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FDA allows automatic 'generic' swap for brand-name insulin

FDA allows automatic 'generic' swap for brand-name insulin

U.S. regulators have taken action that will make it easier to get a cheaper and similar version of a brand-name insulin at the drugstoreBy LINDA A. JOHNSON AP Medical WriterJuly 28, 2021, 10:41 PM• 2 min readShare to FacebookShare to TwitterEmail this articleU.S. regulators took action Wednesday that will make it easier to get a cheaper, near-copy of a brand-name insulin at the drugstore.Doctors now have to specifically prescribe what’s called a biosimilar or OK substituting it for a more expensive brand-name insulin.Wednesday’s move by the Food and Drug Administration will allow pharmacists to automatically substitute the cheaper version, just as they do with generic pills for other kinds of drugs.It’s the FDA’s first approval of an “interchangeable” biosimilar, a near-copy of an injected biologic medicine that’s manufactured inside living cells. It could save diabetics and health plans millions of dollars annually and encourage other drugmakers to create more biosimilar medicines. Health data firm IQVIA projects U.S. savings from increasing use of biosimilars from 2020 through 2024 will top $100 billion.The FDA agreed that Viatris Inc.’s Semglee was interchangeable with widely used Lantus, a fast-acting insulin.Approval of a second such interchangeable biosimilar of a long-acting insulin appears imminent from the same developers, Pittsburgh-based generic giant Viatris and its partner, India’s Biocon.Mylan N.V., one of two companies that merged to create Viatris last December, launched Semglee in the U.S. last summer.Red tape, lengthy patents and pushback from brand-name drugmakers have limited U.S. sales of biosimilars to far below levels in Europe.“These products are highly similar but much more affordable,” said Sean McGowan, head of biosimilars at AmerisourceBergen, a top drug wholesaler.Only 20 of 29 FDA-approved biosimilars — for cancer and immune disorders like rheumatoid arthritis — are sold in the U.S. so far, he said.Depending on the pharmacy, Semglee injector pens cost about $150 to $190 without insurance for a typical month’s supply, compared to $340 to $520 for the same supply of brand-name Lantus.———Follow Linda A. Johnson on Twitter: @LindaJ—on Pharma———The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.

