2014 - Pharmacist Digest

What the 2014 Ebola outbreak taught this biotech CEO about persuasion

PharmaVoice

JULY 18, 2023

A former WHO epidemiologist is applying lessons learned during the Ebola epidemic to her work leading a company at the forefront of women’s health: the reproductive microbiome.

How EU 536/2014 Will Revolutionize Global Clinical Trials

PharmExec

NOVEMBER 2, 2022

November 3rd 2022 9 am CT |10 am ET | 2 pm GMT | 3pm CET The way clinical trials are conducted in the European Union is undergoing major changes with (EU) No 536/2014.

DEA Regs Bulk Up with 2014 Anabolic Steroid Control Law Additions

FDA Law Blog: Biosimilars

AUGUST 4, 2023

Because anabolic steroids are also abused to enhance athletic performance and increase muscle strength, Congress has enacted three laws regulating anabolic steroids: the Anabolic Steroid Control Acts of 1990 and 2004, and the Designer Anabolic Steroid Control Act of 2014 (“DASCA”). DASCA became law, amending the CSA, on December 18, 2014.

Controlled Substances

Controlled Substances Labelling

STAT+: New antibiotics were underprescribed for hard-to-treat infections, study finds

STAT

APRIL 19, 2024

hospitals and then tracked usage of seven antibiotics that were approved by the Food and Drug Administration between 2014 and 2019. They examined data spanning January 2016 through June 2021 at 619 U.S. Continue to STAT+ to read the full story…

Hospitals

STAT+: A Q&A with the CEO of CRISPR Therapeutics on a historic approval and the road ahead

STAT

DECEMBER 8, 2023

Editas Medicine, CRISPR Therapeutics, and Intellia Therapeutics were all started in the 2013-2014 time frame with the same goal of turning the nascent CRISPR gene-editing technology into medicines.

STAT+: New NIH head says government has fallen behind pharma on clinical trials

STAT

NOVEMBER 14, 2023

Industry-sponsored trials increased 43% from 2006 to 2014, while newly registered NIH-funded trials decreased 24% over the same period. ” A Johns Hopkins University study published in 2015 showed that the pharmaceutical industry funds six times more clinical trials than the government. Continue to STAT+ to read the full story…

Why doesn’t the U.S. have more Black midwives?

STAT

SEPTEMBER 18, 2023

Universities have also expanded their course offerings, with the number of new students enrolled in accredited midwifery programs growing from 1,006 students in 2014 to 1,214 in 2018 , according to the latest data available. more than doubled from 1991 and 2012 and has continued to grow steadily in the years since. Read the rest…

Hospitals

STAT+: GSK is replacing its popular Flovent inhaler with authorized generics, raising cost concerns for asthma patients

STAT

JANUARY 5, 2024

The timing of the change is telling: Flovent’s price rose nearly 50% since 2014, according to GoodRx , leaving the drug vulnerable to the new Medicaid penalties going into effect as of this year for medications with price increases that outpace inflation. Prasco, a U.S.

Labelling

Labelling Drug Pricing

STAT+: Oncologists more likely to provide low-value care after receiving pharma money, study finds

STAT

OCTOBER 25, 2023

The researchers examined Medicare beneficiaries who were diagnosed with cancer and received treatment from 2014 through 2019. Overall, the proportion of patients who were prescribed so-called low-value drugs was higher when their oncologist accepted industry payments, according to the study, published in the BMJ.

Chemotherapy

Chemotherapy Pharmaceutical Companies Pharmaceutical Companies

STAT+: For Parkinson’s disease, advances spurred by Apple Watch offer a glimmer of hope

STAT

OCTOBER 24, 2023

Since the Apple Watch was unveiled in 2014, it has been trumpeted not only as a high tech fashion accessory, but also as a way for people to track their own health and fitness. It has evolved as a popular cardio tool for such uses as heart rate monitoring, recording your ECG, and measuring the oxygen saturation of your blood.

