1 Oxford COVID-19 vaccine programme opens for clinical trial recruitment By www.pharmanews.eu Published On :: Thu, 23 Apr 2020 10:00:00 +0200 University of Oxford researchers working in an unprecedented vaccine development effort to prevent COVID-19 have started screening healthy volunteers (aged 18-55) for their upcoming ChAdOx1 nCoV-19 vaccine trial in the Thames Valley Region. The vaccine based on an adenovirus vaccine vector and the SARS-CoV-2 spike protein is already in production but won’t be ready for some weeks still. Full Article Featured Research Research & Development
1 AstraZeneca and Saint Luke’s Mid America Heart Institute initiate Phase III DARE-19 trial with Farxiga in COVID-19 patients By www.pharmanews.eu Published On :: Fri, 24 Apr 2020 10:00:00 +0200 AstraZeneca and Saint Luke's Mid America Heart Institute have initiated a randomised, global Phase III trial to assess the potential of Farxiga (dapagliflozin) as a treatment in patients hospitalised with COVID-19 who are at risk of developing serious complications, such as organ failure. Full Article Featured AstraZeneca Business
1 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
1 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
1 Novartis announces plan to initiate clinical trial of canakinumab for patients with COVID-19 pneumonia By www.pharmanews.eu Published On :: Wed, 29 Apr 2020 10:00:00 +0200 Novartis announced plans to initiate a Phase III clinical trial to study canakinumab in patients with COVID-19 pneumonia. The CAN-COVID trial will examine the efficacy of utilizing canakinumab, an interleukin (IL)-1β blocker, to treat a type of severe immune overreaction called cytokine release syndrome (CRS) in people with COVID-19 pneumonia. Full Article Featured Novartis Business
1 AstraZeneca and Oxford University announce landmark agreement for COVID-19 vaccine By www.pharmanews.eu Published On :: Thu, 30 Apr 2020 10:00:00 +0200 AstraZeneca and the University of Oxford announced an agreement for the global development and distribution of the University’s potential recombinant adenovirus vaccine aimed at preventing COVID-19 infection from SARS-CoV-2. The collaboration aims to bring to patients the potential vaccine known as ChAdOx1 nCoV-19, being developed by the Jenner Institute and Oxford Vaccine Group, at the University of Oxford. Full Article Featured AstraZeneca Business
1 Antibodies from llamas could help in fight against COVID-19 By www.pharmanews.eu Published On :: Fri, 01 May 2020 10:00:00 +0200 The hunt for an effective treatment for COVID-19 has led one team of researchers to find an improbable ally for their work: a llama named Winter. The team - from The University of Texas at Austin, the National Institutes of Health and Ghent University in Belgium - reports their findings about a potential avenue for a coronavirus treatment involving llamas on May 5 in the journal Cell. Full Article Featured Research Research & Development
1 Researchers identify four possible treatments for COVID-19 By www.pharmanews.eu Published On :: Mon, 04 May 2020 10:00:00 +0200 While COVID-19 has infected millions of people worldwide and killed hundreds of thousands, there is currently no vaccine. In response, researchers have been evaluating the effectiveness of various antiviral drugs as possible COVID-19 treatments. Full Article Featured Research Research & Development
1 Study reveals most critically ill patients with COVID-19 survive with standard treatment By www.pharmanews.eu Published On :: Wed, 06 May 2020 10:00:00 +0200 Clinicians from two hospitals in Boston report that the majority of even the sickest patients with COVID-19 - those who require ventilators in intensive care units - get better when they receive existing guideline-supported treatment for respiratory failure. The clinicians, who are from Massachusetts General Hospital (MGH) and Beth Israel Deaconess Medical Center, published their findings in the American Journal of Respiratory and Critical Care Medicine. Full Article Featured Research Research & Development
1 Repurposing existing drugs for COVID-19 offers a more rapid alternative to a vaccine By www.pharmanews.eu Published On :: Thu, 07 May 2020 10:00:00 +0200 Repurposing existing medicines focused on known drug targets is likely to offer a more rapid hope of tackling COVID-19 than developing and manufacturing a vaccine, argue an international team of scientists in the British Journal of Pharmacology today. Since the emergence of the SARS-CoV-2 virus in late 2019, more than 3.5 million people are known to have been infected, leading to over 240,000 deaths worldwide from COVID-19, the disease caused by the novel coronavirus. Full Article Featured Research Research & Development
