gen Mike Pompeo says there is evidence COVID-19 was made in a lab, despite US intelligence saying it occurred naturally By www.pharmafile.com Published On :: Mon, 04 May 2020 09:20:26 +0000 US Secretary of State Mike Pompeo claimed that there is evidence the COVID-19 coronavirus was created in a lab, despite US intelligence officials stating it probably occurred naturally. Full Article coronavirus COVID-19 lab pandemic Wuhan Institute of virology Sales and Marketing
gen FDA approves emergency use of Gilead's remdesivir for hospitalised COVID-19 patients By www.pharmafile.com Published On :: Mon, 04 May 2020 11:31:55 +0000 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. Full Article coronavirus COVID-19 FDA Gilead remdesivir Sales and Marketing
gen Sanofi and Regeneron's Libtayo shows durable responses in world's most common skin cancer By www.pharmafile.com Published On :: Tue, 05 May 2020 09:23:27 +0000 Sanofi and Regeneron’s have lifted the lid on new topline data on their PD-1 inhibitor Libtayo (cemiplimab) in patients with advanced basal cell carcinoma (BCC), the most common skin cancer in the world, with around two million new cases diagnosed each year in the US alone. Full Article cancer Libtayo Regeneron Research and Development Sanofi Manufacturing and Production
gen Amgen adds Otezla to the COVID-19 candidate list By www.pmlive.com Published On :: Mon, 04 May 2020 12:18:21 +0100 Psoriasis therapy may be a potential treatment for COVID-19 Full Article
gen Roche’s COVID-19 antibody test approved for emergency use in the US By www.pmlive.com Published On :: Mon, 04 May 2020 12:25:11 +0100 Ramps up capacity for testing across the country Full Article
gen US clears emergency use of Gilead’s remdesivir By www.pmlive.com Published On :: Mon, 04 May 2020 12:32:39 +0100 Move comes after drug showed preliminary efficacy in clinical trial in late April Full Article
gen Alnylam and Vir plan gene-silencing attack on COVID-19 virus By www.pmlive.com Published On :: Tue, 05 May 2020 12:59:41 +0100 Drug could be ready for clinical trials before the end of the year Full Article
gen Sanofi, Regeneron set up another niche use for PD-1 drug Libtayo By www.pmlive.com Published On :: Wed, 06 May 2020 11:57:45 +0100 Drug has shown “clinically meaningful responses” for basal cell carcinoma Full Article
gen Regeneron says antibody for COVID-19 could be ready this year By www.pmlive.com Published On :: Thu, 07 May 2020 15:59:05 +0100 Two antibody cocktails for COVID-19 could be available as early as this autumn Full Article
gen Glutagenic Virus Protection Kit By www.flickr.com Published On :: Thu, 07 May 2020 08:13:37 -0700 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: www.fda.gov/inspections-compliance-enforcement-and-crimin... More information is available at www.fda.gov/consumers/health-fraud-scams/fraudulent-coron... Photo by FDA's Office of Regulatory Affairs, Health Fraud Branch 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. Full Article
gen BRIEF—US court upholds Amgen Kyprolis patent By www.thepharmaletter.com Published On :: Tue, 05 May 2020 14:43:00 +0100 The US District Court in Delaware issued a decision upholding the validity of patent claims from three… Full Article Amgen/Biotechnology/Cipla/Focus On/Kyprolis/Legal/Oncology/Patents & Trademarks/USA
gen Regeneron rockets as financial results provide perfect picture of growth By www.thepharmaletter.com Published On :: Tue, 05 May 2020 17:29:00 +0100 Investors in Regeneron could afford a rare smile in these difficult times, as the company’s first quarter… Full Article Anti-virals/Biotechnology/Dermatologicals/Dupixent/Eylea/Financial/Immuno-oncology/Inflammatory diseases/Libtayo/Management/Oncology/Ophthalmics/Regeneron/REGN-COV2/USA
gen Gilead's remdesivir scores emergency FDA nod in COVID-19 days after big data reveal By www.fiercepharma.com Published On :: Fri, 01 May 2020 20:01:17 +0000 Days after U.S. officials reported the first positive controlled data for Gilead's remdesivir in COVID-19, the FDA has given the drug an emergency use authorization. Full Article
