The Pharma Data

SEPTEMBER 15, 2020

New indication allows this first FDA-approved biomarker-based test to be used as triage for positive cobas HPV tests run on cobas 6800/8800 Systems in primary screening or co-testing programs. 2016; 2:16086. [3] Basel, 16 September 2020 — Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced U.S. 1999; 189:12-19. [2]

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The Pharma Data

JUNE 18, 2021

Food and Drug Administration (FDA) has approved PREVNAR 20 (Pneumococcal 20-valent Conjugate Vaccine) for the prevention of invasive disease and pneumonia caused by the 20 Streptococcus pneumoniae (pneumococcus) serotypes in the vaccine in adults ages 18 years and older. Following today’s FDA approval, the U.S.

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FDA Law Blog: Biosimilars

JANUARY 18, 2024

At that time, the Agency allowed it to stay on the market under a program that tested edible portions of pigs, a method FDA now claims is not sufficient. The EU prohibited it in 1999, almost immediately after FDA approved the testing methods at issue here, and Canada banned it in 2006.

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FDA Law Blog: Biosimilars

MAY 21, 2024

We wondered how given that HHS and the Drug Enforcement Administration (“DEA”) conducted eight-factor scheduling analyses in 2016, concluding that there was “no substantial evidence that marijuana should be removed from Schedule I.” 12, 2016) ; Denial of Petition to Initiate Proceedings to reschedule Marijuana, 81 Fed. 12, 2016).

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Drug Discovery World

APRIL 27, 2023

Research spotlight : In February 2023, Duke University co-investigators took a groundbreaking step in the treatment of geographic atrophy (GA), an advanced form of dry macular degeneration through the FDA approval of pegcetacoplan, the first ever FDA-approved treatment for GA.

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FDA Law Blog: Biosimilars

APRIL 21, 2024

Usually at this point in a post we would identify the date of approval of the relevant NDA. But that’s the controversy here: Did FDA approve LYTGOBI NDA 214801 on September 30, 2022 when the Agency issued its initial approval letter , or on October 5, 2022 when FDA issued a corrected approval letter ?

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Advarra

AUGUST 16, 2022

Food and Drug Administration (FDA) approval. Since then, the FDA has significantly changed its approach to rare and orphan diseases. The FDA Since 1983. The Orphan Drug Act of 1983 was instrumental in changing the number of orphan drugs approved in the U.S. Before 1983, only 38 orphan drugs had received U.S.

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Drug Discovery World

APRIL 17, 2023

Cancer Moonshot In 2016, when Joe Biden was the US Vice President, he led the Cancer Moonshot initiative with the mission to accelerate the rate of progress against cancer. The survey also showed low awareness that HPV can cause anal, oral, and penile cancer. Read more here. Read more about AACR award winners here.

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FDA Law Blog: Biosimilars

FEBRUARY 11, 2024

There has been no evidence that marijuana’s schedule should change since the last rescheduling review in 2016. FDA has not approved marijuana for medical use because no double-blind, published studies show safety and efficacy for raw marijuana. In other words, no rescheduling.

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Drug Target Review

JUNE 21, 2023

Human genetics evidence supports two-thirds of the 2021 FDA-approved drugs. 2016 May;34(5):531-8. Epub 2016 Apr 11. 2016 May;135(5):477-483. Epub 2016 Mar 11. 2016 Nov 4;354(6312):aag0839. Why Clinical Trials Stop: The Role of Genetics. medRxiv; 2023. DOI: 10.1101/2023.02.07.23285407. PMID: 35804044.

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FDA Law Blog: Biosimilars

FEBRUARY 29, 2024

The use of a surrogate endpoint can considerably shorten the time required prior to receiving FDA approval. If the confirmatory trial shows that the drug actually provides a clinical benefit, then the FDA grants traditional approval for the drug. 8,128,929 was submitted on December 8, 2016 (Docket No.

