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The Latest Breaking News from FDA

FDA Approval For AstraZeneca - Daiichi's Enhertu Expands To Earlier Use In Metastatic Breast Cancer

The FDA has approved AstraZeneca plc (NASDAQ:AZN) and Daiichi Sankyo's (OTC:DSKYF) Enhertu (trastuzumab deruxtecan) for adult patients with unresectable or metastatic HER2-positive breast cancer. The approval covers patients who have received a prior anti-HER2-based regimen either in the metastatic setting or in the neoadjuvant or adjuvant setting and have developed disease recurrence during or within…

Benzinga

Abortion pills: A post-Roe game-changer — and the next battleground

WASHINGTON — The future of abortion in the U.S. is moving to the mailbox.

Los Angeles Times

Don’t believe the high: FDA issues warning over misleading legal weed claims

Food and Drug Administration warns against unproven health claims of delta-8 THC and packaging that appeals to children

The Guardian - US

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22nd Century Group Reports Q1 Net Sales Of $9M, Up 33% YoY, Net Loss Also Grows

22nd Century Group, Inc. (NASDAQ: XXII) reported results for the first quarter ended March 31, 2022.. The company will host a live audio webcast on May 5, at 10:00 a.m. ET.

Benzinga

The Daily Biotech Pulse: AstraZeneca's 3 Product Updates, Jazz Pharma Licenses Sleeping Disorder Product, Argenx Aces Bleeding Disorder Study

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

Benzinga

Commentary: COVID won’t become endemic until we have a vaccine for kids under 5

Last week, Moderna became the first manufacturer to officially ask the Food and Drug Administration to approve its COVID-19 vaccine for children under 6 years old. One of three companies with authorized COVID-19 vaccines in the United States, Moderna made the request a month after saying its data showed efficacy…

Los Angeles Times

Next battle over access to abortion will focus on pills

More than half of abortions in America are now done with pills, rather than surgery

The Independent UK

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FDA contradicts Pfizer’s advice on 2nd course of COVID drug

There is “no evidence” that a second course of Pfizer Inc.’s Paxlovid will help COVID-19 patients whose symptoms return after an initial course of the antiviral, a U.S. Food and Drug Administration official said a day after Pfizer executives advocated the idea.

Tribune News Service

CBD may be getting into milk and eggs from animals, FDA says

U.S. regulators are concerned about the safety of cannabis compounds taken by animals leaching into human foods like milk and eggs.

Tribune News Service

FDA Issues Warning Letters To Companies Illegally Selling Delta-8 THC, Calls It Dangerous To Consumers

The U.S. Food and Drug Administration issued warning letters to five companies for selling products containing delta-8 THC in ways that violate the Federal Food, Drug, and Cosmetic Act. This action is the first time the FDA has issued warning letters for products containing delta-8 THC.

Benzinga

Democrats call on FDA to remove ‘antiquated discriminatory’ limits on gay, bisexual men donating blood amid Canadian decision

Val Demings and Mark Takano tell The Independent the US should also ‘follow science’

The Independent UK

TransMedics Stock Skyrockets On Increased 2022 Guidance

TransMedics Group Inc (NASDAQ:TMDX) shares got a massive boost after better than expected Q1 earnings and 2022 guidance. The company posted an EPS loss of $(0.38) in line with expectations and higher than $(0.29) a year ago despite more than doubling its sales from Q1 FY21. Net revenue of $15.9 million increased 125%…

Benzinga

Regeneron Posts Drop In Q1 Profit As COVID Antibody Sales Hit, Shares Fall

Regeneron Pharmaceuticals Inc (NASDAQ:REGN) earned $11.49 per share for Q1 FY22, up 16% Y/Y, beating the $10.04 estimate. Sales increased 17% to $2.96 billion, surpassing the analysts' consensus of $2.73 billion, fueled by sales of COVID-19 treatment, REGEN-COV. The company reported a net income of $974 million, down 13%, as its COVID-19…

Benzinga

FDA Accepts AstraZeneca's sBLA for Imfinzi (durvalumab) in biliary tract cancer (BTC) with Priority Review

The U.S. Food and Drug Administration (FDA) has accepted AstraZeneca's (NASDAQ: AZN) supplemental Biologics License Application (sBLA) for Imfinzi (durvalumab), in combination with standard-of-care chemotherapy and granted Priority Review for patients with locally advanced or metastatic biliary tract cancer (BTC).

Benzinga

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Benzinga

The Daily Biotech Pulse: Kezar Life's Lead Asset Fails, Brickell Biotech Offloads Late-Stage Asset, Connect Biopharma Ulcerative Colitis Trial Disappoints

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

Benzinga

FDA Grants Fast Track designation To Aptose Biosciences for HM43239 in Relapsed/Refractory AML Patients and FLT3 Mutation

Aptose Biosciences Inc. (NASDAQ: APTO) announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to HM43239, an oral, myeloid kinome inhibitor, for the treatment of patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) with FLT3 mutation.

Benzinga

Brickell Biotech Shares Surge After Offloading Late-Stage Asset To Australia-Based Firm

Brickell Biotech Inc (NASDAQ:BBI) agreed to sell sofpironium bromide rights to Australia-based Botanix Pharmaceuticals Limited. Brickell will receive upfront and potential near-term regulatory milestone payments over the next 18 months of up to $9 million. Brickell also is eligible to receive additional milestone payments of up to $168 million and tiered earn-out payments ranging from high-single…

Benzinga

AstraZeneca's Imfinzi/Chemo Combo Goes Under Priority FDA Review For Bile Duct Cancer

The FDA has accepted AstraZeneca plc’s (NASDAQ) supplemental marketing application seeking approval for Imfinzi (durvalumab), in combination with standard-of-care chemotherapy, for locally advanced or metastatic biliary tract cancer (BTC). Under the Priority Review status, the FDA action date is during the third quarter of 2022. BTC is a group of rare and aggressive…

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Benzinga

80 Biggest Movers From Yesterday

Gainers Blue Water Vaccines, Inc. (NASDAQ: BWV) shares jumped 93.1% to close at $6.45 on Tuesday on above-average volume.

The Conversation

Elon Musk claims his Neuralink brain chip could 'cure' tinnitus in 5 years. But don't hold your breath

The human brain is said to be the most complex biological structure ever to have existed. And while science doesn’t fully understand the brain yet, researchers in the expanding field of neuroscience have been making progress.

Al Jazeera

US abortion advocates vow to fight expected Roe v Wade decision

In Georgia, advocates brace for six-week abortion ban if Supreme Court strikes down landmark Roe v Wade decision.

Reason

The Impact of Overturning Roe v. Wade Will Be Less Dramatic Than Abortion-Rights Advocates Fear

Abortion is likely to remain legal in most states, and workarounds will mitigate the effects of bans.

Benzinga

Mid-Afternoon Market Update: Kymera Therapeutics Drops After Q1 Results; Belite Bio Shares Spike Higher

U.S. stocks traded slightly higher toward the end of trading on Tuesday.

Benzinga

Why Kymera Therapeutics Shares Are Falling Today

In its Q1 earnings release, Kymera Therapeutics Inc (NASDAQ:KYMR) announced the selection of the equivalent of 100 mg, in the fed state, as the dose for the Phase 1 patient cohort (Part C). The cohort is expected to enroll up to 20 patients with hidradenitis suppurativa (HS) and atopic dermatitis (AD). In…

The Independent UK

Pfizer hopes to submit little-kid vaccine data by early June

Pfizer now hopes to tell U.S. regulators how well its COVID-19 vaccine works in the littlest kids by early June

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