The General Pharmaceutical Council has appointed Laura Fraser, former clinical fellow for the Scottish Chief Pharmaceutical Officer as the new Director for Scotland.

Fraser has held leadership roles in community pharmacy across Scotland including board member of Community Pharmacy Scotland. She has also worked for the Scottish Government as Clinical Leadership Fellow. Prior to her position as board member she was area and regional manager for nearly nine years.

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MSD have announced that David Peacock will become Managing Director in the UK and Ireland, succeeding former director Louise Houson, with a start date of October 1st 2019.

Peacock brings with him a broad range of experience and perspectives from senior roles within the company in the United States, Singapore, Vietnam and Japan. Most recently, David was Chief of Staff to Kenneth Frazier, Chairman of the board and Chief Executive Officer of MSD.

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The Association of the British Pharmaceutical Industry (ABPI) has appointed Dr Richard Torbett as its new Chief Executive. He will assume the position on 1 January 2020.

The appointment comes after his predecessor, Mike Thompson, stepped down in June. He had served in the role since March 2016. Torbett was unanimously selected by the ABPI board after an external recruitment process with an executive search agency.

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Nordic Nanovector has appointed Dr Lars Nieba as the interim Chief Executive Officer. He is currently the company’s Chief Technology Officer and replaces Eduardo Bravo who as of today has left Nordic to pursue other career opportunities.

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Andreas Johannesson has been announced as Alligator Bioscience’s new interim Chief Financial Officer (CFO), replacing ex-CFO Per-Olof Schrewelius who it was previously confirmed will no longer serve the company.

Johannesson’s career has spanned 15 years in the consumer goods sector, with him managing the finances of firms including TeamOlmed, Stenqvist, Fitness23Seven and Haldex.

He spent a further nine years of his career as a strategic consultant with a focus on consumer goods, five of which were spent at global consulting firm McKinsey & Company.

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BrainStorm Cell Therapeutics, a firm developing cellular therapies to tackle neurodegenerative diseases, has named industry Big Pharma veteran Dr David Setboun as its new Executive Vice President and Chief Operating Officer.

Dr Setboun has served for two decades at some of the biggest names in pharma. His most recent role was Vice President of Corporate Development, Strategy & Business at Life Biosciences, where he helped drive development of a range of vital commercial, operating and funding milestones.

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Immigrant communities, along with communities of color and people experiencing existing health inequities, are expected to face disproportionate effects.

The post COVID-19 is a Perfect Storm of Hardship for US Immigrant Communities appeared first on Bill of Health.

This morning, Alydia Health, a tiny Menlo Park, Calif., startup co-founded by a 21-year-old woman, announced that it has secured $10 million in funding to test a medical device to prevent mothers from bleeding to death after childbirth.

The solutions enable continuous remote monitoring of body temperature and other vitals, either at home or in care centers, for clinical trials.

The companyâs SiteVault Free tool, designed to enable collaborating between sites and study monitors, now has a remote monitoring feature.

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

The research collaboration will seek to identify candidate biomarkers for a group of inflammatory conditions, using AI and other advanced technology.

An astrophysicist traces genealogy and art history to discover the origin of the famous motto

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Higher temperatures and wetter weather may spur soil microbes to release more carbon into the atmosphere

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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....

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.

The FDA has released a safety communication reiterating the need for doctors to closely monitor COVID-19 patients who are treated with either hydroxychloroquine or chloroquine.

The FDA has moved to approve an oral tablet formulation of AstraZeneca’s Farxiga (dapagliflozin) to reduce the risk of cardiovascular death and hospitalisation in adult patients with New York Heart Association’s functional class II-IV heart failure with reduced ejection fraction.

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After his surprise removal from HHS’ Biomedical Advanced Research and Development Authority—a key agency partnered with pharma companies on COVID-19 drugs, vaccines and diagnostics—former Director Rick Bright is alleging whistleblower retaliation by HHS leadership. 

German drugmaker Fresenius Kabi has made major investments in its U.S. manufacturing operations in recent years with some mixed quality results along the way. Now, one of the drugmaker's products faces a recall for more manufacturing woes.

Jorge De Castro Font, 45, a former senator in the Commonwealth of Puerto Rico, pleaded guilty today to 20 counts of honest services wire fraud and one count of conspiracy to commit extortion.

