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The Latest Breaking News from FDA

After baby formula recall, Abbott says it can restart production at Michigan site within 2 weeks of FDA approval

Abbott Laboratories said it could have some of its recalled infant formulas back on store shelves within eight to 10 weeks after the U.S. Food and Drug Administration gives its approval, though it’s unclear when that approval may come.

Chicago Tribune

Imported infant formula could help lift U.S. supply in weeks -FDA chief

The Food and Drug Administration will outline a plan next week to streamline imports of infant formula, the agency's chief said on Friday, adding that the action along with others would "help dramatically improve the supply in the U.S. in a matter of weeks."

Reuters

House Oversight Committee launches probe into baby formula manufacturers amid nationwide shortage

‘The national formula shortage poses a threat to the health and economic security of infants and families in communities across the country,’ lawmakers write

The Independent UK

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Has Clearmind Developed A Psychedelics-Based Drug That Can Treat Alcoholism? The FDA Is Interested

On Wednesday, May 18, Clearmind Medicine Inc. (OTC Pink: CMNDF) will meet with the Center for Drug Evaluation and Research (CDER), a department within the FDA.

Benzinga

56 Stocks Moving In Friday's Mid-Day Session

Gainers Veru Inc. (NASDAQ: VERU) shares jumped 62.5% to $14.67 after the company reported quarterly results on Thursday. Jefferies maintained Veru with a Buy and raised the price target from $33 to $55.

Benzinga

Amid Slowing Sales at Home, Innovent Biologics Stumbles Overseas

Key takeaways: Innovent Biologics terminated a plan to sell its bevacizumab biosimilar in North America with a local partner after trials for the drug fell behind schedule The company’s loss tripled last year on growing competition for its core product, whose sales fell 22% in this year’s first-quarter

Benzinga

ACHV: First Quarter 2022 Results

By John Vandermosten, CFA NASDAQ:ACHV READ THE FULL ACHV RESEARCH REPORT

Benzinga

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PolarityTE Shares Jump After FDA Regenerative Medicine Advanced Therapy Designation (RMAT) for SkinTE

The U.S. Food and Drug Administration (FDA) has granted a Regenerative Medicine Advanced Therapy (RMAT) designation to PolarityTE’s (NASDAQ: PTE) SkinTE under the its open investigational new drug application (IND).

Benzinga

The Daily Biotech Pulse: FDA Orphan Drug Tags For Neurocrine, Editas Candidates; Sale of BridgeBio's PRV; RMAT Designation For PolarityTE's Product

Here's a roundup of top developments in the biotech space over the last 24 hours:

Benzinga

Tainted baby-formula risk was seen months before Abbott’s recall

Federal inspectors spotted the potential for baby formula made at an Abbott Laboratories plant to become contaminated months before a recall that exacerbated a nationwide shortage, a government document shows.

Tribune News Service

How Bad Government Policy is Fueling the Infant Formula Shortage

Trade restrictions and over-zealous FDA regulation are a big part of the problem, but there's more.

Reason

23 Stocks Moving in Friday's Pre-Market Session

Gainers OTR Acquisition Corp. (NASDAQ: OTRA) rose 88.7% to $18.21 in pre-market trading after filing on Thursday showed shareholders approved merger with Comera Life Sciences.

Benzinga

90 Biggest Movers From Yesterday

Gainers Allena Pharmaceuticals, Inc. (NASDAQ: ALNA) surged 70.5% to close at $0.1330 on Thursday after declining 9% on Wednesday. Allena Pharmaceuticals recently reported a $2.8 million registered direct offering.

Benzinga

How medication abortion works and what the end of Roe v. Wade could mean for it

More people seeking abortions are turning to abortion pills rather than surgical abortion. Here's what to know about the pills, which will likely be at the center of the abortion battles ahead.

WEKU

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The Guardian - UK

UK ministers ‘picking number out of air’ for civil service job cuts, says union

Headcount reduction of 90,000 civil servants is ‘unrealistic’ and poor way to manage government, says FDA union chief

ABC News

US parents swap and sell baby formula amidst country-wide shortage

A US-wide baby formula shortage forces frenzied parents into online groups to swap and sell to each other to keep their babies fed.

The Independent UK

Efficiency minister denies proposed Civil Service cuts are a return to austerity

The Prime Minister was understood to have told his Cabinet on Thursday that the service should be slashed by a fifth.

Chicago Tribune

Editorial: A looming battle over abortion pills threatens cherished freedoms

Following the leak of a draft majority opinion, expectations run high that the U.S. Supreme Court soon will overturn the 1973 Roe v. Wade decision affirming the constitutional right of women to abortion, and we have an idea of what abortion foes will target thereafter: pills.

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Daily Record

Boris Johnson to slash thousands of civil service jobs as PM is accused of letting workers down

The Prime Minister has been repeatedly accused of failing to do enough to tackle the cost of living crisis.

Daily Mirror

Boris Johnson's plan to axe 91,000 civil service jobs branded 'reckless slash and burn'

Boris Johnson told top Tories to cut the number of Whitehall officials by a fifth as he desperately scrambles to free up cash to ease cost of living pressures

The National (Scotland)

Boris Johnson wants to cut civil service jobs back to pre-Brexit levels

BORIS Johnson wants to slash the civil service to its pre-Brexit levels by cutting as many as 90,000 people from the government payroll.

Wales Online

Boris Johnson to axe 90,000 civil service jobs to free cash for tax cuts

The move would reduce Government office staff by 20%

Evening Standard

Jacob Rees-Mogg defends plan to cut 90,000 civil servant jobs

The Prime Minister hinted the money saved by cutting the Civil Service by a fifth could be used for tax cuts

WEKU

Senator says Biden should consider Defense Production Act to boost baby formula supply

Regular and specialized baby formulas have been running low across the U.S. Sen. Kirsten Gillibrand says she will ask President Biden to consider using the Defense Production Act to boost production.

Benzinga

HC Wainwright Says This Stock Is Well Capitalized For Value Realization Of Pipeline, Despite COVID-19 Uncertainty

Given the uncertainty, HC Wainwright moderated its COVID-19 franchise estimates, the primary driver of estimate reductions, and price target reduction to $125 (from $200) on Vir Biotechnology Inc (NASDAQ:VIR). The analyst maintained a Buy rating on VIR shares. The analyst continues to view Vir's platform, validated with successful antiviral therapies against Ebola and COVID-19, and pipeline,…

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