People Management

People Management Diabetes

FDA Approves Pembrolizumab Plus Chemoradiotherapy to Treat FIGO 2014 Stage III-IVA Cervical Cancer

Pharmacy Times

JANUARY 15, 2024

The approval was based on the results of a phase 3 trial that found an improvement in progression-free survival among individuals treated with pembrolizumab.

STAT+: FDA approves high blood pressure device from Recor Medical

STAT

NOVEMBER 8, 2023

But a large-scale clinical trial from Medtronic in 2014 called renal denervation’s efficacy into question, as it did not significantly reduce blood pressure compared to placebo treatments. The therapy, a simple procedure to reduce the blood pressure of millions of Americans , was once seen as a boon for cardiologists and device makers.

STAT+: Study finds heavier reliance on nurse practitioners, physician assistants after private equity takeovers

STAT

JANUARY 9, 2023

The researchers used clinician-level and practice acquisition data to study changes in the makeup of clinician workforces at private equity-acquired versus non-private equity-acquired dermatology, ophthalmology, and gastroenterology practices between 2014 and 2019.

Hospitals

Keytruda Granted Latest FDA Approval in Cervical Cancer

Pharmaceutical Commerce

JANUARY 15, 2024

FDA approves Keytruda (pembrolizumab) combined with chemoradiation for the treatment of patients with FIGO 2014 stage III to IVA cervical cancer, which is the 39th overall approved indication for the drug in the United States.

Does DIY still have a place in diabetes care?

STAT

JUNE 24, 2023

When Dana Lewis built her first artificial pancreas in 2014, she — and millions of other people with type 1 diabetes — didn’t have another option.

Diabetes

STAT+: Former FDA official lays out how to keep patients safe from risky medical devices

STAT

OCTOBER 2, 2023

Dispirited, she left in 2014 to work for consulting firm Avalere to build a device recall database. Critical information, like unique device identifiers that help hospitals keep track of implants in patients, was often missing. Patients and doctors alike often knew very little about the safety record of their devices.

Hospitals

STAT+: Solicitor general recommends Supreme Court shouldn’t review an Amgen patent case

STAT

SEPTEMBER 24, 2022

Amgen filed a lawsuit against the other companies in 2014 for allegedly infringing patents when they sought regulatory approval for their own medication. Continue to STAT+ to read the full story…

STAT+: Spain’s antitrust regulator fines drugmaker for ‘excessive’ pricing of a rare disease drug

STAT

NOVEMBER 15, 2022

But the drug was bought by Leadiant Biosciences which, by 2014, began raising the price in several countries before withdrawing the medicine from the market entirely the following year. At issue is a medicine called CDCA that is used to treat people with a rare genetic metabolic disease known as cerebrotendinous xanthomatosis, or CTX.

Drug Pricing

Generics expected to improve access for patients with idiopathic pulmonary fibrosis

Pharmaceutical Technology

SEPTEMBER 27, 2023

The idiopathic pulmonary fibrosis (IPF) market is underserved with just two licensed pharmaceutical treatments approved by the FDA in 2014.

How doulas could help prevent the harms that can happen during childbirth

STAT

NOVEMBER 4, 2022

When Tamiya Griffin was expecting her first child in 2014, she had what she thought was a straightforward plan: deliver at the hospital down the road, the same place her mother gave birth to her. But when Griffin, then a 22-year-old senior in college, went into labor a few weeks early, she had to undergo an emergency C-section.

Hospitals

STAT+: U.S. Supreme Court gives Amgen a boost by agreeing to review a closely watched patent case

STAT

NOVEMBER 4, 2022

Amgen filed a lawsuit against the other companies in 2014 for allegedly infringing patents when they sought regulatory approval for their own medication. At issue is a long-running battle between Amgen and a pair of rivals — Sanofi and Regeneron Pharmaceuticals — over the market for injectable cholesterol treatments.

