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(Reuters) -A slide in bank and energy stocks hit European shares on Friday, with a hawkish policy outlook from the U.S. Federal Reserve also casting a dampener on the STOXX 600’s fifth straight weekly gain. [.N]Insurers, telecom stocks and energy stocks lost between 0.8% and 1.2%, while industrials and real estate stocks were among the biggest gainers. By 0824 GMT, the pan-European STOXX 600 index was down 0.2%. Germany’s DAX index fell 0.3% as data showed a bigger-than-expected jump in May producer prices. The European mining index slipped 0.1%, bringing its weekly decline to more than 5% due to lower metal prices.
Persons: , Andrea Cicione, “ We’ve, Germany’s DAX, Niemann Organizations: Reuters, U.S . Federal Reserve, REUTERS, Staff, Lombard, European Central Bank, Fed, Orphazyme, U.S . Food, Drug Administration, Tesco, Britain’s Locations: Frankfurt, Germany, Danish, U.S
REUTERS/StaffThe pan-European STOXX 600 index ended 1.6% lower in its worst day in five weeks, with bank and energy stocks leading declines. His comments came after the Fed signalled a hawkish tilt earlier this week, which had rattled risk-driven markets. Commodity markets were also hit by the Fed, with European energy stocks falling 2.9% on Friday, in line with lower oil prices. The sector had its worst week since the peak of the COVID-19 pandemic in March 2020. Bank of Ireland tumbled 7% to the bottom of the STOXX 600, after it announced the sale of some non-performing mortgage exposures.
Persons: speedier, James Bullard, , Andrea Cicione, “ We’ve, DAX, Niemann Organizations: Reuters, Federal Reserve, REUTERS, Staff, European Union, AstraZeneca, Fed, Lombard, Bank of Ireland, Orphazyme, U.S . Food, Drug Administration, Tesco, Britain’s Locations: Frankfurt, Germany, United, U.S
(For a Reuters live blog on U.S., UK and European stock markets, click LIVE/ or type LIVE/ in a news window)June 18 (Reuters) - Mining stocks weighed on European shares on Friday, tracking a slide in commodity prices as a hawkish policy outlook from the U.S. Federal Reserve cast a dampener on the fifth straight week of gains for the STOXX 600. The mining index slipped 0.1%, bringing total weekly declines to more than 5%. The pan-European STOXX 600 was flat by 0708 GMT. The benchmark STOXX 600 recently scaled record highs on assurances from the European Central Bank that it would keep monetary policy loose, but unexpected signals from the Fed around tapering its massive stimulus have dented demand for risky equities. European insurers, banks and energy stocks were also among the biggest decliners in early trading.
Persons: Niemann, Sagarika, Shounak Dasgupta Organizations: Mining, U.S . Federal, European Central Bank, Orphazyme, U.S . Food, Drug Administration Locations: Danish, U.S, Bengaluru
Orphazyme fails to win U.S. backing for arimoclomol drug
  + stars: | 2021-06-18 | by ( ) www.reuters.com sentiment -1.00   time to read: +1 min
June 18 (Reuters) - Danish pharmaceutical company Orphazyme (ORPHA.CO) has failed to win support from the U.S. Food and Drug Administration (FDA) for its arimoclomol drug, a treatment designed for the Niemann-Pick disease type C genetic disorder, the company said on Friday. Following the FDA's review, Orphazyme predicted its revenue for the year will be lower than previously expected and the operating loss significantly wider, forcing the company to cut costs. Orphazyme said the FDA in a letter had said additional qualitative and quantitative evidence was needed for the drug's effectiveness. Orphazyme, which is dually listed in Copenhagen and New York, now expects an operating loss of 670 million crowns to 700 million crowns ($107 million-$112 million) in 2021, against a previous forecast for a loss of 100 million-150 million crowns. ($1 = 6.2456 Danish crowns)Reporting by Boleslaw Lasocki in Gdansk, Editing by Sherry Jacob-PhillipsOur Standards: The Thomson Reuters Trust Principles.
