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Insmed CEO Will Lewis keeps a newspaper story from 2014 framed on the wall of his office. This is the online version of Adam’s Biotech Scorecard, a subscriber-only newsletter. STAT+ subscribers can sign up here to get it delivered to their inbox. The headline reads, “Insmed joins the biotech trash heap.”
Indeed, since 2014, DPD facilitatedthe publication of 42 quarterly batches and dozens of stand-alone PSGs, plus three one-off batches of PSGs updated to align with recommendations in general guidance documents ( g. , Publishing virtually every GDUFA guidance and MAPP since 2014 to fulfill FDAs GDUFA commitments.
The arm of the agency that handles submissions for medicines began requiring fees in September 2014, while the other unit overseeing cancer drugs took that step in April 2015.
Guideline On Similar Biological Medicinal Products, CHMP/437/04 Rev 1. European Medicines Agency. Guideline On Similar Biological Medicinal Products Containing Biotechnology-Derived Proteins As Active Substance: Non-Clinical and Clinical Issues, EMEA/CHMP/BMWP/42832/2005 Rev1. Guillen E, Ekman N, Barry S, et al.
The collapsed talks between Pfizer and AstraZeneca in 2014 highlight the need for flexibility, realistic valuations, and a deep understanding of regulatory hurdles in cross-border deals. Jane Smith, pharmaceutical industry analyst. Insights from Failed Negotiations Learning from unsuccessful negotiations is equally important.
In 2014, the Joint Commission for Pharmacy Practitioners (JCPP) - representing 11 national pharmacy organizations - endorsed a framework for providing clinically oriented patient care services called the Pharmacist's Patient Care Process.
In the generic filers view, the regulatory review period should have started in January 2014 when the patent was reissued rather than in April 2004, when the IND was opened, because the reissued patent did not exist in April 2004. The plain text of 35 U.S.C.
The drug also isn’t new and was first approved in 2014 before being acquired by Currax in 2019. But Currax has seen more uptake in the last few years thanks to the rising profile of obesity meds, especially among patients who might not be a fit for GLP-1s.
In 2014, he became Head of Emerging Markets, overseeing business operations in 80 countries, including Africa, the Middle East, Asia-Pacific, Eastern Europe, the Commonwealth of Independent States (CIS), and Latin America.
Founded in 2014, Sydnexis is a US-based company and has recently concluded the three-year primary endpoint of its Phase III trial of the low-dose atropine formulation.
Inspection categorisation of Official Action Indicated (OAI) for Indian companies has decreased to 11 per cent in 2024 from 23 per cent in 2014, aligning with the global trend of 14 per cent in 2024.
According to a November 2024 GlobalData report, per-trial costs have risen steadily since 2014, with single country trials increasing by 2.9% The rising cost of clinical trials Clinical trials have always been expensive, but costs are reaching new heights. per year and multinational studies rising by 4.9% per year over this decade.
External Links Systematic review of stimulant and nonstimulant laxatives for the treatment of functional constipation, 2014 Oral Lactulose A Safe and Effective Strategy for the Management of Constipation in Individuals with Impaired Glucose Tolerance and Diabetes, 2022 Lactulose in all its glory, 2023 NHS UK - Lactulose
Hervé joined Incyte in 2014 when it was a single product, U.S.-only The company now owns six other approved drugs, including a cream formulation of Jakafi’s main ingredient that’s proved useful treating atopic dermatitis and vitiligo. only company,” said board member Baker, in a statement. billion today.”
a) 2009 b) 2010 c) 2012 d) 2014 13 / 20 What is the primary goal of scientific communication in pharma marketing? a) 75% b) 50% c) 90% d) 30% 12 / 20 In which year was the Sunshine Act enacted in the United States, requiring pharmaceutical companies to disclose payments made to HCPs?
Rachael Willard-Grace and her colleagues (2014) looked at the relationship of team structure and culture to burnout or emotional exhaustion for both primary care clinicians and support staff. Team structure” in their study indicated the consistency with which the same primary care clinicians and support staff worked together. Hessler, D.,
This loss came after losing her 17-year-old son, Graham, in 2014 shortly after leaving rehab. The other, Teresa, lives with the permanent, aching void left by the loss of her beloved son Spencer at age 24 to a preventable overdose. Losing both of her children to this epidemic has left an irreplaceable emptiness. Read the rest…
Soriot, who fended off a takeover from the US predator Pfizer in 2014 , has grown AstraZeneca into Britain’s most valuable company, thanks to an astute eye for promising medicines and developing one of the first Covid vaccines. Continue reading.
Since that time, it was formalized in FDA regulations (21 CFR 314 Subpart H) in 1992, codified in the Food, Drug, & Cosmetic Act by FDAMA (21 USC 356(c)) in 1997, revised by FDASIA in 2012, and described in guidance, most importantly, in the 2014 Expedited Programs for Serious Conditions Drugs and Biologics (2014 Guidance).
Dr. Schneider joined Chilton Medical Center in 2014 as chief nurse and operations officer, eventually being promoted to facility president. President of Chilton Medical Center and Senior Vice President of Atlantic Health System (Pompton Plains and Morristown, N.J.).
The US Food and Drug Administration (FDA) approved Amgen’s Blincyto (blinatumomab), the first bispecific T-cell engager (BiTE), in 2014 for adults with Ph- R/R B-ALL, with its label expanded in 2017 to include Ph+ and paediatric cases.
For documents published in 2014 this number was just six; in 2024 it was 157 ( Figure 2 ). 2014-2024 (Credit: Elsevier BV – Scopus) Figure 2 : Documents by year. 2014-2024 (Credit: Elsevier BV – Scopus) Regionally, the US is dominating rare disease research. 1 Figure 1 : Documents by year.
A whistleblower lawsuit that originated in 2014 and filed by an executive at Aetna — now a CVS Health unit — alleged CVS Caremark inflated Medicare Part D drug prices to offset higher costs in other lines of business.
Steven Smoke, Pharm.D., BCIDP, BCPT Five Things To Know: How To Use Artificial Intelligence To Be A Better Clinical Pharmacist Katarzyna Wojcik, PMP, PhD,Andrea Prinzi, PhD, MPH, CPH, SM(ASCP),Amanda Suchanek, Ph.D., Jessica Blavignac Microbiology Laboratory Strategies to Advance Antimicrobial Stewardship Timothy Gauthier, Pharm.D.,
per year between 2014 and 2023. Here are five notes on the study: Uterine cancer incidence increased 0.7% per year between 2013 and 2022 and mortality increased 1.6% From 2018 to 2050, uterine cancer incidence is projected to increase 28.6% among white women, from 57.7 cases per 100,000. among Black women, from 56.8 cases to 86.9
authored the Sunscreen Innovation Act , which became law in 2014, Americans are still waiting for newer, more effective sunscreen products due to the Food and Drug Administration’s chronic inaction. A decade after Sen. Jack Reed (D-R.I.)
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…
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…
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.
After his spinal cord injury in 2014, Sherown Campbell worked hard to regain as much bodily function as he could. Once a dedicated athlete, Campbell had to learn the new limits of his body. One of them, jarringly, was his body’s inability to sweat.
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.
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.
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.
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…
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.
When I left Syria in 2014, I had a dream of becoming a U.S.-trained trained physician. I quickly realized that the American dream is real and that hard work truly pays off.
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…
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.
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.
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.
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.
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.
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