pp

Methadone to be supplied without new prescription during Covid-19 crisis

Pharmacists will be allowed to give out medication to patients who have already been receiving it

Pharmacists are to be allowed to hand out a range of super-strength medicines, including the heroin substitute methadone, without prescription during the Covid-19 crisis, under emergency measures that official drug policy advisers have warned could trigger a spike in drug misuse.

The Advisory Council for Misuse of Drugs (ACMD), which makes recommendations to the government on the control of dangerous drugs, was asked by the home secretary to consider the risks of lifting restrictions on certain substances controlled under the Misuse of Drugs Act.

Continue reading...




pp

Sanofi's Meningococcal Conjugate Vaccine secures FDA approval in patients aged two and up

Sanofi’s MedQuadfi Meningococcal Conjugate Vaccine has scored FDA approval for the prevention of invasive meningococcal disease, becoming the first and only product available in the US for this indication in patients of at least two years old.




pp

NICE backtracks to approve Janssen's Stelara in ulcerative colitis

NICE has recommended Janssen’s Stelara (ustekinumab) for the treatment of moderately to severely active ulcerative colitis (UC), a move which rows back on the Institute’s decision to reject the drug last year.




pp

EU approval for Novartis' Cosentyx in active non-radiographic axial spondyloarthritis

Novartis has revealed that the European Commission has moved to approve Cosentyx (secukinumab) for the treatment of active non-radiographic axial spondyloarthritis (nr-axSpA) in adult patients.




pp

FDA approves emergency use of Gilead's remdesivir for hospitalised COVID-19 patients

Gilead’s antiviral therapy remdesivir has shown tentatively promising efficacy in the race to find an effective treatment for COVID-19, one of the only therapies to do so at this early stage of the pandemic. Now, the FDA has invoked its Emergency Use Authorization powers to approve the drug for the treatment of patients hospitalised with the novel coronavirus.




pp

UK contact-tracing app being tested on the Isle of Wight

The NHS’s coronavirus contract tracing app has been published to Apple and Google’s app stores with council staff and healthcare workers being invited to download it on the Isle of Wight today.




pp

AZ's Farxiga becomes first FDA-approved SGLT2 inhibitor for heart failure with reduced ejection fraction

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.




pp

FDA approval for Tabrecta in metastatic non-small cell lung cancer with METex14

The FDA has awarded marketing authorisation to Novartis for the Oral MET inhibitor Tabrecta for the first-line treatment of metastatic non-small cell lung cancer in patients whose tumors have a mutation that leads to MET exon 14 skipping (METex14), regardless of whether they have previously received any type of treatment.




pp

Roche’s COVID-19 antibody test approved for emergency use in the US

Ramps up capacity for testing across the country




pp

Coronavirus contact-tracing app trial to begin on the Isle of Wight

Initial roll-out will see key workers utilise the app




pp

EU brings production home amid supply chain worries

Specialty chemicals company Evonik has kicked off a major expansion project at two German facilities,…



  • Europe/Evonik/Generics/Germany/Production

pp

BRIEF—Key appointments at Denmark’s Acesion Pharma

Danish drugmaker Acesion Pharma, which is focused on novel treatments for atrial fibrillation (AF), has…



  • Acesion Pharma/Boardroom/Cardio-vascular/Denmark/Management/Pharmaceutical

pp

FDA approval for Farxiga in new indication in heart failure patients

Farxiga (dapagliflozin) has been approved in the US to reduce the risk of cardiovascular (CV) death and…



  • AstraZeneca/Cardio-vascular/Diabetes/Farxiga/Focus On/Glucosides/Pharmaceutical/Regulation/SGLT2 inhibitors/UK/US FDA/USA

pp

First targeted therapy for aggressive form of lung cancer approved by FDA

Late Wednesday, the US Food and Drug Administration said it has granted accelerated approved for Tabrecta…



  • Biotechnology/capmatinib/Focus On/Incyte Corp/Medical Devices and Diagnostics/Novartis/Oncology/Rare diseases/Regulation/Research/Switzerland/Tabrecta/USA

pp

Japan grants ‘exceptional’ approval for remdesivir in COVID-19

As had been widely expected, Gilead Sciences on Thursday announced that the Japanese Ministry of Health,…



  • Anti-virals/Asia Pacific/Coronavirus/Focus On/Gilead Sciences/Japan/Pharmaceutical/Regulation/Remdesivir/USA/Veklury

pp

Gilead in talks to expand COVID-19 hopeful remdesivir supply chains with outside partner

