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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Health Canada to allow some edible cannabis products starting mid-December

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FILE PHOTO: Cannabis plants fill a room in an aquaponics grow operation by licensed marijuana producer Green Relief in Flamborough, Ontario, Canada January 25, 2019. Picture taken January 25, 2019. REUTERS/Carlos Osorio

(Reuters) - Health Canada said on Friday that some edible cannabis products, extracts and topicals would be sold in physical or online stores from mid-December.

The amended cannabis regulations will come into force on Oct. 17, the health regulator said, adding that cannabis producers with federal license will need to provide a 60-day notice of their intent to sell new products, as they are currently required to do.

“We think these new product forms are going to accelerate the shift away from black market into the legal market,” said Martin Landry, chief of corporate development & strategy at Neptune Wellness Solutions Inc. The Canadian firm specializes in the extraction, purification and formulation of cannabis products.

“They are critical for the legal market to capture a bigger part of the consumer spending,” Landry said.

The amendments will also limit the amount of tetrahydrocannabinol (THC), the substance in cannabis that makes people high, to 10 milligrams per serving in cannabis edibles and extracts. For cannabis topicals, the limit will be 1 gram of THC per package.

The Ontario Chamber of Commerce said even though the new proposed regulations will allow for the development of a range of products to meet consumer demand, the industry body was disappointed to see that multi-packs for edibles cannot exceed 10 mg of THC per package.

The OCC in a recent report had said it supports a THC limit of 10-mg per discrete unit of edibles, as well as the sale of multi-packs or multiple products up to a maximum of 100-mg of THC per package.

Ontario is home to more than half the licensed producers of recreational cannabis in Canada and a majority of employment.

Last year, Canada became one of the first major economies to legalize recreational marijuana, a move that has led to the creation of a multi-billion dollar industry.

Reporting by Shradha Singh in Bengaluru; Editing by Shinjini Ganguli and Maju Samuel

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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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Canada's health regulator says some cannabis products to launch mid December

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FILE PHOTO: Cannabis plants fill a room in an aquaponics grow operation by licensed marijuana producer Green Relief in Flamborough, Ontario, Canada January 25, 2019. Picture taken January 25, 2019. REUTERS/Carlos Osorio

(Reuters) - Health Canada said on Friday that some edible cannabis products, extracts and topicals will be sold in physical or online stores from mid December.

The amended Cannabis regulations will come into force on October 17, the regulator said, adding that cannabis producers with federal license will need to provide 60-days notice of their intent to sell new products, as they are currently required to do.

The amendments will also limit the amount of tetrahydrocannabinol or THC, the substance in cannabis that makes people high, to 10 milligrams per serving in cannabis edibles and extracts. For cannabis topicals, the limit will be 1 gram of THC per package.

Last year, Canada became one of the first major economies to legalize recreational marijuana, a move that has led to the creation of a multi-billion dollar industry.

Reporting by Shradha Singh in Bengaluru; Editing by Shinjini Ganguli

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Pharmacies may not stock naloxone, despite statewide orders

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(Reuters Health) - More than three years after Pennsylvania issued a statewide order expanding access to the life-saving opioid antidote naloxone, the product was still hard to purchase in Philadelphia pharmacies, researchers found.

In 2017, two-thirds of pharmacies in Philadelphia either did not stock naloxone, or they still insisted on a physician’s prescription, which the law said was no longer required.

In the wake of the opioid addiction crisis that has claimed thousands of lives, many U.S. states have passed laws like Pennsylvania’s, which allow the drug to be dispensed without a prescription and mandate that every drugstore carry it.

Laws that let pharmacists sell naloxone without prescription have been associated with a nearly 30% drop in the number of opioid overdose deaths, a separate team of researchers reported last month. (reut.rs/2WM3qMa)

Yet this study is not the first to find that drugstores are slow to comply. Research has shown that most pharmacies in California and Texas, for example, do not carry the drug or make it readily available.

The new results add to the growing body of evidence that these laws are not being enforced, experts said.

“While policy can be put in place, it’s not sufficient and has to be followed up with education, and reinforcement at the county and pharmacy level, and not just assume that the policy itself will ensure access to anyone who needs it,” Dr. Michael Lynch, a toxicologist and emergency medicine physician who was not involved in the study, told Reuters Health.

