Today's Daily Dose brings you news about Blueprint Medicines' disappointing results from gastrointestinal stromal tumor trial; revised timeline of Clearside Biomedical's resubmission of XIPERE NDA; encouraging trial results of INOVIO's MERS coronavirus vaccine and initial data from Syndax Pharma's acute leukemia trial.

As of December 2019, approximately 41 new antibiotics with the potential to treat serious bacterial infections were in clinical development, and four were approved since the previous update in June 2019. The success rate for clinical drug development is low; historical data show that, generally, only 1 in 5 infectious disease products that enter human testing (phase 1 clinical trials) will be...

The COVID-19 pandemic is providing a grim reminder of an unfortunate truism: Public health often does not receive the attention it deserves until a disaster hits.

The Health Impact Project’s toolkit contains resources that help communities, agencies, and other organizations take action to improve public health. The toolkit offers a collection of health impact assessments, guides, and other research to support policymakers’ efforts to consider health when making decisions across sectors, such as housing, planning, and education.

The federal government in March released a pair of long-awaited rules that will give patients greater access to their health data and improve the flow of information across care settings.

Communities and policymakers working to meet the challenges of a global pandemic may need to take a range of targeted actions, such as building awareness, launching preventive measures, boosting health care infrastructure, or allocating emergency funding. These decisions, which can influence health outcomes significantly, highlight the importance of having the information needed to evaluate...

Individuals with opioid use disorder (OUD) struggle to get effective care: Of 2 million Americans with the illness, only 26% receive treatment. Now, as the coronavirus pandemic presents an added strain on the U.S. health care system, it is creating greater hardships for those seeking OUD treatment.

At least 95 percent of individuals in state prisons will eventually return to communities. In fact, in a typical year more than half a million people do so, with many more coming from jails. A disproportionate share of these individuals have one or more chronic illnesses.

Care coordination is considered a hallmark of patient-centered treatment and has been shown to improve health outcomes and patient satisfaction as well as reduce costs. Defined as organizing patient care activities and sharing information among all participants concerned with an individual’s treatment plan in order to achieve safer and more effective results, care coordination is increasingly...

The most effective therapy for people with opioid use disorder (OUD) involves the use of Food and Drug Administration-approved medications—methadone, buprenorphine, and naltrexone. Despite evidence that this approach, known as medications for opioid use disorder (MOUD), reduces relapse and saves lives, the vast majority of jails and prisons do not offer this treatment. This brief examines what...

Pew’s substance use prevention and treatment initiative sent a letter to the Drug Enforcement Administration (DEA) on April 27 encouraging the agency to expedite a final rule that will help opioid treatment programs (OTPs)—federally regulated facilities where patients take medications for opioid use disorder under the supervision of medical staff and receive counseling and other care services—...

The spread of COVID-19 is placing unprecedented strain on Philadelphia’s hospitals, public health systems, and residents. Although the full effects of the emergency have yet to be realized, newly released data from 2018 and 2019 provides insight on the state of public health in the city before the pandemic.

The coronavirus pandemic has infected more than 2.5 million people worldwide, with the United States accounting for nearly 1 million of those cases.

More than 56 million people in the United States live in areas with dentist shortages. Dental therapy is a proven solution that has helped increase access to care. Dental therapists are midlevel providers who deliver preventive and routine restorative treatment at schools, nursing homes, and veterans homes to people who would otherwise struggle to get access to care.

The treatment gap continues to be an obstacle in addressing opioid use disorder (OUD) in the U.S. In 2018, an estimated 2 million Americans had OUD but only about 26% received specialty addiction treatment.

Testing for the novel coronavirus in the United States has not kept pace with the enormous demand despite national efforts to ramp up capacity.

The perennial drug pricing debate has reached a fever pitch, as loud as it’s ever been over the past few decades. Politicians on both sides are bashing the drug industry with the typical talking points about exorbitant prices, countered of

The post Venturing A Perspective On The Drug Pricing Debate appeared first on LifeSciVC.

This blog post was written by Deanna Petersen, CBO of AVROBIO, as part of the From The Trenches feature of LifeSciVC. When AVROBIO went public in June 2018, I found myself on the steep end of an unexpected but interesting

The post Recipe For Managing Data Disclosure Successfully With Academic Partners: A Public Gene Therapy Company Perspective appeared first on LifeSciVC.

In the throes of a full COVID-19 pandemic, most business leaders’ top priority is rightfully the health and safety of their employees, families, and communities. Even though business disruptions are significant and overwhelming, the primary efforts focused on both safety

The post Strategic Planning In Biotech During A Pandemic Crisis appeared first on LifeSciVC.

This blog was written by Ankit Mahadevia, CEO of Spero Therapeutics, as part of the From The Trenches feature of LifeSciVC.  If CEOs have empowered their teams effectively, they have three roles during times of rapid change: Motivator in chief

The post The Balancing Act: Taking A Systematic Approach To Hard Decisions In Times Of Rapid Change appeared first on LifeSciVC.

Venture capital is a long investment cycle business, and never before has that been so clear as now in the face of the ongoing COVID pandemic. Even with the unprecedented public equity market volatility, venture investing into private biopharma companies

The post Booming VC-Backed Biopharma: Strong Market Despite Pandemic appeared first on LifeSciVC.

The biotech IPO market in 2020 remains strong, despite the volatility and COVID headwinds. We’ve seen stellar pricings and good after-market performance, with ten new offerings already this year. And the queue for companies with active S1’s on file is

The post Value Creation And Destruction: Dispersion of Performance In Biotech IPOs appeared first on LifeSciVC.

This blog was written by Andrea DiMella, VP and Head of Talent at Atlas Venture, as part of the From The Trenches feature of LifeSciVC. What a difference a little time makes. When Bruce originally encouraged me to be a

The post Running Rehab: Managing Talent In A Pandemic appeared first on LifeSciVC.

