STAT

SEPTEMBER 12, 2023

A panel of advisers to the Centers for Disease Control and Prevention voted 13-1 Tuesday to recommend updated Covid-19 booster shots for all Americans 6 months and older. CDC Director Mandy Cohen signed off on the recommendation hours later, and vaccines would be available within 48 hours. The recommendation applies to mRNA shots from Pfizer-BioNTech and Moderna, both of which were approved by the Food and Drug Administration Monday.

Vaccines 363

Vaccines 363

PharmaVoice

SEPTEMBER 12, 2023

A new poll shows that Americans generally support several key IRA provisions, including Medicare price negotiations.

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STAT

SEPTEMBER 12, 2023

The blazing success of weight loss drugs like Wegovy and Mounjaro has electrified the pursuit of new treatments for obesity. For now, Novo Nordisk and Eli Lilly are leading the market with injectable drugs that target receptors of the GLP-1 hormone to mimic the hormone’s effects of helping people feel full. But dozens of companies are also jumping into the race, seeing the potential to make millions of dollars if they can bring to market medications that are oral, longer-lasting, avoid si

Drug Development 363

Drug Development 363

European Pharmaceutical Review

SEPTEMBER 12, 2023

As part of The Future of Pharma/Biopharma Analysis 2023 , which took place on 28-29 June 2023, European Pharmaceutical Review ( EPR ) gathered an expert panel to discuss developing a modern contamination control strategy. The participants were: Dr Tim Sandle, Head of GxP Compliance at Bio Products Laboratory Limited (BPL) as moderator; Dr Edward Tidswell, Executive Director within the Microbiological Quality and Sterility Assurance organisation of Merck & Co; Frederic Ayers, Research Scienti

Documentation 125

Documentation 125

Speaker: Chris Antypas and Josh Halladay

Access to limited distribution drugs and payer contracts are key to pharmacy expansion. But how do you prepare your operations to take the next step? Meaningful data: Collect and share clinical data regarding outcomes, utilization, and more Reporting: Limited distribution models require efficient tracking and reporting systems Workflows: Align workflows with specific pharma and payer contractual requirements For in-depth, expert insights on pharmacy expansion, watch this webinar from Inovalon.

STAT

SEPTEMBER 12, 2023

WASHINGTON — The leading decongestant used by millions of Americans looking for relief from a stuffy nose is no better than a dummy pill, according to government experts who reviewed the latest research on the long-questioned drug ingredient. Advisers to the Food and Drug Administration voted unanimously on Tuesday against the effectiveness of the key drug found in popular versions of Sudafed, Allegra, Dayquil and other medications stocked on store shelves.

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PharmaVoice

SEPTEMBER 12, 2023

The biotech’s chief financial officer Robert Landry is retiring in February.

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Express Pharma

SEPTEMBER 12, 2023

JB Chemicals & Pharmaceuticals recently published its 2 nd Sustainability (ESG) Report. The report informs that the overall Green House Gases (GHG) intensity (i.e. Scope 1 and Scope 2) has been reduced by 19 per cent as compared to last year. A statement from the company informs, “This financial year also witnessed the completion of calculating scope 3 emissions for the first time for JB Pharma, where focus will be on total emissions across the organisation and the external supply chain.

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STAT

SEPTEMBER 12, 2023

WASHINGTON — The food industry is anxious that regulators are focusing too much on the health impacts of so-called ultra-processed foods, the popular, ill-defined food group that includes everything from hot dogs and chicken nuggets to cookies and potato chips. Frozen food makers and the meat industry on Tuesday, speaking to a panel of nutrition experts tasked by the federal government with advising on the next round of the national dietary guidelines, raised concerns with its focus on th

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BioPharma Dive

SEPTEMBER 12, 2023

Arialys Therapeutics launched Tuesday with $58 million in funding from a group of life sciences investors that includes Johnson & Johnson’s venture arm.

Immunity 117

Immunity Immunization 117

STAT

SEPTEMBER 12, 2023

The exploding popularity of drugs like Wegovy and Mounjaro has propelled dozens of companies to develop their own obesity treatments, with most of them trying to emulate the same approach as the blockbuster products. Nearly 70 obesity treatments are in development, and about two-thirds use a similar mechanism as Wegovy and Mounjaro, according to the STAT Obesity Drug Tracker , a new database compiled by STAT.

Drug Development 338

Drug Development 338

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Pharmacy Management

Drug Patent Watch

SEPTEMBER 12, 2023

In the world of patents, the right to exclude others from using or selling an invention is granted only during the patent’s validity. Once a patent expires, this exclusivity vanishes.… The post Understanding Patent Term Extensions: An Overview appeared first on DrugPatentWatch - Make Better Decisions.

