US FDA approves Arcutis' drug to treat chronic skin disease

 The U.S. Food and Drug Administration (FDA) on Friday approved Arcutis Biotherapeutics' drug for treating a skin condition called seborrheic dermatitis in individuals nine years of age and older.

Shares of Arcutis jumped 20% in extended trade to $2.94.

The health regulator's nod makes roflumilast foam the first topical drug for treating moderate to severe seborrheic dermatitis with a new mechanism of action in over two decades, according to the company.

Seborrheic dermatitis, a common, chronic and recurrent inflammatory skin disease, affects more than 10 million people in the U.S., Arcutis said.

The drug is a foam-based formulation of the company's roflumilast cream 0.3%, sold as Zoryve, which is approved in the U.S. as a topical treatment of plaque psoriasis in patients 6 years of age and older.

The drug met its primary study goal in the late-stage trial with a success rate of 79.5% on the 5-point assessment scale compared with 58.0% in those treated with the vehicle, which is similar to a placebo.

The formulation, designed to overcome the challenges of delivering topical drugs in hair-bearing areas of the body, also showed meaningful improvement over the vehicle arm in disease symptoms, including itch, scaling, and redness.

Arcutis said it plans to commercially launch Zoryve by the end of January.

Chief Commercial Officer Todd Edwards had earlier said that two of the top three U.S. pharmacy benefit managers are expected to cover the product on approval.

Guggenheim analyst Seamus Fernandez estimates revenue of $30.8 million and $94 million in 2024 and 2025, respectively, for the seborrheic dermatitis indication.

A low dose version of the roflumilast cream to treat atopic dermatitis in adults and children down to age 6 is under the FDA's review, with the regulator set to make a decision in July.

https://finance.yahoo.com/news/1-us-fda-approves-arcutis-221937851.html

Bristol Myers to discontinue trial for colorectal cancer treatment

  Bristol Myers Squibb said on Friday it would discontinue its trial testing a treatment for a type of colon cancer. 

https://finance.yahoo.com/news/bristol-myers-discontinue-trials-colorectal-215946314.html

US FDA approves Astellas' combination therapy for bladder cancer

 The U.S. Food and Drug Administration on Friday approved Astellas Pharma's drug in combination with Merck's Keytruda for a type of bladder cancer.

https://finance.yahoo.com/news/us-fda-approves-astellas-combination-204745724.html

EU watchdog deals blow to GSK blood cancer drug Blenrep

 Europe's health regulator stuck to its recommendation not to renew conditional approval for GSK's blood cancer drug Blenrep on Friday, citing data that did not confirm its effectiveness.

While the recommendation by a European Medicines Agency (EMA) committee has to be formally approved by the European Commission, it represents a setback to a key oncology business which GSK has been looking to strengthen.

The EMA's human medicines committee (CHMP) said the benefits of Blenrep, which was the second-largest contributor to GSK's oncology business in 2022, "no longer outweigh its risks".

GSK's shares closed 2.9% lower at 1,419.2 pence.

The CHMP first recommended against renewing the conditional marketing authorisation (CMA) for the GSK multiple myeloma treatment in September. Multiple myeloma, the second-most common blood cancer in the world, starts in plasma cells in bone marrow and ultimately disrupts the production of normal blood cells.

"We continue to explore potential new treatment options for patients with relapsed/refractory multiple myeloma," a GSK spokesperson said in an emailed statement on Friday.

GSK said last month that Blenrep had reached a key goal in a separate late-stage trial.

Blenrep was pulled from U.S. markets last year after it failed a late-stage study designed to show it was better than an existing treatment available in the market.

The drug belongs to a category of treatments called antibody-drug conjugates, which are engineered antibodies that bind to tumour cells and then release cell-killing chemicals.

https://news.yahoo.com/eu-regulator-reiterates-guidance-stop-142718234.html

US FDA finds control lapses at Moderna manufacturing plant

 U.S. drug regulators in September found quality control lapses at Moderna’s main factory including with equipment used to manufacture drug substance for its COVID-19 vaccine, according to the report obtained by Reuters via a Freedom of Information Act request.

The Sept. 11-21 inspection by the U.S. Food and Drug Administration took place at Moderna’s facility in Norwood, Massachusetts, which is used to manufacture the company’s COVID shot Spikevax and an experimental mRNA cancer vaccine being developed with Merck & Co.

The FDA report noted five separate observations, including that Moderna had released eight batches of "drug substance" - the active ingredient used to make mRNA vaccines - that was produced with equipment that had failed the company's cleaning verification tests.

The FDA did not say in the report if those batches were released to the public but identified the drug substance involved as being for the COVID vaccine. The agency declined to comment on the report.

Moderna in a statement said: "Upon receipt of the FDA’s findings, Moderna immediately and comprehensively updated the specific procedures identified and is confident that the actions taken will be satisfactory to regulators."

The company described the inspection as routine and said the findings do not reflect any product quality or safety concerns, adding that its COVID-19 vaccines are safe and effective.

It said all product released by the company was tested and meets product specifications and international regulatory requirements.

