MOSCOW (Reuters) – A small independent Russian teachers’ union is urging members not to be coerced into accepting shots of the “Sputnik V” coronavirus vaccine which is to be mandatory for military personnel. Moscow clinics last week began receiving supplies of... More »
(Reuters) – AstraZeneca Plc said on Monday it has begun enrolling adults for a U.S.-funded, 30,000-subject late-stage study of its high profile COVID-19 vaccine candidate. Trial participants will receive either two doses of the experimental vaccine, dubbed AZD... More »
MOSCOW (Reuters) – Russia has signed deals to supply South Africa and seven Latin American countries with an anti-viral drug Russian authorities have approved to treat COVID-19, its sovereign wealth fund said on Monday. The Russian Direct Investment Fund (RDIF... More »
MOSCOW (Reuters) – A Russian institute developing one of the country’s potential coronavirus vaccines hopes to start its final stage testing in a small section of the general public in mid-August, the RIA news agency cited the institute’s director as saying on... More »
FRANKFURT (Reuters) – German drugmaker Merck said on Wednesday it had agreed to supply its potential COVID-19 drug Rebif to European Union countries should orders be placed for the treatment. The comment followed a Reuters report earlier on Wednesday about a d... More »
(Reuters) – The U.S. Food and Drug Administration on Monday cleared a new version of Abbott Laboratories’ continuous glucose monitoring device, helping the company build upon the success of its fastest-growing diabetes product. FreeStyle Libre 2, which was app... More »
NEW YORK (Reuters) – While some potential vaccines have emerged in the global race to find a way to stop the spread of COVID-19, many scientists and researchers believe antibody based therapies hold great promise for treating people already infected with the d... More »
(Reuters) – The following is a brief roundup of some of the latest scientific studies on the novel coronavirus and efforts to find treatments and vaccines for COVID-19, the illness caused by the virus. Convalescent plasma disappoints in Chinese trial Infusions... More »
ZURICH (Reuters) – Novartis won European approval for its gene therapy Zolgensma for the hereditary disease spinal muscular atrophy (SMA), the Swiss drugmaker said on Tuesday, adding it is in talks over price with countries in hopes of a quick launch. The Euro... More »
NEW YORK (Reuters) – The following is a brief roundup of the latest scientific studies on the novel coronavirus and efforts to find treatments and vaccines for COVID-19, the illness caused by the virus. New coronavirus antibody test highly accurate A new antib... More »
ZURICH (Reuters) – The Swiss government on Friday boosted its powers to order companies to raise production of critical medical supplies like drugs and protective gear should more be needed in the fight against coronavirus-caused COVID-19. “If the supply…canno... More »
BEIJING (Reuters) – A team of Chinese scientists has isolated several antibodies that it says are “extremely effective” at blocking the ability of the new coronavirus to enter cells, which eventually could be helpful in treating or preventing COVID-19. There i... More »
LONDON (Reuters) – A new version of a breathing aid that can help coronavirus patients has been developed in less a week by a team involving Mercedes Formula One, and is being trialed at London hospitals. Continuous Positive Airway Pressure (CPAP) devices have... More »
(Reuters) – Gilead Sciences Inc’s experimental drug remdesivir, seen as one of the more promising potential treatments for the coronavirus, on Monday received the orphan drug designation from the U.S. Food and Drug Administration. The announcement comes days a... More »
(Reuters) – Drugs used for treating arthritis are being tested as treatments for COVID-19, the disease caused by a new coronavirus, as researchers rush to find ways of helping patients and slowing the number of infections. Sanofi and Regeneron Pharmaceuticals ... More »
(Reuters) – An expert panel formed by the U.S. Food and Drug Administration has endorsed asbestos testing standards for cosmetics that reject long-held industry positions and reflect those of public health authorities and experts for thousands of plaintiffs wh... More »
(Reuters) – The U.S. Food and Drug Administration said on Wednesday it approved Merck & Co Inc’s Keytruda for a hard-to-treat form of bladder cancer, making it the first new treatment for the cancer in more than two decades. The therapy was approved for patien... More »