1 COVID-19 leading to shortage of orphan drugs in Russia By www.thepharmaletter.com Published On :: Tue, 05 May 2020 10:09:00 +0100 The ongoing spread of COVID-19 in Russia is leading to shortages of drugs against orphan diseases in… Full Article Anti-virals/Coronavirus/Focus On/From our correspondent/Hydroxychloroquine/In Depth/Pharmaceutical/Public health/Rare diseases/Russia/Russian market
1 Firms ready RNAi candidate for COVID-19 development By www.thepharmaletter.com Published On :: Tue, 05 May 2020 10:27:00 +0100 A collaboration in COVID-19 between immunology specialist Vir Biotechnology and Alnylam Pharmaceuticals… Full Article Alnylam Pharmaceuticals/Anti-virals/Biotechnology/Cell and Gene Therapy/Coronavirus/Focus On/Public health/Research/USA/Vir Biotechnology/VIR-2703
1 Clinical tests imminent for Junshi's COVID-19 antibody By www.thepharmaletter.com Published On :: Tue, 05 May 2020 13:11:00 +0100 A new collaboration between Shanghai’s Junshi Biosciences and Eli Lilly will seek to develop novel… Full Article Anti-virals/Biotechnology/China/Coronavirus/Drug Trial/Eli Lilly & Company/Focus On/JS016/Junshi Biosciences/Research/USA
1 China and COVID-19 offer test case for blockchain By www.thepharmaletter.com Published On :: Tue, 05 May 2020 15:25:00 +0100 The COVID-19 pandemic did not stop China from launching its national blockchain-based service network… Full Article China/Coronavirus/Digital Pharma/Focus On/GlobalData/Pharmaceutical
1 Pfizer and BioNTech move on COVID-19 vaccine work apace By www.thepharmaletter.com Published On :: Tue, 05 May 2020 16:43:00 +0100 As with other companies, US drug giant Pfizer and its German partner BioNTech are moving forward their… Full Article BioNTech/BNT162/Coronavirus/Drug Trial/Focus On/Pfizer/Pharmaceutical/Research/USA/Vaccines
1 ALK Abello outperforms expectations in strong 1st-qtr By www.thepharmaletter.com Published On :: Wed, 06 May 2020 11:08:00 +0100 Shares of Danish allergy immunotherapy specialist ALK Abello were up almost 10% at 1,788.00 Danish kroner… Full Article Acarizax/ALK Abello/Denmark/Financial/Immunologicals/Itulazax/Pharmaceutical
1 Global pharma and biotech’s fight against COVID-19: an investment perspective By www.thepharmaletter.com Published On :: Wed, 06 May 2020 18:01:00 +0100 Mark Brewer, who heads up the life sciences team at UK broker and M&A advisory company, finnCap, gives… Full Article Actemra/Anti-virals/Avacta/Avigan/Biotechnology/Business Financing/Chloroquine/Coronavirus/Cytiva/Expert View/Faron Pharmaceuticals/favipiravir/Focus On/Fujifilm/Gilead Sciences/Hydroxychloroquine/In Depth/Medical Devices and Diagnostics/Novacyt/Remdesivir/Roche/SNG001/Synairgen/UK
1 Assessing the long-term impact of COVID-19 on clinical research By www.thepharmaletter.com Published On :: Thu, 07 May 2020 10:15:00 +0100 The fallout from the COVID-19 pandemic has been challenging for many life sciences companies due to a… Full Article Anti-virals/Cell and Gene Therapy/Coronavirus/CRA/Feature/Focus On/Global/In Depth/Pharmaceutical/Regulation/Research/Vaccines
1 BRIEF—GSK completes sale of nutrition brands for £3.4 billion By www.thepharmaletter.com Published On :: Thu, 07 May 2020 10:44:00 +0100 GlaxoSmithKline has completed divestment of its Horlicks and other Consumer Healthcare nutrition products… Full Article Companies mergers and acquisitions/Deals/Financial/GlaxoSmithKline/India/Pharmaceutical/UK
1 Teva soars as 1st-qtr beats expectations By www.thepharmaletter.com Published On :: Thu, 07 May 2020 17:21:00 +0100 Israel-based Teva Pharmaceutical Industries today reported results for the quarter ended March 31, 2020,… Full Article Ajovy/Analgesia/Austedo/Copaxone/Financial/Generics/Israel/Musculoskeletal/Rare diseases/Teva Pharmaceutical Industries/Treanda
1 Japan grants ‘exceptional’ approval for remdesivir in COVID-19 By www.thepharmaletter.com Published On :: Fri, 08 May 2020 14:53:00 +0100 As had been widely expected, Gilead Sciences on Thursday announced that the Japanese Ministry of Health,… Full Article Anti-virals/Asia Pacific/Coronavirus/Focus On/Gilead Sciences/Japan/Pharmaceutical/Regulation/Remdesivir/USA/Veklury
1 Recordati 1st-qtr revenues rise 12% as income leaps more than 20% By www.thepharmaletter.com Published On :: Sat, 09 May 2020 10:50:00 +0100 Italian drugmaker Recordati has reported consolidated revenues for the first quarter of 2020 are 429.2… Full Article Financial/Italy/Pharmaceutical/Recordati/Signifor
