Roche's combo lymphoma treatment wins U.S. FDA approval

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FILE PHOTO: The logo of Swiss drugmaker Roche is seen at its headquarters in Basel, Switzerland February 1, 2018. REUTERS/Arnd Wiegmann

(This June 10 story deletes paragraph 9 to clarify that retreatment with Polivy has not been studied.)

(Reuters) - The U.S. Food and Drug Administration on Monday granted earlier-than-expected approval to Roche Holding AG’s antibody- Polivy for treatment of patients with advanced lymphoma.

Polivy was approved in combination with Roche’s older drug Rituxan and a chemotherapy agent for adult patients with advanced diffuse large B-cell lymphoma (DLBCL) whose cancer has worsened despite at least two previous lines of therapy.

Antibody-drug conjugates are designed to deliver a toxic chemotherapy directly to tumors. Roche said the average U.S. list price for a four-month course of Polivy would be $90,000. Rituxan is priced at $39,500 for four months.

Wall Street analysts estimate Polivy sales at nearly $1 billion by 2024, according to IBES data from Refinitiv.

Side effects seen in studies of Polivy included low blood cell counts, nerve damage, fatigue and pneumonia, the FDA said in a statement.

Cell therapies Yescarta, from Gilead Sciences Inc and Kymriah, sold by Novartis AG, are also approved for patients with advanced DLBCL.

Dr. Matthew Matasar, a hematologist at New York’s Memorial Sloan Kettering Cancer Center who was involved in the development of Polivy, said the drug could be an option for some patients to try before determining whether they need to move on to CAR-T treatments.

Roche estimates that nearly 25,000 new cases of DLBCL, a type of non-Hodgkin’s lymphoma (NHL), will be diagnosed in the United States this year. NHL, which is one of the most common cancers, accounts for about 4% of all types of cancers in the United States, according to the American Cancer Society. Continued approval for the treatment may depend on data from a confirmatory trial, Roche said. The FDA’s accelerated approval program allows conditional approval of a medicine that fills an unmet medical need for a serious condition.

Reporting by Aakash Jagadeesh Babu in Bengaluru and Deena Beasley in Los Angeles; Editing by James Emmanuel and Lisa Shumaker

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U.S. drugmakers file lawsuit against requiring drug prices in TV ads

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FILE PHOTO: Used blister packets that contained medicines, tablets and pills are seen, in this picture illustration taken June 30, 2018. REUTERS/Russell Boyce/Illustration

(Reuters) - U.S. drugmakers filed a lawsuit on Friday challenging a new government regulation that would require them to disclose the list price of prescription drugs in direct-to-consumer television advertisements.

The lawsuit was jointly filed by Amgen Inc, Merck & Co, Eli Lilly and Co and the Association Of National Advertisers in the U.S. district court for the district of Columbia.

The new regulation, which was finalized on May 8 by the U.S. Department of Health and Human Services (HHS) and set to take effect in July, is part of the government’s efforts to bring down the cost of prescription medicines for U.S. consumers.

Drugmakers have argued against the regulation, saying list prices do not reflect the final price paid by patients as it excludes rebates and discounts drugmakers may offer, as well as patient assistance programs to make drugs more affordable for some.

“Not only does the rule raise serious freedom of speech concerns, it mandates an approach that fails to account for differences among insurance, treatments and patients themselves, by requiring disclosure of list price,” Amgen said in a statement.

“Most importantly, it does not answer the fundamental question patients are asking: ‘What will I have to pay for my medicine?’” Amgen said.

It remains to be seen whether the advertising regulation would have any actual impact on lowering costs if the requirement goes into effect.

“If the drug companies are embarrassed by their prices or afraid that the prices will scare patients away, they should lower them,” HHS spokeswoman Caitlin Oakley said in an emailed statement.

“President Trump and Secretary Azar are committed to providing patients the information they need to make their own informed healthcare decisions.”

