FDA: Updated COVID boosters will roll out in the fall The updated shots will provide more protection against subvariants that now make up more than 50% of U.S. cases. Axios · Jun 30, 2022
Tweaked COVID boosters in US must target newer omicron types U.S. regulators are telling COVID-19 vaccine makers to tweak any booster doses intended for fall so they protect against the newest omicron relatives The Independent UK · Jun 30, 2022
Wall Street Predicts These 2 Sub-$5 Stocks Have More Than 200% Upside Concerns over the Federal Reserve’s aggressive interest rate hikes to fight elevated inflation and the possibility of the economy tipping into a recession have fostered significant volatility in the market of late. Despite the market uncertainties, Wall Street analysts expect fundamentally sound sub-$5 stocks Provention Bio (PRVB) and Trevi (TRVI)… StockNews.com · Jun 30, 2022
Aura Biosciences' Stock Gains As FDA Grants Fast Track Status To Bladder Cancer Drug The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for Aura Biosciences’ (NASDAQ: AURA) belzupacap sarotalocan (AU-011) for the treatment of Non-Muscle Invasive Bladder Cancer (NMIBC). Benzinga · Jun 30, 2022
The Daily Biotech Pulse: Pfizer/BioNTech Ink New COVID-19 Vaccine Supply Pact, Sanofi Hit By FDA Clinical Hold, Angion Biomedica Halts Second Kidney Disease Trial Here's a roundup of top developments in the biotech space over the last 24 hours: Benzinga · Jun 30, 2022
Avadel Cuts Workforce, Optimizes Cost Structure To Support This Avadel Pharmaceuticals plc (NASDAQ: AVDL) announced its steps to explore every available pathway to accelerate the FDA approval of its lead drug candidate, FT218, before June 2023. Benzinga · Jun 30, 2022
AstraZeneca Says Imfinzi/Chemo Combo Shows Promising Action In Late-Stage Lung Cancer Study AstraZeneca Plc (NASDAQ:AZN) announced high-level results from a planned interim analysis of the AEGEAN Phase 3 trial of Imfinzi (durvalumab) combined with neoadjuvant chemotherapy in patients with resectable non-small cell lung cancer (NSCLC). The data showed that Imfinzi plus neoadjuvant chemo before surgery demonstrated a statistically significant and meaningful improvement in pathologic complete… Benzinga · Jun 30, 2022
Why Sanofi Shares Are Falling Today The FDA has placed Sanofi SA's (NASDAQ:SNY) Phase 3 studies of tolebrutinib in multiple sclerosis and myasthenia gravis on partial clinical hold. New enrollment in the U.S. is paused, and participants in the U.S. who have been in the trial for fewer than 60 days shall suspend the study drug. The participants who… Benzinga · Jun 30, 2022
US Government Calls For Additional Doses Of Pfizer/BioNTech COVID-19 Vaccine Pfizer Inc (NYSE:PFE) and BioNTech SE (NASDAQ:BNTX) have announced a new vaccine supply agreement with the U.S. government. Under the agreement, the U.S. government will receive 105 million doses (30 µg, 10 µg and 3 µg). This may include adult omicron-adapted COVID-19 vaccines, subject to the FDA authorization. The doses are planned to be delivered… Benzinga · Jun 30, 2022
COVID vaccination reboot coming this fall to add tweaks for new coronavirus variants The FDA will have to decide the exact recipe. But expect a combination shot that adds protection against omicron or some of its newer relatives to the original vaccine. Chicago Sun-Times · Jun 30, 2022
This Healthcare Stock Surges Around 115%, Here's 74 Biggest Movers From Yesterday Gainers Allena Pharmaceuticals, Inc. (NASDAQ: ALNA) shares surged 114.3% to close at $0.2550 on Wednesday after the company announced it has terminated its previously announced at-the-market offering. Benzinga · Jun 30, 2022
Editorial: Drastically reducing nicotine levels will save a lot of lives Nicotine kills. Oh, not directly, for the most part. It’s just so addictive that cigarette smokers find it nearly impossible to quit a product that subtracts years off their lives, causes cancer, chronic obstructive pulmonary disease, strokes and heart disease, along with worsening Type 2 diabetes. In 2018, more than… Los Angeles Times · Jun 30, 2022
What you need to know about monkeypox The World Health Organization said June 25 that monkeypox wasn’t yet a public health emergency of international concern. More than 4,500 cases have been reported worldwide, with more than 300 in the U.S. Tribune News Service · Jun 30, 2022
Baby neck floats can cause ‘death or serious injury’, FDA warns Agency says they are sometimes marketed as water-therapy products The Independent UK · Jun 30, 2022
Tribune News Service · Jun 29, 2022 Texas Sen. Ted Cruz blasts Sesame Street – again – after Elmo gets the coronavirus vaccine WASHINGTON — With a little green bandaid on his furry red arm, Elmo, the beloved 3 1/2-half-year-old Muppet on the long-running children’s PBS program Sesame Street, said “there was a little pinch, but it was okay” when he received his coronavirus vaccine this week.
