x Remdesivir: five Australian hospitals to receive experimental coronavirus drug By www.theguardian.com Published On :: 2020-05-01T00:31:31Z Exclusive: St Vincent’s in Sydney is the only confirmed location so far, as NSW Health negotiates with US pharmaceutical giant Gilead Remdesivir: the antiviral drug is being touted as a possible coronavirus treatment – but will it work?Sign up for Guardian Australia’s daily coronavirus emailDownload the free Guardian app to get the most important news notificationsThe US pharmaceutical company Gilead is finalising the location of five hospitals in Australia to receive the highly sought-after experimental coronavirus drug remdesivir.The only confirmed location is St Vincent’s hospital in Sydney, a major tertiary hospital and the centre of many of the New South Wales outbreak areas. A NSW Health spokeswoman confirmed the health department “has been engaging with Gilead on gaining access to the drug for Covid-19 patients”. Related: Remdesivir: the antiviral drug is being touted as a possible coronavirus treatment – but will it work? Continue reading... Full Article Health Coronavirus outbreak Australia news Infectious diseases Sydney Medical research Pharmaceuticals industry
x The promise of an Oxford vaccine reveals how a new Britain could thrive | Will Hutton By www.theguardian.com Published On :: 2020-05-03T06:45:44Z The partnership between AstraZeneca and the Jenner Institute should jolt our industry and banksCoronavirus latest updatesSee all our coronavirus coverageThere was some good news last week. Oxford University’s Jenner Institute announced it was teaming up with AstraZeneca to take a promising prototype of coronavirus vaccine into volume production by the autumn. Of course there are caveats – the institute’s confidence in its vaccine may not be validated by the trials that began last week.Still it was heartening, after so much tragic incompetence, that a British university and a British company could forge a relationship of such potential national importance.The piping through which emergency credit must flow is atrophied and weak Continue reading... Full Article Coronavirus outbreak Infectious diseases Medical research Microbiology Biology Science AstraZeneca University of Oxford Pharmaceuticals industry Banking Business UK news
x 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
x ‘Excess deaths’ in England among the highest in Europe By www.pharmafile.com Published On :: Mon, 27 Apr 2020 09:51:21 +0000 English excess deaths from the coronavirus are comparable to the worst hit countries in Europe, according to a Sky News analysis. Full Article coronavirus COVID-19 deaths pandemic Sales and Marketing
x Italy to relax COVID-19 lockdown in early May By www.pharmafile.com Published On :: Mon, 27 Apr 2020 11:35:23 +0000 Italy has outlined its plans to ease the lockdown restrictions that were implemented across the country 7 weeks ago to combat the COVID-19 coronavirus pandemic. Full Article coronavirus COVID-19 COVID-19 coronavirus Italy Sales and Marketing
x EU approval for Novartis' Cosentyx in active non-radiographic axial spondyloarthritis By www.pharmafile.com Published On :: Wed, 29 Apr 2020 09:28:04 +0000 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. Full Article axial spondyloarthritis Cosentyx EU Novartis pharma Research and Development Sales and Marketing
x 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
x Men most likely to exhibit the worst COVID-19 symptoms, according to a new study By www.pharmafile.com Published On :: Thu, 30 Apr 2020 09:24:33 +0000 Research into coronavirus cases in Shenzhen, China found that men were 2.5 times as likely to exhibit severe symptoms. Full Article coronavirus COVID-19 Business Services
x More than half of US states will relax lockdowns by the end of the week By www.pharmafile.com Published On :: Thu, 30 Apr 2020 10:35:35 +0000 Nearly half of US states will have their ‘stay-at-home’ orders expire this week, paving the way for much of the US to relax its lockdowns. Full Article coronavirus COVID-19 Lockdown quaratine Business Services
x AstraZeneca joins forces with University of Oxford to develop and manufacture potential coronavirus vaccine By www.pharmafile.com Published On :: Thu, 30 Apr 2020 11:05:49 +0000 A “landmark” partnership has been struck between AstraZeneca and the University of Oxford in the ongoing battle against COVID-19, with the former agreeing to aid in the development and large-scale manufacture of the latter’s potential recombinant adenovirus vaccine for the prevention of novel coronavirus infection. Full Article Research and Development Manufacturing and Production
