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#Pharmaceuticals and Medical Research (TRBC)

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Norway biotech Ultimovacs plans IPO to develop cancer drug

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 »

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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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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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Swiss, German drugmakers join U.S. price freeze

ZURICH (Reuters) – European drugmakers Roche, Bayer and Merck KGaA became the latest companies to freeze prices in the United States for the rest of 2018 following criticism by President Donald Trump over the cost of medicine. Roche did boost U.S. prices for n... 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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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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Trump slams Pfizer after July 1 drug price hikes

NEW YORK/WASHINGTON (Reuters) – U.S. President Donald Trump on Monday took aim at Pfizer Inc and other U.S. drugmakers after they raised prices on some of their medicines on July 1, saying his administration would act in response. “Pfizer & others should be as... 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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Hitting cancer early: AstraZeneca’s bid to outmaneuver rivals

LONDON (Reuters) – AstraZeneca (AZN.L) suffered its biggest daily share price drop a year ago after a key cancer drug trial failed amid feverish speculation the chief executive might quit. Yet today two-thirds of analysts tracked by Thomson Reuters recommend t... More »

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Biogen, Eisai’s Alzheimer’s drug succeeds in mid-stage trial,…

(Reuters) – Japanese drugmaker Eisai Co and Biogen Inc said that the final analysis of a mid-stage trial of their Alzheimer’s drug showed positive results for patients who received the highest dose. The news sent Eisai’s shares up as much as 14.6 percent in Fr... 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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Scientists eye genome mapping to help chlamydia-stricken koalas

SYDNEY (Reuters) – Scientists who have mapped the genome of Australia’s symbolic animal, the koala, say it could help them develop better vaccines to treat the animals, who are battling an epidemic of the bacterial disease chlamydia. The development will also ... More »

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AstraZeneca wins speedy approvals for cancer drugs in Japan

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 »

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Roche ‘highly encouraged’ by Tecentriq results in breast cancer

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 »

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NHS has started planning for Brexit no deal

LONDON (Reuters) – Britain’s public health service has started “significant planning” to ensure medicines are still supplied to patients if the government fails to negotiate a Brexit deal with the European Union, its head said on Sunday. Simon Stevens, chief e... 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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Dementia venture fund raises $350 million to hunt new drugs

LONDON (Reuters) – A venture capital fund dedicated to finding new ways to prevent and treat dementia has raised $350 million, far exceeding the initial target of $200 million set on its launch in 2015. The global Dementia Discovery Fund (DDF), an initiative o... 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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Most doctors would give HIV prevention drugs to teens

(Reuters Health) – Last month U.S. regulators said a pill that helps prevent infection with HIV is safe for use by adolescents, and a study suggests most physicians would be willing to prescribe this medicine to teens. So-called pre-exposure prophylaxis (PrEP)... 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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Mixed results for Bristol/Nektar combination in cancer trial

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 »

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FDA wants to shorten new drug monopolies to cut costs

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 »

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Merck’s Keytruda extends lung cancer survival in two trials

CHICAGO (Reuters) – Merck & Co’s immunotherapy Keytruda improved survival as a stand-alone treatment for newly-diagnosed lung cancer patients and with chemotherapy for hard-to-treat squamous cell lung cancer, new data released on Sunday showed, further cementi... More »

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FDA chief outlines new ways to speed cancer drug approvals

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 »

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Roche drugs show limited benefit in lung, breast cancer trials

CHICAGO (Reuters) – In a disappointment for Roche Holding AG (ROG.S), two of its oncology drugs provided only modest protection from disease progression in lung cancer and breast cancer, according to data from separate clinical trials presented on Saturday. Ad... More »

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Loxo Oncology posts improved results for newest cancer drug

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 »

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Gene sequencing study finds new cancers linked with Lynch syndrome

CHICAGO (Reuters) – Lynch syndrome, a rare hereditary disease typically associated with an increased risk of colorectal and endometrial cancers, appears to be linked with several additional types of cancer than previously thought, U.S. researchers said on Satu... More »

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Bluebird myeloma treatment delays cancer progression: trial

