
US FDA declines to approve Capricor's muscle disorder therapy
The FDA said it needed more data to prove the therapy is effective.
Shares of the San Diego-based company fell 33% premarket.
Cardiomyopathy, a condition that affects heart muscles, is the leading cause of death in patients with DMD, a genetic disorder characterized by progressive muscle degeneration and weakness.
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Daily Mail
12 minutes ago
- Daily Mail
World's 'oldest baby' born from embryo frozen in 1994
A baby born just last week holds the title of 'world's oldest baby'—because he was created from an embryo frozen in 1994 and 'adopted' thirty years later. Thaddeus, who is five days old, was born on July 26 to parents Lindsey, 35, and Tim Pierce, 34. The couple from Ohio, were inspired to 'adopt' an embryo after they had struggled to conceive for nearly eight years. Their embryo was one of four created in May 1994 when Linda Archerd, now 62, and her husband underwent invitro fertilisation (IVF) because, like the Pierces, they had struggled to conceive naturally. The process created four viable embryos for the Archerds, one of which resulted in the birth of their daughter, now 30. The other three embryos remained on ice, just in case the family decided to expand their family. Mrs Archerd said: 'I called them my three little hopes. I always wanted another baby desperately.' Once Ms Archerd filed for divorce, she was awarded custody of the embryos which she then decided to put up for adoption. She said: 'I always thought it was the right thing to do.' But, given how long her embryos had been in storage, they were placed under Snowflake's Open Hearts programme, a 'hard to place' scheme for embryos that are less likely to result in a healthy birth. Years later, Mr and Mrs Pierce signed up for the same scheme and the couple finally realised their dream of becoming parents after a successful IVF procedure. Recalling the birth, Mrs Pierce told MIT Technology Review: 'We are in awe that we have this precious baby. 'We had a rough birth, but we're both doing well now. 'We didn't go into it thinking we would break any records. 'We just wanted to have a baby.' Ms Archerd added that she found the whole experience 'surreal', adding it's 'hard to even believe'. IVF procedures often produce far more embryos that can be implanted, resulting in millions of surplus embryos being stored in freezers worldwide. Rejoice Fertility implanted the embryo as part of Dr John Gordon's mission to reduce the number of embryos in storage. Dr Gordon, a reformed Presbyterian, said: 'Every embryo deserves a chance at life and the only embryo that cannot result in a healthy baby is the embryo not given the opportunity to be transferred into a patient.' The previous record for the 'oldest baby' was held by twins born in 2022, who were conceived from embryos frozen 30 years before. The first groundbreaking successful birth through IVF took place in 1978, when Louise Brown was born, paving the way for millions of births worldwide.


Daily Mail
12 minutes ago
- Daily Mail
FDA upgrades recall of cookie products to most dangerous class
The FDA has upgraded a cookie recall danger classification, designating the risk of eating them as causing 'a reasonable probability of death.' The recall was first issued on July 14th when Jalux Americas, Inc, doing business as found undeclared milk and tree nuts not listed on the ingredients label during an inventory audit. Severe allergies can be life-threatening, causing difficulty breathing due to wheezing and throat swelling, a sudden and dangerous drop in blood pressure, a rapid pulse, and shock, as a result of organs and tissues not receiving enough oxygen. The products impacted by the recall are sold as L'espoir cookies and Drycapot cookies, which contain undeclared tree nuts. Milk and tree nut allergies are common, affecting about 6million Americans and 4million Americans, respectively. Both typically begin in childhood and can lead to life-threatening anaphylaxis. According to the FDA : 'People who have an allergy or severe sensitivity to milk and/or tree nuts (almond and macadamia nuts) run the risk of serious or life-threatening allergic reaction if they consume these products.' The recalled products were distributed in California, Illinois, and Washington and sold exclusively at stores in Torrance, CA; San Jose, CA; Arlington Heights, IL; and Lynnwood, WA. The L'espoir, with undeclared milk, was sold at stores between May 26 and June 30, 2025, and the Drycapot, containing undeclared tree nuts, was sold at stores between May 31 and June 30, 2025. There were no online sales. Jalux Americas, Inc, said : 'The recall was initiated after it was discovered during an inventory audit that L'espoir product containing Milk and the Drycapot product containing Tree Nuts were inadvertently distributed in packaging that did not reveal the presence of those allergens. 'No illnesses have been reported to date.' Consumers who have purchased L'espoir L4FN and Drycapot D4FN products with the best before date of September 26, 2025 should return them to where they bought them for a full refund, the company added. The company has already taken remedial steps, telling Newsweek: 'As part of our preventive measures, our supplier partner has added a step at their manufacturing facility to verify that the product matches the label after it is applied, and to record this verification in the production log. 'Our supplier partner will also reinforce allergy and manufacturing procedure training at the facility. 'At the retail store level, we will strengthen our checks during stocking to ensure there are no discrepancies between products and labels, not just for the manufacturer of the recalled products but across all items.' Recalls due to undeclared allergens are not uncommon. Last week, the FDA announced that Tropicale Foods is recalling various Helados Mexico and La Michoacana ice cream products due to undeclared milk, posing a risk of severe allergic reactions. Although 'cream' is listed in ingredients, 'milk' is not explicitly declared, violating allergen labeling laws. And about three weeks ago, the FDA classified a recall by Weaver Nut Company as a dangerous Class 1. Certain chocolate products were recalled due to undeclared milk allergens. The recall was triggered after a customer complaint, and testing confirmed that the chocolate contained milk that was not listed on the ingredients list.


Daily Mail
12 minutes ago
- Daily Mail
Pharma industry latest to be hit by layoffs as industry giant announces sweeping jobs cull
Moderna is set to slash ten percent of its workforce this year, the pharmaceutical giant revealed on Thursday morning. The company - the maker of one of the most prevalent Covid-19 vaccines - now faces uncertainty as that market dwindles. The move, announced in an internal memo by CEO Stephane Bancel, is part of the company's previous plan to cut operating expenses by about $1.5 billion by 2027. 'We've made significant progress by scaling down R&D as respiratory trials conclude, renegotiating supplier agreements, and reducing manufacturing costs,' Bancel said in the memo. Moderna has been banking on revenue from newer mRNA shots, including its experimental COVID-flu combination vaccine, to make up for falling sales of its COVID-19 shot and less-than-expected uptake of its respiratory syncytial virus vaccine. However, investors have been concerned about the prospects of new shots and the changes in vaccine policy under U.S. Health Secretary and vaccine skeptic Robert F. Kennedy Jr.