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#Drug and Device Development

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Sosei, AbbVie sign drug discovery deal worth up to $1 bln

(Reuters) – Japan’s Sosei Group Corp will collaborate with AbbVie Inc on a drug discovery partnership that could be worth up to $1 billion. Sosei shares soared 12.4% in Tokyo trading, compared with a 1.2% slide in the broader market. The partnership will initi... More »

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AstraZeneca accelerates testing of COVID-19 antibody treatments

(Reuters) – AstraZeneca ANZ.L said on Tuesday it expects to move two COVID-19 antibody therapies it has licensed from U.S. researchers into clinical studies in the next two months as the drugmaker ramps up efforts to help combat the health crisis. The British ... More »

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Sanofi and Regeneron’s Dupixent shows more encouraging results

PARIS (Reuters) – Healthcare companies Sanofi and Regeneron announced on Friday more encouraging results for their Dupixent product used to treat severe atopic dermatitis, often commonly known as eczema. The companies said that Dupixent Phase 3 data showed a s... More »

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Novacyt biotech company says winning race for high-speed virus test

PARIS (Reuters) – Franco-British biotech company Novacyt says it can offer a coronavirus test that is faster than rival methods by focusing on a narrow sequence of DNA coding, as it fights stiff competition to turn the outbreak into a business opportunity. In ... More »

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Roche drug fails in early-onset Alzheimer’s disease study

ZURICH (Reuters) – Roche’s experimental drug gantenerumab failed to slow cognitive decline in people with a rare inherited form of Alzheimer’s disease, the latest setback for companies hunting for a cure for the devastating brain-wasting disease. The study foc... More »

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Merck’s Keytruda wins U.S. FDA approval for bladder cancer

(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 »

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Eisai Inc announces U.S. approval for insomnia drug

(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 »

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Health experts warn of emerging threat of Nipah virus

LONDON (Reuters) – A deadly virus called Nipah carried by bats has already caused human outbreaks across South and South East Asia and has “serious epidemic potential”, global health and infectious disease specialists said on Monday. The virus, identified in 1... 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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Trump nominates MD Anderson oncologist as U.S. FDA Commissioner

(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 »

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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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New York to ban flavored e-cigarettes after illnesses, deaths

NEW YORK (Reuters) – New York Governor Andrew Cuomo on Sunday announced a ban on all flavored e-cigarettes besides tobacco and menthol in response to a recent nationwide spate of sometimes deadly lung illnesses that U.S. health officials have linked to vaping.... More »

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Xeris Pharma’s low blood sugar treatment wins FDA approval

(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 »

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Ebola death toll in east Congo outbreak climbs above 2,000

GOMA, Democratic Republic of Congo (Reuters) – The death toll from Democratic Republic of Congo’s year-long Ebola outbreak has climbed above 2,000, government data showed on Friday, as responders battle to overcome community mistrust and widespread security pr... More »

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Congolese girl, 9, dies of Ebola in Uganda- hospital official

KAMPALA (Reuters) – A nine-year-old girl has died of Ebola in the East African nation of Uganda, a hospital official said, a day after she tested positive for the disease after crossing the border from neighboring Democratic Republic of Congo. “It is true she ... 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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FDA approves Celgene’s bone marrow cancer treatment

(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 »

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Experimental drug delays type 1 diabetes onset in mid-stage trial

(Reuters Health) – In people at high risk for type 1 diabetes, 14 days of therapy with the experimental drug teplizumab delayed development of the disease by a year or more, according to results from a mid-stage study presented Sunday. The 76 study participant... More »

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AbbVie halts enrollment after brain cancer trial misses goal,…

(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 »

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Congo records 1,000th Ebola death in current outbreak

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 »

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EU approves AstraZeneca’s drug for adjunct use in Type-1 diabetes

(Reuters) – British drugmaker AstraZeneca Plc said on Monday the European Commission approved its diabetes drug Forxiga for use as an oral supplement to insulin in adults with a rare type of the disease. Forxiga can now be used along with insulin in patients w... 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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Merck KGaA-Pfizer to end late-stage ovarian cancer treatment study

(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 »

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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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Scientists to test tailor-made vaccine tech to fight epidemics

LONDON (Reuters) – A global coalition set up to fight disease epidemics is investing up to $8.4 million to develop a synthetic vaccine system that could be tailor-made to fight multiple pathogens such as flu, Ebola, Marburg and Rabies. The deal, between the Co... More »

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Brain implants might one day help paralyzed patients use tablets

(Reuters Health) – – Paralyzed people might one day be able to operate smartphones and tablets just by thinking about the actions they want to perform, with help from sensors implanted in their brains, a recent experiment suggests. While previous experiments h... 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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Bayer hits back at new Netflix medical device documentary

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 »

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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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Israeli firm gets U.S. nod for advanced trials for non-opiate…

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 »

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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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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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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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U.S. doctors call for health policies that support women