Persons: Niemann, Orphazyme, Bo Jesper Hansen, Boleslaw Lasocki, Sherry Jacob, Phillips Organizations: U.S . Food, Drug Administration, FDA, Thomson Locations: Danish, U.S, Copenhagen, New York, Europe, Gdansk
Danish 'meme stock' Orphazyme plunges after drug setback
  + stars: | 2021-06-18 | by ( Stine Jacobsen | ) www.reuters.com sentiment -1.00   time to read: +2 min
Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File PhotoJune 18 (Reuters) - Orphazyme (ORPHA.CO) slashed its financial forecasts on Friday after U.S. health regulators rejected its key drug candidate, sending shares in Denmark's first so-called meme stock tumbling 75% in early trading. Orphazyme said its application for FDA approval of arimoclomol, a treatment for genetic disorder Niemann-Pick disease type C, had not been successful. As a result, it predicted revenue for the year would be lower than previously expected and its operating loss significantly wider, forcing the company to cut costs. Orphazyme, which is listed in Copenhagen and New York, now expects an operating loss of 670-700 million crowns ($107-$112 million) in 2021, against a previous forecast for a loss of 100-150 million crowns.
Persons: Andrew Kelly, Orphazyme, Niemann, Nordnet, Bo Jesper Hansen, Boleslaw Lasocki, Sherry Jacob, Phillips Organizations: Food and Drug Administration, FDA, REUTERS, U.S . Food, Investors, Thomson Locations: White Oak , Maryland, U.S, Denmark's, Copenhagen, New York, Europe, Gdansk
"I don't feel that we have evidence now that there's a clinical benefit from reducing amyloid," said Dr. Henry Paulson, a neurologist who leads the University of Michigan's Alzheimer’s Disease Center. Large clinical trials of Aduhelm, known chemically as aducanumab, produced contradictory data, with one trial failing and another showing benefit. Nevertheless, the FDA approved Aduhelm under its "accelerated approval" program with the understanding that Biogen would conduct a post-marking study to demonstrate patient benefit. FDA officials said other Alzheimer's drugs will not automatically be eligible for that program. "We can't say right now whether this will be a path for other Alzheimer's drugs, or drugs for other neurodegenerative diseases," Dr. Patrizia Cavazzoni, director of the FDA's Center for Drug Evaluation and Research, told Reuters.
Persons: Brian Snyder, Biogen’s, Eli Lilly, Co's, donanemab, Roche, Eisai, Biogen's, Aduhelm, Henry Paulson, Patrizia Cavazzoni, Caleb Alexander, Biogen, Raymond James, Chris Meekins, Japan's Eisai, , , David Knopman, Deena Beasley, Julie Steenhuysen, Peter Henderson, Bill Berkrot Organizations: REUTERS, Inc, U.S . Food, Drug Administration, FDA, University of Michigan's, Disease, Aduhelm, Eisai, FDA's Center, Drug, Reuters, Johns, Mayo Clinic, Thomson Locations: Boston, Cambridge , Massachusetts, U.S, Rochester, Los Angeles, Chicago
CureVac’s pain may not yet have peaked
  + stars: | 2021-06-17 | by ( Aimee Donnellan | ) www.reuters.com + 0.00   time to read: +3 min
LONDON, June 17 (Reuters Breakingviews) - CureVac’s (5CV.DE) vaccine agony may have further to run. That’s a major blow, but the bigger concern for investors is if CureVac’s so-called “messenger RNA” technology behind its cancer and rabies vaccines has flaws. CureVac’s decision not to use a chemical called uridine to boost the mRNA’s duration in the body may explain its less effective vaccine. If so, and if CureVac’s cancer vaccine trials are more positive, then Jefferies analysts reckon the company’s shares could rebound from $49 to $80. Less positively, Haas has suggested that CureVac’s vaccine may have underperformed because its tests have been on more infectious recent Covid-19 variants.
