2009 - Pharmacist Digest

Impact of IFM 2009 and DETERMINATION Studies

Pharmacy Times

OCTOBER 11, 2024

Panelists discuss how the introduction of triplet therapy prior to transplant in studies like IFM 2009 and DETERMINATION shifted the clinician mindset toward more intensive induction regimens, leading to a focus on achieving deeper responses and longer progression-free survival as primary goals of therapy for newly diagnosed multiple myeloma patients. (..)

Amy Abernethy, former No. 2 at FDA, outlines new company’s plans to streamline clinical research

STAT

OCTOBER 17, 2024

2 official at the Food and Drug Administration, has spent a lot of time thinking about how to leverage data to improve our health, telling STAT in September that the idea for Highlander Health dates back to 2009. Abernethy, who previously served as the No. Read the rest…

Genentech review of Tessier-Lavigne paper finds no evidence of fraud — but hints at a different misconduct case

STAT

APRIL 6, 2023

South San Francisco biotech Genentech on Thursday announced that an internal review of misconduct allegations concerning a landmark 2009 paper co-authored by Marc Tessier-Lavigne, a former top executive at the company and Stanford University’s current president, did not find any evidence of fraud or intentional wrongdoing.

Documentation

Webinars

From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

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Opinion: As a primary care physician, here’s how I hope to partner with AI

STAT

MAY 21, 2024

Since EHRs swept into clinical life with passage of the American Recovery and Reinvestment Act of 2009, we have toiled away trying to make them as useful for clinical care as they are for billing, legibility, and data storage. That goal still seems like the wet pavement mirage on the highway: never getting closer as we speed along.

Precigen Receives the US FDA’s IND Clearance of PRGN-2009 + Pembrolizumab for the Treatment of Recurrent or Metastatic Cervical Cancer

PharmaShots

JUNE 1, 2023

Shots: The US FDA has cleared the IND application to initiate a P-II study evaluating PRGN-2009 (off-the-shelf AdenoVerse immunotherapy) + pembrolizumab vs pembrolizumab monotx. while the secondary objectives incl. while the secondary objectives incl.

STAT+: Greece’s antitrust regulator probes Novartis over practices tied to a pricey eye drug

STAT

SEPTEMBER 3, 2024

These practices, which occurred between 2009 and 2017, allegedly harmed the country and patients. At the same time, the agency is examining accusations that the drug company disseminated “defamatory claims and news” in hopes of influencing physicians and consumers to favor its own treatment over competing medicines.

STAT+: Jeff Shuren, medical devices head at FDA, to leave the agency

STAT

JULY 23, 2024

He became director of the Center for Devices and Radiological Health in 2009 and has served in that position ever since. Shuren, who spent 28 years at the agency, started his FDA career in the Commissioner’s Office in 1998.

Opinion: Do dementia villages actually work? We just don’t know

STAT

OCTOBER 24, 2023

Originating in Weesp, Netherlands, in 2009 in a village known as the Hogeweyk, the concept created a paradigm shift in dementia care, focusing on possibilities instead of disabilities. ” Dementia villages are small-scale communities that offer shared housing, minor medical care, and psychosocial support in a neighborhood setting.

Opinion: New draft recommendations for mammograms take a one-size-fits-all approach

STAT

MAY 17, 2023

This is the USPSTF’s first substantial change to its breast cancer screening recommendations since 2009. In 2009 and 2016, in light of growing evidence of the harms of mammography screening and the limited benefits among average-risk individuals under 50, the USPSTF recommended screening every two years starting at 50.

STAT+: New mega-deal highlights Geisinger’s fall, and raises concerns about where Kaiser is going next

STAT

APRIL 30, 2023

In 2009, when President Barack Obama was touring the country and ginning up support for what would eventually become the Affordable Care Act, Geisinger entered the mainstream.

Hospitals

Opinion: Listen: Putting an end to a racist ‘diagnosis’

STAT

NOVEMBER 8, 2023

The American College of Emergency Physicians recently withdrew a 2009 white paper endorsing the concept, and California has banned it as a cause of death. It came up most recently in the trials of two police officers accused of causing the death of Elijah McClain, a Colorado man; both officers were acquitted this week. Read the rest…

STAT+: ‘It was my call’: Stanford president defends decision not to correct key paper in misconduct investigation

STAT

APRIL 11, 2023

That decision concerned a major study published in the journal Nature in 2009 and co-authored by Marc Tessier-Lavigne, the university’s president and a renowned neuroscientist who at the time was a top researcher at the biotech company Genentech.