gen Seattle Genetics, Astellas' bladder cancer med Padcev blows early expectations out of the water By www.fiercepharma.com Published On :: Tue, 05 May 2020 15:21:47 +0000 Even a pandemic can’t slow down Seattle Genetics and Astellas' new bladder cancer treatment Padcev, which "blew out sales expectations" for the first quarter, analysts said. And now, they're jacking up their long-term sales estimates for the drug as a result. Full Article
gen Amgen ramps up Otezla expansion effort with positive data in mild psoriasis By www.fiercepharma.com Published On :: Wed, 06 May 2020 18:22:16 +0000 Amgen is planning to file for FDA approval of Otezla in mild to moderate plaque psoriasis based on new data showing patients on the drug experienced significant improvements in their symptoms. The label expansion will be key to Amgen's ability to recoup the $13.4 billion it paid to acquire the drug from Celgene last year. Full Article
gen Teva generics benefit from COVID-19 bump––but the boom may not last By www.fiercepharma.com Published On :: Thu, 07 May 2020 13:57:22 +0000 With its multibillion-dollar restructuring plan in the rearview mirror, Teva is pinning its future growth on two of its branded meds with high hopes. But generics are still central to the Israeli drugmaker's business, and increased demand due to COVID-19 gave Teva a welcome gift in the first three months of the year. Full Article
gen Biogen gears up Swiss manufacturing facility for potential aducanumab rollout By www.fiercepharma.com Published On :: Thu, 07 May 2020 14:51:06 +0000 Biogen has had a rocky road with its controversial Alzheimer's disease candidate aducanumab, resurrected late last year. But despite postponing the drug's FDA filing half a year, Biogen is still moving forward with plans to scale up production if aducanumab eventually passes muster. Full Article
gen Federal agency finds 'reasonable grounds to believe' Rick Bright's whistleblower claims: NYT By www.fiercepharma.com Published On :: Fri, 08 May 2020 19:45:56 +0000 Only days after former BARDA chief Rick Bright filed a whistleblower complaint alleging retaliation by the Trump administration, the U.S. Office of the Special Counsel has recommended his temporary reinstatement, the New York Times reports. Full Article
gen FDA grants emergency use authorization to Quidel for first antigen test for COVID-19 By feeds.reuters.com Published On :: Sat, 09 May 2020 11:01:00 -0400 The U.S. Food and Drug Administration (FDA) on Saturday approved emergency use authorization (EUA) to Quidel Corp for the first COVID-19 antigen test. Full Article healthNews
gen Imprisoned Spy and His Son Indicted on Charges of Acting as Russian Agents and Money Laundering By www.justice.gov Published On :: Thu, 29 Jan 2009 14:12:58 EST A federal indictment was unsealed today in U.S. District Court for the District of Oregon charging Harold James Nicholson, 58, of Sheridan, Ore., and Nathaniel James Nicholson, 24, of Eugene, Ore., with two counts of Conspiracy, one count of Acting as Agents of a Foreign Government, and four counts of Money Laundering. Full Article OPA Press Releases
gen Justice Department Settles Lawsuit Alleging Gender Discrimination and Retaliation by the Puerto Rico Police Department By www.justice.gov Published On :: Fri, 30 Jan 2009 12:40:59 EST The Department today announced that it has reached a consent decree with the Policía de Puerto Rico (Puerto Rico Police Department or PRPD) that will, if approved by the federal district court, resolve a complaint the Department filed in March 2008 alleging that the PRPD engaged in unlawful employment discrimination based on gender and retaliation, in violation of Title VII of the Civil Rights Act. Title VII prohibits employment discrimination on the basis of race, color, sex, national origin and religion, and also prohibits retaliation against persons for filing charges of discrimination. Full Article OPA Press Releases
gen Former Employees of Emergency Vehicle Vendors Sentenced for Conspiring to Defraud Employers on Homeland Security Contract By www.justice.gov Published On :: Fri, 30 Jan 2009 19:13:07 EST Two Florida homeland security vendor employees were sentenced today for conspiracy to commit wire fraud and honest services fraud by depriving their employers of money and the right of honest services, the Department of Justice announced today. Full Article OPA Press Releases
