The FDA Law Blog

MAY 13, 2024

Gibbs & Ana Loloei & Véronique Li, Senior Medical Device Regulation Expert — FDA has long touted the use of real-world evidence ( RWE ). FDA recognizes the potential of RWE to support regulatory submissions of medical devices and to inform benefit-risk analysis of such products, while assuring patients have timely access to devices.

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FDA Medical Records Documentation 111

The FDA Law Blog

SEPTEMBER 16, 2024

Schwartz — FDA recently published a Federal Register (FR) Notice [ Docket No. FDA-2024-N-3945 ] announcing the publication of a draft strategy document, for public comment, outlining specific actions FDA plans to take to facilitate the use of innovative manufacturing technologies.

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Documentation FDA Communication 59

The FDA Law Blog

OCTOBER 12, 2023

Koblitz — For years, submitting a Suitability Petition has been like screaming into a void: You’d be lucky if FDA ever responds. This has been a big problem because FDA’s inattentiveness can delay entry of certain types of ANDAs for years—often resulting in the ANDA applicant’s abandonment of the Suitability Petition.

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European Pharmaceutical Review

FEBRUARY 27, 2024

The facility has been designed to meet the highest environmental sustainability standards, to help Amgen’s reach its target of carbon neutrality in all operations by 2027, the company noted. .” Amgen Ohio is nearly 300,000 ft 2 in size and will employ 400 full-time staff.

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Pharmaceutical Companies Pharmaceutical Companies FDA 105

PharmaShots

APRIL 6, 2023

A recent study published in the January 2023 issue of Clinical Pharmacology and Therapeutics described essential characteristics of a PD biomarker for biosimilar development.

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FDA 53

The FDA Law Blog

OCTOBER 24, 2022

355g(a), directed FDA to “establish a program to evaluate the potential use of real world evidence” both “to help to support the approval of a new indication” and “to help to support or satisfy postapproval study requirements.” The sponsor and FDA reach agreement on the study design information to be publicly disclosed.

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FDA Labelling 78

pharmaphorum

JULY 15, 2022

The PureTech group company – which scored the first FDA and EMA approvals for a DTx for attention-deficit hyperactivity disorder (ADHD) – is developing AKL-T01 to tackle cognitive impairments that can affect people with SLE. The post Akili digital therapeutic shows promise in lupus patients appeared first on.

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pharmaphorum

JANUARY 10, 2023

The new Astellas agreement comes a few months after the FORTIS study of AT845 was placed under a clinical hold by the FDA after a serious adverse event – peripheral sensory neuropathy – was seen in one of the trial participants. There has been no update from Astellas since the clinical hold was imposed last June.

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Immunization FDA 119

The FDA Law Blog

NOVEMBER 22, 2023

Earlier this month, FDA issued a proposed rule that would revoke 21 C.F.R. §  180.30 , its interim authorization of the use of brominated vegetable oil (BVO) in in fruit-flavored beverages. BVO has been used as a flavoring oil stabilizer and emulsifier since the 1920s, and it was generally recognized as safe (GRAS) for this use by FDA.

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FDA 52

pharmaphorum

MARCH 21, 2022

Shares in Provention Bio cratered last July when the FDA turned down its marketing application for type 1 diabetes therapy teplizumab. But armed with new data it has tried again, with the FDA due to make a decision on the new filing by 17 August.

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FDA 52

pharmaphorum

NOVEMBER 18, 2022

At its second attempt, Provention Bio has secured FDA approval for teplizumab, as a treatment to delay late-stage type 1 diabetes (T1D) in at-risk individuals – becoming the first disease-modifying therapy for these patients. It is now in line for a $35 million equity investment by Sanofi following FDA approval.

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FDA Immunization 52

pharmaphorum

JANUARY 4, 2022

An appeals court ruling has upheld the validity of a key US patent covering Gilenya (fingolimod), and issued a permanent injunction against HEC Pharma until it expires in December 2027. Generics could still appear on the US market before the end of 2027 however.

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FDA 59

European Pharmaceutical Review

JANUARY 10, 2023

Treatments identified in the report are predicted to be potential blockbuster drugs by 2027 or have potential to serve unmet patient needs for millions of patients worldwide. They have accounted for over 25 percent of Food and Drug Administration (FDA) approvals for the last seven years, the report found.

