US FDA refuses to approve Eli Lilly’s bowel disease drug; Catalent Reports Problems at Its Manufacturing Plants; Departure of CFO and more [Beuzz]

US FDA refuses to approve Eli Lilly's bowel disease drug;  Catalent Reports Problems at Its Manufacturing Plants;  Departure of CFO and more

Here is a summary of health news briefs.

US FDA refuses to approve Eli Lilly’s bowel disease drug

Eli Lilly and Co said on Thursday that the US Food and Drug Administration (FDA) had refused to approve its drug to treat a type of inflammatory bowel disease in adults. The agency’s decision puts Lilly even further in its quest to enter the nearly $20 billion market, which already has disease drugs from rivals such as Abbvie Inc, Pfizer Inc and Johnson & Johnson.

Catalent Reports Problems at Its Manufacturing Plants; Departure of the financial director

Contract drugmaker Catalent Inc warned on Friday that low production at three of its facilities and higher costs would impact its fiscal 2023 results and said its chief financial officer Thomas Castellano had resigned, making fall its shares by 20%. The company’s customers include COVID-19 vaccine makers such as Moderna Inc and Johnson & Johnson.

Philips clarifies respirator replacement numbers after new FDA reprimand

Philips said on Friday that 2.2 million devices it repaired or replaced during a major breathing apparatus recall are actually in the hands of patients in the United States. The Dutch healthcare device maker released a statement clarifying the progress of the ongoing recall program since 2021 after the FDA released a statement on April 13 that the number of devices the company replaced was “significantly lower to the 2.46 million listed on the company’s website.

Biden administration to ask Supreme Court to stop restrictions on abortion pills

U.S. Attorney General Merrick Garland said Thursday the Justice Department will ask the Supreme Court to intervene to end restrictions set by a federal judge on the abortion pill mifepristone, as the administration of President Joe Biden is taking action to defend access to medicine. The administration will seek emergency assistance from the Supreme Court to uphold “the scientific judgment of the United States Food and Drug Administration and protect Americans’ access to safe and effective reproductive care,” Garland said in a statement. a statement.

No evidence COVID came from animals, says former China CDC chief

There is no evidence that the virus that causes COVID came from animals, the former head of China’s Centers for Disease Control and Prevention (CDC) said on Friday. George Gao, who was speaking at a London pandemic preparedness summit, was the head of the agency when COVID first emerged in Wuhan, China in late 2019.

UnitedHealth expects Medicare enrollment gains to boost 2023 profits

UnitedHealth Group Inc beat Wall Street’s quarterly profit targets and raised its full-year guidance on Friday, as the healthcare giant bets on ‘market-leading’ membership growth in its health insurance plans backed by the federal government. UnitedHealth is one of the biggest players in the Medicare Advantage market, where private insurers provide an alternative to the original Medicare – the federal government’s health insurance plan for people age 65 and older or those with certain disabilities.

FDA imposes new safety warnings for opioid painkillers

The U.S. Food and Drug Administration said Thursday it would require new safety warnings to be added to prescribing information on opioid painkiller labels, including a warning about increased sensitivity to pain. The FDA said data suggests that patients who use opioids for pain relief after surgery often have leftover pills, putting them at risk for addiction and overdose.

Florida Governor Desantis signs law banning abortion for 6 weeks

Republican Florida Governor Ron DeSantis signed a bill that bans most abortions after six weeks, paving the way for a drastic reduction in abortion access in the state and in the southern states -United. DeSantis signed the legislation late Thursday night after lawmakers in the state’s Republican-led House of Representatives approved it by a 70-40 vote. The bill passed the US Senate. state by a vote of 26 to 13 on April 3.

Some US abortion pill suppliers limit availability after appeals court ruling

U.S. telehealth and in-person abortion providers rushed Thursday to keep medical abortion services available after a federal appeals court ruled the abortion pill mifepristone could be dispensed as part of ongoing litigation, but with significant restrictions. The United States Court of Appeals for the 5th Circuit, based in New Orleans, on Wednesday upheld a lower court order that limited the use of the pill to the first seven weeks of pregnancy and required medical visits in no one to get it.

Biden seeks to expand access to health insurance for DACA participants

The Biden administration is seeking to allow immigrants brought to the United States illegally as children to have greater access to health insurance through federal programs, the White House said Thursday. The proposal would allow Deferred Action for Childhood Arrivals, or DACA, participants to access health insurance under the Medicaid and Affordable Care Act (ACA) exchanges, he said.

(With agency contributions.)