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STAT

SEPTEMBER 12, 2023

Five years after promising to fix a flawed regulatory pathway widely used by medical device manufacturers, the Food and Drug Administration has issued new guidelines to improve its so-called 510(k) program that has long been lambasted for letting risky devices fall through the cracks. Most medical device companies do not have to test their products on people in order to secure clearance from the FDA — they simply have to show they’re “substantially equivalent” to devi

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Drug Patent Watch

SEPTEMBER 12, 2023

In a recent STAT article Sanofi CEO Paul Hudson discusses the potential of artificial intelligence (AI) in the pharmaceutical industry. While some in the industry have been hesitant to embrace… The post From Expert AI to Snackable AI: A New Era in Pharma, as Seen by Sanofi’s CEO appeared first on DrugPatentWatch - Make Better Decisions.

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STAT

SEPTEMBER 12, 2023

Patients often ask two questions about every medical treatment: Will it help me? Will it hurt me? The Food and Drug Administration knows many of the answers. It wants patients to know them, too. After years of deliberation, the FDA has proposed giving patients a simple one-pager for every prescription drug with the information needed for safe and effective use.

Packaging 310

Packaging 310

Express Pharma

SEPTEMBER 12, 2023

While there are no marketed drugs for nonalcoholic steatohepatitis (NASH) in the EU or US, most NASH therapies in development primarily focus on treating patients with F2 (moderate fibrosis) or F3 (advanced fibrosis). Of the 33 late-stage pipeline assets in development for NASH, only three focus on decompensated cirrhosis (DC) due to NASH. A further look into the mechanisms of action (MOAs) of each agent reveals that Promethera Biosciences and Cellaion’s HepaStem (heterologous human adult liver

Diabetes 109

Diabetes Immunity Immunization 109

STAT

SEPTEMBER 12, 2023

Some two years after splitting biotech company Bluebird Bio into two entities in a bid to “sharpen their focus” and improve operations, the spinout focused on oncology treatments announced major cost cuts and is parting ways with its chief executive. The spinout, 2Seventy Bio, announced Tuesday that it is cutting approximately 40% of its workforce, or about 176 employees.

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The Pharmacist

SEPTEMBER 12, 2023

The community pharmacy sector must work together with the All-Party Pharmacy Group (APPG) of MPs to more effectively influence parliamentarians and policymakers, the Association of Independent Multiple Pharmacies (AIMp) has urged. But Community Pharmacy England (CPE), the Company Chemists’ Association (CCA) and the National Pharmacy Association (NPA) insisted that the three organisations are committed to […] The post Sector disagreement over call for unity appeared first on The Pharmacist.

Community Pharmacies 102

Community Pharmacies 102

STAT

SEPTEMBER 12, 2023

Walmart seems poised to increase its health care footprint by buying value-based senior care company ChenMed, per reports from Bloomberg. Experts largely hailed the rumored sale as a good buy, citing the management of chronic conditions in the Medicare Advantage population through primary care, ChenMed’s specialty, as an area with huge innovation and cost savings over the last 10 years.

Hospitals 281

Hospitals 281

The Pharmacist

SEPTEMBER 12, 2023

More than 400,000 prescription items to treat smoking dependence were dispensed in England between April 2022 and March 2023, new data has shown. And over 46,000 of them were prescribed by Greater Manchester ICB. The total for England included more than 360,600 prescriptions prescribed in primary care and dispensed for nicotine replacement therapies.

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STAT

SEPTEMBER 12, 2023

Hello, everyone, and nice to see you again after our extended break. A little time away is always a good thing, but now we have returned to our usual routine. Of course, we are starting by firing up the coffee kettle to concoct a few cups of stimulation. Our choice today is cinnamon sticky bun. You can never be too sweet, you know? Meanwhile, we have, once gain, gathered a few tidbits for you to peruse.

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Pharma Times

SEPTEMBER 12, 2023

The research will aim to reveal the mechanism of action of a drug target candidate - News - PharmaTimes

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STAT

SEPTEMBER 12, 2023

You’re reading the web edition of D.C. Diagnosis.  Sign up here  to receive this newsletter in your inbox on Tuesdays and Thursdays. PEPFAR’s chances of becoming a plus-one The fight over reauthorizing a once-bipartisan international HIV/AIDS program escalated Monday with seven sit-in protestors arrested on the hill. But lawmakers are growing less optimistic about a full-reauthorization, as champions scale back aspirations and search for a way to break a deadlock triggere

Drug Pricing 217

Drug Pricing 217

Express Pharma

SEPTEMBER 12, 2023

Eminence Business Media’s third edition of the Cleaning Validation program, was recently held at Radisson Blu, Mumbai International Airport on August 24-25, 2023. This programme addressed critical cleaning validation bottleneck issues and provided the attendees with an engaging and solution-oriented experience. The conference began with a warm welcome from Guneet Kaur Hayer, MD of Eminence Business Media, setting the stage for an exceptional two-day educational journey focused on quality.