SAEM Clinical Images Series: A Blistery Mystery

ALiEM - Pharm Pearls

OCTOBER 11, 2024

2009 Jun 25;113(26):6511-21. doi: 10.1182/blood-2009-01-129155. Epub 2009 Apr 24. Consult Hematology early to guide management. References Cines DB, Bussel JB, Liebman HA, Luning Prak ET. The ITP syndrome: pathogenic and clinical diversity. PMID: 19395674; PMCID: PMC2710913.

Immunity

Immunity Immunization

Opinion: Why new guidelines recommending screening at 40 can’t end the mammography wars

STAT

JULY 27, 2023

The agency now recommends beginning at age 40 , reversing the age-50 guideline that had been in place since 2009. New breast cancer screening guidelines from the United States Preventive Services Task Force give the impression that the decades-long debate over when women should start getting mammograms is settled.

STAT+: White House moves closer to a ban on menthol cigarettes, amid intensifying opposition from tobacco companies

STAT

OCTOBER 16, 2023

The proposal, which is supported by a range of public health groups but fiercely opposed by cigarette makers, is one of the most consequential tobacco policies coming out of the FDA since the agency was given the authority to regulate tobacco in 2009.

Documentation

STAT+: Departing Stanford president retracts two widely cited papers, against lead author’s wishes

STAT

AUGUST 31, 2023

His departure was prompted by a 95-page report released by a special committee of the university’s Board of Trustees, which recruited outside scientists and a former federal judge to investigate a dozen papers Tessier-Lavigne co-authored between 1999 and 2009, years before becoming the university’s leader.

Opinion: Physician and Rep. Raul Ruiz: The infectious disease doctor shortage threatens future pandemic preparedness

STAT

NOVEMBER 22, 2023

In 2009, I was practicing in the emergency department when the H1N1 pandemic emerged. Then, I saw firsthand the vital role infectious disease physicians played in not only facilitating a coordinated public health response, but also helping patients, providers, and the public navigate the uncertainty that comes with confronting a novel virus.

Hospitals

STAT+: Vape makers see Supreme Court ruling as a weapon in fighting FDA

STAT

JUNE 28, 2024

Vape manufacturers see the decision as a powerful weapon in their fight against the FDA’s efforts to ban the majority of vapes lining store shelves.

STAT+: What disclosure? Clinical trials run in Canada fail to take basic steps toward transparency

STAT

SEPTEMBER 8, 2022

The analysis examined trials that were completed between 2009 and 2019. More specifically, 47% of those trials, or more than 1,770, were registered in advance, while only 12% reported results in a registry and 48% published their findings. The Continue to STAT+ to read the full story…

STAT+: Most clinical trials run in Canada failed to take basic steps toward transparency, analysis finds

STAT

NOVEMBER 27, 2023

The analysis, which examined trials that were completed between 2009 and 2019, were published in Facets , a medical journal that examines research conducted in Canada and internationally (university and industry performances can be seen here ).

STAT+: A lawsuit over a controversial Sanofi drug shortage is unexpectedly revived

STAT

FEBRUARY 20, 2024

The difficulties began in June 2009, when viral contamination was found at a facility, prompting Genzyme to suspend production and ration supplies of its drug, called Fabrazyme.

Opinion: STAT+: The problem with potential changes to the biosimilar regulatory framework

STAT

SEPTEMBER 26, 2023

Since the Biologics Price Competition and Innovation Act of 2009 created a regulatory pathway for biosimilar medicine review in the U.S., Biosimilars are no longer a new and untested class of medicines. Today, they provide critical treatment options across multiple therapeutic areas.

Biosimilars

King’s Speech confirms tobacco and vapes bill

The Pharmacist

JULY 17, 2024

Under the proposed Tobacco and Vapes bill, children born on or after 1 January 2009 will […] The post King’s Speech confirms tobacco and vapes bill appeared first on The Pharmacist.

