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A batch of Johnson & Johnson's COVID-19 vaccine failed quality standards and can't be used, the drug giant said Wednesday. The drugmaker didn't say how many doses were lost, and it wasn't clear how the problem would impact future deliveries. A vaccine ingredient made by Emergent BioSolutions — one of about 10 companies that Johnson & Johnson is using to speed up manufacturing of its recently approved vaccine — did not meet quality standards, J&J said. J&J said the Emergent BioSolutions factory involved had not yet been approved by the U.S. Foo...
WASHINGTON (AP) — President Joe Biden said Tuesday that the U.S. expects to take delivery of enough coronavirus vaccines for all adults by the end of May, two months earlier than anticipated, as his administration announced that drugmaker Merck & Co. will help produce rival Johnson & Johnson's newly approved shot. With the bolstered supply, Biden also announced he would be using the powers of the federal government to direct all states to prioritize vaccinating teachers, and said the federal government would provide the doses directly through i...
The first one-shot COVID-19 vaccine provides good protection against the illness, Johnson & Johnson reported in a key study released Friday, offering the world a potentially important new tool as it races to stay ahead of the rapidly mutating virus. The pharmaceutical giant's preliminary findings suggest the single-dose option may not be as strong as Pfizer's or Moderna's two-dose formula, and was markedly weaker against a worrisome mutated version of the virus in South Africa. But amid a rocky start to vaccinations worldwide, that may be an...
When natural disasters strike, quickly getting the right aid to people is difficult at best. Doing so amid the worst pandemic in a century increases that challenge dramatically. For thousands of Americans displaced this year by hurricanes, floods and wildfires — plus those trying to avoid COVID-19 — getting their drugs and medical supplies has been critical. Healthcare Ready, a tiny disaster preparedness and response group, serves as a crucial hub for coordinating donations and shipments of medicines, protective gear and other supplies to tho...
As most of the nation hunkered down amid the coronavirus pandemic, visits to doctor offices and outpatient clinics plunged. That's helping cause major swings in prescription drug use. Express Scripts, a top prescription benefit manager with over 100 million customers, saw big jumps in people getting three-month refills via mail delivery, as people with chronic health problems stocked up early in the crisis. Refills jumped 18% between mid-March and mid-April. Then prescription orders started dropping, partly from all the patients who'd just...
U.S. regulators on Friday approved a new drug for an aggressive type of breast cancer that's spread in the body — including into the brain, where it's especially tough to treat. The Food and Drug Administration said Tukysa, a twice-daily pill developed by Seattle Genetics, is for people with what's known as HER2-positive breast cancer that has spread and resisted multiple other medicines. This type of cancer is driven by an overactive gene that makes too much of the HER2 protein, which promotes cancer growth. Each year, about 50,000 people i...
WASHINGTON (AP) — Health officials reported the first U.S. drug shortage tied to the viral outbreak that is disrupting production in China, but they declined to identify the manufacturer or the product. The Food and Drug Administration said late Thursday that the drug's maker recently contacted officials about the shortage, which it blamed on a manufacturing issue with the medicine's key ingredient. Regulators stressed that alternative medicines are available to treat patients. The FDA previously said it had reached out to 180 drug m...
U.S. hospitals fed up with shortages of critical medicines — mostly generic drugs that aren't profitable — have banded together. Seven hospital systems and three philanthropies formed nonprofit CivicaRx in 2018 to produce what they need. The group now includes 1,200 hospitals nationwide — about 1 in 4 — and already is shipping medicines. Shortages of antibiotics, pain, cancer and other injected medications disrupt care and cost hospitals about $590 million annually. That's for expenses including long hours that pharmacy staff spend trying...
Anyone under 21 can no longer legally buy cigarettes, cigars or any other tobacco products in the U.S. The new law enacted last week by Congress also applies to electronic cigarettes and vaping products that heat a liquid containing nicotine. The provision raising the legal limit from 18 to 21 nationwide was in a massive spending bill passed by Congress and signed by the president on Dec. 20. About one-third of states already had their own laws restricting tobacco sales to people 21 and older. "This is a major step in protecting the next...
