STAT

MAY 15, 2023

In the early days of the Covid pandemic, gravely ill patients began to fill America’s hospitals. Hospitals ran short of essential treatment medications and were unable to source those drugs from manufacturers or from the outsourcing facilities that had been authorized by Congress in 2013 to “fill the gap” in such situations. At the urging of the Alliance for Pharmacy Compounding, the trade association I lead, the Food and Drug Administration in April 2020 issued temporary gu

Compounding Pharmacies 246

Compounding Pharmacies Compounding Hospitals 246

ALiEM - Pharm Pearls

MAY 19, 2023

A heavy alcohol drinker, who is well known to your Emergency Department, presents with altered mental status, except that he looks different this time. He looks really bad, stating that he has been vomiting blood. He is hypotensive. He then vomits a copious amount of blood right in front of you. You intubate the patient and initiate the massive transfusion protocol, but everything you pour into him seemingly comes right back out.

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PharmaVoice

MAY 18, 2023

Pending Senate confirmation, NCI head Monica Bertagnolli will take the helm of the collection of research organizations as it faces increasing bipartisan scrutiny.

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BioPharma Dive

MAY 18, 2023

At an investor day, executives highlighted an experimental inflammatory disease drug targeting the protein TL1A as important to their long-term growth prospects.

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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

MAY 19, 2023

Four different companies agreed to buy the assets of Pear Therapeutics at auction on Thursday morning after the digital health company filed for bankruptcy last month. Click Therapeutics, Welt Corp, Harvest Bio, and Nox Health Group each acquired bits of the company for $6.05 million, far short of the $32 million in debt Pear carried. A hearing to approve the sale will be held on May 22.

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Pharmaceutical Technology

MAY 19, 2023

The US Food and Drug Administration (FDA) has granted approval to Bausch + Lomb and Novaliq’s Miebo (perfluorohexyloctane ophthalmic solution) to treat the signs and symptoms of dry eye disease (DED). Formerly known as NOV03, Miebo is a first-in-class eye drop designed for preventing the evaporation of excessive tears and restoring tear balance in evaporative DED patients.

Adverse Reactions 133

Adverse Reactions 133

BioPharma Dive

MAY 17, 2023

Spun out of the lab of former UCSF researcher Nicole Paulk, the biotech is targeting brain and eye tumors with a new kind of treatment it has dubbed “immuno-gene therapy.

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STAT

MAY 15, 2023

When gastroenterologists learned in March that UnitedHealthcare plans to barricade many colonoscopies behind a controversial and complicated process known as prior authorization, their emotions cycled rapidly between fear, shock, and outrage. The change, which the health insurer will implement on June 1, means that any United member seeking surveillance and diagnostic colonoscopies to detect cancer will first need approval from United — or else have to pay out of pocket.

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Pulses

MAY 18, 2023

By: Tayana Cuffee, Pharm D Candidate and Krista Donohoe,Pharm.D., BCPS, BCGP Some pharmacy students have responsibilities caring for others, what can pharmacy schools learn from their experiences? Pharmacy school is a very rigorous program that requires a lot of time and effort both in and outside of the classroom. Pharmacy students regularly experience stressors such as high work demands, numerous assessments, Advanced Practice Pharmacy Experiences (APPEs), and finding the right career path. 1

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PharmaVoice

MAY 18, 2023

Global product teams are common in pharma but have yet to gain traction in biotech. Here's why this model can work.

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Pharmacy Management

BioPharma Dive

MAY 16, 2023

Founded in early 2021, the company is using optogenetics to design treatments that could work across disease genotypes and in the later stages of vision loss.

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STAT

MAY 19, 2023

A defanged form of CRISPR, which doesn’t slice or nick DNA, but rather alters the epigenome — the layers of chemical coding that sit on top of DNA and control the activity of genes — has aced its first substantive test. When researchers used CRISPR “ epigenome editing ” to dial down a cholesterol-associated gene in monkeys, the animals’ blood levels of heart-disease-causing LDL, or “bad” cholesterol, plummeted by more than 50%, Jennifer Kwo

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Drug Patent Watch

MAY 16, 2023

On NPR’s All Things Considered, Sydney Lupkin asked DrugPatentWatch if drug patents could be used to identify injector pens which could then be swapped to fix drug shortages. Referring to… The post NPR and DrugPatentWatch – Can drug injector pens be swapped? appeared first on DrugPatentWatch - Make Better Decisions.

