STAT

AUGUST 14, 2023

Shares of Apellis Pharmaceuticals are rebounding, driven by a growing belief among some investors that the serious safety issue that has derailed Syfovre, the company’s eye disease treatment, is receding. Declaring the crisis over is premature, but that could change with more uneventful weeks. Apellis has been a takeout target before, and may be again, at an acquisition price nearly twice its current market value.

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PharmaVoice

AUGUST 14, 2023

The company believes its platform could deliver safer and more efficient mRNA options for cancer and infectious diseases.

Vaccines 241

Vaccines 241

STAT

AUGUST 14, 2023

Hospitals once dove headfirst into venture capital with splashy headlines and attention-grabbing numbers. Now, in an era of flattened margins and exceedingly uncertain returns, many health systems are quietly pulling back. NewYork-Presbyterian’s venture firm, once managing roughly $40 million in assets, was essentially dissolved, two former employees said, with leaders punting it from the system’s strategy division to innovation, then from innovation to the investment office ȁ

Hospitals 245

Hospitals 245

ALiEM - Pharm Pearls

AUGUST 14, 2023

A 64-year-old female with a history of quadriplegia and bladder rupture secondary to a motor vehicle accident two years ago, complicated by chronic indwelling suprapubic foley, presents from her skilled nursing facility with fever, oliguria, tachycardia, low blood pressure, and a change in the color of her urine. Physical Exam Vitals : T 100.4°F; HR 126; BP 105/74; RR 24 General : Pleasant but mildly confused morbidly obese female smelling strongly of urine Genitourinary : Poorly maintained indw

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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 14, 2023

The International Agency for Research on Cancer (IARC, an entity within the World Health Organization) recently announced that aspartame, a sugar substitute used in about 6,000 products worldwide, is “possibly carcinogenic to humans.” If this sounds familiar, it’s because reports of this assessment have circulated for two weeks, after anonymous sources leaked it to the press.

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PharmaVoice

AUGUST 14, 2023

Biogen’s acquisition of Reata Pharmaceuticals is the latest in a string of high-dollar rare disease deals over the last few months. What does it mean for industry?

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BioPharma Dive

AUGUST 14, 2023

Elrexfio is the third bispecific antibody cleared to treat the blood cancer, and will compete with other therapies that target the “BCMA” protein on myeloma cells.

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STAT

AUGUST 14, 2023

The study of eugenics wasn’t born on Long Island — it’s closer to say it went through puberty there. The idea of eugenics — a pseudoscience that promoted the idea that certain people or groups should be removed from the human gene pool — originated in England with Francis Galton, a cousin of Charles Darwin. Galton took the emerging ideas of evolution and genetics and attempted to apply them to human society.

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The Pharmacist

AUGUST 14, 2023

Nearly double the number of pharmacists worked as locums in 2022 than in 2021, the recently published community pharmacy workforce survey has suggested. But locum pharmacists worked fewer hours on average in autumn 2022 than the previous year. Paul Day, the director of the Pharmacists’ Defence Association (PDA), has suggested that a high-pressure working environment […] The post Poor workplace wellbeing blamed for locum pharmacist increases appeared first on The Pharmacist.

Community Pharmacies 91

Community Pharmacies 91

STAT

AUGUST 14, 2023

CommonSpirit Health, the massive not-for-profit health system formed through a 2019 merger, paid its former CEO $35.5 million in 2021, the latest year for which data is available.  The size of Lloyd Dean’s pay package is likely to reignite questions about health system CEO pay, especially at tax-exempt organizations. It’s more than twice the total compensation paid to the CEO of Ascension, a comparably sized not-for-profit system, and puts him in the upper tier of many for-pro

Hospitals 223

Hospitals Packaging 223

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Pharmacy Management

BioPharma Dive

AUGUST 14, 2023

Stephen Apps discusses how technology can help improve the speed and quality of clinical research and why a dedicated, cross-functional approach is needed to maximize its value for smaller biotechs.

Drug Development 98

Drug Development 98

STAT

AUGUST 14, 2023

Just weeks after the division of UnitedHealth Group that provides care to patients posted its lowest profit margin in a decade, the company has shuffled around several top executives. Amar Desai is now CEO of Optum Health, according to a July LinkedIn post. Optum Health encompasses UnitedHealth’s physician practices, surgery centers, urgent care clinics, and other providers.

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Hospitals 217

Express Pharma

AUGUST 14, 2023

Lupin has received approval from the United States Food and Drug Administration (US FDA) for its Abbreviated New Drug Application for Doxycycline Hyclate Delayed-Release Tablets USP, 50 mg, 60 mg, 75 mg, 80 mg, 100 mg, 120 mg, 150 mg, and 200 mg, to market a generic equivalent of Doryx Delayed-Release Tablets, 50 mg, 75 mg, 80 mg, 100 mg, 150 mg, and 200 mg and Doryx MPC Delayed Release Tablets, 60 mg and 120 mg, of Mayne Pharma International.

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STAT

AUGUST 14, 2023

Emma Albee knows the experimental drug she takes is not a cure. It won’t allow her to stop using the wheelchair she’s relied on since adolescence, and it’s not going to take away the latticework of bone that has locked her hips in place. But for Albee and the roughly 1,000 people with a rare genetic disorder that causes their body to grow rigid bone where it doesn’t belong, the drug symbolizes a future in which years of research, advocacy, and tireless fundraising mig

Drug Development 210

Drug Development 210

European Pharmaceutical Review

AUGUST 14, 2023

Eli Lilly and Company has completed acquisition of two biopharmaceutical companies – Versanis Bio and Sigilon Therapeutics – and their lead assets focused on obesity and diabetes. Lilly announced the successful completion of its acquisition of clinical-stage Versanis Bio and its lead asset bimagrumab, an anti-obesity medicine. Under the terms of the deal – first announced in July – Versanis shareholders could receive up to $1.925 billion in cash, inclusive of the upfront payment and subs

Diabetes 90

Diabetes 90

STAT

AUGUST 14, 2023

PHOENIX — Postal worker Eugene Gates Jr. was delivering mail in the suffocating Dallas heat this summer when he collapsed in a homeowner’s yard and was taken to a hospital, where he died. Carla Gates said she’s sure heat was a factor in her 66-year-old husband’s death, even though she’s still waiting for the autopsy report.