gen Attorney General Eric Holder Addresses Department of Justice Employees By www.justice.gov Published On :: Tue, 3 Feb 2009 09:17:54 EST 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. Full Article Speech
gen United States Files Clean Air Lawsuit Against Louisiana Generating By www.justice.gov Published On :: Wed, 18 Feb 2009 15:14:54 EST The United States has filed a complaint against Louisiana Generating alleging that the company violated the Clean Air Act by operating the Big Cajun 2 Power Plant, a coal-fired power plant in New Roads, La., without also installing and operating modern pollution control equipment after the generating units had undergone major modifications. Full Article OPA Press Releases
gen N.J. Electrical Company Employee Pleads Guilty to Defrauding the Environmental Protection Agency at Superfund Site By www.justice.gov Published On :: Thu, 26 Feb 2009 12:31:51 EST 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. Full Article OPA Press Releases
gen U.S. Border Patrol Agent Indicted on Federal Civil Rights Charge for Assault in Federal Detention Facility By www.justice.gov Published On :: Fri, 13 Mar 2009 13:59:17 EDT A U.S. Border Patrol agent has been indicted by a federal grand jury in Tucson, Ariz., on federal civil rights charges related to an alleged assault on a detainee at a federal detention facility. The two-count indictment, returned on March 11, 2009, alleges that on May 10, 2006, Eduardo Moreno violated the civil rights of a federal detainee by assaulting and causing bodily injury to the individual while Moreno was on duty at the U.S. Border Patrol processing facility in Nogales, Ariz. Full Article OPA Press Releases
gen General Maritime Management (Portugal) Fined $1 Million for Enviromental Crimes By www.justice.gov Published On :: Mon, 16 Mar 2009 12:43:01 EDT A federal judge in Corpus Christi, Texas, has sentenced General Maritime Management (Portugal), the operator of a fleet of tanker vessels, and two crewmembers of the motor tanker Genmar Defiance for making false statements to the U.S. Coast Guard and failing to maintain an accurate Oil Record Book designed to prevent pollution of the worlds oceans as required by United States and international law. Full Article OPA Press Releases
gen Statement of Attorney General Eric Holder Regarding United States V. Theodore F. Stevens By www.justice.gov Published On :: Wed, 1 Apr 2009 08:54:26 EDT “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." Full Article OPA Press Releases
gen Federal, State Partners Announce Multi-Agency Crackdown Targeting Foreclosure Rescue Scams, Loan Modification Fraud By www.justice.gov Published On :: Mon, 6 Apr 2009 11:21:17 EDT As homeowners and communities throughout the country continue to face devastating consequences from the deep contraction in the economy and the housing market, the Obama Administration today announced a new coordinated effort across federal and state government and the private sector to target mortgage loan modification fraud and foreclosure rescue scams that threaten to hurt American homeowners and prevent them from getting the help they need during these challenging times. Full Article OPA Press Releases
gen United States Announces Largest Settlement Under Environmental Protection Agencys Audit Policy By www.justice.gov Published On :: Mon, 13 Apr 2009 13:59:45 EDT Invista will pay a $1.7 million civil penalty and spend up to an estimated $500 million to correct self-reported environmental violations discovered at facilities in seven states. The company disclosed more than 680 violations of water, air, hazardous waste, emergency planning and preparedness, and pesticide regulations to EPA after auditing 12 facilities it acquired from DuPont in 2004. Full Article OPA Press Releases
gen Border Patrol Agent Pleads Guilty for Attempting to Receive Protected Leopard Tortoises By www.justice.gov Published On :: Tue, 14 Apr 2009 12:13:21 EDT 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). Full Article OPA Press Releases