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Pharmaceutical Technology

MAY 19, 2023

The US Food and Drug Administration (FDA) has approved AbbVie’s Rinvoq (upadacitinib) for patients with Crohn’s disease who do not respond to TNF blockers, a common immune suppressant treatment for the condition. Whilst there is a range of FDA-approved biologics for Crohn’s disease, Rinvoq is the first approved oral product for the moderate to severe type of the disease.

Mayo Clinic 105

Mayo Clinic Dosage Biosimilars Immunity 105

BioPharma Dive

MAY 19, 2023

The biotech, best known for its vaccine research, said its clinical trial is the first to report results of a messenger RNA therapeutic designed for intracellular protein replacement.

Vaccines 117

Vaccines 117

STAT

MAY 19, 2023

When cyclist Alison Tetrick joined the sport’s professional ranks, she received the perks that come with the job — new bikes and clothing included. But she could never get comfortable on the bike saddles. After several years, Tetrick suffered so much damage to her genital area that she eventually resorted to surgery to trim excess skin from her labia.

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European Pharmaceutical Review

MAY 19, 2023

A Phase III trial has found that the novel combination antibiotic sulbactam-durlobactam prevents at least as many fatalities of hospital-acquired pneumonia as colistin, the best currently approved treatment. This finding alongside the other data from the trial led the US Food and Drug Administration (FDA)’s Antimicrobial Drugs Advisory Committee to recommend the FDA approve the combination antibiotic for often-fatal pneumonia strain carbapenem-resistant Acinetobacter baumannii–calcoaceticus co

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Hospitals Medical Schools 102

Pharmaceutical Technology

MAY 18, 2023

The European Medicines Agency (EMA) has published recommendations to increase communication and planning efforts in a bid stop the current medicine shortages becoming even worse. Within the 14-page document , published by an EMA special task force, are 10 recommendations of best practices that “marketing authorisation holders, wholesalers, distributors, and manufacturers can consider adopting to ensure continuity of medicinal product supply and reduce the impact of shortages”.

Online Pharmacies 99

Online Pharmacies Communication Documentation 99

BioPharma Dive

MAY 15, 2023

The Dutch biotech sold a portion of royalties owed by CSL Behring on sales of Hemgenix, adding to a cash pile it has built since out-licensing the treatment.

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STAT

MAY 19, 2023

Amid increased concerns over a lack of transparency in clinical trials, a new study found that one in five primary endpoints were changed after a late-stage study had begun, and 70% of the trials examined did not include information about primary endpoint changes in articles published in medical journals. Specifically, 145 of 755 randomized controlled trials for cancer medications — or 19% — had changes to the primary endpoints when using at least one of three different methods to

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Express Pharma

MAY 19, 2023

To combat AMR, the report recommends modifying procurement practices, adding essential antimicrobials in state drug procurement lists A new report released by the Indian School of Business’ Max Institute of Healthcare Management and the Center for Global Development calls on key stakeholders across national and regional governments to improve antimicrobial innovation, accessibility, and stewardship practices to combat Antimicrobial Resistance (AMR) in India.

Hospitals 98

Hospitals Compounding 98

Pharmaceutical Technology

MAY 19, 2023

Myeloid Therapeutics has raised $73m to support the continued clinical development of its lead cell therapy programme, MT-101, in Phase I/II trials for T cell lymphoma. Led by Hatteras Investment Partners, the financing round has seen participation from existing investors, including 8VC, Alexandria Venture Investments and Newpath Partners, along with new investors Moore Strategic Ventures and ARCH Venture Partners.

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Labelling 98

BioPharma Dive

MAY 17, 2023

The company said its “reversible” BTK inhibitor, which trails competitors from Sanofi and Merck KGaA, succeeded in Phase 2 testing without raising new safety concerns.

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STAT

MAY 16, 2023

WASHINGTON — The White House is summoning naloxone manufacturers for a roundtable focused on the medication’s price, the Biden administration’s top drug policy official told STAT. The move would represent the White House’s most concrete action to date to address the price of naloxone , a medication used to reverse opioid overdoses.