STAT+: Pharmalittle: We’re reading about an AstraZeneca bladder cancer drug, Genentech anxiety, and more

STAT

SEPTEMBER 16, 2024

Department of Justice said Walgreens violated the federal False Claims Act between 2009 and 2020 by submitting payment claims to Medicare, Medicaid, and other health care programs for prescriptions it processed but which were never picked up. Walgreens Boots Alliance agreed to pay $106.8

Chemotherapy

SAEM Clinical Images Series: Pediatric Genitourinary Bleeding

ALiEM - Pharm Pearls

NOVEMBER 17, 2023

2009 May;73(5):1008-11. Epub 2009 Mar 13. Always keep a broad differential for prepubertal pediatric patients with genitourinary and vaginal bleeding complaints References HHillyer S, Mooppan U, Kim H, Gulmi F. Diagnosis and treatment of urethral prolapse in children: experience with 34 cases. doi: 10.1016/j.urology.2008.10.063.

STAT+: How the CEO of the largest medical device accelerator molds medtech startups

STAT

NOVEMBER 21, 2023

He started it to empower entrepreneurs discouraged by a funding dry spell precipitated by the 2009 financial crisis, and to fill the void of a medical device-specific accelerator. Mentorship is the guiding principle of MedTech Innovator, a Los Angeles-based accelerator for early-stage medtech companies that Grand founded in 2015.

STAT+: Pharmalittle: Genentech finds no evidence of fraud in paper by former top exec; FDA withdraws approval for premature-birth drug

STAT

APRIL 7, 2023

… Genentech said an internal review of misconduct allegations concerning a landmark 2009 paper co-authored by Marc Tessier-Lavigne, a former top executive at the company and currently president at Stanford University, did not find evidence of fraud or intentional wrongdoing , STAT reports. Well, whatever you do, have a grand time.

STAT+: Pharmalittle: Woodcock to retire from the FDA; Acrotech urged to speed up confirmatory study of cancer drugs

STAT

NOVEMBER 17, 2023

They were approved under the FDA accelerated pathway in 2009 and 2014, respectively, for treating a rare form of blood cancer. The The drugs, Folotyn and Beleodaq, have already been on the market for nearly a decade or more.

Documentation

What The NAPLEX 2022 Pass Rate Tells Us About 2023

Med Ed 101

FEBRUARY 26, 2023

I’ve followed the NAPLEX exam since I graduated in 2009. The NAPLEX was relatively easy from my experience and the experience of many of my classmates. The pass rate that year was an indicator that the NAPLEX was not very difficult. That is not the case anymore.

Driving QbD as a quality standard in drug development

European Pharmaceutical Review

JANUARY 2, 2024

Reviewing implementation of QbD in the pharmaceutical industry To compile the review of Quality by Design in the context of MAAs in Europe, the researchers analysed the implementation of the QbD methodology for all MAAs approved by the European Medicines Agency (EMA) since the ICH Q8(R2) guideline was adopted in 2009.

Drug Development

Drug Development Biosimilars Documentation

STAT+: Pharmalittle: Panel tells FDA that CRISPR sickle cell therapy is safe enough for patients; U.K. is urged to scrap IP demands in trade talks with India

STAT

NOVEMBER 1, 2023

Stelara, introduced in 2009, has been J&J’s top-selling drug since 2019, with sales reaching $9.7 However, the Amgen drug is not expected to launch until 2025 as part of a legal settlement between the two companies earlier this year to delay the entry of the therapy. billion in 2022.

Biosimilars

SAEM Clinical Images Series: Neonatal Rash

ALiEM - Pharm Pearls

FEBRUARY 26, 2024

2009 Jul-Aug;26(4):373-80. Case Discussion Take-Home Points When a vesicular rash is in a neonate < 1 month and all over the face, consider benign neonatal pustular lesions such as neonatal cephalic pustulosis. References Antoniou C, Dessinioti C, Stratigos AJ, Katsambas AD. Clinical and therapeutic approach to childhood acne: an update.

Medscape

RX Note

JUNE 11, 2023

Mobile Application Mobile application for Medscape was released in 2009 and 2011 for iOS and Android system respectively. Introduction Medscape is a comprehensive medical resource that provide up-to-date information on drugs, diseases and clinical procedures, which only requires a FREE account registration.