(Reuters) – Japan-based drugmaker Eisai Co’s U.S. subsidiary announced on Sunday that it had received approval from the U.S. Food and Drug Administration for its insomnia treatment in adult patients. The agency approved the drug, Dayvigo, in doses of 5 mg and ... More »
JERUSALEM (Reuters) – Israel’s IceCure Medical said on Sunday it received U.S. regulatory approval to expand the use of its cryoablation technology to treat benign and cancerous tumors in livers and kidneys, sending its share price up 30%. IceCure’s treatment ... More »
(Reuters) – GlaxoSmithKline’s HIV drugs division ViiV Healthcare said on Saturday that the U.S. Food and Drug Administration declined to approve its long acting HIV injection. ViiV, in which Pfizer and Shionogi have small stakes, said it received a so-called c... More »
(Reuters) – Merck & Co (MRK.N) said on Friday it expects to make licensed doses of its recently approved Ebola vaccine available in the third quarter of 2020 and price the single-dose injection at the lowest possible access price for poor and middle-income cou... More »
(Reuters) – The U.S. Food and Drug Administration said on Friday it had approved Daiichi Sankyo Co Ltd and AstraZeneca Plc’s drug to treat an advanced form of breast cancer, three months ahead of schedule. AstraZeneca in March signed a licensing and collaborat... More »
(Reuters) – Shares of Sarepta Therapeutics Inc (SRPT.O) soared 31% on Friday after U.S. regulators shocked Wall Street by approving the company’s treatment for a muscle-wasting disorder less than four months after rejecting the drug over safety concerns. The F... More »
(Reuters) – Independent advisers to the U.S. Food and Drug Administration on Friday voted unanimously in favor of Horizon Therapeutics Plc’s experimental treatment for active thyroid eye disease, taking the drug closer towards potential approval. If approved, ... More »
(Reuters) – U.S. health regulators on Friday approved expanding the heart benefit claims Amarin Corp can make in promoting its drug Vascepa to include reducing the risk of heart attacks and strokes in high-risk patients, opening a multibillion-dollar market op... More »
(Reuters) – Nearly half of lymphoma patients treated with Gilead Sciences Inc’s Yescarta were alive at least three years after a one-time infusion of the CAR-T cell therapy, according to data presented on Saturday. Out of 101 patients teated with Yescarta for ... More »
(Reuters) – Bristol-Myers Squibb Co on Saturday said that an experimental cancer therapy it acquired as part of its $74 billion deal for Celgene Corp produced positive results in a clinical trial. The company said it will apply for U.S. approval for the treatm... More »
(Reuters) – The U.S. Food and Drug Administration on Friday approved Aquestive Therapeutics’ treatment for neurological disorder amyotrophic lateral sclerosis (ALS). Shares of the company, which developed riluzole oral film (ROF) and will market the film under... More »
(The Nov 16 story corrects to clarify in second graph that patients will be infused by a healthcare provider.) By John Miller and Carl O’Donnell (Reuters) – Novartis AG on Friday won U.S. approval for its experimental sickle cell disease drug, Adakveo, making ... More »
(Reuters) – An Oklahoma judge on Friday said Johnson & Johnson must pay that state $465 million for fueling the opioid epidemic through the deceptive marketing of painkillers, down from his original award of $572 million. The decision by Cleveland County Distr... More »
(Reuters) – China-based drugmaker BeiGene Ltd on Friday priced its drug, Brukinsa, to treat a rare form of lymphoma at $12,935 for a 30-day supply. The U.S. Food and Drug Administration on Thursday approved the drug, giving a boost to the company’s strategy of... More »
ZURICH (Reuters) – Roche’s bid to rival Biogen and Novartis in treating spinal muscular atrophy (SMA) got a lift on Monday when the Swiss drugmaker said its drug risdiplam improved motor function of patients in a key study. Roche, which plans to seek approval ... More »
CHICAGO (Reuters) – Tests of lung samples taken from 29 patients with vaping-related injuries suggest all contained Vitamin E acetate, a discovery U.S. officials described on Friday as a “breakthrough” in the investigation of the nationwide outbreak that has t... More »
