ed European Medicines Agency’s review of Picato finds its risks outweigh its benefits By www.pharmafile.com Published On :: Fri, 24 Apr 2020 12:12:33 +0000 The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has confirmed that the risks from using Picato are too high to end its suspension. Full Article Medical Communications Sales and Marketing
ed FDA urges close monitoring of COVID-19 patients treated with hydroxychloroquine By www.pharmafile.com Published On :: Mon, 27 Apr 2020 08:37:56 +0000 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. Full Article chloroquine coronavirus COVID-19 FDA hydroxychloroquine Sales and Marketing
ed Sanofi's Meningococcal Conjugate Vaccine secures FDA approval in patients aged two and up By www.pharmafile.com Published On :: Mon, 27 Apr 2020 11:58:57 +0000 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. Full Article FDA meningococcal disease MenQuadfi pharma Sanofi US Sales and Marketing
ed 12 British children hospitalised with rare condition linked to COVID-19 By www.pharmafile.com Published On :: Tue, 28 Apr 2020 09:25:30 +0000 12 children have fallen ill across the UK with a new and potentially fatal combination of symptoms linked to COVID-19. Full Article coronavirus COVID-19 NHS NHS UK Manufacturing and Production
ed Nearly half of Americans believe COVID-19 was created in a lab, according to a new survey By www.pharmafile.com Published On :: Tue, 28 Apr 2020 11:31:39 +0000 Almost half of Americans believe that the coronavirus was created in a lab, according to an April survey of 6,300 people. Full Article coronavirus COVID-19 survey Manufacturing and Production
ed Phase 3 Libtayo monotherapy trial halted early due to strong benefit in advanced non-small cell lung cancer By www.pharmafile.com Published On :: Wed, 29 Apr 2020 11:49:31 +0000 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. Full Article cancer Libtayo lung cancer Regeneron Research and Development Sanofi
ed Arizona GOP lawmakers and AAPS say hydroxychloroquine has 90% chance of helping COVID-19 patients, but data is not based on clinical trials By www.pharmafile.com Published On :: Wed, 29 Apr 2020 11:58:38 +0000 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. Full Article chloroquine hydroxychloroquine Research and Development
ed Two studies reveal "positive" data for Gilead's remdesivir in hospitalised COVID-19 patients By www.pharmafile.com Published On :: Thu, 30 Apr 2020 10:12:25 +0000 The first findings of two new studies have been revealed detailing the efficacy of Gilead’s antiviral therapy remdesivir in the treatment of patients hospitalised with COVID-19. Full Article coronavirus COVID-19 Gilead remdesivir Research and Development
ed Teva’s cancer drug Bendeka protected from generics until 2031, judge rules By www.pharmafile.com Published On :: Thu, 30 Apr 2020 11:20:42 +0000 A US federal judge has ruled that generic versions of the cancer treatment Bendeka infringe on four separate patents, and has delayed them from launching until 2031. Full Article Bendeka Teva Teva and Eagle Business Services
ed 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
ed Trump vows to reduce America’s reliance on foreign drug imports By www.pharmafile.com Published On :: Mon, 04 May 2020 11:12:58 +0000 President Donald Trump has vowed to cut the US’s reliance on foreign drugs, singling out China and Ireland as countries he wants to stop buying pharmaceuticals from. Full Article coronavirus COVID-19 Sales and Marketing
ed 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
ed UK contact-tracing app being tested on the Isle of Wight By www.pharmafile.com Published On :: Tue, 05 May 2020 09:58:21 +0000 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. Full Article coronavirus COVID-19 Manufacturing and Production
ed First French case of COVID-19 occurred in December, a month earlier than previously thought By www.pharmafile.com Published On :: Tue, 05 May 2020 11:46:00 +0000 A French patient who suffered from pneumonia in December actually had COVID-19, it has been revealed. Full Article coronavirus COVID-19 Manufacturing and Production
ed Ousted chief of BARDA says Trump administration ignored COVID-19 warnings By www.pharmafile.com Published On :: Wed, 06 May 2020 09:33:46 +0000 Ousted Director of the Biomedical Advanced Research and Development Authority (BARDA), Dr Rick Bright, alleges the Trump administration ignored warnings about the severity of the coronavirus. Full Article BARDA chloroquine coronavirus COVID-19 hydroxychloroquine Research and Development