Walmart, CVS and Rite Aid have pulled some or all 22-ounce bottles of Johnson's baby powder from shelves to avoid confusing consumers, after a minuscule amount of asbestos was found in one bottle. Johnson & Johnson recalled all 33,000 bottles from the same lot as that bottle last Friday, a day after the U.S. Food and Drug Administration notified the company that routine testing discovered the asbestos in one bottle bought from an online retailer. The 22-ounce bottle came from a lot distributed in 2018. Baby powder bottles in other sizes are...
Johnson & Johnson investors exhaled in relief Tuesday, pushing up the company's shares after an Oklahoma judge imposed a $572 million verdict for the health care giant's role in the nation's opioid crisis. During the seven week trial, state prosecutors who sought up to $17 billion described J&J as a "kingpin" in an epidemic that's killed more than 400,000 Americans since 2000. The monetary award announced Monday, and J&J's vow to appeal, reassured investors — at least for now. "The risk of a loss was already baked into the stock price," n...
TRENTON, N.J. (AP) — For decades, bacteria have been figuring out ways to outsmart the antibiotics that once easily killed them. Partly due to overuse, the bugs' ability to resist antibiotics is rising, as are the cost and time to treat patients. Meanwhile, fewer drugmakers are developing new antibiotics, thanks to the economics: Antibiotics are inexpensive, and patients only take them briefly. Drug companies reap far bigger profits from medicines that people take for years. Drug-resistant bacterial infections annually kill about 23,000 A...
U.S. regulators have approved the first generic nasal spray version of Narcan, a drug that reverses opioid overdoses. The Food and Drug Administration on Friday OK'd naloxone spray from Israel's Teva Pharmaceuticals. Naloxone has been sold as a nasal spray in the U.S. since 2016 under the brand name Narcan. Pharmacists can dispense it without a prescription. It is also sold as a generic or brand-name drug in automatic injectors, prefilled syringes and vials. A pack of two Narcan nasal sprays cost about $130 to $150 without insurance. Teva...
TRENTON, N.J. (AP) — The U.S. Food and Drug Administration has approved the first drug specifically developed for severe depression after childbirth. The agency on Tuesday approved Sage Therapeutics' Zulresso, an IV drug given over 2 ½ days. Sage said Zulresso will cost $34,000 without insurance, plus costs for staying in a hospital or infusion center. Whether the treatment gets covered by insurance is determined by each insurance company, which also sets the out-of-pocket costs, depending on the plan. In a company-funded study of new mo...
The U.S. Food and Drug Administration has approved the first immunotherapy drug for breast cancer. Swiss drugmaker Roche's Tecentriq was OK'd Friday for treating advanced triple-negative breast cancer, which accounts for about 15 percent of cases. It's to be given with chemotherapy, the standard treatment. Mount Sinai breast cancer specialist Dr. Amy Tiersten in New York called it "tremendously exciting news." Approved for two other cancers, Tecentriq works by boosting the immune system's ability to spot and kill cancer cells. In a study of...
The first generic version of the popular Advair asthma inhaler has been approved by U.S. regulators. The Food and Drug Administration on Wednesday approved Mylan's version in three strengths for ages 4 and up. The inhalers are used twice daily to keep airways open and prevent flare-ups of wheezing, shortness of breath and other symptoms of asthma or chronic obstructive pulmonary disease. About 42 million Americans have those conditions. The device contains two medicines, inhaled in a precise mixture. That complexity has stymied a couple of...
TRENTON, N.J. (AP) — U.S. regulators on Friday approved a fast-acting, super-potent opioid tablet as an alternative to IV painkillers used in hospitals. The decision by the Food and Drug Administration came over objections from critics who fear the pill will be abused. In a lengthy statement, FDA Commissioner Scott Gottlieb said there will be "very tight restrictions" placed on its distribution and it is intended only for supervised settings like hospitals. The tiny pill was developed as an option for patients who pose difficulties for the u...