Persons: Covid, aren’t, Franz, Werner Haas, Jefferies, Haas, CureVac, George Hay, Oliver Taslic Organizations: CureVac, LONDON, Reuters, company’s, BioNTech, Pfizer, Moderna, America’s Food, Drug Administration, Health, U.S . Food, World Health Organization, CureVac’s Locations: Brussels, Belgium, company’s Frankfurt, U.S, Europe, Latin America, CureVac’s Frankfurt
Live Covid Live Updates: Ahead of Olympics, Tokyo’s State of Emergency to Be Relaxed Japan’s latest outbreak is receding and vaccinations are slowly picking up, but health experts warn that the government must remain vigilant. Tokyo has been under a state of emergency since late April, the third since the start of the pandemic. Credit Credit... Jeremy Woodhouse/Getty ImagesThe U.S. will spend $3 billion on developing antiviral pills to treat Covid-19. Contrary to some social media posts, his condition was not because he had received a coronavirus vaccine. Mr. Cummings said Mr. Raab did a far better job than Mr. Johnson in leading the government’s response to the pandemic.
Persons: Charly Triballeau, Yoshihide Suga, Shigeru Omi, , John Coates, Mahal, Money Sharma, Taj, Shah Jahan, Mumtaz Mahal, Taj Mahal, , Vasant Kumar Swarnkar, ” Kamlesh Tiwari, Mumtaz, Jeremy Woodhouse, Anthony Fauci, Emilio Parra Doiztua, ” Jean Castex, Monika Pronczuk, Isabella Kwai, Christian Eriksen, Martin Meissner, Eriksen, Piero Volpi, Volpi, Mr, Fabrice Muamba, Muamba, Eriksen “, Linda Qiu, Amr Alfiky, Bill de Blasio, de Blasio, Andrew M, Cuomo, Andrew Ward, You’ve, Springsteen, haven’t, “ Springsteen, Walter Kerr, Eduardo Munoz, Bruce Springsteen, Johnson, Truth, James, Bruce, I’ve, Springsteen’s, Boris, Dominic Cummings, Boris Johnson, Facundo Arrizabalaga, Johnson’s, Cummings, Matt Hancock, Hancock, Dominic Raab, Raab, Marcel Kuttab, Katherine Taylor, Parosmia, parosmia Organizations: Agence France, Olympic, New York Times, International Olympic Committee, Survey, Credit, Getty, Department of Health, Human Services, Pandemics, Trump, National Institute of Allergy, World Health Organization, Emory University, The New York, European Union, European, European Commission, European Medicines Agency, Italian, Inter Milan, Finland, Inter, Gazzetta Dello Sport, Pfizer, Twitter, Radio Sportiva, Inter Milan’s, Gazetta, Serie, Bolton Wanderers, Tottenham Hotspur, Sky Sports, American College of Cardiology, New England, of Medicine, Disease Control, Residents, New York Times New, Gov, Williams, Broadway, Walter, Walter Kerr Theatre, Reuters, U.S . Food, Drug Administration, Moderna’s, BioNTech’s, AstraZeneca, Toronto Star, James Theater, The New York Times, Facebook Locations: Tokyo’s State, South Asia, U.S, Tokyo’s, Tokyo, Japan, Okinawa, India, Agra, Mahal, Mumbai, Delhi, Uttar Pradesh, Pakistan, ., Europe, Madrid, Spain, Greece, lockdowns, France, United States, Britain, Republic of Ireland, Moscow, European Union, Australia, South Korea, Albania, Lebanon, North Macedonia, Serbia, Germany, Denmark, Finland, Danish, Inter Milan, Copenhagen, English, New York City, Lucerne, New York Times New York City, Manhattan, Brownsville , Brooklyn, New York, Canada, U.S.A, York’s St, New York State, British, Shutterstock
An antibody treatment developed by Regeneron Pharmaceuticals Inc. REGN -0.24% has been shown to significantly cut the risk of death among certain hospitalized Covid-19 patients, raising hopes for a valuable new tool for tackling severe cases. Antibody therapies for Covid-19 target the spike protein on the surface of the virus with the aim of preventing it from entering cells. Earlier trials of other antibody therapies in hospitalized patients were stopped because the treatments appeared to be ineffective in these severe cases. Regeneron said it would seek emergency-use authorization from the FDA for REGEN-COV among hospitalized patients. In clinical trials, the drug reduced the risk of hospitalization or death by 70% in people with mild to moderate symptoms.