Strong Q2 from J&J as pandemic-hit sales, profit recover

Strong Q2 from J&J as pandemic-hit sales, profit recover

NEW YORK — Johnson & Johnson’s second-quarter profit soared 73%, thanks to strong sales growth across all of its businesses as hospitals and the rest of the health care industry continued recovering from the coronavirus pandemic’s impact.The health care giant handily topped Wall Street expectations and hiked its 2021 sales and profit forecasts sharply..The world’s biggest maker of health care products on Wednesday reported second-quarter net income of $6.28 billion, or $2.35 per share, up from $3.63 billion, or $1.36 per share, a year earlier.Adjusted income came to $6.63 billion, or $2.48 per share, blowing past Wall Street projections for $2.28 per share.Revenue totaled a whopping $23.31 billion, up 27.1% from 2020’s second quarter.The one weak spot was dismal sales of J&J’s COVID-19 vaccine, which brought in just $164 million in the quarter and $264 million so far this year.The vaccine has been plagued by concerns about some very rare side effects and the shutdown of the Maryland factory of J&J’s U.S. contract manufacturer, Emergent BioSolutions, due to contamination problems that led to tens of millions of vaccine doses having to be trashed. It’s unclear when — or if — the U.S. Food and Drug Administration will allow the factory to resume production, which was halted in mid-April.J&J has the only authorized vaccine that only requires one shot, so it had been expected to play a huge role in vaccinating people in rural areas and developing countries. Instead, the company has fallen far short of its supply commitments to the U.S., other governments and a World Health Organization-backed program to get affordable vaccines to poor and middle-income countries. However, J&J recently got approval to make more vaccine doses at its newly expanded factory in the Netherlands.Company executives said they expect total 2021 COVID-19 vaccine sales of roughly $2.5 billion, mostly in the fourth quarter.“We hope this will be the start of what we expect to become a vibrant vaccine business over time,” including vaccines it’s developing for HIV, sepsis and respiratory syncytial virus, Jennifer Taubert, head of the prescription medicine business, told analysts on a call to discuss the quarter’s results.Johnson & Johnson noted recent studies show the vaccine works well against coronavirus variants and protects people for at least eight months. The company said it’s selling its vaccine on a nonprofit basis, for $5 to $8 per dose.J&J, based in New Brunswick, New Jersey, said foreign sales jumped 29.5% to $11.39 billion, while U.S. sales rose 24.9% to $11.92 billion.J&J’s medical device and diagnostics division had been a laggard amid a lengthy restructuring and the pandemic leading people to delay scheduled surgeries and other care. It turned in the best performance in the quarter, with revenue jumping 62.7% to $6.98 billion.Still, the company warned that some U.S. hospital systems are again delaying elective procedures as infections and hospitalizations increase amid the latest surge, caused by the highly transmissible delta variant.The maker of cancer drugs Darzalex and Imbruvica reported that prescription drug sales, long the company’s main growth driver, rose 17.2% to $12.6 billion.Sales of consumer health products like Tylenol and Band-Aids, which have been buoyed during the pandemic by medicine cabinet stocking and an increased focus on wellness, climbed 13.3% to $3.74 billion.“The company’s earnings growth has accelerated, driven by newly launched drugs and a decreasing impact from patent losses,” Edward Jones analyst Ashtyn Evans wrote to investors, adding that the current stock price doesn’t fully reflect the growth of J&J’s new products.Evans, noting recent headlines about lawsuits over J&J’s talc products and a potential $5 billion settlement with states over its sales of opioid painkillers Duragesic and Nucynta, said progress in ending that litigation should reduce uncertainty about the stock.Overall sales had a 4.1% benefit from favorable currency exchange rates. During the quarter, J&J’s effective tax rate declined to 5.8% and the company paid shareholders $2.8 billion in dividends.During the quarter, the FDA approved J&J’s Rybrevant, the first targeted treatment for non-small cell lung cancer that has certain genetic mutations.Johnson & Johnson said it expects adjusted full-year earnings in the range of $9.60 to $9.70 per share, up from its April forecast of $9.42 to $9.57. It expects revenue in the range of $93.8 billion to $94.6 billion, up from $90.6 billion to $91.6 billion.In afternoon trading, J&J shares rose 82 cents to $169.27.———Follow Linda A. Johnson on Twitter: @LindaJ—on Pharma

New Merck pneumonia vaccine OK'd in US weeks after Pfizer's

New Merck pneumonia vaccine OK'd in US weeks after Pfizer's

U.S. regulators have approved a new pneumonia vaccine from Merck, more than a month after OK’ing an improved version of rival Pfizer’s shotBy LINDA A. JOHNSON AP Medical WriterJuly 16, 2021, 10:17 PM• 2 min readShare to FacebookShare to TwitterEmail this articleU.S. regulators have approved a new pneumonia vaccine from Merck, more than a month after OK’ing an improved version of rival Pfizer’s shot.Both new shots offer better protection against bacteria that can cause pneumonia, meningitis and blood infections, as well as garden-variety ear and sinus infections.Merck said Friday that the Food and Drug Administration approved its shot, called Vaxneuvance, for people aged 18 and up. It protects against 15 of the roughly 100 pneumococcal strains, including those most responsible for severe disease.Merck hasn’t disclosed its shot’s price or when it will be launched.Pfizer’s updated vaccine, Prevnar 20, was approved on June 8 for adults. It has a list price of $232, but Pfizer said insured patients likely can be vaccinated for free or at low cost.A panel of U.S. Centers for Disease Control and Prevention vaccine experts is set to review both vaccines in October and recommend who should get them.Pfizer’s new vaccine protects against seven more strains than the decade-old Prevnar 13, long the world’s most-lucrative vaccine with nearly $6 billion in annual revenue. In one large study, the new shot was 75% effective against the most serious disease.Merck said testing showed its new vaccine works as well as Prevnar 13 against the strains both vaccines fight, but that it’s more effective against one strain.Merck and Pfizer have been testing their shots in children and infants and plan to seek approval for those age groups.Meanwhile, Merck will continue selling its 38-year-old Pneumovax 23 vaccine, which protects against 23 strains and is approved for kids. It uses an older technology that doesn’t cause as strong or long-lasting an immune response as the two newly approved shots.———Follow Linda A. Johnson on Twitter: @LindaJ—on Pharma———The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.

