Medical Device Legal News with Sam Bernstein: Episode 18
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 169: Shirley Paddock, Senior VP of Clinical Development, Syneos Health
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 168: Christine Harhaj, Senior Director of Advocacy & Strategic Alliances, PhRMA
Podcast: Unpacking FDA's Final Clinical Decision Support Guidance - Diagnosing Health Care
Podcast: Post-Dobbs - Considerations for Clinical Trials and Research - Diagnosing Health Care
Product Launching in the Era of COVID-19 - Diagnosing Health Care Podcast
JONES DAY PRESENTS® Digital Health and Clinical Research: Understanding Regulatory Regimes
JONES DAY PRESENTS® The Impact of Digital Health on Research and Clinical Trials
Nota Bene Episode 75: Clinical Trial Disclosures on the World Map with TrialScope Chief Strategy Officer Thomas Wicks
Podcast: Non-binding Guidance: SEC Disclosure Issues for Life Sciences Companies
Life Sciences Quarterly (Q3 2019): SEC Enforcement and Class Actions Regarding FDA Communications
Podcast: Non-binding Guidance: Real-World Evidence in Drug Development and FDA Submissions
Passage of Federal Right-to-Try law poses risks and opportunities for patients and the biopharmaceutical industry
Life Sciences Quarterly (Q4 2017): The Use of Social Media and Mobile Applications
State AGs in the News- Governor Newsom Nominates Rob Bonta for California Attorney General- •Governor Gavin Newsom nominated California Assemblyman Rob Bonta to replace Xavier Becerra as California AG. Bonta’s...more
Right before the new year, we told you about some of the Medicaid-related provisions of the COVID relief package that was recently signed into law by President Trump. One provision of that law that we thought merited a...more
In Washington: President-elect Joe Biden unveiled the first plan to is two-part $1.9 trillion stimulus package calling on Congress to approve $415 billion in emergency spending to scale up vaccinations, testing, and other...more
In Washington: The federal government’s role in physically distributing COVID-19 vaccines remains unclear. President Trump said last month that the military would distribute vaccines. But a spokesman for Operation Warp...more
In Washington: House Speaker Nancy Pelosi (D-CA) in a Thursday morning letter to Treasury Secretary Steven Mnuchin pressed the White House for a response to the Democrats' latest coronavirus relief package proposal....more
In Washington: White House communications director Alyssa Farah said Tuesday that the White House still hopes for a coronavirus relief package, probably post-election. Speaking on Fox & Friends, Farah said President Trump...more
In Washington: Tuesday afternoon, House Speaker Nancy Pelosi (D-CA) said Democrats and the White House have moved closer to a deal on a fourth COVID-19 stimulus relief bill ahead of her latest call with Treasury Secretary...more
In Washington - Secretary Steven Mnuchin and Speaker Nancy Pelosi spoke for an hour Wednesday morning and plan to speak again tomorrow. Mnuchin says they continue to “make progress” while Pelosi’s spokesperson says the...more
In Washington - Senate Majority Leader Mitch McConnell (R-KY) and Republicans released the text of their “skinny” or “targeted” coronavirus relief bill. McConnell said a vote to proceed to the bill is expected Thursday....more
Will it be a shot in the arm — or the foot? Americans have invested high hopes in a Covid-19 vaccine. Its development is racing ahead, with researchers deploying novel approaches and governments spending billions of dollars...more
In Washington - The House of Representatives, in a 257-150 vote, passed legislation providing US$25 billion to the United States Postal Service and bans any operational changes to the agency, while reversing...more
In Washington - House Speaker Nancy Pelosi (D-CA) is calling Democrats back from the August recess to vote on legislation that would prohibit operational changes at the U.S. Postal Service that could curtail mail-in...more
In Washington - Senate Majority Leader Mitch McConnell (R-KY) introduced the “Health, Economic Assistance, Liability Protection, and Schools Act” (HEALS Act). The Republican proposal includes several provisions designed to...more
In Washington: Just as some federal agencies are calling for federal employees who are teleworking to return, several Virginia and Maryland lawmakers are warning that it might be too early. ...more
In Washington: Today, the House will meet for a pro forma session and the Senate will resume consideration of John Badalamenti to be United States District Judge for the Middle District of Florida. The full House will be...more
In Washington - The House will be in session on Wednesday and Thursday and is expected to vote on two bills dealing with the Paycheck Protection Program (PPP) giving small businesses more flexibility in the use of the...more
The World Health Organization (WHO) has determined that the 2019 novel coronavirus is a “global pandemic” and President Trump has declared a national emergency as the impact of the virus on all aspects of daily life continues...more
Autologous chimeric antigen receptor (CAR) T-cells—which are “living drugs”—are promising, emerging therapeutics in immuno-oncology. One example of these “living drugs” is Kymriah (tisagenlecleucel). The drug, a CD-19...more
On May 30, President Trump signed the Right to Try Act. The Act authorizes the use of experimental drugs without pre-approval or oversight by the Food and Drug Administration. Both the patient and the drug must meet certain...more
Often those with terminal illnesses wish to try new experimental therapies. Now they can if they are willing to accept the risks. On May 30, 2018, President Trump signed into law the Right to Try Act. The Act allows eligible...more
On May 30, 2018, President Trump signed the Trickett Wendler, Frank Mongiello, Jordan McLinn and Matthew Bellina Right to Try Act of 2018. The bill allows the provision of certain unapproved, investigational drugs to patients...more
On June 4, 2018, the Food and Drug Administration (FDA) announced a major restructuring in its Office of New Drugs (OND) within the Center for Drug Evaluation and Research (CDER). OND currently includes six offices with 19...more
On May 30, 2018, surrounded by patients directly impacted by tragic and intractable diseases, President Trump signed into law the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017...more