CHICAGO (Reuters) – Patients with advanced multiple myeloma treated with bluebird bio’s experimental immunotherapy lived for a median of nearly a year before their cancer worsened, according to data from a small study presented on Friday. The treatment, called... 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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India steps up hunt for origin of mysterious brain-damaging virus

MUMBAI/KOCHI (Reuters) – India began a fresh round of tests to trace the origin of a rare brain-damaging virus that has killed 13 people, a health official said on Monday, as initial tests on animals suspected of carrying the Nipah virus showed no sign of the ... More »

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Danish biotech Genmab hit by ending of trial using key cancer drug

COPENHAGEN (Reuters) – Shares in Danish biotech Genmab fell by as much as 25 percent on Monday after its partner Johnson & Johnson decided to ditch a study using its blockbuster cancer drug. Genmab said Janssen, a Johnson & Johnson business, had decided that t... More »

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Roche drug dramatically reduces bleeds in key hemophilia tests

LONDON (Reuters) – Roche’s new hemophilia drug Hemlibra dramatically reduced bleeding in a broad population of hemophilia patients, results from two clinical trials showed on Monday, setting it up to take a dominant market position. Hemlibra cut by 96 percent ... More »

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Congo to begin Ebola vaccinations on Monday

MBANDAKA, Democratic Republic of Congo (Reuters) – Health workers in Democratic Republic of Congo will begin a vaccination campaign on Monday aimed at containing an outbreak of the deadly Ebola virus, a spokeswoman for the health ministry said. Jessica Ilunga ... More »

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In Congo city where Ebola resides, fear but not panic

MBANDAKA, Democratic Republic of Congo (Reuters) – In the city of Mbandaka in northwest Congo, Mbombo Roge does not shake hands with friends anymore: Ebola changed all that. Roge simply bowed when he met a group of friends on Saturday afternoon, obeying one of... More »

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Congo northwest city Mbandaka confirms three new Ebola cases

KINSHASA (Reuters) – Three new cases of Ebola were confirmed in northwest Congo’s regional capital of Mbandaka on Friday, in a part of the city lying next to the Congo River, the health ministry said. The ministry statement late on Friday said the suspected ca... 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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WHO says 19 dead, 39 infected so far in Congo Ebola outbreak

GENEVA (Reuters) – Democratic Republic of Congo reported 39 suspected, probable or confirmed cases of Ebola between April 4 and May 13, including 19 deaths, the World Health Organization said on Monday. It said 393 people who identified as contacts of Ebola pa... More »

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U.S. drug agency suspends Louisiana distributor over opioid sales

WASHINGTON (Reuters) – The U.S. Drug Enforcement Administration said on Friday it had suspended a Louisiana pharmaceutical distributor from selling controlled substances for allegedly selling unusually large quantities of opioids to pharmacies without reportin... 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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Overactive immune response linked to hair graying

(Reuters Health) – An overactive immune response, which can occur with viral infections, could result in sudden hair graying, according to research in mice. The research revealed that a molecule involved in hair pigmentation also controls certain immune system... More »

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Discovery of malaria parasite survival genes offers new targets

LONDON (Reuters) – Scientists have identified the core genes that are essential for the deadliest malaria parasite to survive, revealing new targets for drugs or vaccines to fight the potentially deadly disease they cause in people. Using new genomic technique... More »

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Scientists devise new, more accurate peanut allergy test

LONDON (Reuters) – British scientists have developed a far more accurate blood test to diagnose peanut allergy, offering a better way to monitor a significant food hazard. Peanuts are the most common cause of fatal food-induced anaphylaxis, or severe allergic ... 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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Zimbabwe says will issue cannabis licences to growers

HARARE (Reuters) – Zimbabweans can now apply for licences to grow cannabis for medical and research purposes, the government has said in a legal notice, making the southern African nation the second country in Africa to legalize cultivation of the plant. Lesot... 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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Global study finds 44 genetic risk factors for major depression

LONDON (Reuters) – International scientists have identified 44 genetic variants that can increase the risk of developing major depression and found that all humans carry at least some of them. The new findings could help explain why not everyone treated with a... 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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GE rides gene therapy wave with ready-made viral drug factories

LONDON (Reuters) – General Electric is raising its bet on biotechnology with the launch of prefabricated manufacturing units for producing virus-based gene and cell therapies, novel anti-cancer treatments and vaccines. Interest in such medicines, which use eng... 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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As cancer drug prices climb, value not keeping pace