1 Gilead in talks to expand COVID-19 hopeful remdesivir supply chains with outside partner By www.fiercepharma.com Published On :: Fri, 01 May 2020 14:30:25 +0000 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. Full Article
1 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
1 With the world waiting, Roche socks $459M into COVID-19 antibody test production By www.fiercepharma.com Published On :: Mon, 04 May 2020 15:05:01 +0000 Roche scored a major win with the FDA's backing for its COVID-19 antibody tests last week in a field marked by products of questionable quality. Now, to cover its booming production goals, Roche plans to infuse nearly half-a-billion dollars into its German manufacturing facility. Full Article
1 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
1 Remdesivir, check. Now, analysts are looking ahead to 'several' COVID-19 drugs to come By www.fiercepharma.com Published On :: Mon, 04 May 2020 15:22:41 +0000 Gilead made waves on Friday with its emergency FDA approval for remdesivir quickly on the heels of a controlled trial data release. But while it’s an important first step, other COVID-19 medicines will likely be coming down the line, analysts wrote. Full Article
1 Pfizer tags 3 U.S. manufacturing sites for possible COVID-19 vaccine launch By www.fiercepharma.com Published On :: Thu, 07 May 2020 13:38:33 +0000 Global coronavirus vaccine makers have been rolling out details about their manufacturing and launch plans—even ahead of any clinical data. Now, Pfizer says it will draw on three sites in the U.S., plus one in Belgium, for the early stages of a launch, provided its BioNTech-partnered shot wins a green light. Full Article
1 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
1 Bristol Myers Squibb's blood thinner Eliquis soars on COVID-19 demand, but Opdivo could suffer: execs By www.fiercepharma.com Published On :: Thu, 07 May 2020 14:53:18 +0000 Bristol Myers Squibb CEO Giovanni Caforio credited COVID-19-related stocking for high sales of some products in the first quarter, including Eliquis, a blood thinner that's being snapped up to reduce clotting risk in patients with the virus. But the pandemic has limited access to oncology clinics and other non-COVID-19 services, raising challenges that could impact sales later this year. Full Article
1 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
1 FiercePharmaAsia—Gilead's Japanese remdesivir nod, licensing talks; Lilly-Junshi COVID-19 antibody pact By www.fiercepharma.com Published On :: Fri, 08 May 2020 10:10:53 +0000 Gilead Sciences' remdesivir, now called Veklury, has won a fast Japanese nod in SARS-CoV-2. The Big Biotech's scouting licensing partners to ramp up supply around the world. Eli Lilly has signed on China's Junshi Biosciences to develop neutralizing antibodies against the novel coronavirus. And more. Full Article
1 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
1 Gilead hit with Iranian cyberattack for role in COVID-19 response: report By www.fiercepharma.com Published On :: Fri, 08 May 2020 19:43:17 +0000 Gilead Sciences has captured worldwide attention with its COVID-19 antiviral, remdesivir, cleared late last week by the FDA—not all of it welcome. With bad actors targeting companies at the head of the spear in the pandemic response, Gilead may have found itself in their sights. Full Article
1 U.S. CDC reports 1,248,040 coronavirus cases, 75,477 deaths By feeds.reuters.com Published On :: Fri, 08 May 2020 21:46:52 -0400 The U.S. Centers for Disease Control and Prevention (CDC) on Friday reported 1,248,040 cases of the new coronavirus, an increase of 28,974 cases from its previous count, and said that the number of deaths had risen by 2,180 to 75,477. Full Article healthNews
1 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
1 China reports one new coronavirus case, 15 asymptomatic cases By feeds.reuters.com Published On :: Fri, 08 May 2020 23:09:58 -0400 China reported one new coronavirus case for Friday, unchanged from the day before, data from the national health authority showed on Saturday. Full Article healthNews
1 FDA commissioner in self-quarantine after exposure to person with COVID-19 By feeds.reuters.com Published On :: Sat, 09 May 2020 00:38:14 -0400 U.S. Food and Drug Administration Commissioner Stephen Hahn is in self-quarantine for a couple of weeks after coming into contact with someone who tested positive for COVID-19, an FDA spokesman told Reuters late on Friday. Full Article healthNews
1 Russia records more than 10,000 new coronavirus cases in past day By feeds.reuters.com Published On :: Sat, 09 May 2020 04:07:00 -0400 Russian authorities said on Saturday they had recorded 10,817 new cases of the coronavirus in the last day, pushing the nationwide tally to 198,676. Full Article healthNews