Steven Lynn, a former head of the FDA's Office of Manufacturing and Product Quality who is now a regulatory compliance consultant, said using the drug substance in question was a serious matter but that it was unclear whether the batches were released to consumers.

The FDA also found in its report that Moderna did not have the right measures at its facility to ensure expired materials were not used to make vaccines and that airborne contaminates did not make it into any products.

Inspectors found more than 2,000 expired items in Moderna's warehouse and cold storage not held in a separate or defined location from other materials, according to the report. It also said it found materials were used beyond their expiration date.

“At face value, it appears multiple controls designed to prevent contamination were deficient,” said Lynn.

There is no evidence that compliance failures flagged in the report known as a Form 483 resulted in harm to people who took Moderna’s COVID shot, its only marketed product, or clinical trial participants for other mRNA vaccines the company is developing.

The FDA has not issued a recall of any Moderna vaccines, according to its recalls, market withdrawals, and safety alerts database.

A Form 483 is a type of agency report containing "observations" that FDA inspectors "deem to be objectionable."

In 2021, Japan suspended use of 1.63 million doses of Moderna’s COVID vaccine after contaminates were found in some vials produced by Rovi, a contract manufacturer based in Spain. No manufacturing problems have previously been reported in any of Moderna’s own facilities.

The drugmaker has also bought a manufacturing facility in Marlborough, Massachusetts, announced in May.

Moderna in September said it was in talks with its partners that fill vials and syringes with its COVID vaccine globally to downsize production and bring more manufacturing in-house as demand has waned.

The vaccine maker said it expects additional capacity from its new mRNA manufacturing facilities in the UK, Canada and Australia when completed in 2025.

https://news.yahoo.com/exclusive-us-fda-finds-control-205231739.html

Actor Matthew Perry died from 'acute effects of ketamine'

 "Friends" actor Matthew Perry died as a result of "the acute effects of ketamine," the Los Angeles County Medical Examiner's office said Friday.

Perry, who played Chandler Bing on the hit TV sitcom from 1994-2004, died at the age of 54, having struggled for decades with addiction and related serious health issues.

"Contributing factors in Mr. Perry's death include drowning, coronary artery disease and the effects of buprenorphine (used to treat opioid use disorder)," the medical examiner said in a statement. "The manner of death is accident. "

Perry was found unconscious in a hot tub at his house in Los Angeles on October 28. First responders were unable to revive him, and an initial post-mortem proved inconclusive, pending a toxicology report.

Doctors and veterinarians often employ ketamine as an anesthetic, and researchers explore it as a treatment for depression. Underground users take it illicitly for its hallucinogenic effects.

"Friends," which followed the lives of six New Yorkers navigating adulthood, dating and careers, drew a massive global following.

But even as he delivered on-air gag after gag -- and earned a fortune -- Perry was struggling.

He attended multiple rehabilitation clinics to combat addiction to painkillers and alcohol. In 2018 he suffered a burst colon, related to drug usage, and underwent multiple surgeries.

In his memoir "Friends, Lovers and the Big Terrible Thing," published last year, Perry described going through detox dozens of times. He dedicated the book to "all of the sufferers out there," and wrote in the prologue: "I should be dead."

"I have mostly been sober since 2001," he wrote, "save for about sixty or seventy little mishaps over the years."

https://news.yahoo.com/matthew-perry-died-acute-effects-221722756.html

US SEC says no to new crypto rules; Coinbase to challenge

 The U.S. Securities and Exchange Commission on Friday denied a petition by Coinbase Global seeking new rules from the agency for the digital asset sector, which the country's largest crypto exchange said it plans to challenge in court.

The five-member commission, in a 3-2 vote, said it would not propose new rules because it fundamentally disagreed that current regulations are "unworkable" for the crypto sphere, as Coinbase has argued. The firm later notified an appeals court that it plans to seek judicial review of the SEC's decision.

The dispute was the latest in a broader tug-of-war between the crypto sector and the top U.S. markets regulator, which has repeatedly said most crypto tokens are securities and subject to its jurisdiction. The agency has sued several crypto companies, including Coinbase, for listing and trading crypto tokens which it says should be registered as securities.

"Existing laws and regulations apply to the crypto securities markets," SEC Chair Gary Gensler said in a separate statement supporting the decision.

Coinbase disputed that assertion.

"No one looking fairly at our industry thinks the law is clear or that there isn’t more work to do," chief legal officer Paul Grewal said in a statement. "We should be working together to create laws and rules that will benefit consumers and US innovation".

Shortly thereafter, Coinbase notified a federal court of appeals in Philadelphia of its plans to seek review of the SEC's denial.

In 2022, the company pressed the SEC to create a bespoke set of rules for the crypto sector, arguing that existing U.S. securities laws are inadequate. In April, Coinbase appealed to a judge to force the SEC to respond to the petition.

The court said it would not force the agency to act, given the SEC had said it would respond to Coinbase's petition.

Crypto firms have said they want a clearer idea of when the SEC views a digital asset to be a security.

https://finance.yahoo.com/news/us-sec-denies-coinbase-petition-151002229.html