Regulatory Affairs
Having passed the mid-year point, it is always an interesting exercise to take stock of where we stand with respect to the approval of new medicines. Overall, when considering the volume of activity, things would seem to be looking up … Continue reading
Posted: August 28, 2023, 6:25 am
For the second time this month and the third time this year, FDA’s OPDP has posted notice that it has taken an enforcement action. Last week, a Warning Letter was posted regarding a sales aid. This week it action came … Continue reading
Posted: August 22, 2023, 1:20 pm
In what has been a long period of relative low activity, FDA’s OPDP has taken the opportunity to remind us that low enforcement does not mean no enforcement when it comes to promotional speech by pharmaceutical companies. This past June … Continue reading
Posted: August 16, 2023, 12:05 pm
Every six months, we do a look-back to see what has changed in the way that FDA is communicating. One might not think there is much difference over time, but there is. For example, the air has pretty much gone … Continue reading
Posted: August 10, 2023, 7:31 am
For those who are regular followers of what FDA’s Office of Prescription Drug Promotion (OPDP) is up to, there was a surprise this week when the office posted the first regulatory action letter – in this case an Untitled Letter … Continue reading
Posted: June 14, 2023, 7:14 pm
Biotechnology
Coya Therapeutics, Inc. (Nasdaq: COYA) (“Coya” or the “Company”), a clinical-stage biotechnology company developing biologics and cell therapies intended to enhance the function of Tregs, announces that management will present at the LD Micro Investor Conference in Los Angeles, CA on October 3 at 8:00am PT.
Posted: September 27, 2023, 12:00 am
Akari Therapeutics, Plc today announced that the company will participate in the Emerging Growth Conference being held October 4 and 5, 2023.
Posted: September 27, 2023, 12:00 am
HotSpot Therapeutics, Inc. today announced it will present additional preclinical data from the Company's CBL-B program in a poster presentation at the 2023 Society for Immunotherapy of Cancer (SITC) Annual Meeting, taking place November 1-5, 2023, in San Diego, CA.
Posted: September 27, 2023, 12:00 am
Smart Immune, a clinical-stage biotechnology company developing ProTcell, a thymus-empowered T-cell progenitor therapy platform to fully and rapidly re-arm the immune system, announced that the first patients have been dosed in its ReSET-02 Phase I/II trial for adult acute leukemia and myelodysplasia syndrome patients.
Posted: September 27, 2023, 12:00 am
Biomind Labs Inc. provides a corporate update outlining its research and development, intellectual property and clinical trials initiatives.
Posted: September 27, 2023, 12:00 am
Pharmaceuticals
On health care issues, the second GOP primary debate spanned drug prices, the opioid crisis, gender affirming care, and even Obamacare.
Posted: September 28, 2023, 3:15 am
A panel of independent advisers to the FDA voted against a polarizing potential treatment for ALS on Wednesday, concluding that the medicine’s supporting data did not meet the standard for…
Posted: September 27, 2023, 10:10 pm
The U.S. government said it would give a small biotechnology firm, Gritstone bio, up to $433 million to conduct a 10,000-volunteer clinical trial testing a new approach to creating a…
Posted: September 27, 2023, 9:08 pm
“I don’t think it was foreseeable,” a gene therapy researcher says about the death of a Duchenne muscular dystrophy patient who had received a CRISPR therapy.
Posted: September 27, 2023, 9:00 pm
Former Biogen employees said that it appeared the vast majority of the digital health group, as many as 100 people, would be departing.
Posted: September 27, 2023, 8:16 pm
Human Resources
All U.S. jobs on the website have skills that can be done or augmented by generative AI, the firm said, though few will be fully replaced by the tech.
Posted: September 27, 2023, 3:23 pm
In a study, hiring managers were asked whether they wanted to see applicants’ education credentials, work history, race and gender, among other things.
Posted: September 27, 2023, 2:13 pm
One of the workers alleged the app’s parent company, ByteDance, retaliated against her after she complained of unfair treatment and derogatory name-calling by a supervisor.
Posted: September 26, 2023, 9:17 pm
Employees also were illegally barred from writing customer-provided, pro-union monikers on cups, among other violations, NLRB found.
Posted: September 26, 2023, 8:15 pm
Leadership development investment varies by industry, including the amount and who receives training and coaching.
Posted: September 26, 2023, 2:51 pm