ranbaxy’s US branch quit last month and have launched a startup in New Jersey. Called Bion Pharma, it will help Indian and European drugmakers expand receive regulatory clearance and distribution rights in the world’s largest drug market – the USA. Economic Times reports: The top team of Bion […]
Areas like generic drug regulation, drug supply chain and clinical trials reporting may be in need of some revamping by the Food and Drug Administration, according to a new Work Plan from the U.S. Department of Health and Human Services’ Office of the Inspector General. All items will be examined by the end of next year. Alexander […]
The many patent cliffs seem to have emboldened generic drugmakers: Pharma patent litigation is on the rise, particularly when it comes to newer IP – 2014 was a record year for ANDA suits, according to a new report from Menlo Park legal analytics firm Lex Machina. This graphic says it all: The Hatch-Waxman/ANDA Litigation Report analyzes 1,671 cases filed […]
By Kurt R. Karst – It was only about a year ago when the topic du jour was generic drug labeling and whether federal law – the FDC Act and FDA’s implementing regulations – preempts state-law product liability claims (failure-to-warn, design defect, failure-to-conform/update, etc.) against generic drug manufacturers. In fact, we were so inundated with […]