Persons: Covid, , Martin Landray, George Yancopoulos, , Regeneron, Denise Roland, Denise.Roland Organizations: Regeneron Pharmaceuticals Inc, University of Oxford, Covid, U.S . Food, Drug Administration, AstraZeneca PLC, FDA, U.S, Health Locations: U.S
The first administration of the drug, Aduhelm, outside of a clinical trial is scheduled to take place in Providence, Rhode Island, at Butler Hospital's Memory and Aging Program. "Hopefully clinicians will follow the clinical trial guidelines, because we really don't have any evidence for more advanced patients with Alzheimer's," Salloway said. The vast majority of patients will be covered by the federal Medicare health program. Still, given that this is the first approved drug that might slow the lethal, memory-robbing condition, hospitals are gearing up. "All the major centers that have an interest in Alzheimer's disease are taking this seriously," Salloway said.
Persons: Brian Snyder, Butler, Stephen Salloway, Aduhelm, Salloway, David Knopman, Mayo, Biogen, Steve Miller, Cigna, Robert Egge, Butler Hospital's, ICER, Oppenheimer, Jay Olson, Deena Beasley, Peter Henderson, Bill Berkrot Organizations: REUTERS, Biogen Inc, Medicare, Brown University Medical, Reuters, Butler, U.S . Food, Drug Administration, Mayo Clinic, FDA, Cigna Corp, Eisai, Alzheimer's Association, U.S . Centers, Medicaid Services, Clinical, Economic, Thomson Locations: Cambridge , Massachusetts, U.S, Providence , Rhode Island, Rochester , Minnesota, United States, Los Angeles
Novartis prostate cancer drug receives U.S. FDA breakthrough designation
  + stars: | 2021-06-16 | by ( ) www.reuters.com sentiment -0.99   time to read: +2 min
The company's logo is seen at the new cell and gene therapy factory of Swiss drugmaker Novartis in Stein, Switzerland, November 28, 2019. REUTERS/Arnd Wiegmann/File PhotoZURICH, June 16 (Reuters) - Swiss drugmaker Novartis AG (NOVN.S) has received breakthrough therapy designation from the U.S. Food and Drug Administration for an experimental treatment for advanced castration-resistant prostate cancer, the company said on Wednesday. Novartis, which acquired the therapy with its $2.1 billion purchase of Endocyte three years ago, has a growing portfolio of radioligand medicines that includes already approved cancer therapy Lutathera. Prostate cancer can often be treated via surgery, radiation therapy or through hormone therapy that stops production of tumour-driving testosterone. Metastatic castration-resistant prostate cancer, however, has failed to respond to such hormone treatment, making it difficult to treat - and a potentially lucrative market.
Persons: Arnd, Lu, Brenna Hughes, Mark Heinrich Our Organizations: Novartis, REUTERS, Novartis AG, U.S . Food, Drug Administration, FDA, Thomson Locations: Swiss, Stein, Switzerland, ZURICH, U.S
Novartis prostate cancer drug receives FDA breakthrough designation
  + stars: | 2021-06-16 | by ( ) www.cnbc.com sentiment -0.99   time to read: +1 min
Swiss drugmaker Novartis has received breakthrough therapy designation from the U.S. Food and Drug Administration for an experimental treatment for advanced castration-resistant prostate cancer, the company said on Wednesday. The therapy attaches a radioactive isotope, lutetium-177, with a half-life of less than seven days, to a small molecule drug, PSMA-617, that binds to an antigen expressed in large amounts by prostate cancer cells. Novartis, which acquired the therapy with its $2.1 billion purchase of Endocyte three years ago, has a growing portfolio of radioligand medicines that includes already approved cancer therapy Lutathera. Prostate cancer can often be treated via surgery, radiation therapy or through hormone therapy that stops production of tumor-driving testosterone. Metastatic castration-resistant prostate cancer, however, has failed to respond to such hormone treatment, making it difficult to treat - and a potentially lucrative market.