New Merck pneumonia vaccine OK'd in US weeks after Pfizer's

New Merck pneumonia vaccine OK'd in US weeks after Pfizer's

U.S. regulators have approved a new pneumonia vaccine from Merck, more than a month after OK’ing an improved version of rival Pfizer’s shotBy LINDA A. JOHNSON AP Medical WriterJuly 16, 2021, 10:05 PM• 2 min readShare to FacebookShare to TwitterEmail this articleU.S. regulators have approved a new pneumonia vaccine from Merck, more than a month after OK’ing an improved version of rival Pfizer’s shot.Both new shots offer better protection against bacteria that can cause pneumonia, meningitis and blood infections, as well as garden-variety ear and sinus infections.Merck said Friday that the Food and Drug Administration approved its shot, called Vaxneuvance, for people aged 18 and up. It protects against 15 of the roughly 100 pneumococcal strains, including those most responsible for severe disease.Merck hasn’t disclosed its shot’s price or when it will be launched.Pfizer’s updated vaccine, Prevnar 20, was approved on June 8 for adults. It has a list price of $232, but Pfizer said insured patients likely can be vaccinated for free or at low cost.A panel of U.S. Centers for Disease Control and Prevention vaccine experts is set to review both vaccines in October and recommend who should get them.Pfizer’s new vaccine protects against seven more strains than the decade-old Prevnar 13, long the world’s most-lucrative vaccine with nearly $6 billion in annual revenue. In one large study, the new shot was 75% effective against the most serious disease.Merck said testing showed its new vaccine works as well as Prevnar 13 against the strains both vaccines fight, but that it’s more effective against one strain.Merck and Pfizer have been testing their shots in children and infants and plan to seek approval for those age groups.Meanwhile, Merck will continue selling its 38-year-old Pneumovax 23 vaccine, which protects against 23 strains and is approved for kids. It uses an older technology that doesn’t cause as strong or long-lasting an immune response as the two newly approved shots.———Follow Linda A. Johnson on Twitter: @LindaJ—on Pharma———The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.

Johnson & Johnson recalling sunscreens due to benzene traces

Johnson & Johnson recalling sunscreens due to benzene traces

Johnson & Johnson says it is recalling five of its sunscreen products after some samples were found to contained low levels of benzene, a chemical that can cause cancer with repeated exposureBy LINDA A. JOHNSON AP Medical WriterJuly 14, 2021, 10:31 PM• 2 min readShare to FacebookShare to TwitterEmail this articleJohnson & Johnson said Wednesday that it is recalling five of its sunscreen products after some samples were found to contain low levels of benzene, a chemical that can cause cancer with repeated exposure.The affected products, packaged in aerosol cans, are Aveeno Protect + Refresh aerosol sunscreen, and four Neutrogena sunscreen versions: Beach Defense aerosol sunscreen, CoolDry Sport aerosol sunscreen, Invisible Daily Defense aerosol sunscreen and UltraSheer aerosol sunscreen.The recall includes all can sizes and all levels of sun protection factor, or SPF. The products were distributed nationwide through retailers.The health care giant said the benzene was found after testing by the company and an independent laboratory. It is investigating how the chemical got into the products.J&J said it’s working to get all lots of the five products removed from store shelves. It urged consumers to stop using the sunscreens immediately and said customers can get a refund by calling J&J’s Consumer Care Center at 1-800-458-1673. More information is available at the websites for Neutrogena and Aveeno.J&J said in a statement that “use of these products would not be expected to cause adverse health consequences” and that it voluntarily decided to recall them “out of an abundance of caution.” The statement added that people should use an alternate sunscreen to protect themselves from the skin cancer melanoma.Benzene is a highly flammable, widely used chemical that’s present throughout the environment. It can cause cancer with repeated exposure at high enough levels. It also can damage the immune system and prevent cells from functioning properly, according to the U.S. Centers for Disease Control and Prevention.The chemical’s effects vary by whether a person accidentally inhales or ingests it or gets it on skin and clothing. Symptoms range from dizziness and irregular heartbeat to convulsions and, at very high levels, death.J&J, which is based in New Brunswick, New Jersey, said it has notified the Food and Drug Administration of the recall.———Follow Linda A. Johnson at https://twitter.com/LindaJ—onPharma.

