The news of the day in Health. Alzheimer’s drug approval slowed. FDA approves therapy for bladder cancer

The news of the day in Health. Alzheimer’s drug approval slowed. FDA approves therapy for bladder cancer
The news of the day in Health. Alzheimer’s drug approval slowed. FDA approves therapy for bladder cancer
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Adoption of Alzheimer’s drug in the US is being slowed by physician skepticism. Nine months after launching the first drug proven to slow the progression of Alzheimer’s disease in the US, Eisai and Biogen’s Leqembi faces an unexpected roadblock to widespread use: a lingering belief among some doctors that treating the memory-impairing disease is useless.

Alzheimer’s experts had anticipated roadblocks because of Leqembi’s requirements, which include additional diagnostic tests, twice-monthly infusions and regular brain scans to prevent potentially fatal side effects, Reuters reports.

The fight for emergency abortions in the US

US Supreme Court grapples with fight over emergency abortions after overturning Roe. The idea that a doctor in the United States would have to consider the risk of prison before performing an emergency abortion might have been difficult to imagine two years ago.

But after the U.S. Supreme Court in June 2022 overturned the 1973 Roe v. Wade decision that had legalized abortion nationwide, such dilemmas are a reality in several states that have since passed Republican-backed near-total bans that include the threat of criminal penalties and loss of medical license.

US FDA approves ImmunityBio’s bladder cancer therapy

The US health regulator on Monday approved ImmunityBio’s combination therapy to treat a type of bladder cancer, marking the end of the company’s efforts to bring its therapy to market. The green light from the agency is a boost for ImmunityBio, which expressed doubts in a regulatory filing last month about its ability to stay in business.

India asks spice makers to check quality after Hong Kong allegations

India’s spice export regulator has asked MDH and Everest to provide details of quality checks after sales of some of their products were halted in Hong Kong for allegedly containing high levels of a carcinogenic pesticide. The companies’ products are extremely popular in India and are exported to countries in Europe, Asia and North America.

Abeona shares fall following FDA refusal to approve treatment for skin condition

Abeona Therapeutics said on Monday that the US Food and Drug Administration (FDA) refused to approve its treatment for a rare condition that causes skin blisters, sending its shares tumbling 51% in after-hours trading.

The health regulator has asked for some additional data to meet chemistry, manufacturing and controls requirements before the treatment, called pz-cel, can be approved in what is called a “complete response letter”.

The Pfizer vs. Patent trial for COVID vaccines begins in UK

Pfizer and BioNTech asked a London court to invalidate rival Moderna’s patents on technology key to the development of COVID-19 vaccines, as the latest stage of a global legal battle began on Tuesday. Pfizer and its German partner BioNTech sued Moderna at the High Court in London in September 2022, seeking the cancellation of patents held by Moderna, which countered a few days later alleging that its patents had been infringed.

Novartis raises forecast after beating expectations in Q1

Swiss drugmaker Novartis raised its annual forecast due to wider use of psoriasis and arthritis drug Cosentyx on Tuesday and said it had recruited the former head of Bristol Myers Squibb (BMS) to become its chairman next year. Its 2024 net sales are expected to grow by a low double-digit percentage by a few tenths of a percentage point, Novartis said in a statement.

Danaher beats quarterly expectations on strength in diagnostics business

Danaher beat quarterly profit and sales estimates on Tuesday thanks to strength in its diagnostics and bioprocessing businesses, sending the life sciences firm’s shares up more than 7% before the market opened. However, the company forecast a single-digit percentage decline in 2024 core adjusted revenue as the impact of reduced demand is expected to continue into the second quarter of 2024.

Quest Diagnostics raises its forecast for profit and revenue in 2024 due to strong demand

Lab operator Quest Diagnostics raised its 2024 profit and revenue forecast on Tuesday after beating first-quarter estimates on strong demand for its diagnostic tests. Demand for routine diagnostic health exams has increased over the past few quarters as more people undergo non-urgent surgeries that have been postponed due to the pandemic.

The new Biden rule protects the privacy of women who have abortions

US President Joe Biden’s administration on Monday issued a final rule designed to strengthen privacy protections for women seeking abortions, barring the release of protected medical information related to reproductive health. The new rule, issued through the Office for Civil Rights of the US Department of Health and Human Services, strengthens existing provisions under the Health Portability Insurance Privacy Rule of 1996 (HIPAA).

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Tags: news day Health Alzheimers drug approval slowed FDA approves therapy bladder cancer

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