1 Indonesia reports 533 new COVID-19 cases, biggest in a day By feeds.reuters.com Published On :: Sat, 09 May 2020 05:33:43 -0400 Indonesia reported on Saturday 533 new coronavirus infections, the biggest daily increase, taking the total number to 13,645, health ministry official Achmad Yurianto said. Full Article healthNews
1 Slovakia records no new coronavirus cases for first time since March 10 By feeds.reuters.com Published On :: Sat, 09 May 2020 05:43:33 -0400 Slovakia on Friday recorded no new cases of coronavirus for the first time since March 10, government figures showed. Full Article healthNews
1 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
1 Journal Watch (Holiday 2019) By www.biotechduediligence.com Published On :: Tue, 24 Dec 2019 02:53:11 GMT Closing out another year at BiotechDueDIligence, thank you for following along! Enjoy another round-up of scientific and medical journal articles driving the conversation and newsflow in biotech.There's lots of great #immunology in @sciencemagazine this week! @JSRustenhoven & @jonykipnis (@kipnislab @UVA) author a fascinating Perspective on how immune cells bypass the blood–brain barrier!https://t.co/6QjcNxU0p6 pic.twitter.com/njjnrn9Yej— Seth Thomas Scanlon (@ImmunoEditor) December 20, [...] Full Article journal watch
1 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
1 Third Individual Pleads Guilty to Illegally Accessing Confidential Passport Files By www.justice.gov Published On :: Tue, 27 Jan 2009 16:08:01 EST A third individual pleaded guilty today to illegally accessing numerous confidential passport application files. Gerald R. Lueders, 65, of Woodbridge, Va., pleaded guilty before U.S. Magistrate Judge Alan Kay in U.S. District Court for the District of Columbia to a one-count criminal information charging him with unauthorized computer access. Full Article OPA Press Releases
1 U.S. Recovers $19 Million from AMEC Construction Management to Settle Litigation Regarding Fraud, False Claims, Kickbacks & Re-Procurement Costs on Federal Construction Contracts By www.justice.gov Published On :: Mon, 2 Feb 2009 17:18:08 EST The United States has recovered more than $19 million from AMEC Construction Management Inc. (ACMI) to resolve allegations of fraud, false claims and kickbacks on four General Services Administration (GSA) construction contracts, as well as litigation over claims by the GSA for excess re-procurement costs incurred by GSA after it terminated ACMIs contract to build the Thomas F. Eagleton United States Courthouse in St. Louis, Missouri. ACMI was formerly known as Morse Diesel International Inc. Full Article OPA Press Releases
1 Coal-Fired Power Plant to Spend More Than $135 Million to Settle Clean Air Violations By www.justice.gov Published On :: Tue, 3 Feb 2009 16:44:24 EST Kentucky Utilities (KU), a coal-fired electric utility, has agreed to pay a $1.4 million civil penalty and spend approximately $135 million on pollution controls to resolve violations of the Clean Air Act. Full Article OPA Press Releases
1 California Man Sentenced to 18 Months in Community Correctional Facility in Connection with Scheme to Defraud First International Bank and Export-Import Bank By www.justice.gov Published On :: Tue, 10 Feb 2009 10:38:41 EST Carlos Serrano, 64, of Glendale, Calif., was sentenced to 18 months in a community correctional facility in connection with a $1.3 million scheme to defraud the First International Bank of Connecticut (FIB) and the Export-Import Bank of the United States (Ex-Im Bank). In addition to his prison sentence, Serrano was placed on five years of probation and ordered to pay restitution of $924,569 to the Ex-Im Bank. Full Article OPA Press Releases
1 Former Tulsa Businessman Sentenced to 11 Years in Prison for Receiving Child Pornography By www.justice.gov Published On :: Tue, 10 Feb 2009 16:38:38 EST Terry Brian Dobbs, an Oklahoma businessman, was sentenced today to 11 years in prison for receiving images of child pornography. Dobbs, 51, was also sentenced to lifetime supervised release following his term in prison by U.S. District Judge Gregory Frizzel, and was ordered to pay an $8,000 fine. Full Article OPA Press Releases
1 Three Miami Physicians and Three Medical Workers Charged with $10 Million Medicare Fraud Scheme By www.justice.gov Published On :: Fri, 13 Feb 2009 16:22:15 EST Six Miami-Dade County residents have been indicted in connection with an alleged $10 million Medicare fraud scheme operated out of Midway Medical, a Miami clinic that purported to specialize in treating HIV/AIDS patients. Full Article OPA Press Releases