Johnson & Johnson recalling sunscreens due to benzene traces

Johnson & Johnson recalling sunscreens due to benzene traces

Johnson & Johnson says it is recalling five of its sunscreen products after some samples were found to contained low levels of benzene, a chemical that can cause cancer with repeated exposureBy LINDA A. JOHNSON AP Medical WriterJuly 14, 2021, 10:21 PM• 2 min readShare to FacebookShare to TwitterEmail this articleJohnson & Johnson said Wednesday that it is recalling five of its sunscreen products after some samples were found to contain low levels of benzene, a chemical that can cause cancer with repeated exposure.The affected products, packaged in aerosol cans, are Aveeno Protect + Refresh aerosol sunscreen, and four Neutrogena sunscreen versions: Beach Defense aerosol sunscreen, CoolDry Sport aerosol sunscreen, Invisible Daily Defense aerosol sunscreen and UltraSheer aerosol sunscreen.The recall includes all can sizes and all levels of sun protection factor, or SPF. The products were distributed nationwide through retailers.The health care giant said the benzene was found after testing by the company and an independent laboratory. It is investigating how the chemical got into the products.J&J said it’s working to get all lots of the five products removed from store shelves. It urged consumers to stop using the sunscreens immediately and said customers can get a refund by calling J&J’s Consumer Care Center at 1-800-458-1673. More information is available at the websites for Neutrogena and Aveeno.J&J said in a statement that “use of these products would not be expected to cause adverse health consequences” and that it voluntarily decided to recall them “out of an abundance of caution.” The statement added that people should use an alternate sunscreen to protect themselves from the skin cancer melanoma.Benzene is a highly flammable, widely used chemical that’s present throughout the environment. It can cause cancer with repeated exposure at high enough levels. It also can damage the immune system and prevent cells from functioning properly, according to the U.S. Centers for Disease Control and Prevention.The chemical’s effects vary by whether a person accidentally inhales or ingests it or gets it on skin and clothing. Symptoms range from dizziness and irregular heartbeat to convulsions and, at very high levels, death.J&J, which is based in New Brunswick, New Jersey, said it has notified the Food and Drug Administration of the recall.———Follow Linda A. Johnson at https://twitter.com/LindaJ—onPharma.

