Fierce Pharma

OCTOBER 19, 2023

The company licensed the med to Genentech in 2011. Amid a cost-cutting drive and a looming commercial threat in Europe, PTC Ther | PTC will hold on to 19% of its royalty interest in the Genentech drug with the option to sell the rest down the line.

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Fierce Healthcare

JULY 17, 2023

Friday, the Federal Trade Commission (FTC) announced its withdrawal of two policy statements outlining its former position on antitrust enforcement in healthcare markets, echoing a similar decision | The two policy statements, issued in 1996 and 2011, "no longer reflect market realities in this important sector of the economy," the regulator (..)

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STAT

OCTOBER 24, 2023

Damian here with news of a 2021-sized biotech round that has echoes of 2011, plus an ESMO recap and a curious stock move. Want to stay on top of the science and politics driving biotech today?    Sign up  to get our biotech newsletter in your inbox. Good morning, everyone. Read the rest…

FDA 102

FDA 102

Fierce Healthcare

AUGUST 14, 2023

The number of cancer patients using immune checkpoint inhibitor drugs has steadily risen since they hit the market in 2011, and a new report from Evernorth offers payers key strategies to manage th | The number of cancer patients using immune checkpoint inhibitor drugs has steadily risen since they hit the market in 2011, and a new report from Evernorth (..)

Immunization 52

Immunization 52

STAT

DECEMBER 12, 2023

In 2011, the Centers for Medicare and Medicaid Services created the annual wellness visit (AWV), a new visit type with no cost to Medicare patients, better reimbursement to primary care practices, and higher assigned credit for clinicians’ work.

Insurance 119

Insurance 119

STAT

OCTOBER 14, 2022

In 2011, Walgreens executives were under pressure. Amid a growing addiction crisis, and with the country already awash in prescription painkillers, the federal government was demanding accountability from the pharmacy giant for filling thousands of opioid prescriptions written by doctors in suspiciously large quantities.  

Documentation 117

Documentation 117

STAT

MAY 16, 2023

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. In the last two decades, Black Americans have suffered 1.63

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Blog: Ask a Student Pharmacist

OCTOBER 4, 2023

Minneceutics Newsletter eomizowh Wed, 10/04/2023 - 12:47 Current Newsletter Expand all + Archive 1993 1994 1995 1999 2000 2001 2002 2003 2004 2006 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021

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STAT

FEBRUARY 1, 2023

” But based on a final regulation published Monday, Medicare is going against that public interest by giving a free pass to Medicare Advantage plans for any erroneous codes they submitted between 2011 and 2017. The amount of taxpayer money that insurers will get to keep because of that decision: $2 billion.

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Insurance 107

Pharmaceutical Commerce

NOVEMBER 13, 2023

Exparel was initially approved in 2011 for single-dose infiltration into a surgical site.

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FDA 40

STAT

NOVEMBER 27, 2023

Amid concerns over the use of medically important antibiotics given to food-producing livestock, sales of veterinary medicines across Europe dropped by 53% between 2011 and 2022, which regulators reported is the biggest drop ever recorded and a sign that campaigns to reduce usage are working.

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STAT

APRIL 30, 2024

Founded in 2011, Akili Interactive made waves in 2020 when it received Food and Drug Administration clearance for EndeavorRx , its treatment for young people with ADHD. Earlier this year, Better Therapeutics, developer of an FDA-cleared app for the treatment of type 2 diabetes shut down operations.

Insurance 97

Insurance FDA 97

STAT

JANUARY 9, 2023

Wall Street had been watching sales figures closely, for fear that competition from biosimilars — a form of generic — and new medicines from rival drugmakers could cut into the sales that have fueled Regeneron’s growth since Eylea was approved in 2011. Continue to STAT+ to read the full story…

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STAT

NOVEMBER 18, 2022

Amid ongoing concerns over the use of medically important antibiotics given to food-producing livestock and farmed fish, sales of veterinary medicines across Europe dropped by nearly half between 2011 and 2021, which regulators reported is the biggest drop ever recorded and a sign that campaigns to reduce use are working.

