5 takeaways from the Human Genome Project investigation
STAT
JULY 9, 2024
But that’s not how it turned out: One individual’s DNA accounted for the vast majority of the genome when a first draft was released in 2001. Read the rest…
2001 Related Topics 
STAT+: Drug shortages reached a record high as 2023 drew to a close
STAT
APRIL 10, 2024
stood at 323 during the fourth quarter of last year — the highest figure reached since such data began being tracked in 2001 — underscoring growing concerns about patient harm across the country. The number of ongoing and active drug shortages in the U.S.
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Opinion: Stigma and the return of syphilis
STAT
MAY 30, 2024
at epidemic rates that have been climbing since 2001. Syphilis, one of the oldest infections known to humans, has returned to the U.S. In 2022, the last year with complete data, the highest number of infections were recorded in more than 70 years.
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STAT+: For one rare type of lung cancer, Pfizer pill reduces progression by 81%
STAT
MAY 31, 2024
The results are an update on the clinical trial that resulted in the Food and Drug Administration granting Lorbrena full approval in 2001, so in a sense they are not even that new. There are a lot of reasons why updated data on Pfizer’s Lorbrena, a treatment for non-small cell lung cancer, might not seem to be a big deal.
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STAT+: Gilead to pay $40 million to settle claims it delayed newer HIV treatment to boost profits
STAT
JUNE 5, 2024
” Here is the back story: In 2001, Gilead won U.S. For its part, the company issued a statement in which it did not admit wrongdoing and continued to maintain it has “never stopped working to improve the lives of people with HIV.”
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Opinion: I grew up in one of Africa’s largest informal settlements. Now I’m helping heal it
STAT
NOVEMBER 24, 2023
In 2001, at the age of 13, I had come to Kenya’s largest informal settlement on the outskirts of Nairobi with my sister. I had only lived in Kibera for 15 minutes when I saw a police officer and was arrested. But it would be years before I saw a real doctor. When we arrived at 3 a.m.,
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STAT+: Departing Stanford president retracts two widely cited papers, against lead author’s wishes
STAT
AUGUST 31, 2023
The retractions come the same day that Tessier-Lavigne’s resignation as Stanford president takes effect.
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Mistakes happen in research papers. But corrections often don’t
STAT
JANUARY 10, 2023
Five studies co-authored by Tessier-Lavigne are now under the microscope for containing alleged altered images: a 1999 Cell study , a 2008 paper in the EMBO Journal, a 2003 Nature study, and two studies published in 2001 in Science.
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Opinion: STAT+: 3 keys to successful biopharma-academia drug development collaborations
STAT
MARCH 31, 2023
Indeed, academic inventors or founders contributed to more than one-quarter of all medicines approved from 2001 through 2019. Academia can be an excellent source of novel drug targets and new technologies that can enhance medicinal discovery. Yet many sponsored research collaborations that hope to tap into academia fail.
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Opinion: STAT+: A California court is setting a dangerous precedent over drug development (or lack thereof) liability
STAT
FEBRUARY 13, 2024
In 2001, Gilead secured FDA approval of tenofovir disoproxil fumarate (TDF), one of first medicines to treat HIV — a product still on the market, despite the potential side effect of causing skeletal and kidney damage.
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Suicides and homicides among young Americans jumped early in the pandemic, study says
STAT
JUNE 15, 2023
The Centers for Disease Control and Prevention report examined the homicide and suicide rates among 10- to 24-year-olds from 2001 to 2021. The homicide rate for older U.S. Read the rest…
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STAT+: Amgen’s $27.8 billion Horizon merger is latest industry bet on pricey rare disease drugs
STAT
DECEMBER 12, 2022
The deal is the largest pharma merger announced this year, and it represents the most that Amgen has spent on an acquisition since its $16 billion purchase of Immunex in 2001. Amgen said Monday it would purchase Horizon Pharmaceuticals for $27.8 Continue to STAT+ to read the full story…
Half of people worldwide at risk of developing mental health condition by age 75, per new study
STAT
AUGUST 8, 2023
The study, published last week in The Lancet Psychiatry , analyzed answers that participants provided between 2001 and 2022 in response to a World Health Organization survey designed to assess the prevalence of major mental health disorders.
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STAT+: Medicare may test policy of paying less for accelerated approval drugs
STAT
JANUARY 31, 2023
The program is widely considered a success and has worked well for many drugs, including the leukemia drug Gleevec , which the FDA approved in 2001 after a review period of just two-and-a-half months, based on study results that correctly predicted successful clinical outcomes. Continue to STAT+ to read the full story…
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How telehealth startups are trying to fill the menopause care vacuum
STAT
JULY 17, 2023
The study was shut down early — and a year later, prescriptions had plummeted to nearly half what they had been in 2001. But in 2002, the therapy went into a free-fall when a landmark trial suggested treating menopause with estrogen and progesterone increased the risk of breast cancer and cardiovascular disease.
