STAT

APRIL 18, 2024

This difference was statistically significant and clinically meaningful, Cerevel said in a press release Thursday. That compared to 0.6 hours of improvement among patients taking placebo and levodopa. There was also a statistically significant decrease in “off time,” the amount of time patients experienced symptoms.

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STAT

MARCH 21, 2024

As of Thursday morning, the organ recipient, a 62-year-old man named Richard Slayman, was “recovering well” and expected to be discharged soon, the hospital said in a news release. Continue to STAT+ to read the full story…

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Hospitals 145

STAT

JANUARY 4, 2024

Contraline, a device startup that released early, positive clinical data in a press release on Thursday, hopes to fill it. Between condoms and vasectomies lies a vast, undeveloped chasm of male birth control. Investigators tested the device on 23 participants in Australia last year and recorded no serious adverse events.

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Pharmafile

APRIL 9, 2024

PureTech Health has announced key progress on its ‘strategic initiatives to deliver innovative medicines to patients and unlock value for shareholders’, according to its press release. This includes the launch of Seaport Therapeutics with $100m oversubscribed series A financing.

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STAT

DECEMBER 27, 2023

The masks, according to a press release from the Department of Justice, were used to diagnose and treat sleep disorders. Philips agreed to pay $2.4 Philips Respironics, a subsidiary of Philips, allegedly gave out masks from 2016 to 2021.

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STAT

MARCH 13, 2024

government scrutiny of it and other Chinese companies, according to a BIO press release shared with STAT on Wednesday. WASHINGTON — The Biotechnology Innovation Organization, an industry trade group, is cutting ties with Chinese company WuXi in response to increasing U.S.

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Hospital Pharmacy Europe

DECEMBER 14, 2022

According to a press release by manufacturer , Moderna (in conjunction with Merck), an investigational, personalised cancer vaccine, mRNA-4157/V940, when combined with pembrolizumab, was more effective than pembrolizumab alone, at reducing the risk of death or recurrence in patients with stage III/IV melanoma following complete resection.

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Vaccines Immunization Hospitals 98

Hospital Pharmacy Europe

JANUARY 29, 2023

The data in the press release is derived from the INTEGRIS-IPF trial , a multi-national, randomised, double-blind, placebo-controlled trial designed to evaluate the safety, tolerability and pharmacokinetics of once-daily bexotegrast in people with IPF. Moreover, the mean increase was statistically superior to placebo at all timepoints.

Hospitals 95

Hospitals 95

Fierce Pharma

OCTOBER 2, 2023

The deal will see the asset manager furnish Amicus with a $400 million loan that will be used for the refinancing of existing debt, Amicus said in a press release. . | Amicus unveiled a $430 million financing pact with Blackstone Life Sciences and Blackstone Credit.

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FDA 107

Pharmaceutical Technology

JANUARY 8, 2024

The layoffs and scaling back of R&D activities will extend Senti Biosciences' cash runway into Q1 2025, according to a press release.

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STAT

DECEMBER 13, 2022

The data, made public in a press release, represent the first evidence of an effective individualized cancer vaccine based on mRNA, the technology used in the Covid shots. Continue to STAT+ to read the full story…

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Vaccines 143

STAT

APRIL 27, 2023

They trumpet the technology in press releases, plaster its use on billboards, and sprinkle AI into speeches touting its ability to detect diseases earlier and make health care faster, better, and cheaper. In public, hospitals rave about artificial intelligence. Read the rest…

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Hospitals FDA 111

Pharmafile

MARCH 19, 2024

This acquisition forms part of AstraZeneca’s goal to ‘transform cancer treatment and outcomes for patients by replacing traditional regimens like chemotherapy and radiotherapy with more targeted treatments’, according to the press release.

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Chemotherapy 59

Pharmafile

MARCH 21, 2024

According to the company’s press release, the candidate is ‘a potent, selective and gut-restricted prostaglandin EP4 receptor agonist that has been uniquely designed […] The post Sosei Heptares doses first patient in trial for inflammatory bowel disease treatment appeared first on Pharmafile.

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Pharmafile

APRIL 5, 2023

Published date: 05/04/2023 Summary: Press Release, Wednesday 5th April 2023, London. Press Release, Wednesday 5th April 2023, London. As part of a long-term strategy to increase its home adaptation services across the UK, Innova Care Concepts are delighted to announce the acqu read more

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Pharmacy Times

OCTOBER 19, 2022

Novavax’s quadrivalent influenza vaccine candidate has previously induced cross-reactive polyfunctional CD4+ T-cell responses, according to a company press release.

Vaccines 81

Vaccines 81

Hospital Pharmacy Europe

JANUARY 26, 2023

The press release relates to the ConquerRSV trial which was a randomised, double-blind trial, designed to evaluate the safety and tolerability of the mRNA-1345 vaccine. The study’s primary efficacy endpoints were based on two definitions of RSV-lower respiratory tract disease with either two or three or more symptoms.

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Adverse Reactions Vaccines Hospitals 98

BioPharm

SEPTEMBER 21, 2023

According to the press release, it is the first turn-key device to utilize Raman spectroscopy for bioprocess control, with no modeling and development required.

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STAT

JUNE 22, 2023

The FDA recently issued 189 formal warning letters to shops selling two brands of vape products, Elf Bar and Esco Bars, the agency announced in a press release Thursday. The FDA has not authorized either brand, both of which are ubiquitous in gas stations and smoke shops around the country. They are therefore illegal to sell.