Gilead Sciences scored a massive win earlier this week with its first positive data readout for investigational candidate remdesivir in treating patients with severe COVID-19. Gilead already has its own supply of the drug humming in anticipation of high demand, but opportunities are out there for a partner to join in. 




pp

Novartis taps real-life Cosentyx patients to thank healthcare workers, pledge patient support

Novartis is using familiar faces—real patients from its Cosentyx TV commercials—to thank healthcare workers and promise support for patients. It’s a shift away from product-centered TV ads as Novartis adjusts its Cosentyx DTC effort during the COVID-19 crisis to highlight resources for patients, the drugmaker said.




pp

AbbVie, Allergan score FTC approval for $63B merger with one final hurdle left to go

AbbVie and Allergan have waited for nearly a year for their much-discussed merger to pass muster. Finally, after pushback from consumer groups and tight scrutiny from regulators, the FTC has granted its green light. The partners face just one final hurdle to consummating their deal. 




pp

China approves Novartis' multiple sclerosis treatment Mayzent

Chinese regulators have approved Novartis' Mayzent to treat relapsing multiple sclerosis in adults, the Swiss drug maker said in a statement on Saturday.




pp

Philippines' coronavirus deaths breach 700

The Philippines' health ministry reported on Saturday that coronavirus deaths have reached more than 700.




pp

Former Shipping Executive Sentenced to 48 Months in Jail for His Role in Antitrust Conspiracy

A former high-level shipping executive was sentenced today to serve 48 months in jail and to pay a $20,000 criminal fine for his role in an antitrust conspiracy involving the transportation of goods to and from the continental United States and Puerto Rico by ocean vessel. This is the longest jail sentence ever imposed for a single antitrust charge.



  • OPA Press Releases

pp

Former Mississippi County Deputy Sheriffs Plead Guilty to Civil Rights Violations

Former Tippah County, Miss., Deputy Sheriff Jeffrey Rogers, 35, pleaded guilty today to a one-count information charging him and former Deputy Sheriff William Rogers with violating the civil rights of an arrestee. William Rogers, 56, who is Jeffrey Rogers’ father, pleaded guilty on Jan. 20, 2009, to the same charge of violating the civil rights of an arrestee.



  • OPA Press Releases

pp

APL Ltd. to Pay U.S. $26.3 Million to Resolve Fraud Allegations for Inflated Shipping Costs to Military in Iraq and Afghanistan

APL Limited has agreed to pay the government $26.3 million to resolve allegations that it submitted false claims to the United States in connection with contracts to transport cargo in shipping containers to support U.S. troops in Iraq and Afghanistan.



  • OPA Press Releases

pp

German National Arrested for Smuggling Coral from the Philippines

Gunther Wenzek, a German national, was arraigned today in U.S. District Court in Alexandria, Va., on a nine count indictment charging him with three felony counts of smuggling protected coral into the United States port of Portland, Ore., three felony counts of violating the Lacey Act and three misdemeanor charges of violating the Endangered Species Act.



  • OPA Press Releases

pp

Shipping Company, Chief Engineer and Second Engineer Indicted for Covering up Pollution

A federal grand jury in Newark, N.J., has returned an eight-count indictment charging a Liberian company that manages an oceangoing bulk carrier vessel, M/V Myron N, along with the ship’s chief engineer and second engineer for covering up discharges of oil-contaminated waste at sea.



  • OPA Press Releases

pp

United States Files Suit Against Missouri-Based Pharmaceutical to Block Manufacturing and Shipping of Unapproved Drugs

The United States has filed a lawsuit to block KV Pharmaceutical Company, its subsidiaries, ETHEX Corp. and Ther-Rx Corp., and its principal officers from making and distributing adulterated and unapproved drugs. At the same time, KV agreed to the injunction in a consent decree.



  • OPA Press Releases

pp

N.J. Industrial Pipes Supply Company and Its Co-Owner Plead Guilty to Fraud at Two N.J. Superfund Sites

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.



  • OPA Press Releases

pp

Mississippi Lawyer Sentenced to 18 Months in Prison for Failure to File Tax Returns

Marshall E. Sanders, an attorney based in Vicksburg, Miss., was sentenced to 18 months in prison for failure to file tax returns by Magistrate Judge James C. Sumner. In addition, Judge Sumner ordered Sanders to pay restitution to the IRS of $1,025,453.