Persons: Lu Organizations: Novartis, Research, U.S . Food, Drug Administration, FDA Locations: Cambridge , Massachusetts, Swiss, U.S
CureVac fails in pivotal COVID-19 vaccine trial with 47% efficacy
  + stars: | 2021-06-16 | by ( Ludwig Burger | ) www.reuters.com + 0.00   time to read: +5 min
As CureVac's only major supply deals, the European Union in November secured up to 405 million doses of the vaccine, of which 180 million are optional. That was followed by a memorandum of understanding with Germany for another 20 million doses. Out of the reported COVID-19 cases in the trial, 124 were sequenced to identify the variant causing the infection, it said. As we are continuing toward the final analysis with a minimum of 80 additional cases, the overall vaccine efficacy may change," said Chief Executive Franz-Werner Haas. read more"We aim for availability of a second-generation COVID-19 vaccine as early as the second half of 2022, subject to regulatory approvals," he said.
Persons: Kai Pfaffenbach, Johnson, Franz, Werner Haas, Amesh Adalja, that's, Peter Hotez, CureVac, Dietmar Hopp, Ludwig Burger, Chris Reese Organizations: REUTERS, CureVac, European Union, AstraZeneca, Johns Hopkins Center for Health Security, National, Tropical Medicine, Baylor College of Medicine, Pfizer, U.S . Food, Drug Administration, World Health Organization, Moderna, Gates Foundation, GlaxoSmithKline, Celonic, Switzerland, Novartis, Bayer, GSK, Thomson Locations: Tuebingen, Germany, Europe, Latin America, Wuhan, U.S, Fareva, Wacker, WCHG.DE
Japanese shares track Nasdaq higher, drug makers shine
  + stars: | 2021-06-15 | by ( Reuters Staff | ) www.reuters.com sentiment -0.94   time to read: +2 min
TOKYO, June 15 (Reuters) - Japanese shares closed higher on Tuesday, buoyed by technology and growth-oriented stocks following a strong finish on the Nasdaq overnight, while drug makers extended their gains. “Today’s strong market finish is simply a reaction to the gains in the Nasdaq overnight,” said Jun Morita, general manager of the research department at Chibagin Asset Management. Eisai shares have been volatile since the company’s Alzheimer’s drug, developed in partnership with Biogen Inc , got a nod from U.S. regulators last week. The U.S. Food and Drug Administration is facing mounting criticism over the drug approval. Growth stocks led the gains after Nasdaq shares outperformed on Wall Street, with the Topix Growth Index rising 1.09%, compared with 0.53% gains in value shares.
Persons: , , Jun Morita, Eisai, Takeda, Junko Fujita, Hideyuki Sano, Shailesh Kuber, Subhranshu Sahu Organizations: Nasdaq, Nikkei, U.S, U.S . Federal, Chibagin Asset Management, “ Investors, , Tokyo Stock, Eisai, Biogen Inc, U.S . Food, Drug Administration, Takeda Pharmaceutical, Toyota Motor Locations: TOKYO, U.S ., U.S, Japan, Tokyo
Vials with a sticker reading, "COVID-19 / Coronavirus vaccine / Injection only" and a medical syringe are seen in front of a displayed Johnson & Johnson logo in this illustration taken October 31, 2020. All the J&J doses authorized from the plant to date are expected to be exported to other countries, one of the sources said. read moreThe agency said it was still not ready to authorize the Emergent plant to restart making the J&J vaccine. Safety concerns about the J&J vaccine paired with flagging U.S. demand for vaccinations in general have slowed rollout of the one-shot vaccine to a crawl. Just under 10 million out of the 21 million doses produced for the United States sit unused.