The former finance director of an Orange County, Calif.-based valve company pleaded guilty today in connection with his role in a conspiracy to pay approximately $628,000 in bribes to numerous foreign government officials.

The Justice Department has aptly been described as the “crown jewel” of the federal government. It has attained this distinction not because of any laws or regulations, cases or controversies, buildings or equipment, but rather because of the quality, integrity, and dedication of the people who work tirelessly to carry out the Department’s vital mission.

A government contractor and former employee of the U.S. Department of the Treasury was sentenced in Washington today in connection with a bribery scheme involving contracts at the U.S. Tax Court in the District of Columbia. Daniel Money, 44, of Shady Side, Md., was sentenced by U.S. District Judge Ricardo M. Urbina of the U.S. District Court for the District of Columbia, to 30 months in prison, three years supervised release and a $7,500 fine.

A federal court in Los Angeles invalidated an abusive tax shelter scheme engaged in by prominent real estate investors James Thomas and Edward Fox. U.S. District Judge John F. Walter also imposed the maximum penalty - forty percent - allowed by the tax code against them.

Michael Haynes, a practicing minister, and David Jett, both of Las Vegas, were sentenced to 37 months in prison and five years probation, respectively, by Chief U.S. District Judge Robert L. Hunt in Las Vegas. Haynes and Jett were also ordered to pay restitution of $834,000 and $150,000, respectively, to the U.S. Treasury.

A former member of the U.S. armed services pleaded guilty today in the U.S. District Court for the District of Arizona in Tucson for his role in a widespread bribery and extortion conspiracy. The charges arise from Operation Lively Green, an undercover investigation conducted by the FBI that began in December 2001. To date, 56 additional defendants have been sentenced for their roles in the conspiracy.

RE/MAX East-West, a real estate firm in Elmhurst, Ill., and one of its former real estate agents, John DeJohn, have agreed to pay $120,000 to settle allegations that they illegally steered prospective homebuyers toward and away from certain neighborhoods based on race and national origin. The consent decree was signed on Feb. 17, 2009, by U.S. District Judge Ruben Castillo.

We appreciate the diligent work of the National Research Council’s committee on forensic science in preparing this report. The Department of Justice’s principal focus in dealing with forensic evidence is on applying it dispassionately to law enforcement challenges, and we regularly use forensics to not only convict the guilty, but also to exonerate the innocent.

U. S. District Judge Steven D. Merryday today sentenced the Japanese corporation Hiong Guan Navegacion Japan Co. Ltd., that operates the commercial cargo ship M/V Balsa-62, to three years probation and $1.75 million in penalties for conspiring to falsify and falsifying environmental compliance records.

A complaint was unsealed today in U.S. District Court in Massachusetts against a New York pharmaceutical company for alleged False Claims Act violations arising from the company’s marketing the drugs Celexa and Lexapro for unapproved pediatric use and for paying kickbacks to induce physicians to prescribe the drugs.

A federal court has permanently barred Harold Mette of Bradenton, Fla., from preparing federal income tax returns for others. Mette, who has a Ph.D. degree and calls his business “The Tax Doctor,” consented to the permanent injunction order, which was entered by U.S. District Judge Richard A. Lazzara in U.S. District Court for the Middle District of Florida.

John Cowdery, a former elected member of the Alaska state senate, was sentenced today to three years probation with a special condition requiring him to serve six months of home confinement for conspiring to bribe another Alaska state legislator.  U.S. District Judge Ralph Beistline for the District of Alaska also ordered Cowdery to pay a $25,000 fine.      

A securities attorney pleaded guilty today to defrauding investors in stock manipulation schemes involving 19 different publicly traded companies. David B. Stocker, 49, of Phoenix pleaded guilty in U.S. District Court in Alexandria, Va., for his participation in a stock manipulation conspiracy known as a “pump-and-dump” scheme.

Laura Wang-Woodford, a U.S. citizen who served as a director of Monarch Aviation Pte, Ltd. (“Monarch”), a Singapore company that imported and exported military and commercial aircraft components for more than 20 years, pled guilty today in federal court in Brooklyn to conspiring to violate the U.S. trade embargo by exporting controlled aircraft components to Iran.