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European Pharmaceutical Review

SEPTEMBER 12, 2023

The next generation of therapeutics has arrived: from simple design and development to theoretically unlimited targets, messenger RNA ( mRNA )‑based therapeutics offer a multitude of benefits. However, creating these innovative treatments harbours challenges. This article explores common developmental and design issues and how to mitigate difficulties before they occur.

Vaccines 101

Vaccines Drug Development 101

BioPharma Dive

SEPTEMBER 12, 2023

Citing “near-term headwinds,” the cancer cell therapy developer will lay off 176 employees and pare back some of its research spending.

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European Pharmaceutical Review

SEPTEMBER 12, 2023

Initial data from the CPHI Annual Report 2023, which provides insight from 250 global pharmaceutical companies, reveals that AI (artificial intelligence) is expected to transform every area of the industry, from drug discovery through to drug development , within the next 24-months. Data predicted that in 2030, more than half of US Food and Drug Administration (FDA)-approved drugs will involve AI in their development and/or manufacturing.

Drug Development 98

Drug Development Pharmaceutical Companies Pharmaceutical Companies 98

Pharmaceutical Technology

SEPTEMBER 12, 2023

The US FDA has approved Pfizer and BioNTech’s sBLA for Omicron XBB.1.5-adapted monovalent Covid-19 vaccine, COMIRNATY 2023-2024 Formulation.

Vaccines 111

Vaccines 111

European Pharmaceutical Review

SEPTEMBER 12, 2023

A T-cell epitope cancer vaccine significantly improved overall survival in non-small cell lung cancer (NSCLC) compared to chemotherapy, Phase III data published in Annals of Oncology has shown. The immunotherapy activating tumour specific T-cells, off-the-shelf, neoepitope-based vaccine Tedopi ® was evaluated in HLA-A2 positive patients with advanced or metastatic NSCLC in monotherapy in third line NSCLC with secondary resistance to immune checkpoint inhibitors, in the Phase III clinical trial A

Vaccines 98

Vaccines Chemotherapy Immunity Immunization 98

BioPharma Dive

SEPTEMBER 12, 2023

The two-year-old San Diego biotech is allied with The Jackson Laboratory to engineer better mouse models of the rare diseases it plans to target.

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European Pharmaceutical Review

SEPTEMBER 12, 2023

CAR T-cell therapy is a form of immunotherapy that uses specially altered T cells to fight cancer. A sample of T cells is collected from the blood of a cancer patient, genetically engineered to produce chimeric antigen receptors (CARs) on their surface, and then expanded and reinfused into the patient. These new receptors enable the cells to latch onto a specific antigen on the patient’s tumour cells and kill them.

Chemotherapy 95

Chemotherapy 95

The Pharmacist

SEPTEMBER 12, 2023

Community pharmacists have been urged to share their views on what a pharmacogenetic service should look like in the UK. Clinical academics in Manchester have launched a new survey seeking healthcare professional’s preferences for the development of a future pharmacogenetic service, as part of an NHS trial. And they have stressed that the involvement of […] The post Pharmacists ‘critical to success’ of future pharmacogenetic service appeared first on The Pharmacist.

Community Pharmacies 98

Community Pharmacies 98

European Pharmaceutical Review

SEPTEMBER 12, 2023

A new state-of-the-art manufacturing facility for microbiome ecosystem therapies has now completed construction. MaaT Pharma, a company focusing on treatments for oncology, and French contract development and manufacturing organisation (CDMO) Skyepharma formed a partnership in February 2022 to build the largest current good manufacturing practice (cGMP) facility, to date, for full ecosystem microbiome therapies in Europe.

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The Pharmacist

SEPTEMBER 12, 2023

Community pharmacies are facing ‘unanswered questions’ about vaccine availability and appointment booking systems that make the final preparations for the winter vaccination service ‘nigh on impossible’, the National Pharmacy Association (NPA) has warned. Flu and Covid-19 vaccinations for care home and housebound patients began this week, with other eligible patients set to begin receiving their […] The post Pharmacies ‘trapped in starting blocks’ as vaccination season begins appeared firs

Vaccines 92

Vaccines Community Pharmacies 92

Pharmaceutical Technology

SEPTEMBER 12, 2023

BioLineRx has received the US Food and Drug Administration approval for Aphexda plus filgrastim to mobilise haematopoietic stem cells.

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The Guardian - Pharmaceutical Industry

SEPTEMBER 12, 2023

Advisory panel reviewed studies of phenylephrine, an active ingredient in Benadryl, Mucinex, Sudafed PE and Tylenol A common decongestant ingredient of numerous popular over-the-counter cold and flu remedies does not work, the Food and Drug Administration (FDA) concluded on Tuesday. An advisory panel spent two days looking at studies of phenylephrine, an active ingredient in well-known medicines including Benadryl, Mucinex, Sudafed PE and Tylenol, and reported to the FDA that it is no more effec

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