Reporting by Ankit Ajmera in Bengaluru; Editing by James Emmanuel and Bill Berkrot

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U.S. drugmakers file lawsuit against rule requiring drug prices in TV ads

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FILE PHOTO: Used blister packets that contained medicines, tablets and pills are seen, in this picture illustration taken June 30, 2018. REUTERS/Russell Boyce/Illustration

(Reuters) - U.S. drugmakers on Friday filed a lawsuit to prevent the companies from disclosing the list price of prescription drugs in direct-to-consumer television advertisements as per a newly proposed government regulation.

The lawsuit was jointly filed by Amgen Inc, Merck & Co Inc, Eli Lilly and Co and the Association Of National Advertisers in the U.S. district court in Columbia.

The new regulation on advertisement, which was finalized on May 8 by the U.S. Department of Health and Human Services (HHS) and takes effect in July, is part of the government’s efforts to bring down costs for U.S. consumers.

However, drug companies have argued against the proposed rule, saying list prices do not reflect the final price paid by patients as it excludes rebates and discounts drugmakers may offer.

“Not only does the rule raise serious freedom of speech concerns, it mandates an approach that fails to account for differences among insurance, treatments and patients themselves, by requiring disclosure of list price,” Amgen said in a statement.

“Most importantly, it does not answer the fundamental question patients are asking: ‘What will I have to pay for my medicine?’”

HHS did not immediately respond to a request for comment.

Reporting by Ankit Ajmera in Bengaluru; Editing by James Emmanuel

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Listening to music may ease cancer patients' pain

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(Reuters Health) - Listening to music at home may reduce cancer patients’ pain and fatigue and ease symptoms like loss of appetite and difficulty concentrating, according to research in Taiwan.

In the study, breast cancer patients assigned to 30 minutes of music listening five times a week had “noticeably” reduced side effects of cancer and its treatment over 24 weeks, researchers report in the European Journal of Cancer Care.

The patients said the music helped their physical and psychological wellbeing because it distanced them from negative thoughts about cancer.

“Music therapy is convenient, does not involve invasive procedures, and can easily be used by people in the comfort of their homes,” said senior study author Kuei-Ru Chou of Taipei Medical University.

“Home-based music interventions can also be used with no cost,” Chou told Reuters Health by email. “Healthcare services have become expensive in the present time.”

The researchers recruited 60 breast cancer patients and randomly assigned half of them to a group that would listen to music at home on an MP3 player provided by the study team with a selection of classical, parlor, popular, Taiwanese and religious music to choose from. The other patients were also given a player and the same instructions about how often to listen, but their selections were various types of ambient music, mainly consisting of environmental sounds, which research has shown does little to reduce pain or symptoms, the study team notes.

Before the women had surgery, and after six, 12 and 24 weeks of music listening, all patients rated the severity of 25 physical symptoms on a five-point scale, as well as rating five categories of fatigue on a separate five-point scale, and the level of pain they felt on a 100-point scale.

The average symptom severity scores of the music therapy group had dropped by five points at the six-week assessment, seven points at 12 weeks and nearly nine points after 24 weeks. Pain scores and overall fatigue scores fell at each assessment as well.

For those listening to music, physical and mental fatigue had also dropped at six weeks but not later.

In contrast, pain and symptom severity scores in the control group increased and remained higher than at the start of the trial.

Based on the results, music therapy may not relieve long-term physical and mental fatigue, the study authors caution. And future studies should use objective measures of pain and fatigue, in addition to the subjective measures used in this study, Chou said.

The researchers are also interested in learning how and why music therapy reduces symptoms and pain. Because listening to music promotes endorphins, dopamine and serotonin in the brain, the chemicals may spark joy and positive emotions that distract patients from the negative emotions, the study authors speculate.

Music could affect functions of the cardiovascular, respiratory, muscular, skeletal, nervous and metabolic systems as well, relieving muscle tension and pain, they add.

“From the neurophysiological point of view,” said Tereza Alcantara-Silva of the Federal University of Goias in Brazil, music-evoked emotions can modulate activity in a variety of brain areas.