Benzinga · Jun 29, 2022 Analysts Still Believe Verrica's Ycanth Is Approvable Despite FDA Response Letter Verrica Pharmaceuticals Inc (NASDAQ:VRCA) held a Type A meeting with the FDA regarding the path forward for the resubmission and potential approval of Ycanth (VP-102) for molluscum contagiosum. HC Wainwright says VP-102 was approvable, and at the time of the Complete Response Letter (CRL), Verrica had already engaged a potential alternate solution supplier. It reiterates…
StockNews.com · Jun 29, 2022 5 "Strong Buy" Pharmaceutical Stocks to Own for the Long Haul The inelastic demand and rising investments in research and development should drive the pharmaceutical industry’s growth in the long run. Therefore, pharmaceutical stocks AbbVie (ABBV), Amgen (AMGN), Catalyst (CPRX), Novo Nordisk (NVO), and Vertex (VRTX), which possess sound fundamentals, could be solid long-term investments. These stocks are rated Strong Buy…
Benzinga · Jun 29, 2022 FDA Green Lights Ceruvia's Phase 2 Psilocybin Trial Program For Obsessive-Compulsive Disorder Treatment Clinical-stage biopharma company Ceruvia Lifesciences recently received FDA approval for its Investigational New Drug (IND) application for a Phase 2 clinical trial to determine the efficacy and safety of proprietary synthetic psilocybin (SYNP-101) in treating obsessive-compulsive disorder (OCD).&nbs
Benzinga · Jun 29, 2022 Pfizer, Moderna Analysts Respond To FDA COVID Booster Ruling: 'Revenues Will Decline' The Food and Drug Administration’s panel of independent vaccine experts recently voted 19 to 2 to recommend a new batch of COVID-19 booster shots targeting the omicron variant this fall. The news, announced Tuesday, June 28, could have a big impact on the share prices of vaccine makers.
Benzinga · Jun 29, 2022 Revive Therapeutics Data Access Plan Approved By The FDA; Partial Unblinded Data In Company Hands Revive Therapeutics Ltd. (OTC: RVVTF) moved closer towards potential endpoint change in their Phase 3 clinical trial to evaluate the safety and efficacy of Bucillamine to treat COVID-19.
Benzinga · Jun 29, 2022 Why Is Allena Pharmaceuticals Jumping By 207%? 45 Stocks Moving In Wednesday's Mid-Day Session Gainers Allena Pharmaceuticals, Inc. (NASDAQ: ALNA) jumped 207% to $0.3650 after the company announced it has terminated its previously announced at-the-market offering.
Benzinga · Jun 29, 2022 The Daily Biotech Pulse: Eli Lilly Modifies COVID-19 Treatment Pact, Oyster Point Outlines Restructuring Plan, Icosavax Posts Interim RSV Vaccine Data Here's a roundup of top developments in the biotech space over the last 24 hours:
Benzinga · Jun 29, 2022 InflaRx Provides Development Update For Vilobelimab In Skin Disorder, COVID-19 InflaRx N.V. (NASDAQ:IFRX) provided a development update for its monoclonal anti-C5a antibody, vilobelimab, in pyoderma gangrenosum (PG) and severe COVID-19. The FDA and the European Medicines Agency (EMA) have granted orphan drug designation to vilobelimab for PG. PG is a rare condition that causes large, painful sores (ulcers) to develop on the skin.…
Reason · Jun 29, 2022 Can the FDA Stop States From Banning Abortion Pills? The FDA could work with the Department of Justice to sue states over mifepristone bans. But should it?
Benzinga · Jun 29, 2022 ALX Oncology Shares Soar As FDA Grants Orphan Drug Status To Blood Cancer Candidate The U.S. Food and Drug Administration (FDA) has granted orphan drug designation to ALX Oncology Holdings’ (NASDAQ: ALXO) Evorpacept for the treatment of patients with acute myeloid leukemia (AML).