Hospitals 170

Hospitals 170

Express Pharma

AUGUST 14, 2023

PharmaTechnologyIndex.com Pvt. Ltd and Drug Marketing & Manufacturing Association (DMMA) are organising the 15 th edition of PharmaTech Expo and LabTech Expo from August 25-27, 2023 at Helipad Exhibition Centre, Sector 17, Gandhinagar. It is a premier event dedicated to pharma innovation, technology and knowledge. PharmaTech Expo brings together the pharma machinery, lab, analytical and packaging equipment, formulation, nutraceuticals, APls, chemical, ingredients, wellness, excipients, fragr

Packaging 87

Packaging 87

STAT

AUGUST 14, 2023

Good morning, everyone, and welcome to another working week. We hope the weekend respite was relaxing and invigorating, because that oh-so familiar routine of online meetings, phone calls, and deadlines has predictably returned, even if this is the dog days of summer. So to cope, yes, we are firing up the coffee kettle and reaching for another cup of delicious stimulation.

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Vaccines 168

Pharmaceutical Technology

AUGUST 14, 2023

HebeCell has forged a strategic collaboration with Logomix for researching and developing gene-edited natural killer cells (NK cells).

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Pharma Times

AUGUST 14, 2023

IDEAL study aims to determine the impact of seladelpar on alkaline phosphatase levels - News - PharmaTimes

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BioPharma Dive

AUGUST 14, 2023

Meet the pharma marketer of the future, primed for personalization and powered by technology.

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Pharma Times

AUGUST 14, 2023

The purchased therapies concerned are Cardioxane, Totect, Ethyol and Savene - News - PharmaTimes

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Pharmaceutical Technology

AUGUST 14, 2023

Daxxify becomes the latest botulinum toxin to make the jump from aesthetics to therapeutics.

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World Pharma News

AUGUST 14, 2023

Pfizer Inc. (NYSE:PFE) today announced the U.S. Food and Drug Administration (FDA) has granted accelerated approval to ELREXFIO™ (elranatamab-bcmm) for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

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PharmExec

AUGUST 14, 2023

Purchase aims to develop therapies for people living with metabolic diseases.

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pharmaphorum

AUGUST 14, 2023

Pfizer joins off-the-shelf BCMA fight with Elrexfio okay Phil.

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PharmExec

AUGUST 14, 2023

H1 Mobile to offer latest information and research in multiple fields.

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pharmaphorum

AUGUST 14, 2023

World Lung Cancer Day: Why awareness days matter Mike.

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GMPSOP

AUGUST 14, 2023

How to perform periodic review of systems and processes in pharmaceuticals? Pharmaceuticals quality assurance & validation procedures GMPSOP How to perform periodic review of systems and processes in pharmaceuticals? Prev PREVIOUS POST NEXT POST Next Table of Contents Imagine you have a new facility where all laboratory instruments are qualified, and all computer systems controlling the production facility are validated.

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Documentation Pharmaceutical Manufacturing Packaging 52

Pharmaceutical Business Review

AUGUST 14, 2023

Lilly signed the definitive agreement to acquire Versanis Bio in July this year. At the time of the deal announcement, its terms specified that shareholders of Versanis were to receive up to $1.92bn in cash, which includes upfront payment and subsequent payments following achievement of some development and sales milestones. The deal widens Lilly’s portfolio to include Versanis’ lead asset, bimagrumab.

Diabetes 52

Diabetes 52

FDA Law Blog: Biosimilars

AUGUST 14, 2023

By Douglas B. Farquhar — At the GMP by the Sea Conference ongoing in Cambridge, Maryland, a presentation was made by a representative of FDA’s Center for Drug Evaluation and Research that shows some interesting trends in enforcement. Jennifer Maguire, the Director of the Office of Quality Surveillance within the Office of Pharmaceutical Quality at CDER, told attendees that there were 163 FDA inspections from the beginning of October 2022 to the end of March 2023 conducted at drug manufacturing f

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Dosage Compounding 52

European Pharmaceutical Review

AUGUST 14, 2023

The US Food and Drug Administration (FDA) has approved Janssen’s Akeega (niraparib and abiraterone acetate), for the treatment of adult patients BRCA-positive metastatic castration-resistant prostate cancer (mCRPC). Akeega is the first-and-only orally administered, once daily dual action tablet of niraparib, a highly selective poly (ADP-ribose) polymerase (PARP) inhibitor, and abiraterone acetate, an androgen biosynthesis inhibitor.

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PharmaTech

AUGUST 14, 2023

Additionally, Poseida has approved Astellas as a board observer seat, which gives Astellas the right to attend Poseida’s scientific advisory board meetings and certain notice rights related to any potential change of control over Poseida.

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BioPharma Dive

AUGUST 14, 2023

The agency needs more time to settle with Valneva the design of a post-marketing study for the shot, which could become the first preventive therapy for chikungunya available in the U.S.

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Vaccines 52

PharmaTech

AUGUST 14, 2023

A report from the UK Bioindustry Association report indicated that biotech venture and public financing rose from £295 million in the first quarter to £382 million in the second quarter.

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