Persons: Johnson, Dado Ruvic, J, Amruta Khandekar, Arun Koyyur Organizations: REUTERS, U.S . Food, Drug Administration, Johnson, FDA, U.S, New York Times, Thomson Locations: U.S, Baltimore, United States
U.S. FDA declines to approve Avenue's IV formulation of non-opioid painkiller
  + stars: | 2021-06-14 | by ( Reuters Staff | ) www.reuters.com sentiment -1.00   time to read: +1 min
REUTERS/Andrew Kelly/File Photo(Reuters) -Avenue Therapeutics Inc said on Monday the U.S. Food and Drug Administration (FDA) declined to approve its intravenous formulation of non-opioid painkiller tramadol for a second time, sending its shares tumbling about 38%. The FDA has been pushing drugmakers to develop alternatives to opioid-based painkillers, as the United States grapples with the menace of opioid addiction. The health regulator in October declined to approve the intravenous formulation of the painkiller, stating it was not safe for the intended population. H.C. Wainwright analyst Joseph Pantginis, however, says that IV tramadol could still have a path forward. Tramadol was approved in the United States in 1995 as a non-controlled analgesic, under the trade name of Ultram, to be sold by drugmaker Johnson & Johnson.
Persons: Andrew Kelly, tramadol, Wainwright, Joseph Pantginis, Tramadol, drugmaker Johnson, Johnson Organizations: Food and Drug Administration, FDA, REUTERS, Therapeutics Inc, U.S . Food, Drug Administration Locations: White Oak , Maryland, U.S, United States
U.S. FDA declines to approve Avenue's IV formulation of painkiller
  + stars: | 2021-06-14 | by ( Reuters Staff | ) www.reuters.com sentiment -1.00   time to read: +1 min
FILE PHOTO: Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. The health regulator in October declined to approve the intravenous formulation of the painkiller, stating it was not safe for the intended population. The agency said on Monday the delayed and unpredictable onset of analgesia - relief from pain - with intravenous (IV) tramadol did not support its benefit as a monotherapy to treat patients with acute pain. H.C. Wainwright analyst Joseph Pantginis, however, says that IV tramadol could still have a path forward. Tramadol was approved in the United States in 1995 as a non-controlled analgesic, under the trade name of Ultram, to be sold by drugmaker Johnson & Johnson.
Persons: Andrew Kelly, tramadol, Wainwright, Joseph Pantginis, Tramadol, drugmaker Johnson, Johnson Organizations: Food and Drug Administration, FDA, REUTERS, Therapeutics Inc, U.S . Food, Drug Administration Locations: White Oak , Maryland, U.S, United States
Novavax Covid-19 Vaccine Is 90% Effective in Key Study
  + stars: | 2021-06-14 | by ( Peter Loftus | ) www.wsj.com + 0.00   time to read: +10 min
Despite the study results, Novavax said it needs much of that time to ensure that its manufacturing processes meet regulatory standards. Novavax started its late-stage, or Phase 3, trial of the Covid-19 vaccine in late December. Novavax said that the vaccine was 93.2% effective combined against the variants of concern and variants of interest in the study. One challenge conducting the study, Novavax said, was the availability of authorized vaccines. In all, about 5,000 people dropped out of the study, Novavax said, meaning the Covid-19 cases that were used to determine efficacy occurred among the remaining 25,000 study subjects, Dr. Glenn said.
Persons: Novavax, , Gregory Glenn, T.J, Kirkpatrick, Stanley Erck, Erck, Biden, Johnson, wasn’t, Glenn, Peter Loftus Organizations: Novavax Inc, Wall, Health, U.S . Food, Drug Administration, Pfizer Inc, Moderna Inc, Pfizer, BioNTech, Moderna, FDA, D.C, GlaxoSmithKline, Johnson, AstraZeneca, National Institutes of Health, peter.loftus Locations: U.S, Mexico, Gaithersburg, Md, China, Covid, Washington, Chile, Brazil, India
Indian shares end higher as Reliance gains; inflation data in focus
  + stars: | 2021-06-14 | by ( Reuters Staff | ) www.reuters.com sentiment -1.00   time to read: +2 min
REUTERS/Francis Mascarenhas/File PhotoBENGALURU (Reuters) - Indian shares closed higher on Monday, boosted by conglomerate Reliance Industries Ltd and software major Infosys Ltd, while investors eyed more inflation data due later in the day. The blue-chip NSE Nifty 50 index ended 0.08% higher at 15,811.85, while the benchmark S&P BSE Sensex rose 0.15% to 52,551.53 at close. In Mumbai trading, Reliance Industries and Infosys were among the top performers on the Nifty 50, gaining 1.4% and 0.9%, respectively. Reliance shares have gained in five of the last eight sessions. Limiting gains was top Nifty 50 loser Adani Ports and Special Economic Zone Ltd, which slumped 8.5%.
