2009 - Pharmacist Digest

STAT+: After Canada required pharma to pay fees, drug agency recommended coverage more often

STAT

MARCH 3, 2025

The analysis tallied a total of 258 approved drugs for which companies submitted applications between 2009 and 2020, and then examined funding recommendations that were subsequently made through December 2020 for most drugs. Recommendations for cancer treatments were reviewed through December 2021.

Drug Pricing

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

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.

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.

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.

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.

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…

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.

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

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.

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.

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

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…

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+: 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+: 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+: 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.

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.

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+: 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

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: 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: 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

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.

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. (..)

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.

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.

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.

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

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.

ACMT Toxicology Visual Pearl: Poison Dart Frog

ALiEM - Pharm Pearls

NOVEMBER 22, 2023

Tetrodotoxin, an Extremely Potent Marine Neurotoxin: Distribution, Toxicity, Origin and Therapeutical Uses. 2015;13(10):6384-6406. Published 2015 Oct 19. PMID: 26492253 Pratap Chand. Marine Envenomations. In: Clinical Neurotoxicology. Pages 454-462. ISBN 9780323052603. Retrieved 2023-06-13. Dumbacher JP, Spande TF, Daly JW.

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

Health Innovators – Jo Brewer, Adaptimmune

pharmaphorum

JULY 14, 2021

Prior to this, he founded pharmaphorum in 2009, which was acquired by Healthware Group in June 2020.

Communication

FDA Publishes Two Guidance Documents, One in Final Version

PharmaTech

JANUARY 7, 2025

The final guidance is a revision of a policy that has existed in some form since at least 2009, while a separate, draft guidance will accept public comment for consideration for its final version through April 8.

Documentation

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.

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.

Health Innovators: Fredrik Debong, Hi.Health

pharmaphorum

JUNE 25, 2021

Prior to this, he founded pharmaphorum in 2009, which was acquired by Healthware Group in June 2020.

Communication

NICE talking to you: Trends in early HTA engagement

pharmaphorum

OCTOBER 29, 2020

In 2009, NICE was one of the first health technology assessment (HTA) agencies to offer the opportunity for early scientific advice, at a cost. Figure 1: NICE early scientific advice projects, 2009/10 to 2019/20. Since 2009 the agency has added further charged-for services; in 2015 NICE added the Office for Market Access (OMA).

Documentation

Documentation Drug Development

Health Innovators: PureTech Health’s Daphne Zohar

pharmaphorum

AUGUST 17, 2021

Prior to this, he founded pharmaphorum in 2009, which was acquired by Healthware Group in June 2020.

Communication

Communication Immunity Immunization

Tick Tock re Tik Tok and FDA’s OPDP

Eye on FDA

OCTOBER 19, 2022

And FDA made tacit acknowledgement of the fact when it held a public Part 15 meeting in April 2009 to put forth a framework for the discussion of regulating social and digital media, with the aim of developing a guidance related to the unique challenges offered up by new media shortly thereafter. In fact, the medium does matter.

Communication

Communication Documentation

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.

Trial of Jazz’ cannabis drug in glioblastoma will start next year

pharmaphorum

NOVEMBER 28, 2021

Aside from chemotherapy the only improvements to treatment in recent years have included Roche’s VEGF-targeted antibody Avastin (bevacizumab), given a green light by the FDA in 2009, although it was subsequently rejected in Europe on the grounds of a lack of evidence for its efficacy.

Chemotherapy

Chemotherapy Hospitals

SAEM Clinical Images Series: An 8-year-old Male with Dysuria

ALiEM - Pharm Pearls

MARCH 27, 2023

2009 Oct 14;9:1119-26. Point of care ultrasound (POCUS) is a tool used in real time by emergency physicians to provide evidence for hydronephrosis, which can lead to the diagnosis of PUV. References Hodges SJ, Patel B, McLorie G, Atala A. Posterior urethral valves. ScientificWorldJournal. doi: 10.1100/tsw.2009.127.

Medical Schools

Medical Schools Hospitals

STAT+: After Canada required pharma to pay fees, drug agency recommended coverage more often

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

Trending Sources

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

SAEM Clinical Images Series: Pediatric Genitourinary Bleeding

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

King’s Speech confirms tobacco and vapes bill

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: A Blistery Mystery

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

Impact of IFM 2009 and DETERMINATION Studies

What The NAPLEX 2022 Pass Rate Tells Us About 2023

SAEM Clinical Images Series: Neonatal Rash

World Pharmacists Day 2021 Celebration

Driving QbD as a quality standard in drug development

SAEM Clinical Images Series: Only a Flesh Wound

ACMT Toxicology Visual Pearl: Poison Dart Frog

SAEM Clinical Images Series: Fever with Rash

Health Innovators – Jo Brewer, Adaptimmune

FDA Publishes Two Guidance Documents, One in Final Version

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

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

Health Innovators: Fredrik Debong, Hi.Health

NICE talking to you: Trends in early HTA engagement

Health Innovators: PureTech Health’s Daphne Zohar

Tick Tock re Tik Tok and FDA’s OPDP

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

Trial of Jazz’ cannabis drug in glioblastoma will start next year

SAEM Clinical Images Series: An 8-year-old Male with Dysuria

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