World Pharmacists Day 2021 Celebration

Pharma Mirror

SEPTEMBER 18, 2021

The idea of celebrating world pharmacists day was generated by International Pharmaceutical Federation (FIP) in 2009, in a conference staged in Istanbul, Turkey. The pharmacist community from all over the world arranges different campaigns, exhibitions, lectures, etc., for serving this purpose.

Between hope and despair: Improving cancer outcomes

PhRMA

JULY 11, 2023

In 2009, there weren’t many treatment options available, and the doctors weren’t sure how to respond because not many Black patients had had similar diagnoses, so there was little information to go forward on. Unfortunately, the tumor was diagnosed late in progression and inoperable.

Hospitals

Asahi Kasei Medical completes new assembly plant for Planova virus removal filters

Express Pharma

MAY 27, 2024

Planova cellulose hollow-fibre membrane filters, developed specifically for removing viruses from biotherapeutic products, were launched in 1989, followed by Planova BioEX hydrophilic PVDF hollow-fibre membrane filters in 2009.

Asahi Kasei Medical launches Planova FG1 next-generation virus removal filter

Express Pharma

OCTOBER 23, 2024

Since its launch in 1989, Planova has seen significant product developments, with the introduction of Planova BioEX hydrophilic PVDF hollow-fiber membrane filters in 2009 and Planova S20N next-generation cellulose hollow-fiber membrane filters in 2022. This business is seen as a key driver for Asahi Kasei Group’s future growth.

SAEM Clinical Images Series: Fever with Rash

ALiEM - Pharm Pearls

JANUARY 22, 2024

2009 Jan;11(1):66-72. Infect Dis Clin North Am. 2007 Dec;21(4):997-1011, ix. doi: 10.1016/j.idc.2007.08.002. 2007.08.002. PMID: 18061086. Hendershot EF, Sexton DJ. Scrub typhus and rickettsial diseases in international travelers: a review. Curr Infect Dis Rep. doi: 10.1007/s11908-009-0010-x. PMID: 19094827. Shiao CC, Lin SY.

Documentation

Documentation Hospitals

FDA grants priority review to Pfizer and Astellas’ sNDA for XTANDI

Pharmaceutical Business Review

AUGUST 23, 2023

A commercial agreement to jointly develop and commercialise XTANDI in the US was signed between Medivation, a part of Pfizer, and Astellas in October 2009. If approved, XTANDI is expected to become the first and only hormone therapy to treat this earlier prostate cancer type.

Cognitive decline in early Alzheimer’s could stem from serotonin loss

Pharma Times

DECEMBER 18, 2023

Scientists recruited 49 volunteers with mild cognitive impairment (MCI) and 45 healthy adults aged 55 years and older who had previously undergone an MRI to measure changes in brain structure and two positron emission tomography (PET) scans of their brains at Johns Hopkins between 2009 and 2022.

SAEM Clinical Images Series: Only a Flesh Wound

ALiEM - Pharm Pearls

SEPTEMBER 29, 2023

2009 Nov;67(5):1046-1050. References Goodwin RB, Beery PR 2nd, Dorbish RJ, et al. Computed tomographic angiography versus conventional angiography for the diagnosis of blunt cerebrovascular injury in trauma patients. The Journal of Trauma. DOI: 10.1097/ta.0b013e3181b83b63. 0b013e3181b83b63. PMID: 19901666.

SAEM Clinical Images Series: Unusual Scalp Lesions

ALiEM - Pharm Pearls

OCTOBER 2, 2023

Epub 2009 Aug 11. Consider pertinent physical exam findings and utility of POCUS in confirming the diagnosis. References Harris AT, Bhatti I, Bajaj Y, Smelt GJ. An unusual cause of pre-auricular swelling. J Laryngol Otol. 2010 Mar;124(3):339-40. doi: 10.1017/S002221510999082X. PMID: 19664319. Minakova E, Doniger SJ. Pediatr Emerg Care.

Medical Schools

Biogen’s $900 million settlement signals scrutiny on speaker fees

Pharmaceutical Technology

OCTOBER 5, 2022

In 2009, former Biogen employee Michael Bawduniak filed a lawsuit claiming that Biogen had violated the False Claims Act and the Anti-Kickback Statute by providing millions of dollars to healthcare providers (HCPs) as an incentive to prescribe three of its multiple sclerosis (MS) drugs.

