Pharmacy Times

JULY 17, 2023

FDA approvals of these biosimilars started in 2016, but only 1 such product has successfully launched.

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FDA 123

STAT

MAY 9, 2023

It will be the first FDA advisory panel hearing for a Duchenne drug from Sarepta since 2016, when hundreds of patients and family members traveled to the FDA campus in Maryland to plead with experts to authorize an earlier therapy from the company despite limited evidence.

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FDA 99

STAT

FEBRUARY 6, 2024

Last week, Biogen announced it will cease both the study and sale of Aduhelm, its FDA-approved monoclonal antibody for the treatment of Alzheimer’s disease. In the eight years between the drug’s spectacular 2016 debut on the cover of Nature and its ignominious end , Biogen made multiple, really bad decisions.

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FDA 144

STAT

NOVEMBER 7, 2023

The FDA previously moved to withdraw approval of the antibiotic in 2016 over carcinogenicity , but the manufacturer, Phibro Animal Health, fought the effort by arguing, in part, that its drug is medically necessary.

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FDA 116

STAT

FEBRUARY 23, 2023

In September, the FDA announced its intentions to regulate many of these AI-powered clinical decision support (CDS) tools as devices — which regulators say has always been their plan and within their purview.

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FDA Patient Care 98

Fierce Pharma

SEPTEMBER 11, 2024

. | Ahead of an advisory committee meeting slated for Friday, the FDA unleashed damning briefing documents calling into question the effectiveness and safety of Intercept’s rare liver disease drug Ocaliva.

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FDA Documentation 85

pharmaphorum

MARCH 9, 2021

Roche’s Tecentriq is the latest medicine to fall foul of a crackdown by the FDA on drugs that have failed to live up to their early promise. Roche said its decision was made in consultation with the FDA as part of an industry-wide review of accelerated approvals.

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FDA Chemotherapy 98

Fierce Pharma

SEPTEMBER 16, 2024

Following a meeting with the FDA’s Gastrointestinal Drug Advisory Committee Friday, the future of Intercept’s rare liver disease drug Ocaliva is under serious threat.

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FDA 80

The FDA Law Blog

OCTOBER 27, 2022

Lewis, Senior Regulatory Device & Biologics Expert — FDA recently published the final guidance document “ Comparability Protocols for Postapproval Changes to the Chemistry, Manufacturing, and Controls Information in an NDA, ANDA, or BLA.” FDA also provided additional examples as to what changes would be considered “annual reportable.”

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FDA Documentation 105

STAT

JUNE 10, 2024

Women generally made up just 33% of participants when the team reviewed 195 trials published from 2016 to 2022. But stakeholders think agencies like the FDA could do more to incentivize the enrollment of women.   The issue isn’t new. Continue to STAT+ to read the full story…

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FDA 128

STAT

SEPTEMBER 29, 2022

One medical device lawyer wrote that the document “violates” the 21st Century Cures Act passed by Congress in 2016 to exempt certain software products from regulatory review. But they are sharply divided on whether that’s a much-needed change, or a dramatic overreach by regulators.

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FDA Documentation Hospitals 93

Pharmaceutical Technology

APRIL 4, 2023

The FDA has seen a record surge in review designations being awarded over the last two years for Alzheimer’s indications, with 12 review designations being awarded to drugs between 2020 and 2022. Between 2020 and 2021, the number of designations increased by 600%, with seven designations being awarded by the FDA in 2021. ©GlobalData.

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FDA 98

STAT

MARCH 20, 2025

In 2016, Ionis won approval for an infusion called Spinraza. Telehealth firms and pharmacies instead intend to sell versions of the obesity drugs tailored for specific patients whose doctors say they need a different dosage than one of the original drugs or a version with extra vitamins added. 

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Compounding Pharmacies Compounding Dosage FDA 84

pharmaphorum

APRIL 27, 2021

FDA advisors will scrutinise three cancer immunotherapies granted conditional approvals at a three-day meeting this week, to see if they should stay on the market. . Briefing documents published by the FDA ahead of the meeting suggest that discussion will focus on ongoing trials that may serve as alternative confirmatory studies.