BEIJING (Reuters) – China has granted conditional approval to its first self-developed treatment for Alzheimer’s disease, a move that may point to revived opportunities in a therapeutic area where drugmakers have burned billions of dollars without yielding a v... More »
NEW YORK (Reuters) – The U.S. Food and Drug Administration on Friday downplayed the risk caused by contamination of the already recalled popular heartburn drug Zantac, and said its tests suggest it does not cause carcinogens to form after ingestion by patients... More »
(Reuters) – U.S. President Donald Trump plans to nominate Dr. Stephen Hahn, chief medical executive of the University of Texas MD Anderson Cancer Center, to lead the Food and Drug Administration, the White House said on Friday. If confirmed, Hahn, a radiation ... More »
(Reuters) – AstraZeneca’s diabetes drug Farxiga has been approved for use in the United States as a treatment to reduce the chances of hospitalisation for heart failure in adults with type-2 diabetes and other cardiovascular risks, the British drugmaker said o... More »
(Reuters) – The U.S. Food and Drug Administration on Friday approved Alexion Pharmaceuticals Inc’s treatment for a second rare blood disorder, the company said. The treatment, Ultomiris, has already been approved in the United States, Japan and the European Un... More »
(Reuters) – Johnson & Johnson said on Friday it is recalling around 33,000 bottles of baby powder in the United States after U.S. health regulators found trace amounts of asbestos in samples taken from a bottle purchased online. J&J shares fell more than 6% to... More »
NEW YORK (Reuters) – The U.S. Food & Drug Administration said on Friday that it found that a sample from one lot of Johnson & Johnson’s baby powder contained chrysotile fibers, a type of asbestos, confirming test results the company disclosed earlier on Friday... More »
DHAKA (Reuters) – Bangladesh’s drug regulatory authority on Sunday issued a ban on sales of popular heartburn drug ranitidine while it investigates a potential cancer-causing substance in the drug. The move comes after the U.S. Food and Drug Administration (FD... More »
(Reuters) – CVS Health Corp said on Saturday it will discontinue sales the popular Zantac heartburn treatment and its own generic ranitidine products from its pharmacies after traces of a known carcinogen were found in some of the products by the U.S. Food and... More »
BARCELONA (Reuters) – GlaxoSmithKline and AstraZeneca both reported trial results that will likely make their competing drugs available to a wider group of ovarian cancer patients, possibly helping GSK catch its rival in a highly contested drug class. The two ... More »
(Reuters) – An experimental Amgen Inc drug that targets a specific genetic mutation shrank tumors in just one of 12 patients with advanced colorectal cancer who were given the highest dose in a small, early-stage trial, the company said on Saturday. The cancer... More »
(Reuters) – A U.S. Food and Drug Administration advisory panel on Friday recommended approving the first therapy for peanut allergies, which affect over 1.6 million children in the United States, despite raising concerns about the risk of severe allergic react... More »
(Reuters) – U.S. and European drug regulators said on Friday they are reviewing the safety of the widely taken heartburn drug ranitidine, commonly known by the brand name Zantac, after they found traces of a probable cancer-causing impurity in some versions of... More »
CHICAGO (Reuters) – U.S. health investigators are casting a wide net to understand what is sickening hundreds of vapers across the country and still have not ruled out any product on the market, even as vaping industry officials highlight the potential role of... More »
(Reuters) – U.S. public health officials are investigating more than 450 cases of severe lung illnesses and have confirmed at least five deaths related to electronic cigarette products including the devices and liquids used inside them. The Centers for Disease... More »
(Reuters) – The U.S. Food and Drug Administration has approved Xeris Pharmaceuticals Inc’s glucagon therapy that aims to treat severely low sugar levels in diabetes patients, the drugmaker said on Tuesday. The condition, called hypoglycemia, can cause acute co... More »
(Reuters) – An unnamed hospital in Oklahoma used contaminated gastroscopes in procedures performed on nearly a thousand patients in recent months, device maker Pentax Medical told U.S. regulators last month, putting the patients at risk of exposure to bacteria... More »
