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Sanofi formally investigated over epilepsy drug Depakine

PARIS (Reuters) – Healthcare company Sanofi Aventis France said it had been placed under formal investigation on charges of manslaughter over Depakine, which is an epilepsy drug that caused birth malfunctions and slow neurological development when taken during... More »

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Steroid’s COVID-19 benefits confirmed- spotlight on immune cells

(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. Full dexamethasone trial results released The full results... More »

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One in three South Korean COVID-19 patients improve with remdesivir

SEOUL (Reuters) – One in three South Korean patients seriously ill with COVID-19 showed an improvement in their condition after being given Gilead Sciences Inc’s antiviral remdesivir, health authorities said. More research was needed to determine if the improv... More »

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Make a vaccine? I’m trying to teach my kids the alphabet

LONDON/BERLIN/MILAN (Reuters) – It’s tough to do any useful work when you’re stuck at home, struggling to home-school bickering kids, let alone when you’re trying to produce a COVID-19 vaccine. British drugmaker AstraZeneca (AZN.L) had spent years preparing fo... More »

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AstraZeneca COVID-19 vaccine to be shared across Europe, says France

PARIS/BRUSSELS (Reuters) – A deal between AstraZeneca and four European countries for COVID-19 vaccines involves doses being shared by European Union members on a pro rata basis based on population, a source at the French President’s office said on Monday. The... More »

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U.S. FDA clears new version of Abbott’s low-cost glucose monitor

(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 »

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Novartis wins conditional EU approval for gene therapy Zolgensma

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 »

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Bayer more stringent in glyphosate settlement talks due to downturn

FRANKFURT (Reuters) – German drugs and pesticides company Bayer said the economic downturn has prompted it to take a tougher stance in talks to settle claims its glyphosate-based weedkillers cause cancer, even as its earnings rose. The pandemic has significant... More »

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Afghanistan confirms first case of coronavirus from three suspected

KABUL (Reuters) – Afghanistan on Monday identified the country’s first case of coronavirus as reported cases outside China jump. Ferozuddin Feroz, the minister of public health, told a press conference in Kabul one of three suspected cases had been confirmed i... More »

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WHO says new virus may have caused China pneumonia outbreak

LONDON/BEIJING (Reuters) – A cluster of more than 50 pneumonia cases in China’s central city of Wuhan may be due to a newly emerging member of the family of viruses that caused the deadly SARS and MERS outbreaks, World Health Organization (WHO) said on Wednesd... More »

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FDA approves Aquestive’s ALS treatment

(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 »

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BeiGene prices lymphoma drug at $12,935 for a 30-day supply

(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 »

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Canadian ambassador says drug imports would not lower U.S. prices

OTTAWA (Reuters) – Canada does not have a large enough supply of prescription drugs to meet U.S. demand, and importing medicines from Canada would not significantly lower U.S. prices, Ottawa’s acting ambassador told U.S. officials in recent meetings, according... More »

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FDA approves Alexion’s Ultomiris for another rare blood disease

(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 »

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Exclusive: While battling opioid crisis, U.S. government weighed…

NEW YORK (Reuters) – The U.S. Department of Justice examined using fentanyl in lethal injections as it prepared last year to resume executing condemned prisoners, a then untested use of the powerful, addictive opioid that has helped fuel a national crisis of o... More »

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Novartis to answer U.S. Senate demand for data manipulation details

ZURICH (Reuters) – Novartis (NOVN.S) plans to answer a U.S. senator who demanded details about data manipulation related to its gene therapy Zolgensma, amid scrutiny of the Swiss drugmaker’s decision to delay informing regulators until after the treatment’s ap... More »

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AbbVie prices new rheumatoid arthritis drug at $59,000 a year

(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 »

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Trump administration considers September unveiling of healthcare…

WASHINGTON (Reuters) – U.S. President Donald Trump’s administration is considering unveiling, as early as September, his healthcare plan as part of his presidential re-election campaign strategy, the Wall Street Journal reported on Saturday. The plan would lay... More »

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Bernie Sanders visits Canadian pharmacy, talks drug prices

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 »