TRENTON, N.J. (AP) — U.S. health regulators have approved the first new type of flu drug in two decades. Wednesday's approval of Xofluza for people age 12 and older comes ahead of the brunt of this winter's flu season. Xofluza is a pill that can reduce severity and shorten duration of flu symptoms after one just dose. It was developed by the Roche Group and Shionogi & Co. It works about as well as Tamiflu, Roche's older flu treatment, which is also available in cheaper generic versions. Tamiflu is taken twice daily for five days. Health o...
TRENTON, N.J. (AP) — For Bridgett Snelten, changing her health insurance meant enduring wild blood sugar swings, bouts of vomiting and weight gain. The Sandy, Utah mother of two young girls has diabetes and has had to change health insurance plans three years in a row. Twice, new insurers wouldn't cover Trulicity, a once-a-week injected diabetes medicine she'd been taking that helped control her blood sugar tightly. Instead, they made her return to an inexpensive, twice-a-day injected diabetes drug she and her doctor knew didn't work for h...
TRENTON, N.J. (AP) — Drugmakers will start disclosing the prices for U.S. prescription drugs that are advertised on TV, but the Trump administration said the move announced Monday doesn't go far enough. The prices won't actually be shown in the TV commercials. But starting next April, advertisements mentioning a drug by name will include a website where the list price and other information will be posted, the industry's largest trade group said. The announcement came hours before a speech by Health and Human Services Secretary Alex Azar on a n...
U.S. regulators Friday expanded the use of Merck's cervical cancer vaccine to adults up to age 45. The vaccine was previously only for preteens and young adults through 26. The Food and Drug Administration approved Gardasil 9 for women and men through 45. The vaccine protects against the human papilloma virus — or HPV — which can cause cervical cancer, certain other cancers and genital warts. The virus is very common and is spread through sex. In most cases, HPV doesn't cause any problems, but some infections persist and eventually lead to can...
TRENTON, N.J. (AP) — A new treatment for pain caused by endometriosis was approved Tuesday by U.S. regulators. The common condition involves abnormal tissue growth from the uterus that can cause severe pain and infertility. Drugmaker Abbvie said the Food and Drug Administration approved the drug, Orilissa, for pain during menstruation and intercourse and at other times. Abbvie says it's the first new pill for endometriosis in a decade. In testing, it significantly reduced menstrual pain in about 45 percent of women given a low dose and 75 p...
U.S. regulators proposed new guidelines Tuesday to make it easier for some common medicines to be sold without a prescription — and more convenient for consumers to get them. The Food and Drug Administration is evaluating ways to make sure patients don't take an inappropriate over-the-counter drug, Commissioner Scott Gottlieb said in a statement. That could include adding information to the packaging label and offering online questionnaires to help people decide if a drug is right for them. Drugmakers would have to do studies showing those s...
The U.S. Food and Drug Administration said Thursday it wants to more aggressively fight medication shortages that have led to rationing of some drugs and disrupted patient care. The agency announced plans for a task force to find ways to improve the supply of crucial drugs. It's a new approach for the drug regulator, which has very little control over drugmakers' operations. It generally can't act until drugmakers tell the agency that shortages are imminent or that it will stop making a drug. FDA Commissioner Dr. Scott Gottlieb said the agency...
U.S. regulators Friday approved the first treatment for smallpox — a deadly disease that was wiped out four decades ago — in case the virus is used in a terror attack. Smallpox, which is highly contagious, was eradicated worldwide by 1980 after a huge vaccination campaign. But people born since then haven't been vaccinated, and small samples of the smallpox virus were saved for research purposes, leaving the possibility it could be used as a biological weapon. Maker SIGA Technologies of New York has already delivered 2 million treatments tha...