x Vertex's Kalydeco seizes EU CHMP recommendation for Kalydeco in R117H+ cystic fibrosis By www.pharmafile.com Published On :: Fri, 01 May 2020 09:50:30 +0000 The European Medicines Agency’s Committee for Medicinal Products for Human Use has given its recommendation for the approval of Kalydeco for the treatment of children and adolescents with cystic fibrosis in a new indication, Vertex has revealed. Full Article cystic fibrosis Europe Kalydeco Vertex Medical Communications Sales and Marketing
x UK testing experimental treatment for use in COVID-19 patients By www.pharmafile.com Published On :: Mon, 04 May 2020 10:06:21 +0000 British scientists are testing an experimental drug to help some of society’s most vulnerable fight off the COVID-19 coronavirus. Full Article coronavirus coronavirus treatment COVID-19 Sales and Marketing
x Portola Pharmaceuticals to merge with Alexion in $1.41bn cash deal By www.pharmafile.com Published On :: Wed, 06 May 2020 10:36:40 +0000 Alexion has announced it is to acquire Boston-based blood disorder specialist Portola Pharmaceuticals in a transaction to the value of $1.41 billion in cash. Full Article Alexion pharma Portola Pharmaceuticals Research and Development Sales and Marketing
x 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
x FDA approval for Tabrecta in metastatic non-small cell lung cancer with METex14 By www.pharmafile.com Published On :: Thu, 07 May 2020 11:35:49 +0000 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. Full Article Incyte Novartis pharma Tabrecta Sales and Marketing
x AstraZeneca partners with Oxford University on UK’s lead coronavirus vaccine By www.pmlive.com Published On :: Fri, 01 May 2020 12:50:48 +0100 AZ has pledged to make the vaccine at cost for the duration of the pandemic Full Article
x 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
x 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
x 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
x 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
x Mallinckrodt’s INOmax successful in trial of neonates with pulmonary hypertension By www.thepharmaletter.com Published On :: Mon, 04 May 2020 17:20:00 +0100 UK-based Mallinckrodt Pharmaceuticals has ended a trial of INOmax (nitric oxide) gas early due to positive… Full Article Drug Trial/Inomax/Mallinckrodt/Nitric Oxide/Pharmaceutical/Research/Respiratory and Pulmonary/UK
x 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
x Portola agrees to takeover bid from Alexion By www.thepharmaletter.com Published On :: Wed, 06 May 2020 12:26:00 +0100 Following a couple of active M&A years, USA-based Alexion Pharmaceuticals has now reached a definitive… Full Article Alexion Pharmaceuticals/AndexXa/Anticoagulants/Biotechnology/Cardio-vascular/Companies mergers and acquisitions/Hematology/Ondexxya/Portola Pharmaceuticals/USA
x FDA approval for Farxiga in new indication in heart failure patients By www.thepharmaletter.com Published On :: Wed, 06 May 2020 14:59:00 +0100 Farxiga (dapagliflozin) has been approved in the US to reduce the risk of cardiovascular (CV) death and… Full Article AstraZeneca/Cardio-vascular/Diabetes/Farxiga/Focus On/Glucosides/Pharmaceutical/Regulation/SGLT2 inhibitors/UK/US FDA/USA
x 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
x Bausch + Lomb licenses Stada and Xbrane’s Lucentis biosimilar By www.thepharmaletter.com Published On :: Wed, 06 May 2020 16:52:00 +0100 Eye health specialist Bausch + Lomb, part Bausch Health Companies, has entered into an exclusive licensing… Full Article Bausch & Lomb/Bausch Health Companies/Biosimilars/Canada/Deals/Germany/Licensing/Lucentis/Ophthalmics/STADA Arzneimittel/Sweden/USA/Xbrane Biopharma AB/Xlucane
x Bausch Health and partners settle Xifaxan IP litigation By www.thepharmaletter.com Published On :: Wed, 06 May 2020 17:28:00 +0100 Canada-based Bausch Health Companies, along with its wholly-owned subsidiary, Salix Pharmaceuticals and… Full Article Alfasigma/Bausch Health Companies Inc./Canada/Deals/Legal/Licensing/Nephrology and Hepatology/Patents & Trademarks/Pharmaceutical/Salix Pharmaceuticals Ltd/Sandoz/Switzerland/USA/Xifaxan
x 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
x 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
x 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
x 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
x 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
x 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
x 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