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FDA Chemotherapy Documentation 90

pharmaphorum

SEPTEMBER 21, 2020

Founded in 2016 by husband and wife entrepreneur team George Goldsmith and Ekaterina Malievskaia, Compass is already backed by investors including PayPal co-founder Peter Thiel and German entrepreneur Christian Angermayer. million with its IPO on Friday and shares are still significantly above their launch price of $17.

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Compounding FDA 134

The FDA Law Blog

JANUARY 15, 2024

FDA , Petitioners, a liquid nicotine manufacturer, sued FDA arguing that the Agency was arbitrary and capricious in rejecting the Petitioner’s Premarket Tobacco Application (“PMTA”) in violation of the Administrative Procedure Act (“APA”). Youth behavioral data was not specifically required but FDA encouraged such information.

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FDA Documentation 115

The FDA Law Blog

JANUARY 18, 2024

Palmer — A new lawsuit against FDA is the latest happening in the veterinary drugs space and, by extension, FDA’s Center for Veterinary Medicine (CVM). 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. By John W.M.

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FDA Communication 59

The FDA Law Blog

FEBRUARY 21, 2024

Mullen — More than five years after FDA first announced its plan to harmonize 21 CFR Part 820 with ISO 13485, on February 2, 2024, FDA finally issued the Quality Management System Regulation (QMSR) Final Rule. FDA further retained some definitions in the QSMR. Revised § 820.3

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FDA Labelling Packaging Documentation 59

European Pharmaceutical Review

FEBRUARY 2, 2023

Amgen’s AMJEVITA was the first biosimilar to Humira approved by the US Food and Drug Administration (FDA), in 2016. Five are FDA-approved in the US and three are approved in the European Union (EU). AMJEVITA (adalimumab-atto), a biosimilar to Humira ® (adalimumab), is now available in the US.

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FDA 98

IDStewardship

MARCH 12, 2023

It’s from 2016 about the future of antibiotics and resistance, but it remains highly relevant today and people consistently give positive feedback about it. ” Labeling the use of an antibiotic as inappropriate or appropriate cannot simply be done based upon whether it is FDA-approved for a given indication.

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Medication Guidelines Documentation Labelling Hospitals 299

The FDA Law Blog

FEBRUARY 22, 2023

Shapiro — More than a decade ago, FDA began systematically to incorporate review of human factors (HF) design validation within 510(k) reviews. Now FDA has issued a draft guidance , Content of Human Factors Information in Medical Device Marketing Submissions (Dec. FDA did not require HF data as a basis for clearance of the predicate.

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FDA Documentation Labelling Hospitals 64

The FDA Law Blog

APRIL 25, 2023

The primary vehicle for FDA to request cybersecurity information in premarket submissions has been guidance documents. However, FDA’s legal standing to insist on cybersecurity features, especially within the substantial equivalence paradigm, has been questionable. It applies whether the software is the entire device (i.e.,

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FDA Documentation Labelling Communication 105

European Pharmaceutical Review

JUNE 29, 2023

The company first described the concept of using generative artificial intelligence for the design of novel molecules in a peer-reviewed journal in 2016. The US Food and Drug Administration (FDA) granted Orphan Drug Designation to INS018_055 for the treatment of IPF in February 2023.

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Dosage FDA 98

pharmaphorum

JUNE 8, 2022

Users can also use the built-in health records feature on the Health app to download current medications, said Ricky Bloomfield, a former director of mobile strategy at Duke University who joined Apple as clinical and health informatics lead in 2016 in a tweet.

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Documentation Labelling FDA 131

The FDA Law Blog

FEBRUARY 26, 2024

Karst — While the Biologics Price Competition and Innovation Act (“BPCIA”) is inherently distinct from the Hatch-Waxman Act, many of the fundamental concepts FDA adopted as it enacted the Hatch-Waxman Act made their way into FDA’s implementation of the BPCIA. FDA borrowed this definition from 21 C.F.R.

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FDA Dosage 59

pharmaphorum

JUNE 6, 2022

With vaccine hesitancy leading to a rise in measles cases, the FDA’s approval of GlaxoSmithKline’s venerable vaccine Priorix for sale in the US looks timely. The post FDA clears GSK’s Priorix, first new MMR vaccine in 50 years appeared first on. Photo credit: CDC/Dr Heinz F Eichenwald via Wikipedia.