ed AZ's Farxiga becomes first FDA-approved SGLT2 inhibitor for heart failure with reduced ejection fraction By www.pharmafile.com Published On :: Wed, 06 May 2020 11:28:32 +0000 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. Full Article AstraZeneca farxiga FDA heart failure Research and Development Sales and Marketing
ed Scientists in the UK and US identify hundreds of mutations in the COVID-19 virus By www.pharmafile.com Published On :: Thu, 07 May 2020 09:42:57 +0000 Two studies from the UK and US have identified hundreds of mutations in COVID-19, which could cause problems for the development of a vaccine. Full Article coronavirus COVID-19 Protein virus Business Services
ed 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
ed Lannett to Be U.S. Distributor of Posaconazole Delayed-Release Tablets By www.thestreet.com Published On :: Wed, 28 Aug 2019 08:18:15 EDT Click to view a price quote on LCI. Full Article
ed Key nose cells identified as likely COVID-19 virus entry points By www.pharmanews.eu Published On :: Mon, 27 Apr 2020 10:00:00 +0200 Two specific cell types in the nose have been identified as likely initial infection points for COVID-19 coronavirus. Scientists discovered that goblet and ciliated cells in the nose have high levels of the entry proteins that the COVID-19 virus uses to get into our cells. The identification of these cells by researchers from the Full Article Featured Research Research & Development
ed Loss of smell associated with milder clinical course in COVID-19 By www.pharmanews.eu Published On :: Tue, 28 Apr 2020 10:00:00 +0200 Following an earlier study that validated the loss of smell and taste as indicators of SARS-CoV-2 infection, researchers at UC San Diego Health report in newly published findings that olfactory impairment suggests the resulting COVID-19 disease is more likely to be mild to moderate, a potential early indicator that could help health care providers determine which patients may require hospitalization. Full Article Featured Research Research & Development
ed Pre-filled Syringes San Francisco Conference 2020 By www.pharmanews.eu Published On :: Tue, 05 May 2020 12:00:00 +0200 14 - 15 September 2020, San Francisco, USA. The global pre-filled syringes market was valued at $4.9 billion in 2018 and with the rapid growth of the industry, is expected to exceed $9.7 billion by 2025. With that in mind, this event will bring together specialists within the industry to provide an exclusive insight into the sphere of regulation, new digital technology trends, human studies and innovative design and delivery systems within the prefilled syringe industry. Full Article Featured Events
ed Vitamin D linked to low virus death rate By www.pharmanews.eu Published On :: Fri, 08 May 2020 10:00:00 +0200 A new study has found an association between low average levels of vitamin D and high numbers of COVID-19 cases and mortality rates across 20 European countries. The research, led by Dr Lee Smith of Anglia Ruskin University (ARU) and Mr Petre Cristian Ilie, lead urologist of Queen Elizabeth Hospital King's Lynn NHS Foundation Trust, is published in the journal Aging Clinical and Experimental Research. Full Article Featured Research Research & Development
ed EU-led coronavirus fundraiser targets initial 7.5 billion euros By www.thepharmaletter.com Published On :: Tue, 05 May 2020 15:20:00 +0100 A pledging conference led by the European Union (EU) has set an initial target of 7.5 billion euros ($8.1… Full Article Anti-virals/Antibiotics and Infectious diseases/Coronavirus/EIB Group/Europe/Focus On/Government Affairs/Health Medical Pharma/Pharmaceutical/Public health
ed Ferring in sight of finish line with first microbiome-based drug By www.thepharmaletter.com Published On :: Wed, 06 May 2020 13:17:00 +0100 Swiss drugmaker Ferring and its Rebiotix subsidiary have announced a world first with a microbiome-based… Full Article Antibiotics and Infectious diseases/Biotechnology/Drug Trial/Ferring Pharmaceuticals/Microbiomes/RBX2660/Rebiotix/Research/Switzerland
ed Alexion exceeds earnings estimates but drops guidance By www.thepharmaletter.com Published On :: Wed, 06 May 2020 15:22:00 +0100 US drugmaker Alexion Pharmaceuticals fared better in its revenue and adjusted earnings figures in the… Full Article Alexion Pharmaceuticals/Autoimmune Disorders/Biotechnology/Financial/Immunologicals/Management/Rare diseases/Soliris/Strensiq/Ultomiris/USA
