FDA Law Blog: Biosimilars

OCTOBER 13, 2024

Tobolowsky — The Rare Pediatric Disease Priority Review Voucher program has had a bit of a tumultuous history in its 12 short years of existence. Over 50 rare pediatric disease priority review vouchers have been awarded to date. Notably, it was reauthorized in 2016 (until 2020) and in 2020 (until 2024).

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Broad Institute

APRIL 25, 2024

He started to imagine how the deadly and contagious disease, if confirmed, might spread to half the city’s population. Eight of the 20 patients died, but the spread of the disease in Nigeria stopped there. Blood and urine samples from the man were waiting for Happi in his lab. Happi felt chilled. They called the idea Sentinel.

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The Pharma Data

DECEMBER 15, 2020

A healthy immune system defends the body against disease and other conditions. Autoimmune disease impacts different parts of the body, weakening functionality. Researchers are aware of more than 80 diseases that occur when the immune system attacks the body’s own organs, tissues and cells. It may be life-threatening.

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NIH Director's Blog: Drug Development

JUNE 14, 2016

People with type 2 diabetes are at increased risk for heart attacks, stroke, and other forms of cardiovascular disease, and at an earlier age than other people. In fact, the evidence suggests that such drugs might even offer some protection against heart disease. 2016 Jun 1;8(341):341ra76. [3] December 2008. [2] Sci Transl Med.

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Molecule Blog

AUGUST 13, 2021

v=uT2-0qoHjbc Who will be there: Molecule & VitaDAO Core Teams If you haven’t yet read up on the research project as well as the researchers behind it, find more about it below: About the Research Project What if therapeutics to slow down the ageing process and prevent age-related disease already existed? billion prescriptions from 4.8

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The Pharma Data

DECEMBER 30, 2020

In December, Gilead shifted from bolstering its oncology business and strengthened its liver disease pipeline with the $1.4 AstraZeneca Dives into Rare Diseases: AstraZeneca has been in the spotlight for the COVID-19 vaccine candidate it developed with Oxford University. But the U.K.-based

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NIH Director's Blog: Drug Development

JULY 20, 2017

Credit: Brittany Mahoney As NIH Director, I often hear stories of how people with serious diseases—from arthritis to Zika infection—are benefitting from the transformational power of NIH’s investments in basic science. Credit: Zhang & Chen, 2016, Cell 167, 1586–1597. First, a bit of history! About 30,000 Americans have CF.

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Drug Target Review

AUGUST 29, 2024

MR : Chimeric antigen receptor T-cell (CAR-T) therapy is very effective in treating patients with B-cell lymphoma, leukemia, and multiple myeloma, where we have six FDA-approved drugs. What potential advantages does the CD5 modulation strategy offer over traditional CAR-T therapies?

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The Pharma Data

JANUARY 31, 2021

Many major disease targets are trimerization-dependent such as the tumor necrosis factor (TNF) superfamily (involved in extrinsic apoptosis, immune co-stimulation and inflammation) as well as enveloped RNA virus antigens responsible for entry into host cells. . CHENGDU, China , Feb. About Trimer-Tag© Technology.

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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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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. In less severe disease, patients will reach adulthood and suffer from motor function deficiencies.

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Advarra

NOVEMBER 17, 2022

In 2016, the Food and Drug Administration (FDA) approved Spinraza (nusinersen). It was the first drug to treat children with spinal muscular atrophy (SMA), a disease affecting children’s muscular strength and movement. While the FDA’s approval of nusinersen may not seem extraordinary, it was.

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The Pharma Data

AUGUST 30, 2021

Dupixent plus TCS reduced overall disease severity by 70% and itch by 49%. Results reinforce well-established safety profile of Dupixent – the first ever biologic medicine for atopic dermatitis currently approved for patients as young 6 years old. Yancopoulos, M.D., President and Chief Scientific Officer at Regeneron. “

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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

DECEMBER 3, 2020

Many major disease targets are trimerization-dependent such as the tumor necrosis factor (TNF) superfamily (involved in extrinsic apoptosis, immune co-stimulation and inflammation) as well as enveloped RNA virus antigens responsible for entry into host cells. About Trimer-Tag © Technology. View source version on businesswire.com: [link].

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The Pharma Data

FEBRUARY 13, 2022

The target action date for the FDA decision on this investigational use is June 9, 2022. Dupixent remains the only biologic medicine approved for patients 6 years of age and older in this indication. Safety results were generally consistent with the safety profile of Dupixent in atopic dermatitis for patients aged 6 years and older.

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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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Codon

NOVEMBER 3, 2024

Physicians working in the early 20th century had little choice but to treat the world’s most rampant infectious disease with methods such as these. But even now, more than a century later, TB remains the deadliest infectious disease on Earth, killing about 1.2 million people every year. coli bacteria from growing.