Documentation

Documentation Pharmaceutical Companies Pharmaceutical Companies

FDA Knows Its Own Strength—and It Includes Concentration

FDA Law Blog: Biosimilars

FEBRUARY 26, 2024

This of course, make sense—after decades of experience implementing the Hatch-Waxman, Congress and FDA had learned a few new tricks by 2009/2010. FDA replied that its definition of strength including concentration was clear even in 2009. mg) and the concentration (e.g., mg/mL) for liquid parenteral drug products.

Biosimilars

Biosimilars Dosage

Impact of IFM 2009 and DETERMINATION Studies

Amy Abernethy, former No. 2 at FDA, outlines new company’s plans to streamline clinical research

Webinars

Trending Sources

Genentech review of Tessier-Lavigne paper finds no evidence of fraud — but hints at a different misconduct case

Webinars

Opinion: As a primary care physician, here’s how I hope to partner with AI

Precigen Receives the US FDA’s IND Clearance of PRGN-2009 + Pembrolizumab for the Treatment of Recurrent or Metastatic Cervical Cancer

STAT+: Greece’s antitrust regulator probes Novartis over practices tied to a pricey eye drug

STAT+: Jeff Shuren, medical devices head at FDA, to leave the agency

Opinion: Do dementia villages actually work? We just don’t know

Opinion: New draft recommendations for mammograms take a one-size-fits-all approach

STAT+: New mega-deal highlights Geisinger’s fall, and raises concerns about where Kaiser is going next

Opinion: Listen: Putting an end to a racist ‘diagnosis’

STAT+: ‘It was my call’: Stanford president defends decision not to correct key paper in misconduct investigation

SAEM Clinical Images Series: A Blistery Mystery

Opinion: Why new guidelines recommending screening at 40 can’t end the mammography wars

STAT+: White House moves closer to a ban on menthol cigarettes, amid intensifying opposition from tobacco companies

STAT+: Departing Stanford president retracts two widely cited papers, against lead author’s wishes

Opinion: Physician and Rep. Raul Ruiz: The infectious disease doctor shortage threatens future pandemic preparedness

STAT+: Vape makers see Supreme Court ruling as a weapon in fighting FDA

STAT+: What disclosure? Clinical trials run in Canada fail to take basic steps toward transparency

STAT+: Most clinical trials run in Canada failed to take basic steps toward transparency, analysis finds

STAT+: A lawsuit over a controversial Sanofi drug shortage is unexpectedly revived

Opinion: STAT+: The problem with potential changes to the biosimilar regulatory framework

King’s Speech confirms tobacco and vapes bill

STAT+: Pharmalittle: We’re reading about an AstraZeneca bladder cancer drug, Genentech anxiety, and more

SAEM Clinical Images Series: Pediatric Genitourinary Bleeding

STAT+: How the CEO of the largest medical device accelerator molds medtech startups

STAT+: Pharmalittle: Genentech finds no evidence of fraud in paper by former top exec; FDA withdraws approval for premature-birth drug

STAT+: Pharmalittle: Woodcock to retire from the FDA; Acrotech urged to speed up confirmatory study of cancer drugs

What The NAPLEX 2022 Pass Rate Tells Us About 2023

Driving QbD as a quality standard in drug development

STAT+: Pharmalittle: Panel tells FDA that CRISPR sickle cell therapy is safe enough for patients; U.K. is urged to scrap IP demands in trade talks with India

SAEM Clinical Images Series: Neonatal Rash

Medscape

World Pharmacists Day 2021 Celebration

Between hope and despair: Improving cancer outcomes

Asahi Kasei Medical completes new assembly plant for Planova virus removal filters

Asahi Kasei Medical launches Planova FG1 next-generation virus removal filter

SAEM Clinical Images Series: Fever with Rash

FDA grants priority review to Pfizer and Astellas’ sNDA for XTANDI

Cognitive decline in early Alzheimer’s could stem from serotonin loss

SAEM Clinical Images Series: Only a Flesh Wound

SAEM Clinical Images Series: Unusual Scalp Lesions

Biogen’s $900 million settlement signals scrutiny on speaker fees

FDA Knows Its Own Strength—and It Includes Concentration

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