Persons: Francis Mascarenhas, Lupin Organizations: REUTERS, Reliance Industries Ltd, Infosys Ltd, BSE, Reliance Industries, Infosys, Reliance, Economic, Ltd, National Securities Depository Ltd, Economic Times, Adani Enterprises, U.S . Food, Drug Administration, U.S Locations: Mumbai, India, BENGALURU, U.S, New Jersey, U.S . Federal
Judge tosses Houston hospital workers' lawsuit over vaccine requirement
  + stars: | 2021-06-13 | by ( Karen Freifeld | ) www.reuters.com sentiment -0.99   time to read: +2 min
An ambulance arrives at the Houston Methodist Hospital emergency room amid a coronavirus disease (COVID-19) outbreak in Houston, Texas, U.S., June 28, 2020. REUTERS/Callaghan O'Hare/File PhotoA U.S. federal judge has dismissed a lawsuit brought by 117 workers at a Texas hospital over its requirement that they be vaccinated against COVID-19. U.S. District Judge Lynn Hughes upheld Houston Methodist Hospital's policy mandating employees be vaccinated, in a ruling issued on Saturday. "Bridges can freely choose to accept or refuse a Covid-19 vaccine; however, if she refuses, she will simply need to work somewhere else." In a statement, Houston Methodist called the lawsuit frivolous and said it was pleased with the judge's decision.
Persons: Callaghan O'Hare, Lynn Hughes, Jennifer Bridges, Hughes, Jared Woodfill Organizations: Houston Methodist Hospital, REUTERS, COVID, U.S, District, Houston Methodist, U.S . Food, Drug Administration, The, Thomson Locations: Houston , Texas, U.S, Texas, United States, The U.S
S.Africa to analyse J&J vaccines made at U.S. plant halted over error
  + stars: | 2021-06-12 | by ( ) www.reuters.com sentiment -1.00   time to read: +2 min
Vials with a sticker reading, "COVID-19 / Coronavirus vaccine / Injection only" and a medical syringe are seen in front of a displayed Johnson & Johnson logo in this illustration taken October 31, 2020. REUTERS/Dado Ruvic//File PhotoSouth African health inspectors will carry out further checks on a batch of Johnson & Johnson (JNJ.N) COVID-19 vaccines following a contamination error earlier this year at the U.S. plant where the doses were produced, the health ministry said. "There is now a real possibility that they may not be, however this is for the regulator to rule on," a ministry statement said. read moreManufacturing at the Baltimore plant owned by Emergent Biosolutions Inc (EBS.N) was halted in April after the discovery that ingredients from AstraZeneca's (AZN.L) COVID-19 vaccine, also being produced at the plant at the time, had contaminated a batch of J&J's vaccine. read moreAn inspection by the FDA also turned up a long list of sanitary problems and bad manufacturing practices at the Emergent plant.
Persons: Johnson, Dado Ruvic Organizations: REUTERS, Johnson, U.S . Food, Drug Administration, FDA, Emergent Biosolutions Inc, Thomson Locations: U.S, South Africa, Baltimore
Wall Street flat with Fed meet in focus
  + stars: | 2021-06-11 | by ( Devik Jain Ambar Warrick | Devik Jain | Ambar Warrick | ) www.reuters.com + 0.00   time to read: +3 min
The Wall St. sign is seen near the New York Stock Exchange (NYSE) in New York City, U.S., May 4, 2021. The S&P 500 (.SPX)traded just below a record high of 4,249.74, with heavyweight technology stocks serving as the largest boost. Sectors such as financials and basic resources, that stand to benefit from an economic bounceback this year, also supported the index. Investors scaled back expectations for early policy tightening by the Fed after May's consumer price data suggested a recent spike in inflation would be transitory. The S&P industrials (.SPLRCI) sector was flat on Friday, and was set to lose for the week.