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FDA 98

European Pharmaceutical Review

MAY 4, 2023

According to Research and Markets 8 , the market for bispecific antibodies for cancer is forecasted to grow by $400 million during 2022-2027, due to the increasing prevalence of cancer worldwide. They are not US Food and Drug Administration (FDA)-approved for these patients due to the lack of benefit. Personalized medicine at FDA.

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Immunization Chemotherapy FDA 98

The FDA Law Blog

JULY 24, 2023

After suing each other in patent litigation and Avadel’s suit against FDA challenging the Agency’s authority to compel patent certifications, it’s Jazz’s turn to sue FDA. Approximately six weeks after FDA approved Lumryz and issued its clinical superiority decision , Jazz filed a Complaint against FDA in the District Court of D.C.

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FDA Patient Care 52

pharmaphorum

MARCH 18, 2022

Akili’s first product – EndeavorRx for treating attention deficit hyperactivity disorder (ADHD) – was the first prescription gaming app approved by the FDA. The company is developing follow-up products for other conditions, including multiple sclerosis, autism, and depression.

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FDA 98

European Pharmaceutical Review

JANUARY 19, 2023

The additional support from Amgen is set to reach more than 300 diverse and community-oriented clinical investigators by 2027. Currently close to 80 percent of participants in clinical research trials are white, according to the Food and Drug Administration (FDA).

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FDA 98

The FDA Law Blog

OCTOBER 6, 2023

Javitt & Philip Won — As we reported last week, FDA has issued a 26 page, single spaced, tiny-font Proposed Rule of Laboratory Developed Tests (LDTs). The brevity of this change belies the foreseeably seismic impact of FDA regulation of clinical laboratories on the healthcare system. By Allyson B. Mullen & Gail H.

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Pharmaceutical Technology

SEPTEMBER 23, 2022

It will expire on 24 November 2026, and the paediatric exclusivity lasts until 24 May 2027. Viatris is seeking approval from the US Food and Drug Administration (FDA) to market Januvia and Janumet’s generic versions in the country. The suit involved two Merck patents. The first is for the dihydrogen phosphate salt of sitagliptin.

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The FDA Law Blog

JUNE 8, 2023

FDA has begun to reintroduce in-person meetings. It is also noteworthy that in the March 27 announcement , FDA distinguished between teleconferences and videoconferences despite using the same online platform (e.g., Applicants should also be aware that FDA has the discretion to decide the format of the meeting (e.g.,

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FDA Communication Documentation 53

pharmaphorum

MAY 27, 2022

Akili’s EndeavorRx is the first FDA and EMA-approved digital therapeutic (DTx) for ADHD and is designed to target and activate neural systems by presenting sensory stimuli and motor challenges to improve cognitive functioning. .” The post Akili partners with gaming giant Roblox on ADHD therapy delivery appeared first on.

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FDA 93

pharmaphorum

JANUARY 16, 2023

There were developments in the past 12 months, true – Biogen/Eisai’s lecanemab (now branded Leqembi) showed clear success in the Clarity AD trial and received approval by FDA on 6th January 2023. Difficile at the end of November 2022, but in 2023 they will be joined by Seres, which expects an FDA decision in April 2023 on its C.

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pharmaphorum

JUNE 22, 2022

Qulipta (atogepant) is already approved for prevention of episodic migraine – where attacks are less frequent – getting the green light from the FDA last September for this use a few months after Biohaven and Pfizer’s Nurtec ODT (rimegepant). The post AbbVie files Qulipta for chronic migraine prevention appeared first on.

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Labelling FDA 69

pharmaphorum

OCTOBER 6, 2021

The orally-active drug was granted breakthrough status by the FDA in August for treating type 1 narcolepsy, a form where the sleep symptoms are accompanied by a sudden loss of voluntary control tone known as cataplexy.

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FDA 64

The FDA Law Blog

AUGUST 23, 2023

This blog provides an update on the DHT-related PDUFA VII goals that were targeted for completion in the first two quarters of FDA’s Fiscal Year (FY) 2023, including: By the end of Q2 FY 2023, FDA will establish a DHT framework document to guide the use of DHT-derived data in regulatory decision-makings for drugs and biological products.