“Music plays a major role in self-regulation of emotional contexts,” said Alcantara-Silva, who wasn’t involved in the study, by email. “Music therapy can bring several benefits to cancer patients, helping them to find ways to deal with stress, fear, and loneliness.”

SOURCE: bit.ly/2Idu5cY European Journal of Cancer Care, online June 5, 2019.

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Enanta's lung infection therapy succeeds in mid-stage trial

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(Reuters) - Enanta Pharmaceuticals Inc said on Friday its treatment for a highly contagious respiratory infection met the main goal of reducing virus levels in the body and improving symptoms in patients in a mid-stage study.

The therapy, EDP-938, developed for treating respiratory syncytial virus (RSV) infection which currently has no available treatment, was compared with placebo, the company said.

RSV could lead to serious lung infections and even death in babies and the elderly who have a weaker immune system.

An average of 57,527 children younger than 5 years and 177,000 adults older than 65 years are hospitalized due to RSV infections every year, according to the Centers for Disease Control and Prevention.

Enanta said study results showed its therapy was generally safe and well tolerated and no drug discontinuations were observed.

Drugmakers Regeneron Pharmaceuticals Inc and Johnson & Johnson have abandoned their programs to find a treatment for the condition, and an experimental vaccine developed by Novavax Inc had failed a late-stage trial, earlier this year.

Reporting by Saumya Sibi Joseph in Bengaluru; Editing by Shinjini Ganguli

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Father's smoking during pregnancy tied to asthma in kids

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(Reuters Health) - Children who are exposed to tobacco smoke from their fathers while they’re in the womb may be more likely than those who are not to develop asthma by age 6, according to a study of chemical changes to DNA.

While prenatal smoke exposure has long been linked to an increased risk of childhood asthma, the current study offers fresh evidence that it’s not just a pregnant mother’s smoking that can cause harm.

Researchers followed 756 babies for six years. Almost one in four were exposed to tobacco by fathers who smoked while the child was developing in the womb; only three mothers smoked.

Overall, 31% of kids with fathers who smoked during pregnancy developed asthma by age 6, compared with 23% of kids without fathers who smoked, the study found.

Asthma was also more common among kids whose fathers were heavier smokers, senior study author Dr. Kuender Yang of the National Defense Medical Center in Taipei said by email.

“Children with prenatal paternal tobacco smoke exposure corresponding to more than 20 cigarettes per day had a significantly higher risk of developing asthma than those with less than 20 cigarettes per day and those without prenatal paternal tobacco smoke exposure,” Yang said.

About 35% of the kids with fathers who were heavier smokers developed asthma, compared with 25% of children with fathers who were lighter smokers and 23% of kids with fathers who didn’t smoke at all during pregnancy.

Smoking by fathers during pregnancy was also associated with changes in methylation - a chemical code along the DNA strand that influences gene activity - on portions of genes involved in immune system function and the development of asthma.

Researchers extracted infants’ DNA from cord blood immediately after birth and examined methylation along the DNA strand. The more fathers smoked during pregnancy, the more methylation increased on stretches of three specific genes that play a role in immune function.

Children who had the greatest methylation increases at birth, affecting all three of these genes, had up to almost twice the risk of having asthma by age 6 as other kids in the study.

While smoking by fathers during pregnancy was linked to childhood asthma, it didn’t appear to impact children’s sensitivity to allergens or total levels of IgE, an antibody associated with asthma.

This suggests that the risk of asthma from tobacco exposure is unlike allergic asthma, which is driven by allergies or allergic sensitization via IgE antibody, said Dr. Avni Joshi, a researcher at the Mayo Clinic Children’s Center in Rochester, Minnesota, who wasn’t involved in the study.

The study wasn’t designed to prove whether or how prenatal smoking exposure might directly cause so-called epigenetic changes, or how those changes cause asthma in children.