For the current study, Dima Qato of the University of Illinois, Chicago and colleagues contacted 418 drugstores in Philadelphia between February and August 2017 and found that only about 34% had naloxone in stock - and 38.5% of those drugstores required a physician’s prescription to dispense the drug.

People living in communities with elevated rates of opioid overdose deaths were the least likely to have access to naloxone without a prescription and had to pay more to buy the drug, the researchers wrote in JAMA Network Open.

“Areas that need this policy enforced the most are areas that lack it and that’s a concern,” Qato told Reuters Health by phone.

An overdose of opioids like morphine or heroin slows breathing, reducing the supply of oxygen to the body. Naloxone helps reverse the effects of an overdose and saves lives.

Lynch, who is also the medical director of the Pittsburgh Poison Center at the University of Pittsburgh Medical Center, notes that the high importance of naloxone may not necessarily translate to high demand.

“If patients or individuals are not coming in and asking for it, pharmacies, especially a local independent pharmacy with pretty narrow margins, may not continue to stock a medication that isn’t being dispensed,” he added.

However, Mel Brodsky, executive director of PARD, an association of community pharmacies in Philadelphia, disputes the study’s findings.

“It is from 2 years ago - a lot has changed. Philadelphia mandates that every pharmacy have 2 doses of naloxone in stock. As I travel to my stores, I see 95% having naloxone in stock,” he told Reuters Health by email.

Dr. Michael Fingerhood, of Johns Hopkins Bayview Medical Center in Baltimore, Maryland, told Reuters Health that the low numbers in the study may be partly due to a shortage of naloxone in 2017.

“I would do a similar study now, (when) we don’t have a shortage of naloxone, and see if there has been any difference, two years later,” he said.

SOURCE: bit.ly/2IEd5LZ JAMA Network Open, online June 7, 2019

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Prosecutors drop Flint, Michigan water charges over 'flawed' probe

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(Reuters) - Michigan prosecutors on Thursday dropped all criminal charges over the deadly contamination of the city of Flint’s water, saying a more thorough investigation was needed before they could proceed with the case.

FILE PHOTO: Volunteers distribute bottled water to help combat the effects of the crisis when the city's drinking water became contaminated with dangerously high levels of lead in Flint, Michigan, March 5, 2016. REUTERS/Jim Young/File Photo

The charges were brought by the Office of Special Counsel (OSC), a federal prosecutorial agency, and were based on an investigation that state prosecutors described as “flawed.”

“Dismissing these cases allows us to move forward according to the non-negotiable requirements of a thorough, methodical and ethical investigation,” Michigan’s Solicitor General Fadwa Hammoud and Wayne County Prosecutor Kym Worthy said in a statement.

Eight former state and city officials, including Michigan’s chief medical officer Eden Wells, faced criminal charges for their roles in the water crisis which killed 12 people and sickened over 70, one of the worst man-made environmental disasters in U.S. history.

According to the prosecutors, the OSC made agreements that gave law firms representing state agencies and officials a role in deciding what information would be turned over to law enforcement during their investigation. As a result, not all evidence was pursued, they said.

Additional investigation by the prosecution team has already identified more individuals of interest in the case, they said.

Flint’s troubles began in 2014 after the city switched its water supply to the Flint River from Lake Huron to cut costs. Corrosive river water caused lead to leach from pipes, contaminating the drinking water and causing an outbreak of Legionnaires’ disease.

Prosecutors said they dropped charges “without prejudice,” meaning they could be brought again once a new investigation is completed.

“Justice delayed is not always justice denied,” Michigan Attorney General Dana Nessel said in a statement.

But Michigan Senate Minority Leader Jim Ananich, a Democrat who represents Flint, expressed his disappointment.

“Months of investigation have turned into years, and the only thing to show for it is a bunch of lawyers who have gotten rich off the taxpayers’ dime,” he said in a statement. “The people of Flint believe that they will never see justice, and sadly, so far they’ve been proven right.”

The U.S. Supreme Court in March allowed two class-action lawsuits filed by Flint residents, who are pursuing civil rights claims against local and state officials.

