Drug Discovery and Development Archives - Page 98 of 158

Biden says he’ll nominate Robert Califf as FDA commissioner

Former FDA commissioner Dr. Robert Califf [Image is public domain]

Former FDA commissioner Dr. Robert Califf could return to his old job if President Joe Biden has his way.

Biden today announced his intention to nominate Califf to serve as FDA commissioner — a job he previously held during the Obama administration from 2016-17.

A cardiology professor at Duke University and a member of the Duke Clinical Research Institute, Califf is also head of clinical policy at Google’s Alphabet sister company Verily Life Sciences.

Get the full story on our sister site MassDevice.

Japanese government agrees to buy 1.6 million molnupiravir courses

Image courtesy of Merck & Co.

Merck & Co. (NYSE:MRK) and its partner Ridgeback Biotherapeutics will sell approximately 1.6 million courses of the COVID-19 antiviral molnupiravir (MK-4482, EIDD-2801).

In related news, Thailand announced that it intends to purchase 50,000 courses of the drug while Taiwan plans on obtaining 10,000 courses.

The U.S. plans on purchasing roughly 3.1 million courses of molnupiravir.

The UK authorized the drug last week.

Assuming molnupiravir receives authorization or approval in Japan, Merck stands to gain approximately $1.2 billion to cover the 1.6 million courses. That equates to roughly $750 per course — slightly higher than the going rate in the U.S.

The company has also taken steps to ensure the drug is affordable in developing countries. For example, it is offering tiered pricing based on nations’ economic means and has also granted vol…

Athira Pharma shares update on its ACT-AD and LIFT-AD studies of Alzheimer’s candidate ATH-1017

Athira Pharma (NSDQ:ATHA) announced that its lead development candidate, ATH-1017, had balanced baseline characteristics to date in two ongoing late-stage Alzheimer’s studies.

Presenting the data at the 2021 Clinical Trials on Alzheimer’s Disease (CTAD) conference in Boston, the company’s chief medical officer Dr. Hans Moebius said that the baseline characteristics are consistent between the ACT-AD and LIFT-AD studies.

Athira expects topline data from the ACT-AD to be available in the first half of 2022.

ACT-AD is a six-month double-blind Phase 2 trial while LIFT-AD is a six-month double-blind Phase 2/3 study.

ATH-1017 is a subcutaneously delivered small molecule drug that can cross the blood-brain barrier. The drug is designed to improve the activity of the hepatocyte growth factor (HGF) and its receptor, MET. The levels of both HGF and MET tend to be reduced in Alzheimer’s patients.

The company’s Aβ- and tau-…

AbbVie, University of Chicago lengthen oncology research partnership until 2025

AbbVie (NYSE: ABBV) has extended an agreement with the University of Chicago related to collaborative preclinical oncology research.

The North Chicago, Illinois–based company and the university are working together on research involving biomarkers and therapeutic applications related to existing AbbVie programs.

In the past, the organizations have also explored new drug delivery methods to improve the immune system’s ability to fight tumors. Their partnership has also focused on testing 3D screening methodologies for selecting promising therapeutic molecules.

Under the terms of the agreement, AbbVie can exclusively license some University of Chicago discoveries resulting from the collaboration.

“Our oncology collaboration with the University of Chicago enables us to combine our expertise in understanding the underlying biology in key areas of interest, such as immuno-oncology, oncogenic pathways, and biomarkers of drug sensitivity or disease,” Ste…

Regenxbio inks deal with AbbVie to pursue development of RGX-314

Regenxbio (NSDQ:RGNX) has closed a license agreement with AbbVie (NYSE:ABBV) to develop RGX-314, a vascular endothelial growth factor inhibitor.

The drug has been the focus of Phase 2 and Phase 3 trials exploring its potential in wet age-related macular degeneration (AMD) and diabetic retinopathy.

AbbVie will make an upfront payment to Regenxbio of $370 million and could pay an additional $1.38 billion if the drug candidate meets proposed development, regulatory and commercial milestones.

In the agreement, Regenxbio will focus on overseeing the completion of ongoing trials related to the RGX-314. The two companies will partner and split the cost of additional studies related to the drug candidate.

The two companies intend to perform an additional pivotal trial testing subretinal delivery to treat wet AMD and future trials.

AbbVie plans on leading clinical development and commercialization of the drug.

In October, Regenxbio released p…

Pfizer and BioNTech file for FDA authorization of COVID-19 vaccine boosters for all adults

Pfizer (NYSE:PFE) and its partner BioNTech (NSDQ:BNTX) have filed paperwork with FDA to authorize their COVID-19 vaccine for all adults 18 and older.

The two companies had filed a supplemental Biologics License Application for a booster dose of the COVID-19 vaccine in adults at least 16 years old.

FDA did not accept the supplemental Biologics License Application, however. Instead, FDA amended the EUA for the Pfizer-BioNTech COVID-19 vaccine in September to allow individuals with an elevated risk to receive a single booster dose. The EUA required that eligible individuals receive a booster dose at least six months after completing the primary series.

Earlier, an advisory committee had decided there was insufficient evidence to warrant approval for all adults. In particular, the committee expressed concerns about the rare risk of myocarditis in some younger vaccine recipients.

