rt Top Ten most popular articles on Pharmafile.com this week By www.pharmafile.com Published On :: Fri, 01 May 2020 09:27:14 +0000 The search for a COVID-19 treatment has ramped up this week, with two new studies detailing the efficacy of Gilead’s antiviral therapy remdesivir in the treatment of patients hospitalised with coronavirus, while researchers in America have been studying famotidine, the active ingredient in Pepcid, as a potential drug to help alleviate symptoms of the virus. Full Article coronaviurs COVID-19 Gilead Research and Development UK Medical Communications Sales and Marketing Business Services Manufacturing and Production
rt 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
rt 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
rt MHRA launches new pharmacovigilance reporting platform for COVID-19 treatments By www.pharmafile.com Published On :: Tue, 05 May 2020 10:27:13 +0000 A new online reporting site has been launched by the Medicines and Healthcare products Regulatory Agency’s (MHRA) to track potential side-effects arising from the use of any therapies used to treat COVID-19, in a bid to build a knowledge base around safe treatment of the pandemic disease. Full Article coronavirus COVID-19 MHRA pharma Research and Development UK Manufacturing and Production
rt 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
rt 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
rt Black people are four times more likely to die from COVID-19 than white in England and Wales, ONS report shows By www.pharmafile.com Published On :: Thu, 07 May 2020 11:53:35 +0000 A recent report from the Office of National Statistics (ONS) has shown that black people in Britain are four times more likely to die from the COVID-19 coronavirus than white Britons. Full Article coronavirus COVID-19 Business Services
rt 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
rt EMA starts rolling review of Gilead’s COVID-19 hope remdesivir By www.pmlive.com Published On :: Fri, 01 May 2020 13:01:24 +0100 New crop of data suggests drug can speed recovery from COVID-19 Full Article
rt Novartis’ asthma triple heads CHMP’s latest meeting By www.pmlive.com Published On :: Tue, 05 May 2020 12:50:48 +0100 Eight new medicines recommended for approval Full Article
rt US trials of Pfizer/BioNTech coronavirus vaccine start By www.pmlive.com Published On :: Wed, 06 May 2020 12:16:48 +0100 It is hoped that the drug may prevent COVID-19 Full Article
rt Endo, Allergan Nearing Deals to Limit Ohio Litigation Over Opioids - Report By www.thestreet.com Published On :: Tue, 20 Aug 2019 07:23:05 EDT Click to view a price quote on AGN. Full Article
rt 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
rt 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
rt US-Swiss partnership takes aim at rare heart condition By www.thepharmaletter.com Published On :: Mon, 04 May 2020 17:15:00 +0100 A new collaboration targeting rare heart diseases has been formed between California’s BioMarin Pharmaceutical… Full Article BioMarin Pharmaceutical/Biotechnology/Cardio-vascular/Deals/DiNA-001/DiNAQOR/Licensing/Rare diseases/Research/Switzerland/USA
rt 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
rt 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
rt 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
rt 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
rt 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
rt Stockpiling spurs sales at Novo Nordisk in first quarter By www.thepharmaletter.com Published On :: Wed, 06 May 2020 15:14:00 +0100 Pandemic-based stockpiling among people with diabetes helped lift revenues beyond analysts’ expectations… Full Article Biotechnology/Denmark/Diabetes/Financial/Management/Novo Nordisk/Ozempic/Research/Rybelsus/Tresiba/USA/Victoza
rt BRIEF—Merck invests in AI chip start-up SynSense By www.thepharmaletter.com Published On :: Wed, 06 May 2020 16:10:00 +0100 Germany’s science and technology company Merck KGaA today announced its investment in SynSense (formerly… Full Article China/Companies mergers and acquisitions/Digital Pharma/Germany/Merck KGaA/Pharmaceutical/Switzerland/SynSense
rt 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
rt An important option in the fight against antimicrobial resistance By www.thepharmaletter.com Published On :: Wed, 06 May 2020 17:33:00 +0100 Positive Phase III data for Recarbrio (imipenem/cilastatin/relebactam) have been announced by New Jersey,… Full Article Antibiotics and Infectious diseases/Biotechnology/Drug Trial/Merck & Co/Recarbrio/Regulation/Research/US FDA/USA
rt 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
rt FDA backs Retevmo for certain lung and thyroid cancers By www.thepharmaletter.com Published On :: Sat, 09 May 2020 12:27:00 +0100 The US Food and Drug Administration has granted accelerated approval for Retevmo (selpercatinib) capsules… Full Article Biotechnology/Eli Lilly/Focus On/Immuno-oncology/Loxo Oncology/Oncology/Regulation/Retevmo/selpercatinib/US FDA/USA