  • OPA Press Releases

pp

Shipping Line Pays $1.4 Million for Environmental Crimes

Holy House Shipping AB, a Swedish corporation, was sentenced today in U.S. District Court in Camden, N.J., to pay a $1 million fine, a special assessment of $400,000 in community service payments and serve three years of probation for failing to maintain an accurate oil record book in an attempt to conceal illegal discharges of oil-contaminated waste directly into the ocean from one of its ships.



  • OPA Press Releases

pp

Individual Indicted in Connection with Costa Rica-based Business Opportunity Fraud Ventures

A British citizen was charged in connection with the operation of a series of fraudulent business opportunities on March 10, 2009, by a Miami federal grand jury. Sirtaj Mathauda was indicted on charges that he and his co-conspirators purported to sell vending machine, beverage and greeting card business opportunities, including assistance in establishing, maintaining and operating such businesses. The charges form part of the government’s continued nationwide crackdown on business opportunity fraud.



  • OPA Press Releases

pp

Iranian Man and His Company Charged in International Scheme to Supply Iran with Sensitive U.S. Technology

An Iranian citizen and his Tehran business have been charged with purchasing helicopter engines and advanced aerial cameras for fighter bombers from U.S. firms and illegally exporting them to Iran using companies in Malaysia, Ireland and the Netherlands. Among the alleged recipients of these U.S. goods was an Iranian military firm that has since been designated by the United States for being owned or controlled by entities involved in Iran’s nuclear and ballistic missile program.



  • OPA Press Releases

pp

Irish Trading Firm and Its Officers Charged in Scheme to Supply Iran with Sensitive U.S. Technology

An Irish trading company and three of its officers have been charged with purchasing helicopter engines and other aircraft components from U.S. firms and illegally exporting them to Iran using companies in Malaysia and the United Arab Emirates. Among the alleged recipients of these U.S. goods was an Iranian military firm that has since been designated by the United States for being owned or controlled by entities involved in Iran’s nuclear and ballistic missile program.



  • OPA Press Releases

pp

Wyoming Highway Patrol Trooper Arrested for Violating Civil Rights by Kidnapping

Agents with the FBI, Immigration and Customs Enforcement and the Wyoming Department of Criminal Justice arrested Wyoming Highway Patrol Trooper Franklin Joseph Ryle late yesterday in Douglas, Wyo., on criminal civil rights charges.



  • OPA Press Releases

pp

GSA Contractor NetApp Agrees to Pay U.S. $128 Million to Resolve Contract Fraud Allegations

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.



  • OPA Press Releases

pp

Former Mendenhall, Mississippi, Police Chief Sentenced for Using Excessive Force

A federal judge today sentenced Jimmy “Jimbo” Sullivan, the former chief of police in Mendenhall, Miss., to 30 months in prison for using excessive force when he repeatedly stomped on the head of an arrestee. At his guilty plea hearing on Jan. 30, 2009, Sullivan admitted that he used excessive force on July 22, 2005, after joining other law enforcement officials in the apprehension of a man who led police on a car chase.



  • OPA Press Releases

pp

Colombian National Arraigned on Charges of Providing Material Support to the FARC

A 32-year-old Colombian citizen, Luz Mery Gutierrez Vergara, who was extradited from the Republic of Colombia on Thursday, made her initial appearance today in federal court in Washington, D.C., to face charges for allegedly participating in a conspiracy to provide material support to the Fuerzas Armadas Revolucionarias de Colombia, commonly known as the “FARC.”



  • OPA Press Releases

pp

Former Mississippi Deputy Sheriffs Sentenced to Serve Time on Civil Rights Violations

Former Tippah County, Miss., Deputy Sheriff William Rogers and his son, former Tippah County Deputy Sheriff Jeffrey Rogers, were sentenced in federal court on April 30, 2009, for violating the civil rights of an arrestee by shooting him with a taser unnecessarily.



  • OPA Press Releases

pp

Two South Florida Men Indicted in Connection with Fraudulent ATM Business Opportunity Venture

A Miami federal grand jury has charged two South Florida men with conspiracy, mail and wire fraud in connection with the operation of a fraudulent ATM business opportunity. The criminal charges are part of the government’s continued nationwide crackdown on business opportunity fraud.