ed First targeted therapy for aggressive form of lung cancer approved by FDA By www.thepharmaletter.com Published On :: Thu, 07 May 2020 11:10:00 +0100 Late Wednesday, the US Food and Drug Administration said it has granted accelerated approved for Tabrecta… Full Article Biotechnology/capmatinib/Focus On/Incyte Corp/Medical Devices and Diagnostics/Novartis/Oncology/Rare diseases/Regulation/Research/Switzerland/Tabrecta/USA
ed Mediolanum buys French I-O company By www.thepharmaletter.com Published On :: Thu, 07 May 2020 15:33:00 +0100 Privately-held Italian pharma group Mediolanum Farmaceutici has acquired the French immuno-oncology specialist… Full Article Biotechnology/Companies mergers and acquisitions/Elsalys Biotech/France/Immuno-oncology/Italy/Leukotac/Mediolanum/Oncology
ed Dr Reddy's gets FDA nod for migraine drug Elyxyb By www.thepharmaletter.com Published On :: Thu, 07 May 2020 16:10:00 +0100 Shares of Dr Reddy’s Laboratories rose more than 2% to 3,936.35 rupees, after the Indian drugmaker… Full Article Analgesia/celecoxib/Dr Reddy's Laboratories/Elyxyb/Focus On/India/Migraine/Neurological/Pharmaceutical/Regulation/US FDA/USA
ed B-MS’ quarterly financials exceed estimates By www.thepharmaletter.com Published On :: Thu, 07 May 2020 17:36:00 +0100 US pharma major Bristol-Myers Squibb saw its revenue reach $10.8 billion in the first quarter of 2020,… Full Article Bristol-Myers Squibb/Cardio-vascular/Celgene/Eliquis/Financial/Hematology/Immuno-oncology/Immunologicals/Management/Oncology/Opdivo/Orencia/Pharmaceutical/Pomalyst/Revlimid/USA
ed Novartis taps real-life Cosentyx patients to thank healthcare workers, pledge patient support By www.fiercepharma.com Published On :: Sat, 02 May 2020 21:13:54 +0000 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. Full Article
ed Fair price for Gilead's COVID-19 med remdesivir? $4,460, cost watchdog says By www.fiercepharma.com Published On :: Mon, 04 May 2020 15:09:09 +0000 While Gilead has yet to present a marketing plan for remdesivir—much less a price—ICER figures the COVID-19 drug could be cost-effective at up to $4,460 per patient. That means it could easily rake in blockbuster sales this year, at least theoretically. Full Article
ed 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
ed Ousted BARDA director pushed back on chloroquine claims and faced whistleblower retaliation, complaint says By www.fiercepharma.com Published On :: Tue, 05 May 2020 19:56:27 +0000 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. Full Article
ed GBT chief blames COVID-19 for 'clear' slowdown in Oxbryta launch, but analysts are still impressed By www.fiercepharma.com Published On :: Thu, 07 May 2020 18:11:22 +0000 Global Blood Therapeutics' sickle cell disease medicine Oxbryta got off to a hot start after a November FDA approval. But early in its launch, execs now say they're seeing a "clear headwind" from the COVID-19 pandemic. Lately, new patient starts have tanked by 60%, CEO Ted Love said. Full Article
ed Cadila shutters Indian ingredients plant after 26 workers test positive for COVID-19: report By www.fiercepharma.com Published On :: Fri, 08 May 2020 13:40:29 +0000 Global drugmakers are working overtime to keep supplies coming amid the novel coronavirus pandemic. But in manufacturing facilities packed with workers, COVID-19 presents a particularly difficult challenge—and now one Indian plant has been forced to shutter due to a rash of infections. Full Article
ed 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
ed Germany's confirmed coronavirus cases rise by 1,251 to 168,551: RKI By feeds.reuters.com Published On :: Fri, 08 May 2020 22:09:29 -0400 The number of confirmed coronavirus cases in Germany increased by 1,251 to 168,551, data from the Robert Koch Institute (RKI) for infectious diseases showed on Saturday. Full Article healthNews
ed New York governor says 5-year old died from rare COVID-related complications By feeds.reuters.com Published On :: Sat, 09 May 2020 07:36:14 -0400 A 5-year old boy has died in New York from a rare inflammatory syndrome believed to be linked to the novel coronavirus, highlighting a potential new risk for children in the pandemic, Governor Andrew Cuomo said on Friday. Full Article healthNews
ed Half of Spaniards will see lockdown eased from Monday as death toll falls By feeds.reuters.com Published On :: Sat, 09 May 2020 10:11:10 -0400 Spain's daily death toll from the coronavirus fell to its second lowest since mid-March on Saturday, as half the country prepared to move to the next phase of an exit from one of Europe's strictest lockdowns. Full Article healthNews