(Reuters Health) – The cost of new anti-cancer drugs increased more than five-fold from 2006 to 2015, but a new analysis suggests that cancer patients and insurers may be getting less for their money. Anticancer medications account for the lion’s share of glob... More »

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GSK slims portfolio with sale of rare disease gene therapy drugs

LONDON (Reuters) – GlaxoSmithKline is divesting its rare disease gene therapy drugs to private biotech company Orchard Therapeutics as Chief Executive Emma Walmsley makes good on her promise to prune the drugmaker’s pharmaceuticals portfolio. Financially, the ... More »

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Researchers propose new Alzheimer’s definition based on biology

(Reuters) – Alzheimer’s researchers have proposed a radical change in the way the disease is defined, focusing on biological changes in the body rather than clinical symptoms such as memory loss and cognitive decline. The new research framework, released on Tu... 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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Antidepressants in pregnancy tied to changes in babies’ brains

(Reuters Health) – Babies’ brains may develop differently when their mothers take antidepressants during pregnancy, a small U.S. study suggests. Researchers examined brain scans of 16 newborns whose mothers took medications known as selective serotonin reuptak... 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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Trump to unveil China tariff list this week, targeting tech goods

WASHINGTON (Reuters) – The Trump administration this week will unveil the list of Chinese imports targeted for U.S. tariffs to punish Beijing over technology transfer policies, a move expected to intensify trade tensions between the world’s two largest economi... More »

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People with sinus infections stay on antibiotics too long

(Reuters Health) – Most people prescribed antibiotics for sinus infections are on treatment courses of 10 days or longer even though infectious disease doctors recommend five to seven days for uncomplicated cases, a U.S. study suggests. Researchers examined da... 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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Thyroid removal linked to increased bone-thinning, fracture risk

(Reuters Health) – Thyroid surgery that totally or partially removes the gland may increase the long-term risk of bone thinning and bone breaks, especially for younger patients and women, according to a large study from Taiwan. In particular, osteoporosis and ... 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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Childhood cancer survivors may develop heart problems sooner

(Reuters Health) – Adult survivors of childhood cancer have a greater risk of heart disease and develop risk factors like high blood pressure and elevated cholesterol earlier in life compared to the general population, a German study suggests. Researchers stud... More »

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GSK wins new reprieve as Hikma’s generic Advair delayed again

(Reuters) – GlaxoSmithKline has won a further reprieve for its blockbuster Advair lung drug after U.S. regulators insisted Hikma Pharmaceuticals conduct a further clinical study evaluating its generic version of the drug. The Jordan-based firm said on Monday i... More »

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AstraZeneca sees pivotal lung cancer trial results later in 2018

FILE PHOTO: The logo of AstraZeneca is seen on medication packages in a pharmacy in London April 28, 2014. REUTERS/Stefan Wermuth/File Photo LONDON (Reuters) – AstraZeneca now expects a key lung cancer study of two immunotherapy drugs to produce overall surviv... 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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Mylan teams up with Revance on biosimilar for Botox

NEW YORK (Reuters) – Mylan NV on Wednesday struck a licensing agreement with Revance Therapeutics Inc to develop a biosimilar of Allergan Plc’s blockbuster Botox wrinkle treatment. The deal includes an upfront payment of $25 million to Revance​, Mylan said. Re... More »

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Geely covets Daimler tech with $9 billion stake, shares surge

FILE PHOTO: Li Shufu, founder and chairman of Zhejiang Geely Holding Group, attends the Volvo’s S90 news conference in Shanghai, China November 2, 2016. REUTERS/Aly Song/File Photo HONG KONG/SHANGHAI (Reuters) – Geely Automobile Holdings Ltd’s (0175.HK) shares... More »

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Geely’s Li Shufu is betting billions on global push

FILE PHOTO: Li Shufu, founder and chairman of Zhejiang Geely Holding Group, attends the Volvo’s S90 news conference in Shanghai, China November 2, 2016. REUTERS/Aly Song/File Photo SHANGHAI (Reuters) – Li Shufu, chairman of Chinese carmaker Geely, is making wa... 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 »