New research finds that sleep problems in a baby's first 12 months may not only precede an autism diagnosis, but also may be associated with altered growth trajectory in a key part of the brain, the hippocampus.

A lipid metabolism enzyme controls brain stem cell activity and lifelong brain development. If the enzyme does not work correctly, it causes learning and memory deficits in humans and mice, as researchers have discovered. Regulating stem cell activity via lipid metabolism could lead to new treatments for brain diseases.

Scientists have successfully developed a new technique to reliably grow crystals of organic soluble molecules from nanoscale droplets, unlocking the potential of accelerated new drug development.

A task force has been set up in the UK to accelerate the development of a coronavirus vaccine.

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NASA has selected teams led by Blue Origin, Dynetics and SpaceX to develop lunar landing systems capable of putting astronauts on the moon by as early as 2024. "We want to be able to go to the moon, but we want to be a customer," NASA Administrator Jim Bridenstine told reporters today during a teleconference. "We want to drive down the costs, we want to increase the access, we want to have our partners have customers that are not just us, so they compete on cost and innovation, and just bring capabilities that we've never had before." Fixed-price contracts totaling… Read More

The latest news on the COVID-19 global pandemic (all times Eastern): 10:45 a.m. Ontario is reporting 346 new cases of COVID-19 and 59 new deaths. There are now a total of 19,944 cases of COVID-19 in the province, and the rate of growth in cases dropped below two per cent for the first time

Divock Origi has insisted that he still sees his future at Liverpool, despite suggestions that he could be jettisoned to make way for attacking reinforcements this summer.

With the all clear to begin clearing land at Mount Gilead for a 1,700-home housing estate, there have been renewed calls for a national park isolating the area's koalas.

The NSW Government will discuss establishing a national park south of Sydney to protect the state's last chlamydia-free koala colony under threat by urban expansion.

Court documents provide insight into the shambolic and costly planning issues being created by a major housing expansion on the southern outskirts of Sydney.

Australian all-rounder Ellyse Perry has notched up plenty of career highlights, but her biggest is being involved in the "watershed moment" of women's sport in Australia.

Who would you cast to play the megastar?

Angels owner Arte Moreno's company could disclose before the end of the month whether it plans to build a new ballpark or renovate Angel Stadium.

Scientists have successfully developed a new technique to reliably grow crystals of organic soluble molecules from nanoscale droplets, unlocking the potential of accelerated new drug development.

When seeking the fastest pathway to a vaccine to prevent coronavirus disease 19 (COVID-19), defining the stakes and potential hurdles is critical, says Barney Graham in this Perspective.

The Victorian Government announces a proposal for a 101-storey building is one of four to be approved amid moves to fast-track development in the wake of the coronavirus pandemic.

Here’s how developers can maximize scalability and performance while minimizing cost and infrastructure usage.

Keep on reading: Why IoT Development Needs Microservices and Containerization

The World Health Organization joined with global leaders to accelerate production of vaccines and treatments aimed at stamping out the coronavirus.

The experimental 5-HT1A receptor agonist and D2 receptor antagonist was not effective on primary or secondary endpoints

StrideBio have announced the appointment of Maritza McIntyre Ph.D., as its first Chief Development Officer.

The newly created role will see Dr McIntyre oversea the translational development of the company’s research-stage gene therapy programs. This includes regulatory filings, initiating early clinical studies and starting Investigational New Drug enabling preclinical studies.

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A collaboration in COVID-19 between immunology specialist Vir Biotechnology and Alnylam Pharmaceuticals…

"Helping foreign countries improve their criminal justice systems so they can cooperate more effectively with us and with their neighbors in real time is an important aspect of this department’s mission."

The Department announced a simultaneous lawsuit and settlement with the state of Texas concerning the care given to residents of the state’s 13 facilities for persons with developmental disabilities. Along with the settlement agreement, the Department will file a complaint initiating a lawsuit against the state in federal court. An independent monitor will be appointed to oversee the state’s compliance with the settlement agreement and the court will retain ultimate jurisdiction.

Cooper Land Development, Inc., a luxury home development company headquartered in Rogers, Ark., has agreed to pay a civil penalty and implement a storm water compliance program at its construction sites to settle allegations that it violated the Clean Water Act.

The department’s motion for preliminary injunction aims to prevent the segregation of children with developmental disabilities in dangerous conditions and to address accusations of imminent and serious threats to the safety of the facility’s more than 500 current residents.

"Only by working together, across borders and jurisdictions, can we ensure that the ideals set forth in the Anti-Bribery Convention more than a decade ago are realized today and in the future.  And only by working together will the promise of democracy be fulfilled, and will the rule of law be respected, across the globe," said Attorney General Holder.