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VBI’s shares plunge after hep B vaccine fails secondary goal in…

(Reuters) – VBI Vaccines Inc said on Monday a late-stage study was unsuccessful in showing two doses of its hepatitis B vaccine were as effective as three doses of an older vaccine from GlaxoSmithKline, sending its shares plunging 66%. The study tested VBI’s S... More »

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GSK pharma head flags need for speed in high-pressure drug market

LONDON (Reuters) – Doing things one at a time in drug development is not a luxury that GlaxoSmithKline can afford any longer, the head of pharmaceuticals at Britain’s largest drugmaker told Reuters. Luke Miels, who joined GSK in September 2017 after a contract... More »

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Co-owner, ex-employee of pharmacy in U.S. meningitis outbreak…

BOSTON (Reuters) – A federal judge on Friday tossed the convictions of a co-owner and former employee of a Massachusetts compounding pharmacy accused of conspiring to help it evade regulatory oversight before its drugs caused a deadly 2012 fungal meningitis ou... More »

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For Anderson family, an early bet on SMA gene therapy

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 »

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U.S. states accuse Teva, other drugmakers, of price-fixing: lawsuit

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 »

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China draws up tighter rules on human gene and embryo trials: Xinhua

BEIJING (Reuters) – China’s top legislature will consider tougher rules on research involving human genes and embryos, the first such move since a Chinese scientist sparked controversy last year by announcing he had made the world’s first “gene-edited” babies.... More »

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FDA rejects Sanofi-Lexicon add-on pill for type 1 diabetes

(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 »

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New cancer-causing toxin found in recalled blood pressure pills

(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 »

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UniQure gene therapy shows rise in blood-clotting protein levels

(Reuters) – Drug developer UniQure NV said on Friday its gene therapy to treat hemophilia B increased the levels of a protein that helps in blood clotting after 12 weeks in a small study. The company’s shares rose 5.5 percent in light premarket trading. The up... More »

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Gene therapy stocks plunge after poor trial data

(Reuters) – Shares of U.S. gene therapy companies sank on Thursday after drugs developed by two small firms failed to show promise in separate clinical trials, underscoring the challenges in an emerging, lucrative field of biotech. Experimental treatments deve... More »

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New California governor tackles drug prices in first act

(Reuters) – Hours into his new job, California Governor Gavin Newsom signed an executive order on Monday that could dramatically reshape the way prescription drugs are paid for and acquired in the most populous U.S. state. The order, along with another naming ... More »

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GlaxoSmithKline to look for early-stage assets: CEO

(Reuters) – GlaxoSmithKline Plc will actively look to buy early-stage assets and partner with companies, the drugmaker’s chief executive officer said on Tuesday. Britain’s biggest drugmaker is also likely to evaluate licensing deals and would continue to inves... More »

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Alexion wins early U.S. approval for rare blood disorder drug

(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 »

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RedHill Biopharma’s antibiotic succeeds in late-stage study

(Reuters) – Israel-based RedHill Biopharma Ltd said on Monday its combination antibiotic met the main goal of a late-stage study testing the drug in patients with a type of bacterial infection that affects the stomach and small intestine. The drug, Talicia, er... More »

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FDA declines to approve Insys Therapeutic’s opioid painkiller

(Reuters) – Insys Therapeutics Inc said on Friday the U.S. Food and Drug Administration declined to approve its opioid painkiller, citing potential safety concerns. Insys shares slid nearly 9 percent to $6.62 on Friday, hitting their lowest level in more than ... More »

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FDA staff raises efficacy doubts on GSK’s lung disease treatment

(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 »

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Bayer to phase out Essure birth control device in U.S.