NORMAN, Okla./BOSTON (Reuters) – An Oklahoma judge on Monday ordered Johnson & Johnson (JNJ.N) to pay $572.1 million to the state for its part in fueling an opioid epidemic by deceptively marketing addictive painkillers, a sum that was substantially less than ... More »
(Reuters) – AbbVie Inc has priced its new rheumatoid arthritis treatment at $59,000 a year after gaining U.S. approval on Friday, a big boost for the drugmaker struggling with rising competition for Humira, its blockbuster therapy for the same condition. A fou... More »
(Reuters) – Roche Holding AG has priced its personalized cancer treatment, Rozlytrek, at about $17,050 per month, nearly half of the monthly price of a rival drug from Bayer AG and Eli Lilly and Co that was approved last year. Roche’s drug and Bayer/Lilly’s Vi... More »
(Reuters) – The U.S. Food and Drug Administration on Friday approved Celgene Corp’s Inrebic to treat certain rare forms of bone marrow cancer called myelofibrosis, making it the second approved drug to treat the disease. Inrebic belongs to a class of drugs kno... More »
(Reuters) – A U.S. judge on Friday upheld two patents relating to Amgen Inc’s blockbuster rheumatoid arthritis drug Enbrel, denying a challenge by Novartis AG, which is seeking to launch a copycat version. The decision was a relief to investors concerned about... More »
NEW YORK/FRANKFURT (Reuters) – Bayer AG has not offered to pay billions of dollars to settle claims in the United States related to the Roundup herbicide, mediator Ken Feinberg said, dismissing a report to that effect which drove its shares as much as 11% high... More »
(Reuters) – The U.S. Food and Drug Administration on Friday approved Daiichi Sankyo Co Ltd’s treatment for adult patients with a type of rare, non-cancerous tumor affecting joints and limbs. The label for the treatment, Turalio, includes a boxed warning flaggi... More »
ZURICH (Reuters) – Novartis’s heart failure drug Entresto failed a trial in a new use, the Swiss drugmaker said on Monday, calling into question billions of dollars in potential revenue and taking the shine off one of the company’s biggest growth prospects. Th... More »
WINDSOR, Ontario (Reuters) – U.S. Senator and Democratic presidential hopeful Bernie Sanders joined diabetes patients as they drove across the border on Sunday to buy cheap insulin in Canada, highlighting his argument in favor of federally negotiated prescript... More »
(Reuters) – Oklahoma’s attorney general is expected on Monday to urge a judge to find Johnson & Johnson responsible for flooding the market with painkillers and fueling the U.S. opioid epidemic, as the first trial in nationwide litigation over the drug crisis ... More »
(Reuters) – British drugmaker AstraZeneca Plc said on Monday the U.S. Food and Drug Administration declined to approve its diabetes treatment, Farxiga, for use as a supplement to insulin in adults with a rare-type of the condition. The company said the regulat... More »
(Reuters) – The U.S. drug regulator on Friday approved Palatin Technologies and Amag Pharmaceuticals’ drug to restore sexual desire in premenopausal women, the latest attempt to come up with a therapy that some have dubbed as “female Viagra”. The therapy, Vyle... More »
(Reuters) – Pfizer Inc said on Monday it would buy Array Biopharma Inc for $10.64 billion in cash, a deal it hopes will help make it a leader in colon cancer and build up its pipeline of oncology drugs. The largest U.S. drugmaker agreed to pay a hefty premium ... More »
TEL AVIV (Reuters) – Zebra Medical Vision, an Israel medical imaging analytics company, said on Monday it received its third clearance from the U.S. Food and Drug Administration for its alert for intracranial hemorrhage, based on head CT scans. The latest clea... More »
ZURICH/NEW YORK, (Reuters) – Swiss drugmaker Novartis on Friday won U.S. approval for its gene therapy Zolgensma for spinal muscular atrophy (SMA), the leading genetic cause of death in infants, and priced the one-time treatment at a record $2.125 million. The... More »
NEW YORK (Reuters) – A doctor and a surgical funding consultant were arrested on Friday on charges that they defrauded women into having unnecessary surgeries to remove transvaginal mesh implants in order to profit from settlements paid to the women by mesh ma... More »
NEW YORK (Reuters) – When Malachi Anderson was diagnosed with a rare and often deadly disease called spinal muscular atrophy (SMA) as an infant nearly four years ago, his parents Tina and Torence had a decision to make. In years past, many of the babies born w... More »
