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The Latest Breaking News from FDA

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

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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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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

The Guardian - UK

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.

ABC News

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.

The Independent UK

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.

Chicago Tribune

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 Record

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

Daily Mirror

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.

The National (Scotland)

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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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The Independent UK

Company says it could restart production of baby formula within weeks amid severe shortage

Joe Biden set to discuss the issue and ways to address the shortage with manufacturers

The Independent UK

LOCALIZE IT: Ideas for local coverage of baby formula crisis

Parents across the U.S. are scrambling to find baby formula because supply disruptions and a massive safety recall have swept many leading brands off store shelves.

The Independent UK

EXPLAINER: What's behind the baby formula shortage?

Many parents are hunting for infant formula after a combination of short- and long-term problems hit the biggest U.S. brands

Benzinga

Senators Cory Booker And Brian Schatz Call On Federal Agencies To Research Psychedelics

Senators Brian Schatz (D-HI) and Cory Booker (D-NJ) sent a letter to the National Institutes of Health (NIH) and the FDA whom they called on to study the therapeutic potent

Mic

These F.D.A. approved underwear protect against STIs

Who are they for, exactly?

Benzinga

COCP: Cocrystal Pharma Releases 2022 1st Quarter Results and Provides an Update on the Current Pipeline Programs

By Thomas Kerr, CFA NASDAQ:COCP READ THE FULL COCP RESEARCH REPORT

Benzinga

58 Stocks Moving In Thursday's Mid-Day Session

Gainers Allena Pharmaceuticals, Inc. (NASDAQ: ALNA) jumped 102.6% to $0.1580 after declining 9% on Wednesday. Allena Pharmaceuticals recently reported a $2.8 million registered direct offering.

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