Instead, the U.S. authorized Pfizer booster doses in October for adults 6…

AbbVie shares new Rinvoq data involving patients with psoriatic arthritis

Abbvie’s JAK inhibitor Rinvoq (upadacitinib) beat out placebo at week 24 in posthoc analyses of two Phase 3 studies focused on people with active psoriatic arthritis. In particular, the drug led to a superior clinical response related to axial involvement, which occurs in a substantial portion of people with psoriatic arthritis.

Sharing the data at the American College of Rheumatology (ACR) Convergence 2021 conference, AbbVie says the data underscore the drug’s potential for many people with psoriatic arthritis. “These data further add to the body of evidence that support the potential of upadacitinib to be an important treatment option that helps reduce the impact of the many disease manifestations of psoriatic arthritis,” said Dr. Thomas Hudson, senior vice president, research and development, chief scientific officer of AbbVie, in a press release.

Last year, Rinvoq generated $731 million in net revenues globally.

FDA approved Rinvoq in 2019 to treat m…

U.S. to buy 1.4 million additional courses of molnupiravir

Merck (NYSE:MRK) and Ridgeback Biotherapeutics appear to be gaining growing support for their oral COVID-19 therapy molnupiravir.

One week after Great Britain granted conditional marketing authorization for the drug, the companies announced that the U.S. government intends to purchase 1.4 million additional medicine courses for approximately $1 billion.

The U.S. has committed to buy approximately 3.1 million molnupiravir courses for $2.2 billion, which equates to about $710 per course.

For the sake of comparison, the U.S. pays about $40 per dose of COVID-19 vaccines.

Molnupiravir photo courtesy of Merck.

The U.S. has the option of buying an additional 2 million courses of molnupiravir.

Merck and Ridgeback are awaiting news from FDA regarding their submission for emergency use authorization of molnupiravir. The application would cover adults with mild-to-moderate COVID-19 who have …

Moderna pursues EU authorization of its COVID-19 vaccine in children aged 6 to 11

Moderna (NSDQ: MRNA) has filed paperwork to permit the evaluation of two 50-µg doses of its Spikevax (mRNA-1273) vaccine in children ages 6-11 years in the European Union.

Moderna has filed paperwork to permit the evaluation of its Spikevax vaccine in children ages 6–11 years in the European Union.

Last week, the company announced that FDA had delayed its review of the mRNA-1273 vaccine in 12- to 17-year-olds to investigate reports of myocarditis apparently linked to the vaccine.

EU regulatory authorities have not yet authorized a COVID-19 vaccine for children younger than 12. The Austrian capital of Vienna, however, will begin vaccinating young children against the novel coronavirus on November 12.

Cambridge, Massachusetts–based Moderna has an ongoing Phase 2 trial, dubbed “KidCOVE,” investigating the use of its vaccine in children as young as 6 months of age.

The company reports that vaccine efficacy — measured as protection against sympt…

Sanofi completes $1.9B purchase of Kadmon Holdings

Sanofi announced today that it has completed its acquisition of Kadmon Holdings, maker of the FDA-approved Rezurock to treat chronic graft-versus-host disease in transplant patients.

Kadmon shareholders approved the deal on November 5 and will receive $9.50 per share in cash. The company becomes a wholly-owned subsidiary of Sanofi.

When announcing the deal in September, Sanofi’s EVP of General Medicines Olivier Charmeil said he thought the French pharma giant’s scale, expertise, and relationships in transplant would enable the realization of the “full potential of Rezurock.” The treatment, he said, addresses the significant unmet medical needs of patients with chronic graft-versus-host disease.

Kadmon’s pipeline includes drug candidates for immune and fibrotic diseases — and immuno-oncology therapies.

Harnessing the power of real-world data requires careful consideration

Image courtesy of Pixabay

The use of real-world data (RWD) has boomed during the pandemic, but the pharmaceutical industry has only scratched the surface in terms of tapping its potential.

The use of such data, however, is set to grow, given the FDA’s recent release of new guidance concerning the use of electronic health records and medical claims data for regulatory decision-making for drugs and biologics.

Two years ago, some people in the industry questioned “whether RWD would have any application in the world of clinical development,” said Jeff Elton, CEO of ConcertAI. Those days are over. It is now clear that RWD is important, given the FDA guidance and the surge in use in RWD during the pandemic.

The level of rigor concerning RWD is set to grow, given FDA’s feedback concerning the use of such data in clinical trial designs, trial interpretation. “The expectati…

Ketamine research on the upswing for severe depression

Interest in the dissociative anesthetic ketamine continues to be strong as a therapy for treatment-resistant depression and similar conditions.

But the enthusiasm surrounding the drug is likely higher than the quality of evidence supporting its use to treat severe depression.

Research into the drug’s potential to treat depression, however, is ramping up.

One recent small study published in the Journal of Clinical Psychiatry found that a single dose of the drug reduced the severity of depression in individuals with suicidal ideation.

The study administered intravenous ketamine to 39 participants and midazolam, a benzodiazepine, to another 39. Investigators administered ketamine at relatively low dose levels where it did not have an anesthetic effect.

The blinded study also found that the drug made patients feel safer, and it also quickly improved neurocognition. In addition, it provided persistent therapeutic effects for up to six weeks afte…