(Reuters) – The U.S. Food and Drug Administration warned of risks of serious injury or death from surgical staplers made by Johnson & Johnson’s Ethicon unit, labeling a recent recall of the device as its most serious. The recall, initiated early April by Ethic... More »
(Reuters) – AbbVie Inc said on Friday it has halted enrollment of patients in all ongoing studies testing its brain cancer treatment after the drug failed to meet the main goal in a late-stage trial. The company’s shares fell 1.8 percent to $78.10 before the b... More »
WASHINGTON (Reuters) – U.S. states filed a lawsuit accusing Teva Pharmaceuticals USA Inc of orchestrating a sweeping scheme with 19 other drug companies to inflate drug prices – sometimes by more than 1,000% – and stifle competition for generic drugs, state pr... More »
GOMA, Democratic Republic of Congo/GENEVA (Reuters) – The death toll from an Ebola outbreak in Congo rose above 1,000 on Friday, with attacks on treatment centers continuing to hamper efforts to control the “intense transmission” of the second-worst epidemic o... More »
GOMA, Democratic Republic of Congo (Reuters) – The death toll from the Ebola outbreak in Democratic Republic of Congo rose above 1,000 on Friday, as violent attacks on treatment centres hamper efforts to control the second-worst epidemic of the virus on record... More »
(Reuters) – Novartis AG, which this week announced positive interim trial results for its experimental gene therapy for spinal muscular atrophy, on Friday said investigation is underway into whether a second trial death could be related to the treatment. Novar... More »
(Reuters) – Generic drugmaker Teva Pharmaceutical Industries Ltd on Friday received approval from the U.S. Food and Drug Administration (FDA) to market its generic nasal spray for opioid overdose, the health regulator said. This is the first approval of a gene... More »
(Reuters) – The U.S. Food and Drug Administration declined to approve a drug developed by Sanofi SA and Lexicon Pharmaceuticals Inc intended for use with insulin in patients with type 1 diabetes, the companies said on Friday. The decision comes about two month... More »
(Reuters) – The Trump administration is working on a new payment approach for treating kidney disease that favors lower cost care at home and transplants, a change that would upend a dialysis industry that provides care in thousands of clinics nationwide. The ... More »
(Reuters) – U.S. health regulators said on Friday a third cancer-causing toxin was found in some blood pressure pills recalled by India’s Hetero Labs Ltd a day earlier, adding to a global recall of commonly used drugs to treat hypertension. The U.S. Food and D... More »
(Reuters) – Endo International Plc said on Friday the U.S. health regulator has decided not to include blood pressure treatment vasopressin in its list of drugs that can be used in compounding, in a boost to the drugmaker that makes the only FDA-approved versi... More »
CHICAGO (Reuters) – Johnson & Johnson said on Thursday it will start adding the price of its medicines to television commercials by next month, becoming the first drugmaker to heed a call by U.S. President Donald Trump for price transparency of drugs advertise... More »
(Reuters) – The U.S. Food and Drug Administration said on Thursday it was taking action against certain retailers including Walgreen Boots Alliance for repeatedly flouting tobacco sale rules, including sale of cigars and menthol cigarettes to minors. Walgreens... More »
(Reuters) – The U.S. Food and Drug Administration (FDA) plans to meet top-level executives of e-cigarette makers, the agency’s chief said on Thursday, hinting that some companies seem to be backing away from commitments related to youth’s access to e-cigarette... More »
(Reuters) – Merck KGaA and Pfizer Inc said on Friday they were ending a late-stage study for their drug to treat a form of ovarian cancer in previously untreated patients. The results showed the drug, Bavencio, in combination with, or as a follow-on treatment ... More »
(Reuters) – The U.S. Food and Drug Administration on Friday approved Stemline Therapeutics Inc’s Elzonris for the treatment of a rare blood disease in adults and children aged two years and above. This is the first approved treatment for the condition, blastic... More »