Smokers’ views on harms of vaping worsened in recent years

The Pharmacist

MARCH 4, 2024

The Cancer Research UK funded analysis has tracked survey responses since 2014 among more than 28,000 smokers in England. Perceptions of the safety of vaping have worsened considerably over the past decade amongst people who smoke, a UK study has found.

Opinion: STAT+: Medical devices makers are trying to take a page from Uber’s playbook

STAT

MARCH 22, 2024

million in 2014 to $250,000 in 2016. In New York City, for example, it quickly achieved a large share of the consumer transport business. Its market dominance was so profound that it drove down the cost of taxi medallions from $1.3

Opinion: Another Ebola outbreak, another missed opportunity for preparedness

STAT

JANUARY 11, 2023

When I learned that an outbreak of Ebola was declared in Uganda last fall, I had a flashback to 2014 when I was working at Merck and an outbreak of Ebola disease caused by a different species of the virus emerged in full force in West Africa.

Vaccines

New Study Finds Direct-to-Consumer Pharmaceutical Advertising Can Benefit Public Health Goals When Incentives Align

PharmExec

MARCH 13, 2024

Data shows that from 2014-2019, pneumococcal vaccinations in seniors increased by 10%, growing sales for Prevnar 13 due to government recommendation in addition to a high-profile advertising campaign.

Vaccines

PTC Duchenne drug approval set to be revoked in Europe

BioPharma Dive

JANUARY 26, 2024

The EMA’s drugs committee again recommended rescinding an OK for Translarna, which was cleared in 2014 despite questions about its benefit.

Merck's Keytruda Receives Third FDA Approval for Cervical Cancer

PharmExec

JANUARY 15, 2024

The FDA issued the 39th overall approval for Keytruda (pembrolizumab), with the latest in combination with chemoradiation for the treatment of patients with FIGO 2014 stage III to IVA cervical cancer.

FDA Approves IgG-Hyaluronidase Recombinant for the Treatment of Adult Patients With CIDP

Pharmacy Times

JANUARY 16, 2024

Previously, IgG-hyaluronidase recombinant was approved by the FDA in 2014 for the treatment of primary immunodeficiency in adult patients and has expanded to include some pediatric patients.

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

STAT+: Pharmalittle: Some Lilly workers want transfers due to Indiana abortion law; GSK cancer drug flops in late-stage study

STAT

NOVEMBER 7, 2022

Amgen filed a lawsuit against the other companies in 2014 for allegedly infringing patents when they sought regulatory approval for their own medication. At issue is a long-running battle between Amgen and a pair of rivals — Sanofi and Regeneron Pharmaceuticals — over the market for injectable cholesterol treatments.

Dr Bruce Warner retires as deputy CPhO

The Pharmacist

MAY 31, 2023

Dr Warner has been the deputy CPhO since 2014, having previously worked […] The post Dr Bruce Warner retires as deputy CPhO appeared first on The Pharmacist.

Pharmacy Technician

Pharmacy Technician Community Pharmacies

FDA approves Merck’s Keytruda with chemoradiotherapy as cervical cancer treatment

Pharmafile

JANUARY 15, 2024

Merck, known as MSD outside of the US and Canada, has announced that the US Food and Drug Administration (FDA) has approved Keytruda (pembrolizumab) in combination with chemoradiotherapy (CRT) for the treatment of FIGO (International Federation of Gynecology and Obstetrics) 2014 Stage III-IVA cervical cancer.

STAT+: Pharmalittle: Biogen hires Viehbacher as its CEO; new dengue vaccine rolled out amid safety concerns

STAT

NOVEMBER 10, 2022

But he was ousted in 2014 after an embarrassingly public conflict with the Sanofi board. At Sanofi, Viehbacher was largely responsible for repositioning the staid drugmaker and for deepening its partnership with Regeneron Pharmaceuticals. But Continue to STAT+ to read the full story…

Vaccines

Novo Nordisk weight-management drug lands FDA approval

Outsourcing Pharma

JUNE 7, 2021

The pharmacy company's Wegovy (semaglutide) is the first therapy designated for chronic weight management that the agency has granted approval since 2014.