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The Pharma Data

JUNE 18, 2021

“The results add to the extensive clinical evidence supporting the use of single-agent ibrutinib for long-term disease control.” IMBRUVICA ® is now approved in 101 countries and has been used to treat more than 230,000 patients worldwide across its approved indications. Barr , M.D., 1 Additionally, at 6.5

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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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Codon

JUNE 18, 2024

Dr. Karl Dussik, an Austrian physician, was among the first to suggest that ultrasound could be used to diagnose diseases within the body in 1941. 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.

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Agency IQ

OCTOBER 27, 2023

12/29/2023 FDORA, Section 3607 Clinical Trials Modernization : FDA must issue or revise draft guidance regarding “the use of seamless, concurrent, and other innovative clinical trial designs.” Within 180 days, FDA will release a report on the proceedings of the public meeting and any recommendations.

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Agency IQ

JUNE 16, 2023

An update on the Medical Device Quality Management System Regulation : In February 2022, the FDA proposed a new rule which would effectively transition the agency away from its longstanding Quality System Regulation (QSR) in favor of the ISO 13485:2016 standard. Read our analysis of that rule here and here. ]

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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. in 2020, according to the American Cancer Society, and about 4,290 women will die from the disease this year.

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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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FDA Law Blog: Biosimilars

JANUARY 18, 2024

District Court challenging FDA’s plan to remove their products from the market. Specifically, FDA is looking to remove a drug called carbadox from the market. Used for over 50 years, carbadox is an antimicrobial drug used to treat gastrointestinal disease in pigs. 360b(d)(1)(I).

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The Pharma Data

DECEMBER 21, 2020

Five other countries participated in a concurrent submission and review process through FDA’s Project Orbis. This approval reinforces how critical it is to test all lung cancer patients for EGFR mutations before deciding how to treat them and regardless of their stage at diagnosis. 0.23; p<0.0001). 0.23; p<0.0001).

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The Pharma Data

JUNE 28, 2021

If approved, Xarelto will be the only oral Factor Xa Inhibitor indicated in the U.S. There are currently no FDA-approved anticoagulation therapies for pediatric patients with congenital heart disease who have undergone the Fontan procedure. for use in pediatric patients. EINSTEIN-Jr. About the EINSTEIN-Jr.

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The Pharma Data

JUNE 26, 2021

If approved, XARELTO ® will be the first and only oral Factor Xa inhibitor indicated in the U.S. There are currently no FDA-approved anticoagulation therapies for pediatric patients with congenital heart disease who have undergone the Fontan procedure, a surgical procedure that redirects blood flow from the lower body to the lungs.

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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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Agency IQ

DECEMBER 1, 2023

12/29/2023 FDORA, Section 3607 Clinical Trials Modernization : FDA must issue or revise draft guidance regarding “the use of seamless, concurrent, and other innovative clinical trial designs.” Within 180 days, FDA will release a report on the proceedings of the public meeting and any recommendations.

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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. Endometriosis is an estrogen-dependent, inflammatory disease in which tissue similar to the uterine lining is found outside the uterine cavity, commonly in the lower abdomen or pelvis, on ovaries, the bladder, and the colon.

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Broad Institute

NOVEMBER 6, 2024

Kerry Reynolds: The first immune checkpoint inhibitor was FDA-approved in 2011 to treat melanoma, with nearly a dozen more ICIs approved for various cancers since then. But by 2016, we started to see an increasing number of patients admitted to our hospital with adverse events after having these novel therapies.

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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. The average case fatality rate of Ebola virus disease (EVD) is about 50%.

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FDA Law Blog: Biosimilars

MAY 5, 2024

FDA/HHS Analysis, 2023 FDA/HHS last conducted an eight-factor analysis of marijuana in 2016 and concluded that marijuana continued to meet schedule I criteria. 12, 2016); Denial of Petition to Initiate Proceedings to Reschedule Marijuana, 81 Fed. Denial of Petition to Initiate Proceedings to Reschedule Marijuana, 81 Fed.

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Drug & Device Law

FEBRUARY 22, 2024

The history of litigation over a June 2009 to March 2012 shortage of a drug called Fabrazyme, which was at the time the only FDA-approved drug to treat a nasty thing called Fabry’s disease, helps to explain our view. We do not even need to call out the emphasis that plaintiff lawyers place on FDA approval when it suits them.

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Drug & Device Law

FEBRUARY 5, 2024

2016) (pro se dismissals “should generally be without prejudice”)). Moreover, allowing a state-law duty to foreclose the sale of an FDA approved medication. . . would also frustrate the purposes of the FDA’s regulatory scheme. Thus, Beaver II addressed the pre-approval design defect theory we have repeatedly criticized.

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