It’s not yet clear how the alterations seen along the DNA strand where methylation increased might cause asthma, the study team notes in Frontiers in Genetics.

Still, the message to parents should be clear, Joshi said by email.

“Smoking is bad at ANY point in time: before the baby is born and after the baby is born,” Joshi said. “Many parents defer quitting until the baby is born, but this study stresses that the prenatal exposure to tobacco creates changes to the unborn child’s immune system, hence it is best to quit as a family decides to have children, even before the conception happens.”

SOURCE: bit.ly/2WG9lhM Frontiers in Genetics, online May 31, 2019.

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Many epinephrine self-injectors still potent long after expiration date

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(Reuters Health) - EpiPens and other autoinjectors filled with epinephrine to treat severe allergic reactions may still be potent enough to work many months past their labeled expiration date, according to a new study that concludes patients might need expensive refills less often.

These autoinjectors contain a pre-set dose of epinephrine, a life-saving drug used by people at risk of experiencing anaphylaxis, a severe allergy attack. Untreated, anaphylactic shock can be fatal because blood pressure can drop suddenly and airways can narrow, making it difficult to breathe.

Patients who need these life-saving devices must carry at least one with them at all times and have access to one everywhere they go. Soaring prices and out-of-pocket costs for the autoinjectors have made it increasingly difficult for many patients to keep throwing out and replacing unused devices when they expire, researchers note in the Journal of Allergy and Clinical Immunology: In Practice.

The U.S. Food and Drug Administration (FDA) requires autoinjector expiration dates to ensure that the devices never contain less than 90% of the original dose of epinephrine, the study team notes.

For the study, researchers tested the contents of 46 different autoinjectors to see how much epinephrine remained after the expiration dates on the labels. Half of the devices were tested at least two years after their labeled expiration date. At this point, 80% of the devices still retained 90% or more epinephrine, indicating they were still effective under the FDA rules.

“If the expiration dating on these devices was changed, this means that patients would not need to replace their auto-injectors as frequently, limiting cost to them, their insurance, and the healthcare system, while still feeling secure that they have access to adequate treatment for anaphylactic reactions,” said lead study author Lynn Kassel of Drake University College of Pharmacy & Health Sciences in Des Moines, Iowa.

Devices six months past their labeled expiration date in the study still had 100% of the original epinephrine dose. One year after the labeled expiration date, devices still had 95% of the original epinephrine dose.

And all of the autoinjectors tested that were up to 30 months beyond their labeled expiration date still had 90% of the dose remaining.

The study tested far too few devices to help determine with certainty whether all epinephrine autoinjectors in the U.S. might be safely used past their expiration dates, Kassel said by email.

The authors also note that they did not test the expired injectors’ effectiveness in stopping an anaphylaxis episode.

“Until the FDA changes the expiration dating guidance for these devices, patients with anaphylactic allergies should carry auto-injectors that have not yet expired,” Kassel advised.

“The greatest risk of using an expired auto-injector is that the epinephrine is no longer potent enough to combat the anaphylactic reaction, and this could result in death or critical illness.”

Right now, the expiration date is 18 months from the time the product is manufactured, a duration that is shorter than the expiration date for most other medications, said Dr. Kao-Ping Chua of the C.S. Mott Children’s Hospital and the University of Michigan Medical School in Ann Arbor.

While the study results build on a growing body of evidence suggesting that expiration dates for epinephrine autoinjectors could be extended, in the meantime, patients should use the devices as labeled, Chua, who wasn’t involved in the study, said by email.

“I don’t think anyone should postpone refilling an epinephrine auto-injector if they can afford it,” Chua said. “In a life-or-death situation, you want to have as much certainty as possible that the rescue medication is going to work.”

SOURCE: bit.ly/2F7WrTT Journal of Allergy and Clinical Immunology: In Practice, online May 28, 2019.