Persons: Brendan McDermid, Hogan, Peter Cardillo, Cardillo, Dow Jones, Joe Biden's, Stocks Organizations: New York Stock Exchange, REUTERS, Reserve, National Securities, Fed, Spartan Capital Securities, Dow Jones, Nasdaq, U.S . Food, Biogen Inc, Dow, Cruise, Royal Caribbean Group, NYSE, Thomson Locations: New York City, U.S, New York
In addition, the FDA approval ignored the recommendation of its outside advisors, who said Biogen did not provide enough evidence of clinical benefit. Three of the advisory panel's members have resigned in protest since the FDA decision was announced on Monday read more . Karlawish ran one of the trial sites for the Biogen drug. The FDA approval allows Biogen to sell its product over several years - with forecasts for potential annual sales reaching as high $10 billion to $50 billion - until the company completes a required follow-up study. FDA officials said other Alzheimer's drug developers cannot assume their therapies will be considered under the same framework.
Persons: Brian Snyder, Biogen, Jason Karlawish, Karlawish, Johns, Caleb Alexander, Alzheimer's, Alfred Sandrock, Sandrock, Peter Stein, Aduhelm, Eli Lilly, drugmakers, Patrizia Cavazzoni, Jim Shehan, Lowenstein Sandler, UsAgainstAlzheimer's Organizations: REUTERS, U.S . Food, Drug Administration, FDA, Penn Memory Center, Alzheimer's Association, New Drugs, Reuters, Roche Holding, FDA's Center, Drug, Institute for Clinical, Economic, Thomson Locations: Cambridge , Massachusetts, U.S, Philadelphia
EU won't use J&J COVID shots from time of U.S. contamination issue
  + stars: | 2021-06-11 | by ( ) www.reuters.com sentiment -1.00   time to read: +1 min
Johnson & Johnson coronavirus disease (COVID-19) vaccine is seen at the OSU Wexner Medical Center in Columbus, Ohio, U.S. March 2, 2021. REUTERS/Gaelen Morse/File PhotoEurope's drug regulator said on Friday batches of Johnson & Johnson's (JNJ.N) COVID-19 vaccine made for the region around the time when contamination issues were revealed at a U.S. manufacturing site would, as a precaution, not be used. The production of J&J's vaccine at the site was halted by U.S. authorities and J&J was put in charge of manufacturing at the plant. read moreThe U.S. Food and Drug Administration is close to approving about 10 million doses of the vaccine made at the plant, CNN reported on Friday. read moreThe April error involved ingredients from AstraZeneca's (AZN.L) COVID-19 vaccine, also being produced at the plant, contaminating a batch of J&J's vaccine, developed by its Janssen unit.
Persons: Johnson, Gaelen Morse, J's, J, Janssen Organizations: OSU Wexner Medical, REUTERS, Johnson, European Medicines Agency, Reuters, EMA, Emergent, U.S, U.S . Food, Drug Administration, CNN, European Union, Thomson Locations: Columbus , Ohio, U.S, Europe, Maryland
In addition, the FDA approval ignored the recommendation of its outside advisors, who said Biogen did not provide enough evidence of clinical benefit. Three of the advisory panel’s members have resigned in protest since the FDA decision was announced on Monday. Karlawish ran one of the trial sites for the Biogen drug. The FDA approval allows Biogen to sell its product over several years - with forecasts for potential annual sales reaching as high $10 billion to $50 billion - until the company completes a required follow-up study. FDA officials said other Alzheimer's drug developers cannot assume their therapies will be considered under the same framework.
Persons: Biogen, Jason Karlawish, Karlawish, Johns, Caleb Alexander, Alzheimer's, Alfred Sandrock, Sandrock, Brian Snyder, Peter Stein, Aduhelm, Eli Lilly, drugmakers, Patrizia Cavazzoni, Jim Shehan, Lowenstein Sandler, UsAgainstAlzheimer’s Organizations: U.S . Food, Drug Administration, FDA, Penn Memory Center, Alzheimer's Association, REUTERS, New Drugs, Reuters, Roche Holding, FDA's Center, Drug, Institute for Clinical, Economic, Thomson Locations: U.S, Philadelphia, Cambridge , Massachusetts
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