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STAT+: Pharmalittle: Amgen agrees to pay $27.8 billion for Horizon Therapeutics; Roche pharma head steps down
STAT
DECEMBER 12, 2022
The deal is the largest pharmaceutical merger announced this year, and it represents the most that Amgen has spent on an acquisition since its $16 billion purchase of Immunex in 2001. The The product is expected to generate $1.97 billion in 2022 and $2.26 billion in 2023, according to FactSet, an investment data firm.
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STAT+: Pharmalittle: We’re reading about drug shortages, Medicare spending on an Alzheimer’s drug, and more
STAT
APRIL 11, 2024
stood at 323 during the fourth quarter of last year — the highest figure reached since such data began being tracked in 2001 — underscoring growing concerns about patient harm across the country, STAT tells us. Unresolved The number of ongoing and active drug shortages in the U.S.
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Regulatory-first for gene editing therapy
European Pharmaceutical Review
OCTOBER 19, 2023
The Investigational New Drug (IND) application for Intellia Therapeutics’ in vivo CRISPR-based candidate NTLA-2001, has been cleared as a gene editing therapy for transthyretin (ATTR) amyloidosis with cardiomyopathy (ATTR-CM) in the US. This supports NTLA-2001’s potential as a single-administration therapeutic.
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PulmCrit Hot Take: Aggressive glycemic control is dead (TGC-Fast Trial)
EMCrit Project
SEPTEMBER 28, 2023
Major interest in tight glycemic control in the ICU began in 2001 with an RCT by the same group of investigators, also […] EMCrit Project by Josh Farkas. background Today the Van de Bergh group in Belgium released a RCT investigating tight versus liberal glycemic control in the ICU.
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Ichnos Glenmark Innovation presents first clinical data from phase 1 study of Trispecific TREAT Antibody, ISB 2001
Express Pharma
DECEMBER 9, 2024
The post Ichnos Glenmark Innovation presents first clinical data from phase 1 study of Trispecific TREAT Antibody, ISB 2001 appeared first on Express Pharma.
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REGiMMUNE Entered into a License Agreement with San Fu Biotech to Develop and Commercialize RGI-2001 for the Prophylaxis of Acute Graft-Versus-Host Disease
PharmaShots
APRIL 3, 2023
REGiMMUNE’s RGI-2001 is currently in P-III trial for the prophylaxis of aGVHD Ref: Businesswire | Image: Regimmune Related News:- Omega Therapeutics Entered into a Clinical Supply Agreement with Roche to Evaluate OTX-2002 for Hepatocellular Carcinoma
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Women in Science: Trinity Life Sciences’ Leslie Orne: ‘I love the energy and dynamism of consulting’
Outsourcing Pharma
JULY 26, 2023
Leslie Orne joined Trinity Life Sciences in 2001 and was recently appointed CEO and president of the fast-growing healthcare consultancy. She previously held the title of chief commercial officer (CCO) and president.
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Intellia, Regeneron ace first trial with ‘in vivo’ CRISPR drug
pharmaphorum
JUNE 28, 2021
Preliminary results from a phase 1 trial run by Regeneron and CRISPR specialist Intellia Therapeutics – co-founded by Nobel Prize winner Jennifer Doudna – showed steep reductions in a biomarker of ATTR amyloidosis disease activity with a single dose of the NTLA-2001 drug.
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SAEM Clinical Images Series: Didn’t See That Coming
ALiEM - Pharm Pearls
SEPTEMBER 30, 2024
2001 Dec;59(12):1462-70. However, non-traumatic hyphema should prompt investigation for hematologic disorders such as Sickle cell disease. References Brandt MT, Haug RH. Traumatic hyphema: a comprehensive review. J Oral Maxillofac Surg. doi: 10.1053/joms.2001.28284. 2001.28284. PMID: 11732035. Gragg J, Blair K, Baker MB. 2022 Dec 26.
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Heart failure: clinical trials update 2022
European Pharmaceutical Review
NOVEMBER 11, 2022
NTLA-2001, a novel CRISPR/Cas9-based therapy in the first-ever human gene editing trial ( NCT04601051 ) in vivo (in the body), reduced transthyretin (TTR) proteins by at least 90 percent in amyloidogenic transthyretin (ATTR) cardiomyopathy patients, 28 days after a single IV infusion, with benefits lasting four to six months.
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World’s first malaria vaccine rolled out in Cameroon
Express Pharma
JANUARY 22, 2024
The drugmaker received funding to develop the RTS,S-based vaccine for young children in 2001, it said. The vaccine has been in the making for nearly 40 years. It was first created in 1987, according to GSK.
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Officials Release Draft Legislation Aimed at Prescription Drug Shortage Issues
Pharmacy Times
MAY 8, 2024
Ongoing and active shortages are currently at the highest number since January 2001.
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What Can One Life Tell Us About the Battle Against H.I.V.?
NY Times
DECEMBER 2, 2021
In 2001, U.N. estimates suggested 150 million people would be infected with H.I.V. That preceded an ambitious global campaign to curb the virus. How well did it work?
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Intellia’s gene editing therapy shows early potential in rare heart condition
Pharmaceutical Technology
NOVEMBER 18, 2024
Intellia presented data from its Phase I study of NTLA-2001 at the 2024 American Heart Association scientific meeting in Chicago.