  • OPA Press Releases

pp

U.S. Intervenes in Suit Against Former Beef Suppliers to National School Lunch Program

The United States has intervened in a civil lawsuit against two former suppliers to the National School Lunch Program – Hallmark Meat Packing Company and Westland Meat Company Inc. – for submitting false and fraudulent claims to the Agricultural Marketing Service (AMS), a division of the U.S. Department of Agriculture (USDA). All ground beef containing defendants’ products was recalled by USDA as of Feb. 16, 2008, and defendants no longer supply beef to the National School Lunch Program or AMS.



  • OPA Press Releases

pp

Justice Department to Monitor Elections in Mississippi

The Department announced that on May 5, 2009, it will monitor municipal elections in the towns of Cleveland, Como, Meridian and Sardis, Miss., to ensure compliance with the Voting Rights Act of 1965.



  • OPA Press Releases

pp

U.S. Court of Appeals for the Fifth Circuit Joins Other Circuits in Invalidating Tax Losses Claimed in “Son of Boss” Tax Shelter

On May 15, 2009, the Fifth Circuit, in Klamath Strategic Investment Fund v. United States (No. 07-40861), affirmed the district court’s decision denying over $50 million in claimed tax losses arising from the taxpayers’ investment in a “Son of Boss (BLIPS)” tax shelter.



  • OPA Press Releases

pp

Minneapolis Man Pleads Guilty to Conspiracy to Provide Material Support to Al-Qaeda

Mohammed Abdullah Warsame, a 35-year-old resident of Minneapolis, has pleaded guilty to one count of conspiring to provide material support and resources to al-Qaeda.



  • OPA Press Releases

pp

Justice Department to Monitor Elections in Mississippi, New Jersey and South Dakota

On June 2, 2009, the Department of Justice will monitor elections in the following jurisdictions to ensure compliance with the Voting Rights Act of 1965 and other federal voting rights statutes: the towns of Como, Drew, Greenwood, Isola, Louise and Meridian, Miss.; Bergen County, Middlesex County and the borough of Penns Grove, N.J.; and the town of Martin, S.D.



  • OPA Press Releases

pp

Appeals Court Affirms Government’s Default Termination of Navy Contract for A-12 Stealth Attack Aircraft

The U.S. Court of Appeals for the Federal Circuit has affirmed a judgment upholding the Navy’s termination for default of a contract with McDonnell Douglas and General Dynamics for the A-12 stealth attack aircraft.



  • OPA Press Releases

pp

Appeals Court Rejects Challenge to Conviction of Former Mississippi Klansman in 1964 Kidnapping and Murder of Two African American Men

The U.S. Court of Appeals for the Fifth Circuit today rejected a challenge to the conviction of James Ford Seale, a former member of the White Knights of the Ku Klux Klan of Mississippi. Seale was convicted by a federal jury in Mississippi in 2007 and sentenced to three life terms in prison.



  • OPA Press Releases

pp

Defendant Found Guilty of Conspiracy to Support Terrorists

After a bench trial held last week in the Northern District of Georgia, U.S. District Judge William S. Duffey, Jr., announced today that Syed Haris Ahmed, 24, has been found guilty of conspiracy to provide material support to terrorists.



  • OPA Press Releases

pp

Justice Department Files Lawsuit Alleging Racial Discrimination at Mobile Home Park in Gulfport, Mississippi

The Department today filed a lawsuit against the former owner and managers of Homestead Mobile Home Village, a mobile home park in Gulfport, Miss., for violating the Fair Housing Act by discriminating against black tenants on the basis of race or color.



  • OPA Press Releases

pp

Attorney General Eric Holder at the D.C. Court of Appeals Judicial Conference

"We will not solve all the problems we are forced to confront over night, but I am confident that if we take a measured and deliberate approach, we can take out that most ancient instrument – an old technology – the scales of justice, and say that they are balanced. This will be the true measure of our success."




pp

Florida Man Indicted in Connection with Fraudulent Vending Machine Business Opportunity Venture

A Tampa federal grand jury has charged a Florida man with criminal contempt of a federal court order in connection with the operation of a fraudulent vending machine business opportunity. The criminal charges form part of the government’s continued nationwide crackdown on business opportunity fraud.



  • OPA Press Releases

pp

Superseding Indictment Returned in Federal Kidnapping and Drug Case

Additional charges and defendants have been added to a federal case arising from the abduction of a boy from his Las Vegas home in October 2008.



  • OPA Press Releases