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 »

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Agios Pharmaceuticals leukemia drug gets U.S. approval

(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 »

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CTI Biopharma’s cancer drug fails late-stage trial, shares tumble

(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 »

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Europe recalls generic heart drug made in China on cancer fears

LONDON (Reuters) – A number of high blood pressure and heart drugs containing an ingredient made in China are being recalled across Europe after an impurity that may cause cancer was found in them, officials said on Thursday. The European Medicines Agency said... More »

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Missouri appeals court tosses $55 million J&J talc-powder verdict

(Reuters) – A Missouri appeals court on Friday threw out a $55 million verdict against Johnson & Johnson in a lawsuit by a woman who claimed she developed ovarian cancer after using talc-based products, including J&J’s baby powder, citing a U.S. Supreme court ... More »

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U.S. approves first marijuana plant-derived drug for epilepsy

(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 »

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Pfizer’s breast cancer drug combo falls short of survival goal

(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 »

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Lilly’s Jardiance meets main goal of two diabetes trials

(Reuters) – Eli Lilly & Co said on Monday that its drug Jardiance, along with insulin therapy, met the main goal of two trials testing it in patients with type 1 diabetes. Jardiance, although not approved for type-1 diabetes, is approved for use in adults with... More »

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Merrimack to scrap development of pancreatic cancer treatment

(Reuters) – Merrimack Pharmaceuticals Inc said on Monday it would stop developing its experimental treatment for pancreatic cancer after it failed to meet the main and secondary goals in a mid-stage trial. The company said it would now focus on developing othe... More »

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British PM May calls on health, tech sectors to work on cancer

LONDON (Reuters) – Prime Minister Theresa May will call on Britain’s health service, charities and artificial intelligence sector to work together to better identify patients with the early stages of cancer and stop thousands dying each year. May, who is strug... More »

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Remedy for high drug costs: Let Medicare negotiate

CHICAGO (Reuters) – (The writer is a Reuters columnist. The opinions expressed are his own.) Americans do not agree on much these days, but we are united on the cost of medicine. Large majorities of Republican, Democratic and independent voters say they would ... More »

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J&J defends itself in trial over baby powder asbestos claims

(Reuters) – A trial for a lawsuit alleging that Johnson & Johnson Baby Powder was responsible for the death of a woman due to her exposure to cancer-causing asbestos began in South Carolina on Monday in the latest case against the healthcare conglomerate and a... More »

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U.S. to consider expanding Medicare drug price negotiation

WASHINGTON/NEW YORK (Reuters) – The Trump administration is considering expanding Medicare’s ability to negotiate the cost of drugs by giving private payers a role in setting the price of medicines administered in hospitals and doctors’ offices, Health and Hum... More »

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FDA chief questions protections on drug rebates, stocks fall

(Reuters) – U.S. Food and Drug Administration chief Scott Gottlieb on Thursday questioned whether rebates that drugmakers provide to health insurers should remain protected by federal law, sparking new concerns on Wall Street over efforts to curb drug pricing.... More »

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Too many cancer drugs? Crowded market gives investors pause

LONDON (Reuters) – In London’s world-famous Great Ormond Street children’s hospital, Dr. Karin Straathof is excited about a new cell-based medicine that offers hope for toddlers with incurable nerve tissue cancer. Her progress with a handful of children for wh... More »

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Ninety-eight now sick from romaine lettuce-linked E. coli: CDC

(Reuters) – Fourteen more people fell ill from an E. coli outbreak linked to romaine lettuce, U.S. health officials said on Friday, bringing the number of people affected to 98 across 22 U.S. states. The reported strain of E. coli, which produces poisonous sub... More »

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Allergan migraine drug succeeds in second late-stage trial

NEW YORK (Reuters) – Allergan Plc on Friday announced positive results from a second Phase III trial for the 50 milligram dose of its drug for acute migraine, reproducing results from the previous trial. A lower dose of the drug, ubrogepant, failed to meet one... More »

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Vertex Pharma profit tops estimates on strong launch of new CF drug

(Reuters) – Vertex Pharmaceuticals Inc topped analysts’ forecasts for quarterly profit on Thursday, led by stronger-than expected sales of its latest cystic fibrosis drug as well as double-digit growth in sales of older treatments. Boston-based Vertex, like ot... More »

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AbbVie’s beat fueled by demand for Humira, Hep C drugs

(Reuters) – AbbVie Inc reported a better-than-expected quarterly profit on Thursday, on higher sales of its rheumatoid arthritis treatment Humira and its Hepatitis C drugs, leading the company to raise its full-year earnings forecast. The company’s shares, whi... More »

