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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These policies restricting abortion are unlikely to conserve PPE, and more importantly, they mischaracterize the nature and importance of abortions.

The post The Harms of Abortion Restrictions During the COVID-19 Pandemic appeared first on Bill of Health.

The Japanese pharma development firm will harness risk-based quality management solutions to help sponsors improve trial quality and safety.

The company has incorporated electronic trial master file document storage capabilities to its Engility clinical trial management platform.

The companyâs global analysis from thousands of studies and sites indicates dramatic shifts in enrollment across several countries since the pandemic began.

The data management solution is designed to help sponsors and CROs manage data more effectively, increasing cost efficiency and effectiveness.

The 100th anniversary of astronomy’s “Great Debate” prompts thoughts on the hunt for life in the universe

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WASHINGTON–(BUSINESS WIRE)–The Association of Clinical Research Organizations (ACRO) applauds Research!America for a recently released survey on the public’s perception of clinical trials....

Washington, DC – October 24, 2017 – On October 19 ACRO Executive Director Doug Peddicord, Ph.D., testified at a public hearing of...

Following meetings with then-Commissioner Scott Gottlieb and senior leadership from the Center for Drug Evaluation and Research on the role of CROs and technology companies in designing and implementing risk-based monitoring (RBM) of clinical trials, ACRO this week submitted extensive comments on recent FDA Guidance.Increasing the use of innovative RBM technologies helps make clinical trials safer, more efficient and higher quality. ACRO’s comments offer unique insights into the recent expansion of RBM implementation and call for further increasing the use of these oversight technologies.

On July 17, 2019, under cooperative agreement with the FDA, the Duke-Margolis Center for Health Policy (Duke Margolis) held a public workshop. The event, titled Improving the Implementation of Risk-Based Monitoring Approaches of Clinical Investigations, aimed to identify opportunities to improve Risk Based Monitoring (RBM) implementation and solicit stakeholder input on the challenges, barriers, and enablers that impact the successful adoption of RBM.

Any vaccine has to work, but it also has to be safe. Making it happen is one of the government’s biggest priorities

• Patrick Vallance is the UK government chief scientific adviser

• Coronavirus – latest updates
• See all our coronavirus coverage

Covid-19 has made fundamental and long-lasting changes to the way we live our lives, not just in the UK, but across the world.

As we continue with social-distancing measures and deal with the most immediate issue of reducing the number of cases to protect the NHS and save lives, and keeping R, which is the average infection rate per person, below one, we also need to progress ways to tackle the disease in the longer term.

The vaccines taskforce will be working in lockstep with the public and private sector

Related: New UK taskforce to help develop and roll out coronavirus vaccine

Gilead’s remdesivir, which has been hailed as one of the few truly promising treatments for COVID-19 at this early stage of the ongoing pandemic, has failed in its first randomised clinical trial, leaked data has revealed.

A Phase 3 study of Sanofi and Regeneron’s Libtayo (cemiplimab) as a monotherapy for advanced or metastatic non-small cell lung cancer (NSCLC) has been stopped early after showing strong overall survival benefit, it has emerged.

The Association of American Physicians and Surgeons (AAPS) wrote a letter to Republican Arizona Governor Doug Ducey urging the wider use of hydroxychloroquine, based on data they have collected.

Eight new medicines recommended for approval

Initial roll-out will see key workers utilise the app

It is hoped that the drug may prevent COVID-19

The U.S. Food and Drug Administration posted a photo:

This product is promoted with unapproved claims to prevent, treat, mitigate, or cure COVID-19. FDA warns consumers to avoid unproven and potentially unsafe products. See the Warning Letter for more information:

CBD Product – Patriot Hemp Company: www.fda.gov/inspections-compliance-enforcement-and-crimin...

More information is available at www.fda.gov/consumers/health-fraud-scams/fraudulent-coron...

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This photo is free of all copyright restrictions and available for use and redistribution without permission. Credit to FDA's Office of Regulatory Affairs, Health Fraud Branch is appreciated but not required.

Click to view a price quote on LCI.

India continues to be on the 'Priority Watch List' of the US Trade Representative (USTR) for lack of…

UK-based Mallinckrodt Pharmaceuticals has ended a trial of INOmax (nitric oxide) gas early due to positive…

India’s Lupin has announced positive top-line results from its pivotal Phase III clinical trial to…

Positive top-line data for a pivotal, single-arm, open-label trial of PD-1 inhibitor Libtayo (cemiplimab)…

Shares of US biotech Akebia Therapeutics were up more than 35% at $11.72 by early afternoon today, after…

GlaxoSmithKline has completed divestment of its Horlicks and other Consumer Healthcare nutrition products…

The world of biotech suffered a great loss in 2019 with the passing on Michael Becker. Be sure to take in the tributes to Michael from around the Twitterverse. [...]