gen Deputy Attorney General David Ogden at the Attorney General’s Law Enforcement Summit By www.justice.gov Published On :: Mon, 20 Apr 2009 16:35:22 EDT "Community policing in the United States is built on two partnerships: first, and fundamentally, the partnership between state, local and tribal law enforcement and the communities they serve. And second, the partnership between these law enforcement agencies and the Department of Justice." Full Article Speech
gen Kansas Man Charged with Immigration Crimes in Connection with 1994 Genocide in Rwanda By www.justice.gov Published On :: Thu, 23 Apr 2009 17:56:33 EDT Lazare Kabaya Kobagaya, 82, of Topeka, Kan., was arrested today on charges of naturalization fraud and misuse of an alien registration card. According to the indictment, Kobagaya allegedly participated in genocidal activities during the 1994 Rwandan conflict including mobilizing attackers to commit arson and murder. Kobagaya is alleged to have failed to disclose his alleged participation in these activities during his immigration and naturalization processes. Full Article OPA Press Releases
gen Attorney General Holder Announces Recovery Act Grants to Save or Create Justice Related Jobs By www.justice.gov Published On :: Wed, 29 Apr 2009 15:41:33 EDT U.S. Attorney General Eric Holder today announced that more than $424 million in Recovery Act funds will go to 20 states, territories and the District of Columbia to maintain or increase public safety, while creating or retaining jobs within the law enforcement community. Full Article OPA Press Releases
gen Deputy Attorney General David Ogden's Address at the American Bar Association Section of Litigation 2009 Annual Conference John Minor Wisdom Public Service and Professionalism Awards Luncheon By www.justice.gov Published On :: Fri, 1 May 2009 17:11:18 EDT "To ensure that the Department holds itself to the highest standards during discovery -- as in every stage of litigation -- in our criminal cases, and also in our civil litigation, we have taken both short-term and long-term action." Full Article Speech
gen Deputy Attorney General David W. Ogden at His Installation Ceremony By www.justice.gov Published On :: Fri, 8 May 2009 17:30:44 EDT "This is an exciting time as well as a challenging one, and under the leadership of this President and this Attorney General, we are up for the job together." Full Article Speech
gen Attorney General Eric Holder at the Semi-Annual Conference of the Office of Overseas Prosecutorial Development Assistance and Training (OPDAT) Resident Legal Advisors and Foreign Service Nationals By www.justice.gov Published On :: Mon, 11 May 2009 16:36:46 EDT "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." Full Article Speech
gen Associate Attorney General Tom Perrelli Before the United States Senate Committee on the Judiciary in a Hearing Entitled “Helping State and Local Law Enforcement” By www.justice.gov Published On :: Tue, 12 May 2009 11:17:18 EDT "If our partnership with state, local and tribal law enforcement is to endure, federal financial support cannot be a one time occurrence. This country is facing prolonged problems that require steadfast commitment and long-term cooperation." Full Article Testimony
gen Attorney General Eric Holder at the National Law Enforcement Officers Memorial Fund Candlelight Vigil By www.justice.gov Published On :: Fri, 15 May 2009 11:11:00 EDT "Tonight we hold a vigil, but every day we must be vigilant. So let us bind ourselves together with a new bond of service -- to make our country brighter, safer and more hopeful -- and in so doing, let us honor the memory of our fallen heroes every day." Full Article Speech
gen Attorney General Eric Holder at the National Peace Officers’ Memorial Service By www.justice.gov Published On :: Fri, 15 May 2009 17:34:08 EDT "Let us bind ourselves together in a new bond of service -- to make our country brighter, safer, and more hopeful -- and in so doing, let us bear true witness to the legacies of our fallen heroes." Full Article Speech
gen Attorney General Eric Holder at the University of Pennsylvania Department of Criminology Commencement Ceremony By www.justice.gov Published On :: Tue, 19 May 2009 10:38:13 EDT "You will be starting your service at a time when your government is placing a new and long overdue value on the scientific skills you have developed in this program." Full Article Speech