Reporting by Andrew Hay in Taos, New Mexico; Editing by Bill Tarrant and James Dalgleish

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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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New review suggests proven ways to cut back on sugary drinks

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(Reuters Health) - With sugary sodas and other sweetened drinks considered a key driver of the obesity epidemic worldwide, a new research review evaluates how well various measures work to reduce consumption of these calorie laden drinks.

Strategies including limited availability of sodas in schools, removal from children’s menus at restaurants and better labeling could help reduce consumption, according to the analysis published in The Cochrane Database of Systematic Reviews.

The authors of the new report did not respond to requests for an interview. Study coauthor Hans Hauner said in a statement, “Rates of obesity and diabetes are rising globally, and this trend will not be reversed without broad and effective action.” Hauner, a professor of nutritional medicine at the Technical University Munich, added, “Governments and industry in particular must do their part to make the healthy choice the easy choice for consumers. This review highlights key measures that can help accomplish this.”

The researchers pored through the literature seeking studies that evaluated so-called environmental strategies for reducing sugary drink consumption - meaning interventions that change the physical or social setting in which a person chooses what drink to consume or buy. Fifty-eight studies involving a total of more than 1 million adults, teens and children met their criteria. Most lasted about a year and were done in schools, stores or restaurants.

Some of the studies were less well designed, the researchers allowed, simply asking participants how much sugary soda they consumed, for example.

Ultimately, the researchers found moderate-to-low-certainty evidence supporting a number of measures that appeared to help people cut back on sugary drinks. These included: labels that were easy to understand and that rated the healthfulness of beverages; limits on availability of sugary sodas in schools; price increases on sugary sodas in restaurants, stores and leisure centers; inclusions of healthier beverages in children’s menus; and promotion of healthier beverages in supermarkets.

Strategies that raise the price of sugar-sweetened drinks were also supported by moderate-quality evidence while lowering prices on low-calorie drinks was not as well supported.

The new study “lays out evidence that there are things that actually do work,” said Dr. Bruce Y. Lee, executive director of the Global Obesity Center and an associate professor at Johns Hopkins Bloomberg School of Public Health in Baltimore, Maryland.

What makes these sugary beverages especially bad for health is the fact that they represent “empty calories,” said Lee, who was not involved in the review. “So you’re essentially drinking sugar.”

While these strategies may not be the entire solution, “we are clearly having an obesity and diabetes epidemic,” said Dr. Robert Rapaport, a professor of pediatrics and director of the division of pediatric endocrinology and diabetes at the Kravis Children’s Hospital at Mount Sinai in New York City. “Anything that can be done to improve that would certainly be welcome.”

Rapaport welcomes strategies such as removing sugary drinks from schools and making labels easier to read. In general, he said, it makes sense to “tell children to drink water. If they want it with carbonation and flavors that’s fine. All are preferred to having drinks that contain high calories.”

The new study highlights the importance of education, especially for kids, said Shelly Kendra, clinical nutrition manager at the Magee-Womens Hospital of the University of Pittsburgh Medical Center, who also wasn’t involved in the review. “What we learn as kids is what we’re going to carry with us into adulthood,” Kendra said. “Having an environment to help support that is potentially creating the building blocks to healthier choices.”

SOURCE: bit.ly/2IbuoVp The Cochrane Database of Systematic Reviews, online June 12, 2019.

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Britain's BBC gets green light to enhance iPlayer

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LONDON (Reuters) - Britain’s media regulator has given the BBC provisional permission to change its popular iPlayer on-demand platform from a 30-day catch-up service to one where programs are available for 12 months or longer.

Ofcom said the changes would help the BBC stay relevant in the face of changing viewing habits and deliver value to the public, which funds the broadcaster by paying an annual license fee of 154.50 pounds ($196) per household.

It said the changes would pose challenges for other public service broadcasters’ video-on-demand services, and would therefore need to be subject to conditions to mitigate against risks to fair competition.

The BBC launched iPlayer in 2007, offering programs for seven days after broadcast. The viewing window was extended to 30 days in 2014.

Ofcom said it was inviting other views before publishing a final decision by August.

Reporting by Paul Sandle; editing by Stephen Addison

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