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FDA 106

STAT

JULY 11, 2023

The company said in a press release that it will review whether to proceed with trying to bring the vaccine to the U.S. Takeda announced Tuesday that it has voluntarily withdrawn its application to the Food and Drug Administration for its dengue vaccine, making it unclear when or if the vaccine will be licensed in this country.

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Vaccines FDA 98

Hospital Pharmacy Europe

APRIL 14, 2023

Bimekizumab has been shown to be an effective treatment for hidradenitis suppurativa according to the findings of two phase 3 trials In a press release from the manufacturer, UCB , two phase 3 trials showed that bimekizumab provides a clinically meaningful benefit to patients with hidradenitis suppurativa.

Hospitals 98

Hospitals 98

STAT

OCTOBER 4, 2022

The press release issued by pharmaceutical companies Eisai and Biogen on Sept. 27 might someday be remembered as the beginning of a revolution in Alzheimer’s diagnosis and treatment.

Pharmaceutical Companies 124

Pharmaceutical Companies Pharmaceutical Companies 124

Hospital Pharmacy Europe

MARCH 16, 2023

According to the press release, LAVENDER evaluated the efficacy and safety of trofinetide compared to placebo in 187 female patients with Rett syndrome, five to 20 years of age. The drug is likely to be available in the US from April 2023 although the press release provides no information on its release elsewhere.

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FDA Hospitals 98

Hospital Pharmacy Europe

APRIL 3, 2023

The current press release relates to the EMERGENT-3 Trial , a phase 3, randomised, double-blind, parallel-group, placebo-controlled, multicentre study, with xanomeline-trospium in patients with schizophrenia.

Hospitals 97

Hospitals FDA 97

STAT

APRIL 10, 2023

Neither company issued a press release. The deal for Crystal Run, a network of almost 400 doctors, nurse practitioners, and other clinicians, closed in late February. There was no fanfare. The deal only came to light from an email obtained by the Mid-Hudson News. Continue to STAT+ to read the full story…

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Insurance 97

STAT

AUGUST 9, 2023

Minutes after the company issued its press release, shares in Illumina dipped from $184.49 The market’s response was swift. to below $172 during after-hours trading.

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Hospital Pharmacy Europe

JANUARY 26, 2023

In 2019, the phase 3 Mosaico study (also referred to as HPX3002/HVTN706) was initiated and which is the trial referred to in the press release. Despite HIV having been first discovered in 1983 , there are still no vaccines available against the virus. The aim of the study was to evaluate the efficacy of a heterologous vaccine, Ad26.Mos4.HIV,

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Vaccines Immunization Hospitals 98

STAT

DECEMBER 1, 2022

Amgen released detailed data on Thursday suggesting an early-stage drug can induce significant weight loss in patients with obesity, with less frequent dosing than current treatments but a safety profile that remains unclear. Continue to STAT+ to read the full story…

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BioPharm

OCTOBER 3, 2023

The new customized system is designed for fully automated and integrated labeling, orientation, and palletization, and it is expected to streamline the current manual processes, according to the press release.

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Packaging Labelling 52

STAT

SEPTEMBER 7, 2022

In its press release on the ruling, Illumina acknowledged that, although it will appeal, that may not prevent the European Commission from forcing it to divest Grail, which it purchased before regulatory approvals were in place. The worse news?

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Hospital Pharmacy Europe

MARCH 6, 2023

While yet to be approved, the press release describes how omaveloxolone has been granted Orphan Drug designation in Europe for the treatment of Friedreich’s ataxia and is currently under review by the European Medicine Agency.

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FDA Specialty Pharmacies Labelling Hospitals 97

Hospital Pharmacy Europe

FEBRUARY 23, 2023

According to the press release, syfovre is currently under review by the European Medicines Agency with a decision expected in early 2024. Similarly, data from DERBY observed a 18 and 17% reduction in GA growth rate for monthly and alternate monthly injections respectively.

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FDA Immunization Hospitals 98

Pharmafile

DECEMBER 6, 2023

According to the company’s press release: “Fabhalta is a Factor B inhibitor that acts proximally in the alternative complement pathway of the immune system, providing […] The post FDA approves Novartis’ Fabhalta for PNH treatment appeared first on Pharmafile.

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FDA Immunization 59

BioPharm

OCTOBER 18, 2023

These results will provide insights from more than 250 global pharma executives, including discoveries such as pharma confidence dipping below the record scores of 2022, although it has remained extremely resilient despite wider macro uncertainly, according to the press release.

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The FDA Law Blog

FEBRUARY 7, 2024

Gilbert — Last week, DEA and DOJ announced a $59 million civil penalty settlement with eBay related to the failure to comply with Controlled Substances Act (CSA) requirements for identifying purchasers, maintaining records, and filing reports of individuals selling/purchasing pill presses and encapsulating machines.

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Controlled Substances Documentation 116

BioPharm

SEPTEMBER 26, 2023

BenevolentAI will leverage its suite of AI chemistry design tools in combination with its fully equipped wet lab facility in Cambridge, UK, to deliver small molecule drug development candidates into the Merck pipeline, according to the press release.

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STAT

DECEMBER 6, 2022

But most of the AI models described in journals — and lionized in press releases — never make it into clinical use. It can detect cancers on images earlier, find heart issues invisible to cardiologists, and predict organ dysfunction hours before it becomes dangerous to hospitalized patients. Read the rest…

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Hospitals 98