A securities attorney was charged in an indictment unsealed today with participating in a stock registration evasion scheme involving nine different publicly traded companies and with defrauding investors in a manipulation scheme related to three of the companies.

A federal jury in Miami today convicted two physicians and two medical assistants in connection with a $5.3 million Medicare fraud scheme. After a two-week trial in federal court in Miami, a jury found David Rothman, M.D., 66; Keith Russell, M.D., 65; Eda Marietta Milanes, 43; and Jorge Luis Pacheco, 50; guilty on all charged counts, including conspiracy to commit health care fraud and multiple counts of health care fraud for submitting claims to Medicare for unnecessary medications.

Four Miami-area residents pleaded guilty today in connection with a $10 million Medicare fraud scheme involving HIV infusion clinics. Dr. Roberto Rodriguez, 54; Dr. Carlos Garrido, 69; Gonzalo Nodarse, 38; and Alexis Carrazana, 41; all pleaded guilty before U.S. District Judge Paul C. Huck to one count of conspiracy to commit health care fraud.

Two Miami-area residents pleaded guilty today in connection with a $10 million Medicare fraud scheme involving HIV infusion clinics. Dr. Carmen Del Cueto, 65, and Alexis Dagnesses, 44, each pleaded guilty to one count of conspiracy to commit health care fraud before U.S. District Judge Paul C. Huck. Both defendants admitted to working at Midway Medical Center Inc. (Midway), a Miami clinic that purported to specialize in the treatment of patients with HIV.

“In connection with the post-trial litigation in United States v. Theodore F. Stevens, the Department of Justice has conducted a review of the case, including an examination of the extent of the disclosures provided to the defendant. After careful review, I have concluded that certain information should have been provided to the defense for use at trial. In light of this conclusion, and in consideration of the totality of the circumstances of this particular case, I have determined that it is in the interest of justice to dismiss the indictment and not proceed with a new trial."

The Department announced that on April 7, 2009, it will monitor the election in Kane County, Ill., to ensure compliance with the Voting Rights Act of 1965, as amended. Under the Voting Rights Act, the Justice Department is authorized to ask the Office of Personnel Management to send federal observers to areas that are specially covered in the act or by a federal court order.

Consultores De Navegacion, a Spanish company that operates the M/T Nautilus, an ocean-going chemical tanker ship, pleaded guilty today in U.S. District Court in Boston and has agreed to pay a fine of $2.5 million for criminal violations related to the overboard discharge of oil-contaminated bilge waste on the high seas.

A former owner of an asbestos monitoring contractor that provided services to New York Presbyterian Hospital (NYPH) pleaded guilty today for making false statements to FBI agents and representatives of the Department’s Antitrust Division. Stephen E. McAnulty, of Brooklyn, N.Y., pleaded guilty in U.S. District Court in Manhattan, for lying about his knowledge of a kickback and fraud conspiracy that took place at NYPH.

Two Department of Defense (DOD) contractors were charged with conspiracy and bribery relating to their roles involving DOD contracts in Afghanistan. A Lebanese contracting company is also charged with participating in the same conspiracy.

Tax return preparer Lawrence Sperling pleaded guilty today to aiding in the preparation of false tax returns. Sperling was scheduled to begin trial on April 14, 2009 before Judge Deborah Chasanow in Greenbelt, Md. According to the indictment and the plea agreement, Sperling knowingly prepared tax returns for his clients that contained false and fraudulent items, including inflated medial expenses, charitable contributions, miscellaneous employment-related expenses, and child care credits.

Rene Soliz of Alice, Texas, pleaded guilty today in U.S. District Court in Corpus Christi, Texas, to a violation of the Lacey Act for attempting to receive fifteen Tanzanian leopard tortoises that were transported into the United States in violation of a law, regulation or treaty, specifically, the Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES).

The United States has reached a settlement with NetApp Inc. and NetApp U.S. Public Sector Inc. (collectively NetApp), following an investigation of alleged false claims and contract fraud. NetApp has agreed to pay the United States $128 million, plus interest. This is the largest contract fraud settlement the General Services Administration (GSA) has obtained to date.

Timothy Smith, a resident of Cullman, Ala., pleaded guilty today in federal court in Birmingham to one count of tax evasion, the Justice Department and Internal Revenue Service (IRS) announced.