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FDA grants orphan drug status for Ichnos’ multiple myeloma antibody
Pharmaceutical Technology
JULY 10, 2023
The US FDA has granted orphan drug designation (ODD) for Ichnos Sciences’ ISB 2001 to treat patients with multiple myeloma.
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Huge inequalities found in access to myeloma clinical trials in Europe, says MPE
pharmaphorum
DECEMBER 1, 2022
Led by the MPE CEE Workgroup on Access, the report – Addressing access barriers to myeloma clinical trials in Central and Eastern Europe – evaluated the number of clinical trials held in CEE countries between 1 January 2001 and 28 September 2020. Approximately 50,000 people in Europe are diagnosed with myeloma each year.
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2022 spells change for EU pharmaceutical legislation
European Pharmaceutical Review
JUNE 24, 2022
Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use. One of the key priorities of the EU’s strategy is to encourage innovation to solve unmet medical needs. Brussels; 2020.
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Nuclear Pharmacist by Day, DJ by Night
Pharmacy Is Right For Me
OCTOBER 21, 2022
I worked in Dallas from 95-2001, then moved to NYC, then years later went to the University of Colorado for the NTPD program and received the PharmD. What makes your career path unique? My focus in Pharmacy School at OU was Nuclear Medicine. There was a fully operational Nuclear Pharmacy on campus, and I took all the courses.
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Episode 890: How to Succeed at Journal Club Without Really Trying
Pharmacy Joe
JANUARY 24, 2024
For example, if the new article is about glucose control in the ICU, you can be sure that the letter to the editor will mention other landmark trials such as 2001 article by Van Den Berghe and NICE-SUGAR.
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Psychedelic medicines: are they gaining traction in Europe?
European Pharmaceutical Review
APRIL 13, 2023
For example, the relaxed attitude towards cannabis in the Netherlands is well-known and Portugal has decriminalised the possession and consumption of all illicit substances since 2001.
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Envision acquires commercial solutions firm Two Labs
pharmaphorum
NOVEMBER 18, 2020
Since being founded in 2001, Envision has delivered strong year-on-year organic growth and established leadership in medical affairs strategy, medical communications, and enterprise-wide Envision technology.
Bridging the healthcare digital divide: a gradual approach to adopting ePI
European Pharmaceutical Review
JANUARY 25, 2024
Proposal for a Directive of the European Parliament and of the Council on the Union code relating to medicinal products for human use, and repealing Directive 2001/83/EC and Directive 2009/35/EC.” References European Commission, (26 April 2023). Article 63 EMA (29 January 2020). Article 63 Euractiv (26 September 2023).
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New CEO Mortazavi takes UK biotech e-therapeutics into gene silencing
pharmaphorum
OCTOBER 13, 2020
Since it was founded in 2001 the company has become one of the country’s best known biotechs thanks to its approach to designing drugs based around network biology.
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ExeVir ready for clinic with variant-targeting llama antibody
pharmaphorum
MARCH 9, 2021
billion acquisition at the end of 2018, span out of VIB in 2001 and developed drugs based on similar technology. ExeVir is not the first company to spin out of VIB to focus on camelid antibodies. Ablynx, which is now a subsidiary of Sanofi following a $4.8
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Roivant joins RNA splicing push with Eisai deal
pharmaphorum
JANUARY 6, 2022
H3B-8800 – now renamed RVT-2001 – will be taken in a slightly different direction by Roivant, which said it plans to develop it as a therapy for transfusion-dependent anaemia in patients with lower-risk MDS, according to the company.
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Join Us for an HP&M Webinar – Demystifying DEA Inspections: Accountability Audits, Mirror Reviews and Mock Inspections (Wednesday, May 24: 12:00-12:45)
FDA Law Blog: Biosimilars
MAY 3, 2023
Before joining HP&M in 2001, Mr. Houck conducted numerous scheduled cyclic and targeted inspections and investigations as a DEA Diversion Investigator in the field for ten years. Registrants are far from powerless when DEA investigators inspect their controlled substance operations.
Have you checked your brand’s temperature?
pharmaphorum
DECEMBER 14, 2020
Since the beginning of her career in 2001, Elena has partnered with various stakeholders, such as patients, healthcare professionals and life-science companies, to create impact for modern marketing activities. She can be contacted via elena.pirofalo@healthwareinternational.com.
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Botanical drugs – what is the best way forward for regulatory and market approval?
European Pharmaceutical Review
JULY 4, 2024
11 The THR pathway was created with the purpose of establishing a simplified registration procedure for all traditional herbal medicines that do not fulfil the requirements for the MA (strict) pathway under Directive 2001/83/EC. 10,12 The THR scheme is also limited to products used for oral or external use and/or inhalation. 2012/1916).
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GSK enters agreement with Canada for influenza vaccines
Pharmaceutical Technology
JULY 18, 2022
The latest contract comes after previous agreements between the parties for seasonal influenza and pandemic vaccines dating back to 2001. The company intends to supply both vaccines from its 230,000ft² Sainte-Foy facility in Quebec. .
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