rt 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
rt 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
rt 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
rt Fresenius Kabi recalls anti-inflammation drug Ketorolac after finding particles in vials By www.fiercepharma.com Published On :: Wed, 06 May 2020 15:25:53 +0000 German drugmaker Fresenius Kabi has made major investments in its U.S. manufacturing operations in recent years with some mixed quality results along the way. Now, one of the drugmaker's products faces a recall for more manufacturing woes. Full Article
rt 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
rt 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
rt Early missteps, transparency questions dog U.S. government's remdesivir rollout: reports By www.fiercepharma.com Published On :: Fri, 08 May 2020 13:50:52 +0000 When Gilead Sciences scored a groundbreaking FDA emergency use authorization for COVID-19 therapy remdesivir, the company made the unusual move of handing distribution rights to the U.S. government. But the federal rollout has gotten off to a rocky start. Full Article
rt 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
rt 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
rt 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
rt Thailand reports four new coronavirus cases, one new death By feeds.reuters.com Published On :: Sat, 09 May 2020 01:23:35 -0400 Thailand reported four new coronavirus cases and one more death on Saturday, bringing the total to 3,004 cases and 56 deaths since the outbreak started in January. Full Article healthNews
rt Singapore reports 753 new coronavirus cases, taking total to 22,460 By feeds.reuters.com Published On :: Sat, 09 May 2020 03:27:35 -0400 Singapore registered 753 new coronavirus infections, its health ministry said on Saturday, taking the city-state's total to 22,460 cases. Full Article healthNews
rt China approves Novartis' multiple sclerosis treatment Mayzent By feeds.reuters.com Published On :: Sat, 09 May 2020 03:29:42 -0400 Chinese regulators have approved Novartis' Mayzent to treat relapsing multiple sclerosis in adults, the Swiss drug maker said in a statement on Saturday. Full Article healthNews
rt Tokyo reports 36 new cases of coronavirus infection on Saturday: TV Asahi By feeds.reuters.com Published On :: Sat, 09 May 2020 05:18:54 -0400 Tokyo reported 36 new cases of coronavirus infections on Saturday, TV Asahi said, three less than a day earlier and the seventh consecutive day that new infections have remained below 100. Full Article healthNews
rt 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
rt Malaysia reports 54 new coronavirus cases and one new death By feeds.reuters.com Published On :: Sat, 09 May 2020 05:37:14 -0400 Malaysia health authorities on Saturday reported 54 new coronavirus cases for a total of 6,589. Full Article healthNews
rt Portugal's low-income households struggle to survive pandemic By feeds.reuters.com Published On :: Sat, 09 May 2020 08:02:25 -0400 One in four Portuguese with a monthly household income of 650 euros ($705) or less have lost all their income because of the economic impact of the coronavirus outbreak, a study by the National School of Public Health showed on Saturday. Full Article healthNews
rt 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
rt 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
rt 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
rt Justice Department Settles Allegations of Disability and Religious Discrimination Against Nashville, Tenn. By www.justice.gov Published On :: Thu, 29 Jan 2009 10:39:59 EST The Department today announced a settlement resolving allegations that the Metropolitan Government of Nashville and Davidson County (Metropolitan Government) violated the Fair Housing Act (FHA) and the Religious Land Use and Institutionalized Persons Act (RLUIPA) by discriminating against Teen Challenge, a Christian substance abuse treatment program. Full Article OPA Press Releases
rt 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
rt Justice Department Files Lawsuit on Behalf of North Dakota Army National Guard Member By www.justice.gov Published On :: Thu, 29 Jan 2009 12:12:55 EST The Department today filed a lawsuit on behalf of Suzanne L. Halverson, an Army National Guard member, against Grand Forks County, N.D., alleging violations of the Uniformed Services Employment and Reemployment Rights Act of 1994 (USERRA), which prohibits employers from discriminating against service-members because of their past, current or future military service obligations. Full Article OPA Press Releases
rt 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