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The Pharma Data

OCTOBER 14, 2020

Food and Drug Administration (FDA) approved Inmazeb, a three-antibody cocktail to treat Ebola infections in adults and children. It has also been approved for newborns of mothers who have tested positive for Ebola. during the 2014 to 2016 epidemic. In 2019, the FDA approved an Ebola vaccine, Merck’s Ervebo. “We

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Molecule Blog

AUGUST 13, 2021

If successful, this work could result in the repurposing of several FDA-approved therapeutics for the purpose of extending the human lifespan, at a lower cost and over faster timelines than conceivably possible with de novo drug discovery. The Scheibye-Knudsen lab has analyzed 1.5 billion prescriptions from 4.8

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Agency IQ

MARCH 25, 2024

FDA addressed the expanding practice of drug compounding in 1992 by issuing a compliance policy guide that clarified that pharmacies which compounded products at certain scales, for certain purposes, or without FDA approval were clearly operating “outside the bounds of traditional pharmacy practice.”

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Broad Institute

APRIL 25, 2024

Christian Happi Christian Happi However, in other parts of West Africa , Ebola was spreading, infecting nearly 29,000 people and killing more than 11,000 before the outbreak was contained in 2016. This year they began testing for 19 bloodborne pathogens such as Ebola, yellow fever, Lassa, and HIV.

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Advarra

NOVEMBER 17, 2022

In 2016, the Food and Drug Administration (FDA) approved Spinraza (nusinersen). While the FDA’s approval of nusinersen may not seem extraordinary, it was. Nusinersen’s approval marked the first time nonclinical data supported conducting initial clinical trials involving children.

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FDA Law Blog: Biosimilars

FEBRUARY 26, 2024

Relevant here, FDA interpreted in Guidance that a proposed injectable biosimilar must “demonstrate that its product has the same strength as the reference product by demonstrating that both products have the same total content of drug substance (in mass or units of activity) and the same concentration of drug substance.”

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Agency IQ

JUNE 17, 2024

As reported by POLITICO , “The decision — if allowed by the Supreme Court to take effect — would roll back actions the federal government has taken since 2016 to make the pills more accessible, including rules allowing online ordering, mail delivery, and pharmacy dispensing of the drugs. Read AgencyIQ’s analysis of that case here. ]

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The Pharma Data

DECEMBER 30, 2020

billion in cash to gain control of FDA-approved Palforzia , a first-of-its-kind treatment for patients with peanut allergies. Nestlé has been a longtime partner of Aimmune, first investing in the company in 2016. Nestlé and Peanut Allergies – In August, Nestlé Health Science acquired the outstanding stakes of Aimmune for $2.6

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The Pharma Data

JUNE 28, 2021

There are currently no FDA-approved anticoagulation therapies for pediatric patients with congenital heart disease who have undergone the Fontan procedure. From November 2016 to June 2019, a total of 112 participants were enrolled across 36 sites in 10 countries. UNIVERSE was conducted in two parts.

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The Pharma Data

JANUARY 31, 2021

Having raised more than USD $350 million in total capital since 2016, Clover is utilizing its proprietary Trimer-Tag© technology platform to develop novel biologics targeting trimerization-dependent pathways. FDA approval for prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older.

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The Pharma Data

FEBRUARY 13, 2022

In 2016, the FDA granted Breakthrough Therapy designation for Dupixent for the treatment of severe atopic dermatitis (in children aged 6 months to 11 years). About Regeneron Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents life-transforming medicines for people with serious diseases.

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The Pharma Data

JUNE 18, 2021

BOTOX ® Cosmetic is the first and only product of its kind FDA-approved to treat three areas, temporarily improving the appearance of moderate to severe forehead lines, glabellar lines and crow’s feet in adults. Data on File, Allergan, 2016; Clinical Study Report Satisfaction Table. . . .

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The Pharma Data

SEPTEMBER 10, 2021

The FDA approved MYFEMBREE for this indication on May 26, 2021, based on data from the Phase 3 LIBERTY program. Founded in 2016, we have two FDA-approved products. ORGOVYX® (relugolix) was approved by the U.S. In the U.S., Myovant and Pfizer are jointly developing and commercializing MYFEMBREE in the U.S.