This blog was written by Josh Brumm, CEO of Dyne Therapeutics, as part of the From The Trenches feature of LifeSciVC. I stood in front of 15 skeptical parents and prepared to sell them on an improbable mission. They had

The post Ordinary People Achieving The Extraordinary: Lessons In Leadership From The Court To The C-suite appeared first on LifeSciVC.

This blog was written by Rene Russo, CEO of Xilio Therapeutics, as part of the From The Trenches feature of LifeSciVC. In an environment where senior leaders are tasked with defining agile strategies in uncertain times, there are many perspectives

The post Long-Range Planning (LRP): Reframed Leaders Require Purpose appeared first on LifeSciVC.

Rend Al-Mondhiry has joined the firm Amin Talati from the Council for Responsible Nutrition (CRN) as Senior Counsel, resident in the Washington, D.C. Office.

Probi's largest clinical trial ever, focused on probiotic immune health, has recently been completed.

At Engredea 2018 in March in Anaheim, CA, OmniActive will be highlighting the latest addition to its ginger ingredient range, Gingever 10% powder, expanding its application to tablets, capsules and beverages.

Nutrition 21, LLC has announced its Nitrosigine® is now featured in EVERTRAIN PRE, a recently launched pre-workout supplement designed to provide athletes with sustained energy, superior focus and increased endurance.

InstantGMP, Inc. released a much-anticipated enhancement to the Equipment Logs feature.

In this SupplySide West edition of the Healthy INSIDER podcast, Rachel Adams, managing editor, and Scott Steinford, founder and CEO of Trust Transparency Consulting, discuss the role of transparency in establishing trust with supplements consumers.  

New Legal Motion Challenges Tony Huge’s Supposed Unpaid Role in Enhanced Athlete

The Organic Trade Association and The Organic Center on Thursday applauded Senators Bob Casey (D-PA) and Susan Collins (R-ME) for introducing The Organic Agriculture Research Act of 2018.

Natural product brands can boost trade show ROI by investing in PR to work with trade press via press releases and onsite interviews.

Rousselot, the collagen-based ingredients producer, has revealed a new study which it says provides important answers surrounding the bioavailability of collagen peptides and the modifications they undergo during digestion.

French beauty supplement firm D+ For Care has launched a mouth spray to aid sleep and has a flurry of holistic wellbeing innovation primed for 2020 â the year nutricosmetics could really take off, its founder says.

We need it for inclusive policymaking

APEC economies, data privacy regulators, and other stakeholders are exploring ways to bolster the Cross-Border Privacy Rules (CBPR) system.

Policies impacting women’s economic advancement have improved in some areas, but more reforms are needed to enable women to fully thrive, reports the newly updated APEC Women and the Economy Dashboard 2019.

The challenge: Innovative mobile apps and platforms that empower the aging society

Medical supplies and personal protective products are facing barriers worldwide

Trade Ministers agree to work together towards a healthy, resilient and inclusive Asia-Pacific community.

From : Communities>>Regulatory Open Forum
Hello Jose, To my knowledge, the change of O/O does not trigger a notification that needs to be confirmed, nor does it trigger a review of enforcement history.  The change of ownership and O/O is merely an administrative update that gives FDA both current information and a history of changes.  Of course, if there are known red flags with any of the involved organizations, changes can be scrutinized. Regards, James ------------------------------ James Bonds J.D. Director Regulatory Affairs Atlanta [More]

From : Communities>>Regulatory Open Forum
Thank you Dinar! ------------------------------ MARIA GUDIEL Brea CA United States ------------------------------

From : Communities>>Regulatory Open Forum
Thank you Richard! ------------------------------ MARIA GUDIEL Brea CA United States ------------------------------

From : Communities>>Regulatory Open Forum
The short answer is "yes" provided that the development cell bank was the source for the GMP bank and is comparable in terms of performance. However, the devil is in details and you need to evaluate "comparability" carefully between the development bank and the GMP bank with respect to the characterization data you plan to use for, e.g., to support GMP bank for production, etc. Two ICH guidance documents are useful to look at, Q7 Table 1 and Q5D. The US FDA generally follows ICH guidance but EMA [More]

From : Communities>>Regulatory Open Forum
This message was posted by a user wishing to remain anonymous Have you looked into PRA Health Sciences?

From : Communities>>Regulatory Open Forum
Hi All, Always appreciate and respect the great advice that comes through this forum: The scope of my question is CE Mark of a Class IIa medical device system under the MDD (and then eventually MDR): We have Class I devices which will be CE Marked through self-certification. These devices can be used with other CE marked products (not owned by us). One of which is not CE Marked as a medical device (conformity to machinery and low voltage directives). In terms of what we consider this vendor, what [More]

From : Communities>>Regulatory Open Forum
I disagree with Richard. I just had a conversation with the COVID-19 hotline (11:45 am, May 7) and asked about this issue after having read an update from the FDA that said UDIs for EUA devices are waived and GMPs are under limited enforcement. The person I spoke with said the update is correct and that UDIs are waived for EUA devices.  Feel free to contact me if you have any questions.  Bob Bard ------------------------------ Robert Bard JD, RAC [Managing Director] South Lyon MI United States - [More]

From : Communities>>Regulatory Open Forum
Hi everyone, As currently drafted,  the 2020 Chinese Pharmacopeia, the benchmark publication on the safety and efficacy of pharmaceuticals legally available in China, includes 319 new entries. The publication includes more than 5,500 traditional Chinese and Western medicines. The official compendium of the standards of purity, description, test, dosage, precaution, storage, and the strength for each drug legally marketed in China is published by the Chinese Pharmacopoeia Commission. It is designed [More]