(Reuters) – The U.S. Food and Drug Administration approved on Friday Alexion Pharmaceuticals Inc’s rare blood disorder drug Ultomiris, an early backing that also solidifies the company’s dominant market position. The company’s flagship drug, Soliris, was the l... More »
OSLO (Reuters) – Norway’s Ultimovacs plans to raise around 700 million Norwegian crowns ($82 million) in an initial public offering in early 2019 to help fund the development of its immunotherapy cancer drug. “Our main investors are positive and will take a si... More »
(Reuters) – Netherlands-based biopharmaceutical company argenx SE said it signed a deal with Cilag GmbH International, an affiliate of Johnson & Johnson’s Janssen Pharmaceutical Companies unit, to develop its Cusatuzumab drug in certain types of cancer. The de... More »
NEW YORK (Reuters) – Bayer AG disputed accusations in a new Netflix documentary that claims medical device makers and the U.S. Food and Drug Administration placed profits before patient safety. The company, in a statement released Thursday night, said the docu... More »
(Reuters) – U.S. Food and Drug Administration staff reviewers have raised doubts over the effectiveness of GlaxoSmithKline Plc’s drug Nucala in treating a disease that limits airflow to the lungs. Nucala, already approved for treating severe asthma patients, i... More »
NEW YORK (Reuters) – Life sciences company Bayer AG said on Friday it would discontinue the sale of its birth control product Essure in the United States, citing a decline in sales of the implantable device that made the business no longer sustainable. The dec... More »
(Reuters) – Agios Pharmaceuticals Inc said on Friday the U.S. Food and Drug Administration approved its treatment for a type of leukemia, the first targeted drug for patients with a specific genetic mutation. The company plans to launch the drug, Tibsovo, in t... More »
JERUSALEM (Reuters) – Israeli pharmaceuticals company PainReform has received approval from the U.S. Food and Drug Administration (FDA) to begin late-stage clinical studies for a pain relief drug that is a departure from opiate-based narcotics, it said on Tues... More »
(Reuters) – CTI Biopharma Corp said on Monday its treatment for a type of blood cancer did not meet the main goal of a late-stage trial, sending its shares down 17 percent. The drug, Pixuvri, did not show improvement in the length of time patients survived wit... More »
LONDON (Reuters) – AstraZeneca has won rapid regulatory approval for new uses of two of its important cancer drugs in Japan, less than six months after the first global approvals in Western markets. The decisions by the Japanese Ministry of Health, Labour and ... More »
ZURICH (Reuters) – Swiss drugmaker Roche said on Monday that a trial showed its immunotherapy Tecentriq plus the chemotherapy Abraxane significantly reduced the risk of disease worsening or death in people with metastatic triple negative breast cancer. The com... More »
(Reuters) – The U.S. health regulator approved GW Pharmaceuticals Plc’s epilepsy treatment on Monday, making it the first cannabis-based drug to win approval in the country and opening floodgates for more research into the medicinal properties of cannabis. The... More »
(Reuters) – Pfizer Inc said on Monday a combination of its breast cancer drug, Ibrance, and another drug was not statistically significant in extending overall survival in certain patients, the secondary goal of a late-stage trial. Ibrance is Pfizer’s blockbus... More »
Chicago (Reuters) – Mixed results over the weekend from closely watched studies combining Bristol-Myers Squibb Co’s cancer immunotherapy with Nektar Therapeutics experimental drug NKTR-214, led at least one Wall Street analyst to reassess expectations. Bristol... More »
CHICAGO (Reuters) – In an effort to increase competition and bring down prescription drug prices, FDA Commissioner Dr. Scott Gottlieb wants to speed approval times for rivals to promising new first-to-market medicines. The U.S. Food and Drug Administration chi... More »
CHICAGO (Reuters) – The U.S. Food and Drug Administration is taking steps to streamline the approval process for cancer drugs, reviewing clinical trial data up front to make sure applications companies submit are complete. The new approach, outlined on Saturda... More »
CHICAGO (Reuters) – An experimental cancer drug from Loxo Oncology performed even better in patients with a rare mutation of the RET gene than previously reported, according to updated results from an early stage clinical trial presented on Saturday. Last mont... More »