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European Pharmaceutical Review

MAY 19, 2023

Final draft guidance has been published for the first National Institute for Health and Care Excellence (NICE)-recommended treatment for symptomatic chronic heart failure with preserved or mildly reduced ejection fraction. The regulatory body’s decision means up to 150,000 patients would be eligible for AstraZeneca-made dapagliflozin (Forxiga).

Hospitals 101

Hospitals 101

Pharmaceutical Technology

MAY 19, 2023

Multiple sclerosis (MS) is a primary autoimmune disease in which inflammation is a core contributor to the degeneration of the central nervous system (CNS), leading to neurological disability and affecting sensory, visual, motor, and autonomic systems. While MS is not a terminal diagnosis, the effect of the disease on the CNS can significantly impact patients’ independence and disturb their daily lives.

Biosimilars 98

Biosimilars 98

Express Pharma

MAY 16, 2023

WHO, in partnership with the Global AMR R&D Hub , has released a report for G7 Finance and Health Ministers detailing progress on incentivising the development of new antibacterial treatments. The Global AMR R&D Hub is a partnership of countries, non-governmental donor organisations and intergovernmental organisations to address challenges and improve coordination and collaboration in global AMR R&D using a One Health approach.

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STAT

MAY 17, 2023

TARRYTOWN, N.Y. — As post-lunch drowsiness settled on an auditorium full of leaders from the drug development industry, Peter Fernandes, CEO of Bellerophon Therapeutics, seized the presentation clicker and jolted them awake. “I don’t believe in dreams, I believe in nightmares,” he told the audience, drawing a laugh.  “And I love nightmares.

Drug Development 285

Drug Development 285

Community Pharmacy

MAY 15, 2023

With winter far behind us and those long, hot days of Texas summer ahead comes ample opportunities to get outside and absorb some Vitamin D. While we all love having some fun in the sun, too much of a good thing can become a problem, and this adage rings especially true when it comes to sunlight and skin cancer. Excessive unprotected sun exposure has been linked to an increase in skin cancer risk.

Community Pharmacies 98

Community Pharmacies Immunity Immunization 98

Pharmaceutical Technology

MAY 17, 2023

Chinook Therapeutics and Ionis Pharmaceuticals have entered a partnership to develop an antisense oligonucleotide (ASO) therapy to treat a rare, severe chronic kidney disease. The collaboration aims to discover, develop and commercialise an ASO therapy. It will use the precision medicine approach, as well as the deep expertise of Chinook Therapeutics in nephrology and knowledge of Ionis Pharmaceuticals in RNA-targeted therapeutics.

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Express Pharma

MAY 16, 2023

The Annual Event of the Federation of Pharmaceutical and Allied Products Merchant Exporters (FPME) was held on May 13, 2023, at the Indian Merchant Chamber in Mumbai. The event was organised to provide a platform for the members of FPME to discuss the latest trends, challenges, and opportunities in the pharma export industry. The event was attended by a diverse group of participants, including pharma exporters, government officials and industry experts.

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STAT

MAY 16, 2023

In the last two decades, Black Americans have suffered 1.63 million excess deaths and lost more than 80 million years of life compared to white Americans, according to a new analysis that is the first comprehensive attempt to quantify the impact of health disparities by tallying years of potential life lost. The analysis showed improvement was made in narrowing long-standing health gaps between Black and white Americans between 1999 and 2011, but progress stalled through 2019.

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Drug Patent Watch

MAY 13, 2023

Annual Drug Patent Expirations for BANZEL Banzel is a drug marketed by Eisai Inc and is included in two NDAs. It is available from one supplier. There is one patent… The post New patent expiration for Eisai Inc drug BANZEL appeared first on DrugPatentWatch - Make Better Decisions.

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PharmaTech

MAY 15, 2023

Forge will provide adeno-associated virus (AAV) process development, toxicology, cGMP manufacturing, and analytical services to Life Bio, which will occur at Forge’s gene therapy facility in Columbus, Ohio called the Hearth.

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Express Pharma

MAY 16, 2023

Eminence Business Media recently announced the third Annual Computer Software Assurance 2023, Live and In-stereo. The third Annual Computer Software Assurance 2023 aims to strengthen and empower Computer System Validation (CSV) and provide key insights on the CSA approach. The idea is to create a programme that examines various elemental components to strengthen the CSV gameplan, address challenges to boost the existing system and explore various aspects of CSA by analysing the knowledge gaps an

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