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FDA Documentation 52

ISPE

NOVEMBER 23, 2022

Some of the highlights of the presentations given during the Symposium were as follows: The PIC/S Chairperson, Paul Gustafson, Health Canada, presented on PIC/S’ new strategic plan for 2023-2027 which covered the following elements: Promote, improve and monitor inspection reliance amongst PIC/S member authorities.

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Documentation FDA Communication 98

European Pharmaceutical Review

MARCH 4, 2024

Indeed, in 2022, biologics constituted 40 percent of all US Food and Drug Administration (FDA) approved drugs, projecting a compound annual growth rate (CAGR) of 9.5 percent through 2027. He was on the faculty of Johns Hopkins Medicine and served as a medical officer with the US/HHS FDA before joining KCR. cited 2024Jan].

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FDA Vaccines Immunization Compounding 98

The FDA Law Blog

JUNE 14, 2023

In the ever-changing landscape of medical device development, FDA is touting steps it is taking that it says will enhance efficiency, foster innovation, and address key challenges faced by developers. It remains to be seen how FDA would define and actually implement the role of a TAP Advisor.

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FDA Communication 45

pharmaphorum

DECEMBER 10, 2020

Novo Nordisk’s semaglutide, available both as a weekly injection and as a daily pill, is its main competitor and Lilly needs to find a follow-up before the Trulicity’s patent expires in 2027. Tirzepatide is also taken weekly, cutting the number of injections needed to control blood sugar.

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Vaccines FDA 64

pharmaphorum

FEBRUARY 2, 2022

Along with the one-off settlement, Gilead has agreed to pay ViiV a 3% royalty rate on Biktarvy sales and any other bictegravir-containing product in the US until 5 October 2027, when ViiV’s US patent on dolutegravir expires.

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Compounding FDA 72

The FDA Law Blog

NOVEMBER 17, 2022

The TAP Pilot is one of the commitments agreed to between FDA and industry as part of the Medical Device User Fee Amendments of 2022 (MDUFA V) and the Agency hopes the program will help ensure that U.S. CDRH plans to take a phased approach to implement the TAP Pilot throughout the duration of MDUFA V (FY 2023 – FY 2027).

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Communication FDA 69

Roots Analysis

OCTOBER 4, 2023

During the research, I noticed a significant increase in the number of FDA approvals for bispecific antibodies in recent years. This allows them to potentially be more effective in treating diseases by targeting multiple pathways simultaneously. I, recently, worked on a market research report, titled Bispecific Antibodies Market , 2023-2035.

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Chemotherapy Immunization FDA 40

The Checkup by Singlecare

AUGUST 20, 2024

Currently, there is no generic version of Stiolto Respimat approved by the Food and Drug Administration (FDA). However, the earliest the patent for the brand name may expire is 2027 , after which a generic version may come to the market. In addition, any potential generic must go through rigorous testing.

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Insurance Insurance Coverage Health Insurance Companies FDA 98

pharmaphorum

MARCH 11, 2022

Qulipta was approved by the FDA last September for the preventive treatment of episodic migraine, a few months later than its main rival in the oral CGRP category, Biohaven’s Nurtec ODT (rimegepant), got a green light for the same indication. billion by 2027.

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Labelling FDA 52

pharmaphorum

JANUARY 13, 2021

Spry’s Loop System wearable has already been approved by the FDA for the collection of physiological data like oxygen levels, respiration and heart rate in patients with chronic obstructive pulmonary disease (COPD) and other chronic health conditions. The condition affects around 54 million people in the US alone.

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FDA 59

pharmaphorum

JULY 18, 2022

It had expected the drug would not face biosimilar competition in Europe until at least 2027. The subcutaneous version was approved in the EU and UK last year but didn’t make it past the FDA in the US, which said it was unable to give it the green light in a complete response letter sent to Biogen in May.

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FDA 52

The FDA Law Blog

NOVEMBER 21, 2022

The TAP Pilot is one of the commitments agreed to between FDA and industry as part of the Medical Device User Fee Amendments of 2022 (MDUFA V) and the Agency hopes the program will help ensure that U.S. CDRH plans to take a phased approach to implement the TAP Pilot throughout the duration of MDUFA V (FY 2023 – FY 2027).

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Communication FDA 59