x AstraZeneca's Farxiga scores landmark FDA nod in heart failure patients with or without diabetes By www.fiercepharma.com Published On :: Wed, 06 May 2020 14:42:58 +0000 AstraZeneca has watched superstar SGLT2 diabetes med Farxiga nail trial after trial in highly coveted kidney and heart failure indications, with the FDA expediting reviews to back them up. The one thing AstraZeneca was missing? The agency taking Farxiga across the finish line. Full Article
x 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
x 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
x 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
x 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
x Factbox: Latest on the worldwide spread of the coronavirus By feeds.reuters.com Published On :: Sat, 09 May 2020 09:28:30 -0400 More than 3.95 million people have been reported to be infected by the novel coronavirus globally and 273,805 have died, according to a Reuters tally, as of 0214 GMT on Saturday. Full Article healthNews
x Puerto Rico Senator Jorge De Castro Font Pleads Guilty to Honest Services Wire Fraud and Conspiracy to Commit Extortion By www.justice.gov Published On :: Wed, 21 Jan 2009 14:18:53 EST 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. Full Article OPA Press Releases
x LAN Cargo S.A., Aerolinhas Brasileiras S.A. and EL AL Israel Airlines Ltd. Agree to Plead Guilty for Fixing Prices on Air Cargo Shipments By www.justice.gov Published On :: Thu, 22 Jan 2009 11:57:56 EST Three air cargo carriers, LAN Cargo S.A. (LAN Cargo), Aerolinhas Brasileiras S.A. (ABSA), and EL AL Israel Airlines Ltd. (EL AL), have each agreed to plead guilty and pay criminal fines totaling $124.7 million for their roles in a conspiracy to fix prices in the air cargo industry. Full Article OPA Press Releases
x 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
x Defendant Pleads Guilty to Conspiring to Export Military Aircraft Parts to Iran By www.justice.gov Published On :: Mon, 26 Jan 2009 12:23:03 EST Hassan Saied Keshari and his corporation, Kesh Air International, pleaded guilty this morning in the Southern District of Florida to charges of conspiring to illegally export military and commercial aircraft parts to Iran. Full Article OPA Press Releases
x Former NFL Player, Ex-Casino Owner and Nevada Businessman Indicted in Massive Tax Fraud Scheme By www.justice.gov Published On :: Thu, 29 Jan 2009 11:46:41 EST A Las Vegas federal grand jury has returned an indictment charging Alan Rodrigues, a former pit boss and casino owner from Henderson, Nev.; Weston Coolidge, a businessman from Las Vegas; and Joseph Prokop, a former National Football League punter from Upland, Calif., with a tax fraud scheme for their promotion of a fraudulent tax product through the now defunct National Audit Defense Network (NADN). Full Article OPA Press Releases
x Justice Department Sues Ypsilanti, Mich., Landlords for Sexual Harassment By www.justice.gov Published On :: Thu, 29 Jan 2009 13:22:37 EST The Department today filed suit against Ronald D. Peterson and Glen E. Johnson, the owner and rental manager, respectively, of 11 single family homes in Ypsilanti, Mich., alleging a pattern or practice of sexual harassment of female tenants. Full Article OPA Press Releases
x Former Shipping Executive Sentenced to 48 Months in Jail for His Role in Antitrust Conspiracy By www.justice.gov Published On :: Fri, 30 Jan 2009 12:39:34 EST 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. Full Article OPA Press Releases
x Former Mendenhall, Miss., Police Chief Pleads Guilty to Using Excessive Force By www.justice.gov Published On :: Fri, 30 Jan 2009 18:46:12 EST Jimmy Jimbo Sullivan, the former chief of police in Mendenhall, Miss., pleaded guilty today to a felony civil rights violation, admitting that he used excessive force when he repeatedly stomped on the head of an arrestee. Full Article OPA Press Releases
x Brothers Plead Guilty to Conspiring to Steal Military Optics from U.S. Marine Corps and Export Them Overseas By www.justice.gov Published On :: Mon, 2 Feb 2009 15:00:33 EST Timothy Oldani, 24, of Scott Depot, W.Va., and Joseph Oldani, 21, of Camp Lejeune, N.C., both pleaded guilty today in the Southern District of West Virginia to conspiring to steal military optics from the U.S. Marine Corps and illegally export them from the United States. Full Article OPA Press Releases
x Federal Court Bars Maine Resident from Preparing Tax Returns for Others By www.justice.gov Published On :: Tue, 3 Feb 2009 16:51:43 EST A federal court in Maine has permanently barred Robert A. Grover from preparing federal tax returns for others. The court also ordered the Maine resident to provide his customer lists to the government and to mail copies of the complaint and court order to his customers. Grover consented to the civil injunction order. Full Article OPA Press Releases