Condo collapse victim fought at failed Bay of Pigs invasion

Condo collapse victim fought at failed Bay of Pigs invasion

Sixty years before Juan Mora’s Florida condo building came crashing down, killing him and at least 89 others, he was among hundreds of Cuban exiles who signed up for a covert, CIA-funded operation to overthrow Fidel Castro’s Soviet-backed dictatorship.Mora’s dream of restoring democracy in his homeland took him from military training at a Guatemalan jungle camp to the failed 1961 Bay of Pigs invasion, where he was captured and then crammed into a decrepit, rat-filled Cuban prison for 20 months, friends once imprisoned with him told The Associated Press.Authorities on Wednesday identified the remains of 80-year-old Juan A. Mora, also known as Juanito, recovered from the rubble of the Champlain Towers South building in Surfside. Others killed included his wife, Ana, and their adult son, Juan Mora Jr., who worked in Chicago and had been staying with his parents when their 12-story building suddenly pancaked on June 24.Mora Sr. was a much-liked figure in the Miami area Cuban-American community, once active in the Bay of Pigs Veterans Association and the Bay of Pigs Museum it houses, museum board member Humberto Lopez said Friday. Mora was “always trying to help,” organizing events, writing editorials about the invasion and emailing with other members of the veterans group, Lopez recalled.Lopez said he and the loquacious Mora were close for the past decade, and described his wife as “charismatic.”Ana Mora had worked as assistant to the president of a prestigious Catholic high school in Miami, Belen Jesuit Prep, from which the couple’s son had graduated, said another family friend, Johnny Lopez de la Cruz, president of the museum and veteran’s association.Mora Jr. was a manager for Morton Salt’s road salt business in Chicago, according to a close friend there, Matthew Kaade, who graduated with him from Loyola University in Chicago in 2011.Lopez de la Cruz said Mora Sr. also had two daughters from a prior marriage. Another friend, Humberto Diaz Arguelles, said Mora’s first wife died of cancer.Mora Sr. was part of a band of Cuban exiles funded by the CIA late in the Eisenhower administration to help counter Soviet influence and missiles placed in Cuba. The volunteers were sent to training camps in Guatemala’s jungle in 1960 and early 1961. The force came to be known as Brigade 2506 — the ID number of the first casualty, a man who fell off a cliff during a training accident, said Diaz Arguelles, who trained at one of the camps with Mora.They lived in tents, eating food that was sometimes spoiled and drinking river water as they learned to use machine guns, grenades, bazookas and mortars.“We were so convinced about what we were doing to go free Cuba that nobody complained,” Diaz Arguelles remembered.He said Mora, a radio operator in the brigade’s Battalion 3, was lively and popular and “always talking about every subject you can think of.”When training ended in April 1961 and the fighters headed to Cuba, they realized they weren’t getting the help they’d been promised by the U.S. military, including aerial support and a “navy armada,” Diaz Arguelles said. Roughly 1,400 men were transported from a Nicaraguan port in rusty merchant cargo ships to the Bay of Pigs on Cuba’s southern coast, then had to climb down ropes in the dark to board “18-foot aluminum boats from Sears” and reach the beach — while under fire, because Castro had learned of the invasion in advance.“There was no time to get scared,” said Diaz Arguelles, whose boat sank after hitting a reef, forcing him to swim ashore with a mortar tube and two boxes of ammo.President John F. Kennedy, who authorized the mission barely three months into his term, had canceled a second planned airstrike after U.S. support for the April 17, 1961, invasion became known, according to the JFK Library.After three days fighting the overwhelming Cuban force, hiding in swamps and running out of ammunition, water and food, more than 100 members of the 2506 Brigade had been killed. Diaz Arguelles and about 20 invaders were surrounded by Cuban troops and taken to Castillo del Principe, or Castle of the Prince, a huge military fort in Havana. There Diaz Arguelles again met Mora, who like him had been captured.Diaz Arguelles said the prison was deteriorated and full of fungus, and they had to sleep on the floor with rats running over them at night. Their meager food had rats and cockroaches in it, and contaminated water left the men sick and weak.Lopez also was imprisoned there and spent about eight months in the same cell with Mora, who was then moved elsewhere in the prison.Nearly 1,200 prisoners eventually were returned to the U.S. in exchange for $53 million in food and medicine, according to the JFK Library. The Brigade 2506 survivors were flown to Florida just before Christmas 1962 and reunited with whatever family they had there.Diaz Arguelles said he and Mora both got jobs and worked their way through college.The men had drifted apart for years but reconnected after retirement. Diaz Arguelles recalled Mora had owned a business selling hurricane-proof windows and doors for at least a decade, and said they last spoke a couple months ago, naturally about the Bay of Pigs veterans group.———Follow Linda A. Johnson on Twitter: LindaJ—onPharma

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