Coronaviridae Infections

ASHBURN, Va., Jan. 18, 2023 /PRNewswire/ -- The American College of Clinical Pharmacology® (ACCP) published a Position Paper entitled "The Importance of Diversity and Inclusion in Drug Development and Clinical Trial Conduct" addressing the topic of diversity in clinical trials and drug development. This position highlights the need for greater diversity in participants in the drug development process. ACCP strongly recommends that researchers and health care professionals across the care continuum be more active regarding the need for greater diversity of trial participants. While federal agencies, advocacy groups and the pharmaceutical drug/medical device sectors are aligned on the importance of diversity in clinical research, the actions taken to date have produced, at best, a partial response from our communities within the United States. A recent FDA Diversity guidance, which ACCP fully supports, recommends that sponsors submit a diversity plan as part of the Investigational New Drug application as soon as practical during drug development and before conducting the pivotal trials. This new guidance is certainly timely considering the global attention placed on vaccine development to prevent COVID infections and recent findings that showed members of racial/ethnic minority groups and older adults living in structural and socially unequal communities were underrepresented in the clinical trials for approved vaccines. The ACCP strongly recommends that researchers and health care professionals across the care continuum be more active regarding the need for a greater diversity of participants in drug development and clinical trials. This can be supported through active participation in their professional and academic institutions, societies and local communities. Health care professionals should strongly consider actions of advocacy, mentoring, education and volunteering to better inform all stakeholders regarding the need for a greater diversity of participants in clinical trials and the drug development process. As health care professionals, regulators and researchers, we should strive to ensure our actions in the design, conduct, reporting and communication of clinical research reflect the diverse needs of our communities. About ACCP ACCP is a non-profit association providing accredited Continuing Education, publications and career-enhancing opportunities to clinical pharmacology healthcare professionals.

The J.P. Morgan Healthcare Conference continues Tuesday, with GSK, Sage Therapeutics and much more expected to present. Welcome to Day 2 of the annual J.P. Morgan Healthcare Conference, finally back in person after a COVID-imposed virtual hiatus. Here's what you need to know. The deals began to flow before San Francisco had even woken up yesterday, with AstraZeneca and Ipsen both announcing acquisitions. As the conference doors opened, we were treated to a flurry of licensing deals—including from Eli Lilly, whose chief scientific officer caught up with Fierce Biotech to map out their jam-packed launch schedule for the year. Want more? Fierce Biotech’s conference's kick-off Day 1 is available here and Fierce Pharma’s can be found here. 9:55 a.m. ET Jan. 11: Editas Medicine's JPM session came a day after the gene editing company announced a major pipeline reorganization and staff cuts. Executives said the shuffle will free up cash and allow focus to shift to sickle cell treatment EDIT-301.  “Given the unfriendly state of the equity markets, we feel really comfortable that this cash extension will put us in a good position for once we get to the value inflection points,” Chief Financial Officer Michelle Robertson said in the session. Story   9:45 a.m. ET Jan. 11: BioNTech CEO Ugur Sahin, M.D., said Tuesday that the company is not giving up on tackling symptomatic COVID infections, with work underway on a T-cell-enhanced vaccine. The news comes as much of the discourse around the COVID vaccines and booster shots has centered on preventing severe illness and death. But evidently, at least for the time being, Sahin and BioNTech are pushing for better protection. Meanwhile, the company’s larger clinical ambitions continue to widen, particularly in oncology. Story   3:24 p.m. ET: Sage Therapeutics is ready to address pockets of the depression market that have long lacked adequate treatment options with zuranolone, including post-partum depression. Executives dismissed the idea that PPD is just a niche market and hoped the FDA would act quickly via a priority review. Story   2:36 p.m. ET:  Zai Lab says business is humming as it braces for a bevy of new readouts and near commercial profitability. But executives conceded that the recent COVID outbreaks in China were more than just a blip on the radar. “[W]e're dealing with the reopening and COVID impacts in China right now,” said new Chief Operating Officer Josh Smiley. “We expect there'll be some modest impacts in the first quarter.” But he emphasized that whatever the impact is, it shouldn’t knock the company off its planned clinical and regulatory timelines. The China-focused company is currently readying the launch of a number of critical studies, including a bridging study in China for Karuna’s schizophrenia med KarXT and joining Amgen’s FORTITUDE-101 trial testing bemarituzumab in patients with gastrointestinal cancer.   1:49 p.m. ET: Karuna Therapeutics is 24 months out from a hotly anticipated schizophrenia drug launch and the industry is buzzing with rumors that the biotech will seek a Big Pharma partnership or other deal for commercialization. CEO Bill Meury suggested his company has the know-how and cash to launch the drug alone. He also declined to commit to a price for the therapy, but said the resulting number will be "intuitive." Story   Despite the chaotic market over the past three years, Sofinnova Partners Chair and Managing Partner Antoine Papiernik believes biotech is still in a much better position than it was a decade ago. “Generally speaking, the collective knowledge is a lot higher,” Papiernik told Fierce Biotech on the conference sidelines. There's a lot more joint connection between pharma and biotech, exemplified in portfolio company Cincor Pharma’s sale to AstraZeneca yesterday, he argued. VCs have also raised a lot of money over the past three years, Papiernik pointed out, adding that Sofinnova’s own coffers are pretty full, with more money than ever before to fund companies, though it has to be carefully allocated. “The VC world in general has raised a lot of cash that will allow for sustaining those companies,” Papiernik said. “If you have enough resources, you're not going to die in the middle of the river.”

BEIJING, Jan 10 (Reuters) - Merck & Co's (MRK.N) COVID-19 antiviral treatment molnupiravir was priced at 1,500 yuan ($221.21) per bottle in Tianjin, according to the northern Chinese city's medical purchasing centre on Tuesday. Each bottle contains 40 pills - enough for one course of treatment - according to the centre. The treatment, which is sold under the brand name Lagevrio, was approved for adults with mild to medium COVID infections and a high risk of progressing to severe cases. China granted conditional approval for the import of molnupiravir, which was developed by Merck and partner Ridgeback Biotherapeutics. Merck has a deal in place for China's Sinopharm (1099.HK) to import and distribute the medication. "Supply has been shipped and we are working closely with Sinopharm to distribute Lagevrio as quickly as possible. Both parties are working to ensure Lagevrio is accessible to appropriate adult patients in China," a Merck spokesperson said in an email. "We have not disclosed a price per course specific to this agreement." ($1 = 6.7810 Chinese yuan renminbi) Our Standards: The Thomson Reuters Trust Principles.