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Vaccines FDA 59

pharmaphorum

JULY 11, 2021

In another twist to the Aduhelm approval tale, FDA’s Janet Woodcock has called for an independent investigation into the relationship between agency staffers and Biogen executives. In the letter, she writes: “FDA’s decisions are far ranging and it is inevitable that some of those decisions will lead to controversy.”

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FDA Communication Labelling 52

pharmaphorum

JUNE 20, 2022

Nuplazid (pimavanserin) is already FDA-approved to treat psychosis caused by Parkinson’s disease, but Acadia’s hope to expanding that use to the Alzheimer’s population were shot down by a complete response letter (CRL) from the regulator last year. At one point it had been tipped as a future blockbuster.

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FDA Labelling 52

Pharmaceutical Technology

NOVEMBER 3, 2022

The US Food and Drug Administration (FDA) has granted approval for the supplemental new drug application (sNDA) of Gilead Sciences ’ Vemlidy (tenofovir alafenamide) to treat chronic hepatitis B virus (HBV) infection in paediatric patients.

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FDA 52

STAT

MAY 24, 2024

She described standing on a train platform, while on the phone with her study therapists, and considering jumping in front of a train, according to a video of the participant describing the experience at a 2016 conference on psychedelic therapy that STAT has seen.

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FDA 110

pharmaphorum

JUNE 6, 2022

The results have set up a pre-filing meeting with the FDA, according to BMS. Rozlytrek was approved by the FDA in 2019 but has just started to gather sales momentum, making around $17 million in the first quarter of this year, an increase of 78% on the first three months of 2021.

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Chemotherapy FDA Labelling 98

pharmaphorum

MAY 13, 2021

Pfizer added the gene therapy to its pipeline in 2016, when it acquired Bamboo Therapeutics in a deal worth up to $645 million. There are already several drugs on the market to treat Duchenne, notably from Sarepta Therapeutics which has three FDA-approved drugs that use “exon skipping” technology.

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Hospitals FDA 102

The FDA Law Blog

MARCH 10, 2024

Last August the Food and Drug Administration (“FDA”)/Health and Human Services (“HHS”) recommended that the Drug Enforcement Administration (“DEA”) reschedule cannabis from schedule I under the federal Controlled Substances Act (“CSA”) to schedule III.

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Controlled Substances FDA 64

The FDA Law Blog

OCTOBER 5, 2022

By Riëtte van Laack — On September 28, 2022, FDA announced the availability of the proposed rule for the implied nutrient content claim “healthy.” The term healthy, as an implied nutrient claim, was first defined by FDA in 1994. FDA also announced it would be re-evaluating the regulatory criteria for use of the “healthy” claim.

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FDA Labelling Packaging Documentation 52

European Pharmaceutical Review

JULY 4, 2024

In the US, botanical dietary supplements can be sold without US Food and Drug Administration (FDA) approval, 1 prompting many vendors to promote the use of botanical products as dietary supplements , 2 rather than pursue a path of regulatory approval. 3 Is two too few? 3 Is two too few?

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FDA Documentation Compounding Pharmaceutical Companies 103

Birth Control Pharmacist

APRIL 18, 2023

In June 2022, the AMA urged the FDA to approve an OTC contraceptive method with no age restriction. In order for a drug to be approved for OTC use by the FDA, certain criteria must first be met. The next step is having a pharmaceutical company manufacture a product that can be FDA-approved for OTC use. What is Opill?

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FDA Pharmaceutical Companies Pharmaceutical Companies 52

The FDA Law Blog

NOVEMBER 1, 2023

Gibbs — For more than three decades, FDA has claimed that the Federal Food, Drug & Cosmetic (FD&C Act) gives the agency legal authority to regulate laboratory developed tests (LDTs) as medical devices (see our prior post here ). Javitt & Michael D. Shumsky & Philip Won & Adrienne R. Gaulkin & Jeffrey N.

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FDA Hospitals Immunization 81