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STAT

OCTOBER 19, 2022

In 2011, the same year that Makena received accelerated approval from the FDA, I was a member of a similar FDA advisory committee hearing in which we considered withdrawing the breast cancer indication for the drug Avastin. We’ve been here before.

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FDA 93

Pharmafile

AUGUST 24, 2022

The West African nation has successfully eliminated dracunculiasis (Guinea worm disease), elephantiasis (lymphatic filariasis), human African trypanosomiasis (sleeping sickness) and trachoma, in an effort spanning between 2011 and 2022. read more.

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STAT

AUGUST 3, 2023

In 2011, President Obama signed the National Alzheimer’s Project Act into law, establishing a national goal of preventing and effectively treating the disease by 2025. Medicare’s policies are creating obstacles that make it more difficult for patients who are highly likely to benefit to obtain access to diagnosis and treatment.

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STAT

APRIL 18, 2023

A February 2023 report from Chartis , a health care consulting firm, found that 217 labor and delivery units have closed across the nation since 2011. The trend of rural hospitals shuttering perinatal services is not new. When these facilities close, the care of both pregnant people and their newborns must occur elsewhere.

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Hospitals 98

The Guardian - Pharmaceutical Industry

MARCH 3, 2023

It was patented in 1993, eventually approved in 2011 and is now one of the leading treatments of advanced prostate cancer, branded as Zytiga. In the early 1990s, he and his colleagues at the Institute of Cancer Research in London designed the hormone therapy drug abiraterone acetate.

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STAT

OCTOBER 23, 2024

regulators in 2011. Court of Appeals for the Federal Circuit rejected Regeneron’s request to block the launch during its appeal of a related decision for Amgen in a patent case in West Virginia. Eylea can treat eye diseases like macular degeneration, macular edema, and retinopathy, and was first approved by U.S. billion in U.S.

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Compounding Compounding Pharmacies FDA Documentation 94

European Pharmaceutical Review

OCTOBER 17, 2024

World Allergy Organization (WAO) White Book on Allergy 2011-2012: Executive Summary. Finger Injection With High-Dose (1:1,000) Epinephrine: Does It Cause Finger Necrosis And Should It Be Treated? Hand (N Y). 2007; 2(1):5-11. Derived from IQVIA Claims Data, 2023. Casale TB, Ellis AK, Nowak-Wegrzyn A, et al.

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FDA 121

The FDA Law Blog

AUGUST 12, 2024

Patent and Trademark Office consulted with FDA on the appropriate timelines, FDA claimed that the INAD, and thereby the testing phase, was not effective until August 4, 2011 because no NCIE was submitted until then. Thus, the Agency concluded, the June 2011 date should stand. On August 8, 2024, the Court granted Nissan et al.’s

FDA 57

FDA 57

STAT

FEBRUARY 21, 2024

Founded in 2011, Dario started with a diabetes app targeted at consumers before expanding it to hypertension and weight management. The move is a bet that a consolidated offering can attract a critical mass of large customers in a market where profits have been elusive.

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STAT

JUNE 25, 2024

The justices threw out a lower court ruling that revived a lawsuit brought by the military personnel and civilians who said they were harmed between 2005 and 2011 in the Iraq war. The justices asked the lower court to reconsider the case.

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European Pharmaceutical Review

MARCH 1, 2024

MHRA confirmed that this new marketing authorisation was granted to Amgen Limited, as a line extension of the original marketing authorisation for XGEVA 120mg solution for injection, which was granted on 13 July 2011. The post New antibody drug formulation wins novel MHRA approval appeared first on European Pharmaceutical Review.

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Pharmaceutical Technology

JUNE 19, 2023

Novartis and Incyte Corp’s Jakafi was the first FDA-approved drug for the treatment of myelofibrosis in November 2011. First-in-line treatment for myelofibrosis currently involves treatment with Jakafi (ruxolitinib) in combination with other drugs such as danazol.

