STAT

AUGUST 21, 2023

MEXICO CITY — Kellogg’s is waging a war here over Tigre Toño and Sam el Tucán. A 2019 policy requires companies that make unhealthy foods to include warning labels on the front of any boxes they sell in Mexico to educate consumers about things like excess sugar and fat. Any food with a warning label — like Kellogg’s Fruit Loops or its Frosted Flakes, which typically contain more than 37 grams of added sugar in a 100-gram serving — is also banned from

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PharmaVoice

AUGUST 21, 2023

The depression space recently got a stinging FDA rebuke — but Brii thinks it can break through with improved formulations.

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STAT

AUGUST 21, 2023

The Food and Drug Administration on Monday approved a Pfizer vaccine that aims to protect newborns against RSV by vaccinating pregnant people in the latter part of pregnancy. The vaccine, Abrysvo, has also been approved for use in adults 60 and older to protect them against respiratory syncytial virus.

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PharmaVoice

AUGUST 21, 2023

Using real-time data, patient centricity and personalized medicine to accelerate clinical trials.

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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

AUGUST 21, 2023

Earlier this month, Intellia Therapeutics announced it was scrapping plans to include U.S.-based sites in one of its mid-stage CRISPR trials after the Food and Drug Administration requested additional data to support including female patients of childbearing potential. The move left many researchers wondering whether the specter of accidental germline transmission — which haunted early gene therapy trials — had now risen over the field of gene editing.

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Packaging 235

ALiEM - Pharm Pearls

AUGUST 21, 2023

A 50-year-old male with a history of polysubstance use disorder and poorly-controlled type 2 diabetes mellitus presents with left hand pain. One week ago, the patient sustained a macerating injury of the left distal middle digit. Since that time he has experienced worsening pain throughout the digit, now associated with diffuse swelling and discoloration.

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Digital Pharmacist

AUGUST 21, 2023

As we gear up for the upcoming flu season of 2023-2024, it’s important to reflect on the lessons of the previous year , and understand how the coming year may look different. In this article, we’ll delve into a comprehensive breakdown of the past season’s dynamics and provide valuable insights to equip you for the challenges and opportunities that lie ahead.

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STAT

AUGUST 21, 2023

Good morning, everyone. Damian Garde here, filling in for Ed Silverman on yet another dog day of what has been a particularly canine summer. So begins another working week for those of us unlucky, unwise, or un-European enough to not be on a beach someplace. Here as always are a few items to get your day started. And if you hear anything curious out there, do let us know.

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Drug Pricing 204

The Pharmacist

AUGUST 21, 2023

The UK Health Security Agency (UKHSA) has confirmed that it has not placed any restriction on the private sale of Covid vaccinations, meaning that manufacturers could agree deals with pharmacies to supply them. Community pharmacy leaders have said that they would welcome the opportunity to provide private Covid vaccinations for those that want them.

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Vaccines Community Pharmacies 95

STAT

AUGUST 21, 2023

To much of the public, the promise of telehealth is all about convenience — get the prescription you need quickly, and get it delivered right to your door. But as digital health companies build out their weight loss businesses, capitalizing on the popularity of drugs like Wegovy and Ozempic, they’re courting a very different audience: payers and employers who have a vested interest in preventing quick scripts.

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Diabetes 204

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Pharmacy Management

Drug Patent Watch

AUGUST 21, 2023

Loss of exclusivity (LOE) doesn’t have to spell doom for branded drug revenue streams. In the face of impending patent expirations, pharmaceutical companies can adopt key approaches to preserve meaningful… The post Strategies to Maximize Product Value Amid Loss of Exclusivity in the Pharmaceutical Industry appeared first on DrugPatentWatch - Make Better Decisions.

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Pharmaceutical Companies Pharmaceutical Companies 98

STAT

AUGUST 21, 2023

Good morning, everyone. Damian Garde here, filling in for Ed Silverman on yet another dog day of what has been a particularly canine summer. So begins another working week for those of us unlucky, unwise, or un-European enough to not be on a beach someplace. Here as always are a few items to get your day started. And if you hear anything curious out there, do let us know.

Drug Pricing 130

Drug Pricing 130

The Pharmacist

AUGUST 21, 2023

Use of vapes in teenagers and young adults is associated with an increased risk of wheeze, bronchitic symptoms and shortness of breath, a US study has concluded. The findings from a series of surveys, which began when participants were school pupils, remained when researchers controlled for smoking and second-hand smoke. More than 2000 Californian students […] The post Respiratory symptoms linked to young people who vape appeared first on The Pharmacist.

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PharmExec

AUGUST 21, 2023

In this exclusive Q&A with Pharmaceutical Executive, Janice Chang, CEO of TransCelerate BioPharma, provides an inside look into her career journey, her work at the company, how the industry has changed in the last 10 years, as well as her thoughts on where the industry should put its efforts in clinical trials.

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BioPharma Dive

AUGUST 21, 2023

Analysts expect the approval of Ingrezza in Huntington’s patients with a movement disorder known as chorea to intensify a commercial battle between Neurocrine and Teva.