Toothbrushing

RX Note

JANUARY 23, 2024

2014 An analysis of methods of toothbrushing recommended by dental associations, toothpaste and toothbrush companies and in dental texts, 2014 Powered versus manual toothbrushing for oral health, 2014 American Dental Association - Toothbrushes, 2019

Community Pharmacies

Pharma R&D investment report shows positive signs: Deloitte

Outsourcing Pharma

JANUARY 14, 2022

According to the companyâs 12th Annual Pharmaceutical Innovation Report, pharmaceutical R&D return on investment has climbed to its highest peak since 2014.

Direct-acting Antivirals for Hepatitis C Infection Are Underused in the US, Study Finds

Pharmacy Times

DECEMBER 15, 2022

While the use of direct-acting antiviral treatment for hepatitis C virus increased from 2014 to 2018, treatment rates have declined since 2019 and remain suboptimal.

From GRP to SIUU – the Evolution of FDA Guidance on Off-Label Dissemination of Scientific Information

FDA Law Blog: Biosimilars

OCTOBER 24, 2023

Previous iterations of this guidance from 2009 and 2014 (blogged on here and here ) were known as Good Reprint Practices (GRP). The SIUU Guidance, which supersedes the 2014 Draft GRP Guidance, is not substantially different in that regard and contains similar information as to the types of disclosures previously recommended.

Labelling

Labelling Communication

Developing an effective contamination control strategy

European Pharmaceutical Review

SEPTEMBER 12, 2023

The panelists referred to other documents that are useful for CCS development: the 2014 Pharmaceutical Healthcare Sciences Society (PHSS) Technical Monograph No 20 Bio-Contamination 2 as well as the Parenteral Drug Association (PDA) Technical Report 90: Contamination Control Strategy Development, 3 published in February 2023.

Documentation

Nonpharmacologic Treatments Surpass Opioid Treatment for Patients with Chronic, Nonsurgical Pain

Pharmacy Times

NOVEMBER 11, 2022

Updated prescribing guidelines issued in 2014 and 2016 may explain lower use of opioids by 11.7% among patients with chronic, nonsurgical pain.

AstraZeneca’s Lynparza to dominate PARP inhibitors market with $4 bn in sales by 2027: GlobalData

Express Pharma

APRIL 25, 2024

In 2014, the FDA approved the first (adenosine diphosphate-ribose) polymerase (PARP) inhibitor AstraZeneca /Merck’s Lynparza (olaparib) for use in breast cancer gene (BRCA)-mutated metastatic ovarian cancer patients who have received three or more prior lines of chemotherapy.

Chemotherapy

Protect From Light

RX Note

DECEMBER 11, 2023

Examples Amphotericin B Doxorubicin Doxycycline Pegfilgrastim and biosimilars Phytonadione Selexipag Sodium nitroprusside Thiotepa - subject to manufacturer External Links Light-sensitive injectable prescription drugs, 2014 Light-Sensitive Injectable Prescription Drugs, 2022

Packaging

Packaging Biosimilars

Trick of the Trade: Gel-free ultrasound-guided peripheral IV technique

ALiEM - Pharm Pearls

APRIL 12, 2023

Hynynen, 10.08 – Ultrasound Therapy, Editor(s): Anders Brahme, Comprehensive Biomedical Physics, Elsevier, 2014, Pages 153-168, ISBN 9780444536334. Egan, Pharmacology and Physiology for Anesthesia (Second Edition), Elsevier, 2019, Pages 390-411, ISBN 9780323481106. DOI: 10.1016/B978-0-323-48110-6.00020-X R. Alerhand S, Singh M, editors.