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FDA 98

Hospital Pharmacy Europe

APRIL 27, 2023

However, the FDA warned in 2011 that 5-ARIs may increase the risk of a more serious form of prostate cancer. A 2003 study suggested that 5-alpha reductase inhibitors (5-ARIs) such as finasteride, prevent or delay the appearance of prostate cancer. In addition, use of dutasteride, also gave rise to a lower risk of incident prostate cancer.

Hospitals 98

Hospitals FDA 98

European Pharmaceutical Review

DECEMBER 14, 2023

Between 1999 and 2001, it supported 17 percent of withdrawals, between 2002 and 2011, it supported 26 percent of withdrawals and by 2012 to 2016, 80 percent of withdrawals were supported by observational studies (cohort, case-control, or other epidemiologic design). Meta-analyses contributed least frequently (31.4 EMA/95098/2010.

Medical Records 116

Medical Records Vaccines Hospitals 116

pharmaphorum

JANUARY 25, 2023

BMS’ lawsuit claims that Imjudo (tremelimumab) infringes two patents covering its own CTLA4 drug Yervoy (ipilimumab), which has been on the market since 2011 and is a key component of combination therapies for cancer with BMS’ PD-1 inhibitor Opdivo (nivolumab).

Chemotherapy 52

Chemotherapy FDA 52

The Guardian - Pharmaceutical Industry

JULY 6, 2022

UK pharmaceutical firm to spin off Haleon – which will include brands such as Sensodyne and Panadol – in largest listing since 2011 Investors in the British pharmaceuticals giant GSK have voted to approve a demerger of its consumer brands into a new company, Haleon , firing the starting gun on the largest London stock market listing in a decade.

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pharmaphorum

FEBRUARY 23, 2021

Any changes to AMNOG will likely be a worry to industry as there has already been a toughening in AMNOG assessments since 2011.”. The AMNOG (Act on the Reform of the Market for Medicinal Products) was implemented on the 1 January 2011. Figure 1: AMNOG procedures and findings, 2011-2019. Tougher pricing?

Insurance 74

Insurance Medical Records 74

PharmaShots

APRIL 26, 2023

The therapy also showed a reduction in need or eligibility for SRT Ref: Businesswire | Image: Bristol Myers Squibb Related News:- BMS’ Camzyos (mavacamten) Receives the US FDA’s Approval for the Treatment of Symptomatic New York Heart Association Class II-III Obstructive HCM

FDA 40

FDA 40

Pharmaceutical Technology

APRIL 7, 2023

Makena was approved by the FDA under the accelerated approval pathway in 2011 to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of spontaneous preterm birth. The decision was made after studies did not prove the effectiveness of the drug in preventing preterm birth.

FDA 97

FDA 97

European Pharmaceutical Review

AUGUST 23, 2022

To achieve this objective, the regulation amends Directive 2011/24/EU on the application of patients’ rights in cross?border Directive 2011/24/EU had the merit of drawing attention to the need for an appropriate and centralised assessment of health technologies but failed to ensure effective harmonisation on the issue. Lorgelly PK.,

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The FDA Law Blog

MAY 27, 2024

Jennifer was with the firm from 2011-2017, before leaving for in-house roles at Apple, Abbott Laboratories, and Cognito Therapeutics. “Jennifer’s return adds depth and breadth to our device practice and her strong relationships from her earlier time at the firm has made for a seamless reentry,” said J.P. Ellison, Managing Director at HPM.

FDA 57

FDA 57

Pharmaceutical Technology

APRIL 7, 2023

Makena was approved by the FDA under the accelerated approval pathway in 2011 to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of spontaneous preterm birth. The decision was made after studies did not prove the effectiveness of the drug in preventing preterm birth.

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FDA 95

The People's Pharmacy

MARCH 27, 2023

Coffee and Cholesterol: The problem with French press and other types of unfiltered coffee techniques lies with blood lipids. Compounds from coffee can raise total cholesterol, triglycerides and bad LDL cholesterol ( European Journal of Clinical Nutrition , Aug.,

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Compounding 63