The Department of Justice and the Rainbow River Child Development Center of Hawthorne, Calif., have joined in a settlement agreement to assure that children with diabetes will receive appropriate care so that they may participate fully in the programs and activities at the center.

The Justice Department today announced that it has entered into a comprehensive settlement agreement that will transform the state of Georgia’s mental health and developmental disability system and resolve a lawsuit the United States brought against the state.

A Florida man and two U.K. nationals pleaded guilty Dec.10, 2010, to immigration fraud charges for their roles in a scheme to fraudulently procure visas from the U.S. Embassy in London through a Florida property development company called Royal Development.

Richard A. Murdoch of Florida was sentenced today to 30 months in prison for immigration fraud and tax evasion charges related to his role in a scheme to fraudulently procure visas from the U.S. Embassy in London through a Florida property development company called Royal Development.

"You are here today because you know how important it is to continue finding innovative and effective ways to fight violent crime. As someone who focuses on criminal prosecution, I am absolutely committed to doing everything I can to help make our communities safer."

The Academy for Educational Development (AED) in Washington, D.C., has agreed to settle allegations that the company submitted false claims to the United States Agency for International Development (USAID) in connection with two cooperative agreements under which AED provided foreign assistance in Afghanistan and Pakistan.

The Justice Department today announced that it has entered into a comprehensive settlement agreement that will transform the Commonwealth of Virginia’s system for serving people with developmental disabilities, including intellectual disabilities, and will resolve violations of the Americans with Disabilities Act.

The U.S. District Court for the Eastern District of Virginia has approved a comprehensive settlement agreement between the United States and the Commonwealth of Virginia, resolving the department’s findings that Virginia’s system for serving people with intellectual and developmental disabilities violated the Americans with Disabilities Act (ADA). The department had found that Virginia was violating the ADA requirement, as interpreted by the Supreme Court’s decision in Olmstead v. L.C., to provide people with intellectual and developmental disabilities the opportunity to live and receive services in the community.

The Technological Research and Development Authority (TRDA) has agreed to pay $15 million to resolve allegations that it violated the False Claims Act in connection with grants from the National Aeronautics and Space Administration (NASA) and the Economic Development Administration (EDA) of the Department of Commerce, the Justice Department announced today. TRDA, which was created by the Florida legislature as a special district, owns and operates a system of incubator facilities to nurture small businesses by providing low-rent office space and business development assistance.

Today, the Justice Department announced that yesterday afternoon it filed in federal court a comprehensive agreement that will resolve long running litigation with the state of Tennessee originally concerning conditions of care at the former Arlington Developmental Center (ADC).

New guidance released today by the U.S. Department of Housing and Urban Development (HUD) and the U.S. Department of Justice reinforces the Fair Housing Act requirement that multifamily housing be designed and constructed so as to be accessible to persons with disabilities.

A senior official in Venezuela’s state economic development bank has pleaded guilty in New York federal court to accepting bribes from agents and employees of a New York-based broker-dealer (Broker-Dealer) in exchange for directing her bank’s security-trading business to the Broker-Dealer.

Six Miami-area residents, including three former loan officers, pleaded guilty in the Southern District of Florida this week to participating in a fraudulent scheme designed to enrich real estate developers.

Attorney General Eric Holder released the following statement Thursday following his meeting earlier today with President Obama to discuss the latest developments in Ferguson, Missouri

The following statement was released Sunday by Justice Department spokesman Brian Fallon concerning the federal civil rights investigation into the shooting of Michael Brown in Ferguson, Missouri

Attorney General Eric Holder released the following statement Monday following his briefing of President Obama on the latest developments in the federal civil rights investigation in Ferguson, Missouri

Attorney General Eric Holder is set to announce a partnership between the Department of Justice’s Office of Juvenile Justice and Delinquency Prevention (OJJDP) and the Department of Housing and Urban Development (HUD). HUD will offer new grants to support collaborations between HUD-funded organizations, and civil legal aid programs and public defender offices. The grant funded collaborations will focus on expunging and sealing juvenile records – improving the chances that reentering youth will be able to obtain degrees, find work and secure housing. The announcement is set to be made this evening during the Attorney General’s remarks to the Legal Services Corporation 40th anniversary celebration.

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...

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]

As part of our follow up to our recent Biotech in Wisconsin Meetup about professional development skills, we are asking folks to fill out this poll.

Today I had the chance for a panel conversation with Geeta Vemuri from Baxter Ventures and Ed Silverman from Pharmalot blog (Wall Street Journal) at the Midwest Healthcare Venture Forum. Our general topic was how we (an entrepreneur and a corporate venture capitalist) look at bringing drugs/devices to market. Here are a couple of takeaways from our