Trigger Finger

RX Note

JULY 8, 2023

Case-control study, 2008 Outcome of corticosteroid injection versus physiotherapy in the treatment of mild trigger fingers, 2012 Prospective study on the management of trigger finger, 2014 Multidisciplinary consensus guideline for managing trigger finger: results from the European HANDGUIDE Study, 2014

Diabetes

Diabetes Community Pharmacies

What the 2014 Ebola outbreak taught this biotech CEO about persuasion

How EU 536/2014 Will Revolutionize Global Clinical Trials

Trending Sources

DEA Regs Bulk Up with 2014 Anabolic Steroid Control Law Additions

STAT+: New antibiotics were underprescribed for hard-to-treat infections, study finds

STAT+: A Q&A with the CEO of CRISPR Therapeutics on a historic approval and the road ahead

STAT+: New NIH head says government has fallen behind pharma on clinical trials

Why doesn’t the U.S. have more Black midwives?

STAT+: GSK is replacing its popular Flovent inhaler with authorized generics, raising cost concerns for asthma patients

STAT+: Oncologists more likely to provide low-value care after receiving pharma money, study finds

STAT+: For Parkinson’s disease, advances spurred by Apple Watch offer a glimmer of hope

FDA Approves Pembrolizumab Plus Chemoradiotherapy to Treat FIGO 2014 Stage III-IVA Cervical Cancer

STAT+: FDA approves high blood pressure device from Recor Medical

STAT+: Study finds heavier reliance on nurse practitioners, physician assistants after private equity takeovers

Keytruda Granted Latest FDA Approval in Cervical Cancer

Does DIY still have a place in diabetes care?

STAT+: Former FDA official lays out how to keep patients safe from risky medical devices

STAT+: Solicitor general recommends Supreme Court shouldn’t review an Amgen patent case

STAT+: Spain’s antitrust regulator fines drugmaker for ‘excessive’ pricing of a rare disease drug

Generics expected to improve access for patients with idiopathic pulmonary fibrosis

How doulas could help prevent the harms that can happen during childbirth

STAT+: U.S. Supreme Court gives Amgen a boost by agreeing to review a closely watched patent case

Smokers’ views on harms of vaping worsened in recent years

Opinion: STAT+: Medical devices makers are trying to take a page from Uber’s playbook

Opinion: Another Ebola outbreak, another missed opportunity for preparedness

New Study Finds Direct-to-Consumer Pharmaceutical Advertising Can Benefit Public Health Goals When Incentives Align

PTC Duchenne drug approval set to be revoked in Europe

Merck's Keytruda Receives Third FDA Approval for Cervical Cancer

FDA Approves IgG-Hyaluronidase Recombinant for the Treatment of Adult Patients With CIDP

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

STAT+: Pharmalittle: Some Lilly workers want transfers due to Indiana abortion law; GSK cancer drug flops in late-stage study

Dr Bruce Warner retires as deputy CPhO

FDA approves Merck’s Keytruda with chemoradiotherapy as cervical cancer treatment

STAT+: Pharmalittle: Biogen hires Viehbacher as its CEO; new dengue vaccine rolled out amid safety concerns

Novo Nordisk weight-management drug lands FDA approval

Toothbrushing

Pharma R&D investment report shows positive signs: Deloitte

Direct-acting Antivirals for Hepatitis C Infection Are Underused in the US, Study Finds

From GRP to SIUU – the Evolution of FDA Guidance on Off-Label Dissemination of Scientific Information

Developing an effective contamination control strategy

Nonpharmacologic Treatments Surpass Opioid Treatment for Patients with Chronic, Nonsurgical Pain

AstraZeneca’s Lynparza to dominate PARP inhibitors market with $4 bn in sales by 2027: GlobalData

Protect From Light

Trick of the Trade: Gel-free ultrasound-guided peripheral IV technique

Trigger Finger

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