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IBM, Walmart, Merck in blockchain collaboration with FDA

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FILE PHOTO: The Walmart logo in New York, U.S., May 1, 2018. REUTERS/Brendan McDermid/File Photo

(Reuters) - IBM, Merck and Walmart have been chosen for a U.S. Food and Drug Administration pilot program that will explore using blockchain technology to improve the security of prescription drug supply and distribution.

The companies said they would work with consultancy KPMG to create a shared blockchain network that will allow real-time monitoring of products in the pharmaceutical supply chain.

The project has been authorized under the U.S. Drug Supply Chain Security Act (DSCSA) that was set up to increase regulatory oversight of counterfeit, stolen, contaminated or otherwise harmful drugs.

The FDA has previously used the DSCSA to issue a warning letter to drug distributor McKesson Corp for violations involving opioid medications.

Opioids have been tied to thousands of overdose deaths and state and local governments across the United States have filed lawsuits seeking to hold pharmaceutical companies responsible for the epidemic of abuse.

The new project is aimed at reducing the time needed to track and trace prescription drugs, improving access to reliable distribution information and ensuring products are handled appropriately and stored at the right temperature while being distributed, the companies said in a statement.

Blockchain technology, originally conceived a decade ago as the basis for the cryptocurrency bitcoin, will help stakeholders establish a permanent record and can be integrated with existing systems used to trace products while they are distributed.

The project is scheduled to be completed in the fourth quarter of 2019 and results will be published in a report, the companies said.

Reporting by Tamara Mathias in Bengaluru; Editing by Shinjini Ganguli

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GSK signs up gene-editing pioneers in drug discovery alliance

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(Reuters) - British drugmaker GSK said it has struck a research deal with the early pioneers of a prominent gene-editing technology at the University of California, in a boost to its prospects for developing new drugs.

GlaxoSmithKline, Britain’s largest drugmaker, will pay up to $67 million over a five-year period for the new Laboratory for Genomics Research, which will be jointly run with the University of California and led by researchers such as Jennifer Doudna, a co-inventor of the CRISPR gene-editing technology.

New gene editing tools - with CRISPR/Cas9 as the most prominent example - have thrown the door wide open for rearranging the genetic code much more precisely and at lower costs than previously possible.

The technology made headlines last year when a Chinese scientist caused outrage with a claim to have “gene-edited” babies, but CRISPR/Cas9 can also be used in medical and agricultural research without interfering with the human germline.

CRISPR works as a molecular scissors that can trim away unwanted pieces of genetic material and replace them with new ones. Easier to use than older techniques, it has quickly become a preferred method of gene editing in research labs.

The new GSK lab will run tests on various irregularities in the human genome and track the malfunctions they trigger in cells, hoping to gain a clearer understanding of the causes of cancer as well as neurological and immunological diseases.

“Once we understand how that changes its function, we can think about how to mitigate that functional impairment and normalize the cell, and normalize, hopefully, the patient by just developing a drug that could prevent them from developing the disease,” said GSK’s Chief Scientific Officer Hal Barron.

GSK, which had hired Barron from Alphabet-backed biotech firm Calico in 2017, will become more dependent on its drug development fortunes as it prepares to fold its consumer health business into a joint venture with Pfizer that will be separately listed.

Automation and heavy-duty computing will allow researchers to analyze hundreds of millions of genetic combinations per experiment at the new lab, Barron added.

The University of California in February scored a victory in a drawn-out legal battle with the Cambridge, Massachusetts-based Broad Institute over the CRISPR patent application that Doudna filed together with Emmanuelle Charpentier of the University of Vienna in 2012.

The new lab in San Francisco will include facilities for 24 full-time university employees funded by GSK plus up to 14 full-time GSK staff.

Other pharma companies are investing in the new method. Bayer and Vertex Pharmaceuticals have independently established collaborations with CRISPR Therapeutics, a biotech firm working on gene therapies.

For GSK, the California lab project ties in with existing data-driven alliances in genetic research with Alphabet-funded gene testing company 23andMe, or with the UK Biobank, a genetic database project.

Additional reporting by Michael Erman in New York, editing by Deepa Babington

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