gen Attorney General Eric Holder Delivers Remarks at Columbia College Commencement By www.justice.gov Published On :: Tue, 19 May 2009 11:20:19 EDT "Graduates, as you dive head first toward tomorrow, I call upon you to never loosen nor lose your grip on hope. The optimism that seems to come naturally with youth need not be lost as the years pass." Full Article Speech
gen Texas-Based Regency Nursing and Rehabilitation Centers to Pay U.S. $4 Million to Resolve False Claims Act Allegations By www.justice.gov Published On :: Thu, 21 May 2009 11:30:26 EDT Regency Nursing and Rehabilitation Centers Inc. nursing home chain will pay the United States $4 million to settle allegations that Regency submitted false claims to Medicare and the Texas Medicaid program. The Victoria, Texas-based chain currently owns and operates 24 nursing home facilities located through the state. Full Article OPA Press Releases
gen Deputy Attorney General David W. Ogden at the National Missing Children’s Day Ceremony By www.justice.gov Published On :: Thu, 21 May 2009 14:34:04 EDT "Preventing the sexual exploitation of children, and stopping and punishing those who do it are a leading priority. The Department aggressively enforces the laws at our disposal to protect our children." Full Article Speech
gen Assistant Attorney General Tony West Announces New Members to Civil Divisions Senior Leadership By www.justice.gov Published On :: Fri, 22 May 2009 12:49:06 EDT Tony West, Assistant Attorney General (AAG) for the Justice Departments Civil Division, today announced four new members of the Divisions leadership team. Full Article OPA Press Releases
gen Associate Attorney General Tom Perrelli on the First 100 Days of Recovery Act at Law Enforcement Symposium on Violence Against Women By www.justice.gov Published On :: Wed, 27 May 2009 13:02:24 EDT "The Department of Justice and this Administration are fully committed to supporting state, local and tribal law enforcement and criminal justice agencies. The Recovery Act is not a one-time investment. Only by sustained investment in our communities can we make them safer and make them fit for long-term economic development." Full Article Speech
gen Attorney General Vacates Compean Order, Initiates New Rulemaking to Govern Immigration Removal Proceedings By www.justice.gov Published On :: Wed, 3 Jun 2009 13:06:14 EDT Attorney General Eric Holder today vacated the order issued in Matter of Compean by Attorney General Mukasey in January and announced his intention to initiate a new rulemaking proceeding for regulations to govern claims of ineffective assistance of counsel in removal proceedings. Full Article OPA Press Releases
gen Deputy Attorney General David W. Ogden at the Compliance Week Keynote Address By www.justice.gov Published On :: Thu, 4 Jun 2009 17:36:10 EDT "The current financial crisis requires a well-coordinated, proactive law enforcement response that draws on all the resources of the federal government. The appropriate role of the Department of Justice in responding to this crisis is clear: We will be relentless in our investigation of corporate wrongdoing, and will not hesitate to bring charges, where appropriate, for criminal misconduct on the part of businesses and business executives." Full Article Speech
gen Former State Department Official and Wife Arrested for Serving as Illegal Agents of Cuba for Nearly 30 Years By www.justice.gov Published On :: Fri, 5 Jun 2009 15:31:04 EDT A former State Department official and his wife have been arrested on charges of serving as illegal agents of the Cuban government for nearly 30 years and conspiring to provide classified U.S. information to the Cuban government. Full Article OPA Press Releases
gen Attorney General Holder at the Announcement of the National Southwest Border Counternarcotics Strategy By www.justice.gov Published On :: Fri, 5 Jun 2009 13:42:34 EDT "By focusing on increased cooperation between the U.S. and Mexican governments as well as enhanced communication within U.S. law enforcement agencies, the National Southwest Border Counternarcotics Strategy we introduce today provides an effective way forward that will crack down on cartels and make our country safer." Full Article Speech