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NIH Director's Blog: Drug Development

JUNE 14, 2016

That’s critical considering that just 1 in 10 drug candidates entering human clinical trials successfully goes on to receive FDA approval [5]. 2016 Jun 1;8(341):341ra76. [3] 2016 March 4. [5] December 2008. [2] Scott RA, Freitag DF, Li L, Chu AY, Ehm MG, Wareham NJ, Waterworth DM, et al. Sci Transl Med. Novo Nordisk.

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Drug Discovery World

AUGUST 10, 2022

Finally, in 2017, after years of improving T cell engineering techniques, the first chimeric antigen receptor (CAR) T cell therapy received FDA approval. Since 2017, five CAR T cell therapies have been approved and have shown incredible success in the clinic. Blood (2016) 127 (26): 3321f–3330. BMC Biotechnology.(2018)

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NIH Director's Blog: Drug Discovery

MARCH 8, 2016

The approach might also be put to use for optimizing drug candidates or for discovering new uses for cancer drugs that have already been FDA approved. 2016 Feb 29. With PRISM, it’s now feasible to screen entire small molecule libraries across large panels of cancer cell lines. Nat Biotechnol.

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The Pharma Data

JUNE 18, 2021

” The pivotal Phase 3 RESONATE-2 study served as the basis for the FDA approval of IMBRUVICA as a single-agent in first-line treatment for CLL/SLL in 2016, following initial approval for relapsed/refractory (R/R) patients in 2014 based on the RESONATE study.

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The Pharma Data

DECEMBER 3, 2020

Having raised more than USD $350 million in total capital since 2016, Clover is utilizing its proprietary Trimer-Tag © technology platform to develop novel biologics targeting trimerization-dependent pathways. FDA approval for prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older.

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Dark Matter Blog

AUGUST 27, 2020

In early August, risdiplam, an orally available small molecule that binds to a stem-loop structure in the SMN2 pre-mRNA, received FDA approval for the treatment of spinal muscular atrophy , a devastating genetic disease. A different therapeutic modality was pursued by Avexis, working with Novartis.

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Codon

MARCH 28, 2023

The meeting took place before the launch of Neuralink, in July 2016. DARPA invested more than $200 million in support of the White House’s Brain Research through Advancing Innovative Neurotechnologies ( BRAIN ) Initiative between 2014 and 2016 alone. The company was not publicly unveiled until the following year.)

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NIH Director's Blog: Drug Development

JULY 20, 2017

Credit: Zhang & Chen, 2016, Cell 167, 1586–1597. The first major advance in molecularly targeted drug treatment for the disease came in 2012, when the Food and Drug Administration (FDA) approved ivacaftor (Kalydeco). People with CF have a misspelling of both copies of the CFTR gene, one inherited from each parent.

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Codon

MARCH 24, 2024

In 2012, an Israeli company called Protalix gained approval for their plant-based enzyme product for Gaucher’s disease. In 2016, a company called Synageva BioPharma (formerly AviGenics) was acquired by Alexion for $8.4B. ” Finally, “pharmed” drugs are making their way onto the market.

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The Pharma Data

AUGUST 30, 2021

In 2016, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for Dupixent for the treatment of severe atopic dermatitis (in children aged 6 months to 11 years of age). Detailed results from this trial will be presented at a future medical meeting, and data will be submitted to regulatory authorities.

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Codon

JUNE 18, 2024

By 2016, Shapiro had set up a research laboratory at the California Institute of Technology in Pasadena and began to devote his attention entirely to gas vesicles. At least six types of CAR-T cells have already passed through clinical trials and garnered FDA approval.

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The Pharma Data

DECEMBER 21, 2020

2016:8;S494-S497. Related Articles: Tagrisso (osimertinib) FDA Approval History. LUNGevity Foundation. Types of Lung Cancer. Available at [link] Accessed August 2020. Sethi S, et al. Incidental Nodule Management – Should There Be a Formal Process? Journal of Thorac Onc. LUNGevity Foundation. Screening and Early Detection.

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Agency IQ

SEPTEMBER 15, 2023

Until recently, the FDA relied on a monograph process through which firms could bring OTC drugs to market without FDA approval so long as it adhered to pre-set terms under the monograph. Four comments were submitted to the docket established for the 2015 Petition.

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