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Express Pharma

AUGUST 21, 2023

Pfizer announced that the US Food and Drug Administration (FDA) has approved ABRYSVO ( Respiratory Syncytial Virus Vaccine ), the company’s bivalent RSV prefusion F (RSVpreF) vaccine, for the prevention of LRTD and severe LRTD caused by RSV in infants from birth up to six months of age by active immunisation of pregnant individuals at 32 through 36 weeks gestational age.

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European Pharmaceutical Review

AUGUST 21, 2023

According to a market report , the global RNA therapy clinical trials market is anticipated to reach $3.5 billion by 2030 and grow at a CAGR of 3.84 percent from 2023 to 2030. The data stated that expansion of the market in emerging countries is due to factors such as the rising success rate of RNA-based COVID-19 vaccines, regulatory approval, as well as demand for personalised medicines.

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BioPharma Dive

AUGUST 21, 2023

The Series B round brings the total funding for Genesis, a California startup backed by Andreessen Horowitz and Nvidia’s VC arm, to over $280 million.

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Pharmaceutical Technology

AUGUST 21, 2023

The EC approved Janssen's Type II variation application for reduced dosing frequency of bispecific antibody TECVAYLI for multiple myeloma.

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BioPharma Dive

AUGUST 21, 2023

The agency cleared high-dose Eylea less than two months after rejecting it, and approved a separate Regeneron drug for an ultra-rare disease as well.

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Express Pharma

AUGUST 21, 2023

Gilead Sciences announced that the US Food and Drug Administration (FDA) has placed a partial clinical hold on the initiation of new patients in US studies evaluating magrolimab to treat acute myeloid leukemia (AML). The FDA action follows the previously announced discontinuation of the Phase 3 ENHANCE study of magrolimab in higher-risk myelodysplastic syndromes (HR-MDS).

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European Pharmaceutical Review

AUGUST 21, 2023

For 20 of the leading biopharmaceutical companies, the second quarter (Q2) of 2023 has brought an aggregate market capitalisation growth of 2.3 percent. Data and analytics company GlobalData has reported a rise from $3.49 trillion in the Q1 of 2023 to $3.56 trillion in Q2 2023. Q2 2023 biopharma market capitalisation results Eli Lilly “Eli Lilly witnessed the largest market capitalisation growth of 36.1 percent over Q2 2023, moving up to first position in the list and displacing Johnson & Jo

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Express Pharma

AUGUST 21, 2023

The Biden administration plans to urge all Americans to get a booster shot for the coronavirus this autumn to counter a new wave of infections, informed a White House official. The official said that while the Centers for Disease Control and Prevention are reporting an increase in infections and hospital admissions from the virus, overall levels remain low.

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Pharma Times

AUGUST 21, 2023

Mitazalimab is a monoclonal antibody that has been created to sensitize tumours to chemotherapy - News - PharmaTimes

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Chemotherapy 96

BioPharma Dive

AUGUST 21, 2023

The hold is the latest setback for a drug that was the center of Gilead’s $5 billion acquisition of biotech Forty Seven in 2020.

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Express Pharma

AUGUST 21, 2023

Avantor, inaugurated its expanded Singapore Hub which includes a newly added cGMP manufacturing and a world class quality control laboratory. The hub is a one-stop facility serving the needs of customers across Asia, Middle East, and Africa (AMEA), strengthening the region’s innovation and biopharma ecosystems. A company statement informed that strategically located in Singapore, the hub enables quicker turnaround times and expedites customers’ access to raw materials that are essential in AMEA’

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Drug Development 82

Pharmaceutical Technology

AUGUST 21, 2023

The US Food and Drug Administration (FDA) has granted approval to Regeneron Pharmaceuticals’ EYLEA HD injection 8 mg.

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Outsourcing Pharma

AUGUST 21, 2023

The US Food and Drug Administration (FDA) has given orphan drug designation (ODD) to Redxâs Zelasudil for the potential treatment of idiopathic pulmonary fibrosis (IPF).

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Pharmaceutical Technology

AUGUST 21, 2023

The company’s generative and predictive AI-powered drug discovery platform is already being used by Eli Lilly.

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BioPharma Dive

AUGUST 21, 2023

The expanded approval follows the FDA’s May clearance of the shot, called Abrysvo, in older adults.

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Pharma Times

AUGUST 21, 2023

The treatment is indicated for adults with moderate-to-severe chronic hand eczema - News - PharmaTimes

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BioPharma Dive

AUGUST 21, 2023

By partnering with an accomplished CTDMO, gene therapy innovators can benefit from guidance and support.

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Outsourcing Pharma

AUGUST 21, 2023

Novartisâ board of directors has unanimously agreed to separate Sandoz as a 100 per cent spin-off with a $15 billion share buyback.

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World Pharma News

AUGUST 21, 2023

DNA can be damaged by toxins, radiation, or even normal cell division, but human cells must continually fix DNA breaks to survive. In cells that cannot repair DNA effectively, changes (mutations) can occur that lead to cancer. Most cells rely on a system called homologous recombination or HR, which uses proteins called BRCA1 and BRCA2 for accurate DNA repair.

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pharmaphorum

AUGUST 21, 2023

'Virtual wards' for respiratory infections backed by NICE Phil.

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