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

[ad_1]

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

Our Standards:The Thomson Reuters Trust Principles.

[ad_2]

Source link

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

[ad_1]

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

Our Standards:The Thomson Reuters Trust Principles.

[ad_2]

Source link

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

[ad_1]

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

Our Standards:The Thomson Reuters Trust Principles.

[ad_2]

Source link

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

[ad_1]

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

Our Standards:The Thomson Reuters Trust Principles.

[ad_2]

Source link

IBM, Walmart, Merck in blockchain collaboration with FDA

[ad_1]

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

Our Standards:The Thomson Reuters Trust Principles.

[ad_2]

Source link

Canadian panel calls for universal public drug coverage

[ad_1]

OTTAWA/TORONTO (Reuters) - A Canadian advisory council studying prescription drug coverage said on Wednesday the federal government should create a C$15.3 billion ($11.5 billion) universal, single-payer public pharmacare system, and warned that the current system requires a major overhaul.

A pharmacist counts prescription drugs at the at the CentreTown Pharmacy in Ottawa, Ontario, Canada, June 12, 2019. REUTERS/Chris Wattie

The council said the plan should be implemented no later than Jan. 1, 2027, with coverage for essential medicines in place by Jan. 1, 2022.

Canada is the only country with a universal health care system that does not include universal coverage for prescription drugs. Most prescriptions are paid for through employer-funded drug plans, while some are covered by government programs for the elderly, or people with low incomes or very high costs.

“We can’t tinker with what exists. We have to transform it,” council chair Eric Hoskins, a former Ontario health minister, said at a news conference.

The report said public and private drug providers had told the council the system is “near the breaking point.”

Canadian Prime Minister Justin Trudeau’s Liberal government has promised some kind of national pharmacare program, and its approach may be a key issue in the country’s October election.

Minister of Health Ginette Petitpas Taylor said in a statement that the government would “carefully study” the recommendations “over the coming months.”

The council estimated the national pharmacare would cost the federal government an additional C$3.5 billion at its launch in 2022, and C$15.3 billion in 2027.

If implemented in full, the plan would likely cut into profits of insurers and drugmakers in Canada, while saving employers and patients money.

Shares of three major insurers listed in Canada, Manulife Financial Corp, Sun Life Financial Inc and Great-West Lifeco Inc, all dropped.

‘SPACE’ FOR THE PRIVATE SECTOR

Canada’s drug insurance system is a patchwork of more than 1,000 public and 100,000 private plans, which can make it difficult for smaller payers to negotiate discounts with pharmaceutical companies.

The Canadian Life and Health Insurance Association (CLHIA)urged the government to work with private plans to negotiate lower drug prices. CLHIA president Stephen Frank said in a statement that all Canadians can have access to the medications they need “without putting at risk what’s working today.”

Hoskins said costs associated with the proposed program are already being paid by Canadians. By 2027, total prescription drug spending would be about 10% lower with the proposed changes, Hoskins said. Canadians spent C$34 billion ($25.6 billion) on prescription medicines in 2018.

Hoskins said he envisions “space” for the private drug insurance sector after a universal public program is rolled out.

“The profit that insurance companies generate through drug insurance plans is modest, I would describe it, compared to other aspects of benefits provided,” he said.

Pamela Fralick, president of pharmaceutical industry group Innovative Medicines Canada, said whatever path the government chooses, “no Canadian should be worse off than they are right now.”

NEW DRUG PRICE RULES IN THE WORKS

Speaking after the report’s release, Petitpas Taylor said work on the Canadian government’s proposal to reduce patented drug prices is still underway, and “movement” would come in the very near future.

New regulations, set to go into effect in January 2019, were delayed amid heavy lobbying from drugmakers.

Slideshow (3 Images)

Patented drug prices in Canada are among the highest in the world. Government surveys show some 20% of Canadians are uninsured or under-insured.

In its most recent budget the Trudeau government promised modest changes, including new funds for expensive drugs that treat rare diseases.

Reporting by Kelsey Johnson in Ottawa and Allison Martell in Toronto; Editing by Bill Berkrot

Our Standards:The Thomson Reuters Trust Principles.

[ad_2]

Source link