ed Former Florida State Corrections Officer Convicted of Federal Civil Rights Crime By www.justice.gov Published On :: Wed, 21 Jan 2009 11:01:29 EST A federal jury in Jacksonville, Fla., found Paul Tillis, a former Florida Department of Corrections officer, guilty on Jan. 16, 2009, of a felony federal civil rights violation for an August 2005 assault on an inmate. Full Article OPA Press Releases
ed Chicago Police Officer Pleads Guilty to Violating Federal Civil Rights of a Man Beaten While Restrained in a Wheelchair By www.justice.gov Published On :: Thu, 22 Jan 2009 14:28:08 EST A Chicago police officer pleaded guilty today to violating the federal civil rights of a man whom the officer struck repeatedly with a dangerous weapon while the man was handcuffed and shackled in a wheelchair. Full Article OPA Press Releases
ed Twentieth Member of Casino-cheating Criminal Enterprise Pleads Guilty to Racketeering Conspiracy Targeting Casinos in the United States and Canada By www.justice.gov Published On :: Thu, 22 Jan 2009 17:38:03 EST Phat Ngoc Tran, 35, pleaded guilty today in San Diego to conspiring to participate in a racketeering enterprise, the Tran Organization, in a scheme to cheat at least 12 casinos across the United States and Canada out of millions of dollars. Tran admitted that he and his co-conspirators unlawfully obtained up to $2.5 million during card cheats. Full Article OPA Press Releases
ed Foreign National Sentenced to Five Years in Prison for Smuggling East Africans to the United States By www.justice.gov Published On :: Thu, 22 Jan 2009 17:51:34 EST A Ghanian man was sentenced today in the District of Columbia for his role in smuggling East Africans into the United States. Mohammed Kamel Ibrahim, a/k/a Hakim, 27, a native of Ghana and naturalized citizen of Mexico, was sentenced to five years in prison by U.S. District Judge Ricardo M. Urbina after pleading guilty to one count of conspiracy and three counts of bringing aliens to the United States for profit. Full Article OPA Press Releases
ed Former New York Power Authority Employee Sentenced to 37 Months in Jail for Bribery and Fraud Scheme By www.justice.gov Published On :: Fri, 23 Jan 2009 13:22:43 EST A former employee of the New York Power Authority (NYPA) was sentenced today to serve 37 months in jail and to pay a $5,000 criminal fine for his role in a kickback and bribery scheme. Full Article OPA Press Releases
ed Canadian Company to Pay U.S. More Than $1 Million Related to Sale of Defective Bullet-proof Vests By www.justice.gov Published On :: Fri, 23 Jan 2009 16:03:49 EST Barrday Inc. and two related companies have agreed to pay the United States more than $1 million to resolve allegations that they violated the False Claims Act in connection with their role in the weaving of Zylon fabric used in the manufacture and sale of defective Zylon bullet-proof vests. Barrday, headquartered in Cambridge, Ontario, Canada, is a weaver of ballistic fabrics and designs and produces specialty industrial textiles. Full Article OPA Press Releases
ed New York Man Pleads Guilty to Federal Hate Crime Conspiracy By www.justice.gov Published On :: Mon, 26 Jan 2009 11:47:13 EST Brian Carranza, 21, pleaded guilty today before U.S. District Court Judge Carol B. Amon in Brooklyn, N.Y., to conspiring to assault African-American residents in Staten Island, N.Y., in retaliation for President Barack Obama winning last years presidential election. Full Article OPA Press Releases
ed Former Oak Ridge Complex Employee Pleads Guilty to Unlawful Disclosure of Restricted Atomic Energy Data By www.justice.gov Published On :: Mon, 26 Jan 2009 11:57:12 EST 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). Full Article OPA Press Releases
ed Three Men Indicted for Racially-Motivated Church Arson in Springfield, Mass. By www.justice.gov Published On :: Tue, 27 Jan 2009 17:45:48 EST Three individuals were indicted today by a federal grand jury in the District of Massachusetts for conspiring to interfere with the civil rights of members of the Macedonia Church of God in Christ, a Springfield, Mass., church with a predominantly African-American congregation. Full Article OPA Press Releases
ed Former AIG Vice President Sentenced to Four Years in Prison for Role in Fraudulent Manipulation Scheme By www.justice.gov Published On :: Tue, 27 Jan 2009 17:01:37 EST The former vice president of reinsurance of American International Group Inc. (AIG), was sentenced today to four years in prison for his role in a fraudulent scheme to manipulate AIGs financial statements. Full Article OPA Press Releases