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Gates backs gene technologies in fight to end malaria

LONDON, April 18 (Reuters) – Gene-editing technologies that alter mosquitoes’ DNA could prove critical in the fight against malaria, Bill Gates said on Wednesday, and ethical concerns should not block progress in such gene-modifying research. Speaking at the M... More »

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J&J Baby Powder litigation takes new focus with asbestos claims

NEW YORK (Reuters) – A $117 million verdict against Johnson & Johnson (JNJ.N) and a supplier in favor of a man who said his asbestos-related cancer was caused by long-term use of J&J’s Baby Powder could open a new front for thousands of cases claiming the wide... More »

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Apricus mulls options- to sell U.S. rights to Vitaros

(Reuters) – Apricus Biosciences Inc said on Monday it was considering options for the company and looking to sell the U.S. rights to its erectile dysfunction cream Vitaros, after the Food and Drug Administration asked it to make a new formula for the product. ... More »

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Cancer drug choices tied to drugmaker payouts to doctors

(Reuters Health) – Some oncologists may be more likely to prescribe certain cancer medicines when they receive payments from the companies that make these drugs, a U.S. study suggests. Researchers examined data on payments drug companies made to doctors in 201... More »

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Few Americans aware of cancer drug shortages

(Reuters Health) – Most Americans aren’t aware of cancer drug shortages that might lead some patients to receive less effective or more toxic treatments, a U.S. study suggests. In a nationally representative survey of 420 adults, just 16 percent said they knew... More »

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U.S. FDA restricts sale of Bayer’s Essure birth control device

(Reuters) – The U.S. Food and Drug Administration (FDA) on Monday slapped restrictions on the sale of Bayer AG’s implanted birth control device Essure, two years after the agency put a severe warning label on the product. The FDA said here some women were not ... More »

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Arkansas sues opioid manufacturers for roles in epidemic

(Reuters) – Arkansas’ attorney general on Thursday joined the widening mass of litigation against opioid manufacturers, accusing three drugmakers of promoting addictive painkillers in ways that falsely denied or trivialized their risks. Arkansas Attorney Gener... More »

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Pfizer’s rare heart disease drug succeeds in late-stage study

(Reuters) – Pfizer Inc’s experimental drug to treat a rare and fatal disease linked to heart failure reduced deaths and need for hospitalizations in a late-stage study. The company’s clinical study investigated the efficacy, safety and tolerability of an oral ... More »

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Worst flu season to lift U.S. hospital operator results

(Reuters) – One of the most severe flu seasons in the United States this past decade is proving to be a shot in the arm for U.S. hospital operators that have struggled with tepid patient admissions in recent quarters. Hospital operators Tenet Healthcare Corp (... More »

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Big pharma, big data: why drugmakers want your health records

FILE PHOTO: A surgery nurse is seen beside the heart beat monitor in the operating theatre of the Unfallkrankenhaus Berlin (UKB) hospital in Berlin, Germany February 29, 2008. REUTERS/Fabrizio Bensch /File Photo LONDON (Reuters) – Drugmakers are racing to scoo... More »

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KemPharm’s opioid painkiller gets FDA approval, shares soar

(Reuters) – KemPharm Inc said on Friday the U.S. Food and Drug Administration approved its opioid painkiller Apadaz for the short-term management of acute pain, sending the shares of the drugmaker up as much as 36 percent in late afternoon trading. The company... More »

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Shares of Apricus tank after FDA declines to OK erectile…

FILE PHOTO: – A view shows the U.S. Food and Drug Administration (FDA) headquarters in Silver Spring, Maryland August 14, 2012. REUTERS/Jason Reed/File Photo (Reuters) – The U.S. Food and Drug Administration on Friday declined to approve Apricus Biosciences In... More »

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Apricus says FDA declines to approve erectile dysfunction cream

FILE PHOTO: – A view shows the U.S. Food and Drug Administration (FDA) headquarters in Silver Spring, Maryland August 14, 2012. REUTERS/Jason Reed/File Photo (Reuters) – The U.S. Food and Drug Administration on Friday declined to approve Apricus Biosciences In... More »