Roy Lynn Oakley, 67, a resident of Harriman, Tenn., pleaded guilty today in U.S. District Court in Knoxville, to count one of an indictment charging him with unlawful disclosure of Restricted Data under the Atomic Energy Act, in violation of 42 U.S.C., Section 2274(b).

Five commercial fishermen in St. Mary’s County, Md., a fish wholesaler, its owner and an employee have been charged in Maryland and Washington, D.C., for their role in the illegal harvest, sale, and purchase of hundreds of thousands of pounds of striped bass from the Chesapeake Bay and Potomac River from 2003 through 2007.

Patriot Coal Corporation, one of the largest coal mining companies in the United States, has agreed to pay a $6.5 million civil penalty to settle violations of the Clean Water Act.

Theodore Allan, 54, of Glendale, Ariz., was sentenced today to five years in prison for distribution of child pornography. Allan was indicted on charges of distribution, receipt and possession of child pornography on March 6, 2007.

A fish wholesaler, its owner and an employee have all pleaded guilty in U.S. District Court for the District of Columbia for the illegal purchase and sale of striped bass from the Chesapeake Bay and Potomac River from 2003 through 2007.

Five St. Mary’s County, Md., commercial fisherman pleaded guilty today to illegally overfishing striped bass also known as rockfish.

U.S. District Judge Samuel B. Kent pleaded guilty today to obstruction of justice in federal court in Houston. Kent, 59, a district judge in the Southern District of Texas, pleaded guilty to making false statements to a special investigative committee of the U.S. Court of Appeals for the Fifth Circuit during an investigation of a judicial misconduct complaint filed against him.

An employee of a Sewell, N.J., company that provided temporary electrical utilities pleaded guilty today to participating in a fraud conspiracy at an Environmental Protection Agency (EPA)-designated Superfund site in New Jersey.

The Department announced today that it has filed a lawsuit on behalf of Kevin Stenger, an Indiana National Guard member, against Wagner Industrial Electric Inc. (Wagner), alleging violations of the Uniformed Services Employment and Reemployment Rights Act of 1994 (USERRA). USERRA was enacted in 1994 to protect service members from being disadvantaged in their civilian careers due to serving in the uniformed services.

A Middlesex, N.J., industrial pipes, valves and fittings supply company and its co-owner pleaded guilty today to participating in a fraud conspiracy at two U.S. Environmental Protection Agency (EPA)-designated Superfund sites in New Jersey. The sites are Federal Creosote, located in Manville, N.J., and Diamond Alkali, located in Newark, N.J.

A former Nazi concentration camp guard who settled in Racine, Wis., after World War II and acquired U.S. citizenship, has been removed to Austria due to his participation in Nazi-sponsored acts of persecution during World War II. Josias Kumpf, 83, served as an armed SS Death’s Head guard at the Nazi-run Sachsenhausen Concentration Camp in Germany and at the Trawniki Labor Camp in Poland.

The United States has settled its claims filed under the False Claims Act against Lighthouse Disaster Relief and its partners, Gary Heldreth and Kerry Farmer. In its complaint, which was filed in the U.S. District Court for the Middle District of Louisiana, the United States alleged that Lighthouse, Heldreth, and Farmer accepted a $5.3 million payment for work that was not completely performed on a contract with the Department of Homeland Security.

U.S. District Judge Samuel B. Kent was sentenced today to 33 months in prison for obstruction of justice related to an investigation of a judicial misconduct complaint filed against him.

The Department has entered into a consent decree with Wagner Industrial Electric Inc. that, if approved by the court, will resolve the Department’s complaint the company failed to properly reemploy Indiana Army National Guard Reservist Kevin Stenger in violation of the Uniformed Services Employment and Reemployment Rights Act of 1994 (USERRA).

Michael Fisher, owner of Fisher Sand & Gravel Co. Inc. (FSG), based in Dickinson, N.D., today pleaded guilty to nine felony counts of tax fraud.

Donald Sikma, a businessman from Dyer, Ind., has pleaded guilty to filing a false tax return. Sikma, whose trial was scheduled to begin today, entered his guilty plea Monday before Judge Theresa L. Springmann in Fort Wayne, Ind.

The Department of Justice today asked the U.S. Court of Appeals for the Ninth Circuit to remand the cases of former Alaska State Representatives Victor Kohring and Peter Kott, who were convicted on corruption charges in 2007, to the District Court.

Willie Borden, a former Washington, D.C., Metropolitan Police Department officer, pleaded guilty today to a criminal tax charge before U.S. District Court Judge James Robertson.

The city of Duluth, Minn., and the Western Lake Superior Sanitary District have agreed to make improvements to the area’s sewer system, estimated to cost about $130 million, to eliminate sanitary sewer overflows in an agreement filed today in U.S. District Court in Minneapolis, Minn.

“As demonstrated by today’s charges and arrests, we will strike back against those whose fraudulent schemes not only undermine a program upon which 45 million aged and disabled Americans depend, but which also contribute directly to rising health care costs that all Americans must bear,” said Attorney General Holder.