(Reuters Health) – Making it easier and more affordable for women to access care, and supporting research that includes how treatments work in both sexes, can improve the health of all Americans, not just women, U.S. doctors argue. “Women and their families ar... 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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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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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 »

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AstraZeneca is sued by Array BioPharma over cancer drug royalties

NEW YORK (Reuters) – Array BioPharma Inc on Thursday sued AstraZeneca AB, accusing the pharmaceutical company of refusing to pay required royalties for a cancer drug after entering into an $8.5 billion collaboration with Merck & Co. In a complaint filed in the... More »

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AstraZeneca’s three-in-one inhaler helps COPD patients in trial

A sign is seen at an AstraZeneca site in Macclesfield, central England May 19, 2014. REUTERS/Phil Noble/File Photo (Reuters) – AstraZeneca said an inhaler for chronic obstructive pulmonary disease (COPD) delivered improved lung function in a late stage trial t... More »

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Aclaris’s drug to treat common skin growth gets FDA nod

(Reuters) – Aclaris Therapeutics Inc’s drug to treat a common kind of skin growth called seborrheic keratoses received approval from the U.S. Food and Drug Administration, the company said on Friday. It is the only topical medicine for the condition to receive... More »

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FDA allows Alnylam to restart hemophilia treatment trials

(Reuters) – The U.S. Food and Drug Administration has allowed Alnylam Pharmaceuticals Inc to restart clinical trials on a drug to treat patients with a rare bleeding disorder, the company said on Friday. All ongoing studies of the drug, fitusiran, had been pla... More »

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U.S. scientists take step toward creating artificial life

A scientist does research in a lab in San Diego, California April 26, 2009. REUTERS/Mike Blake CHICAGO (Reuters) – In a major step toward creating artificial life, U.S. researchers have developed a living organism that incorporates both natural and artificial ... More »

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Regeneron-Sanofi drug succeeds mid-stage study

Regeneron Pharmaceuticals Inc and Sanofi SA said on Monday their drug to treat inflammation in the esophagus, mainly caused by food allergies, met the main goal of a mid-stage study. More »

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Flexion`s knee pain drug gets FDA nod, shares hit life high

Flexion Therapeutics Inc said its injectable drug to treat osteoarthritis-related knee pain was approved by the U.S. Food and Drug Administration, sending the drug developer's shares soaring to a record high in regular trading on Friday. More »

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FDA aims to speed up arrival of complex generic drugs

The U.S. Food and Drug Administration on Monday announced a series of measures designed to speed to market generic versions of complex drugs such as Mylan NV's emergency EpiPen in an effort to address the rising cost of pharmaceuticals. More »

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FDA declines to approve J&J arthritis drug sirukumab

The U.S. Food and Drug Administration has declined to approve Johnson & Johnson's rheumatoid arthritis drug sirukumab, saying additional clinical data is needed to further evaluate its safety, the company said on Friday. More »

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Eight to 10 Republicans have concerns on healthcare bill: Collins

U.S. Senator Susan Collins (R-ME) talks to reporters as she leaves a meeting of the Senate Republican caucus to unveiling of Senate Republicans’ revamped proposal to replace Obamacare health care legislation at the U.S. Capitol in Washington, U.S. July 13, 201... More »

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Lupin sets off down Indian pharma`s long road to redemption

An employee inspects tablets as they move along the production line at a pharmaceutical plant of Lupin, India’s No. 2 drugmaker, in Verna, in the western state of Goa, India, June 9, 2017. Picture taken June 9, 2017. REUTERS/Danish Siddiqui In 28 years in Indi... More »

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Key Republican Collins has `serious concerns` on healthcare bill

Senator Susan Collins (R-ME) speaks to reporters after Senate Republicans unveiled their version of legislation that would replace Obamacare on Capitol Hill in Washington, U.S., June 22, 2017. REUTERS/Joshua Roberts Republican Senator Susan Collins of Maine sa... More »

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Conservative Koch network criticizes U.S. Senate healthcare bill

FILE PHOTO: An Americans for Prosperity banner is seen during an event in Manchester, New Hampshire, July 22, 2015. REUTERS/Dominick Reuter Officials with the conservative U.S. political network overseen by the Koch brothers say they are unhappy with the healt... More »

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Portola shares soar after FDA approves clot preventing drug

A view shows the U.S. Food and Drug Administration (FDA) headquarters in Silver Spring, Maryland August 14, 2012. REUTERS/Jason Reed The U.S. Food and Drug Administration on Friday approved a new oral blood-thinner made by Portola Pharmaceuticals Inc to preven... More »

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Factbox: How Senate, House Obamacare overhaul bills compare

Speaker of the House Paul Ryan (R-WI) speaks after Senate Republicans unveiled their version of legislation that would replace Obamacare on Capitol Hill in Washington, U.S., June 22, 2017. REUTERS/Joshua Roberts After weeks of discussions behind closed doors, ... More »