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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Pharmaceutical Technology

MAY 19, 2023

The US Food and Drug Administration (FDA) has approved AbbVie’s Rinvoq (upadacitinib) for patients with Crohn’s disease who do not respond to TNF blockers, a common immune suppressant treatment for the condition. The FDA nod means Rinvoq is now approved for seven indications in gastroenterology, rheumatology and dermatology.

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Mayo Clinic Dosage FDA Immunization 105

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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pharmaphorum

AUGUST 12, 2020

The FDA has started its review of Israeli biotech Protalix BioTherapeutics and partner Chiesi’s Fabry disease therapy pegunigalsidase alfa, setting up a possible approval by 27 January. The initial application with the FDA is for dosing of 1mg/kg pegunigalsidase alfa every two weeks, the same interval as Fabrazyme and Replagal.

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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 101

pharmaphorum

JUNE 8, 2021

The FDA “has failed in its responsibility to protect patients and families from unproven treatments with known harms” in approving Biogen’s Alzheimer’s disease drug Aduhelm. billion in 2027. The post FDA slammed over Aduhelm OK as Biogen takes heat for $56k price tag appeared first on.

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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

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

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 58

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 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

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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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 93

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 90

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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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 83

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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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

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 68

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 63

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 9, 2023

FDA approval in this indication would unlock the additional $10 CVR payment, providing it takes place before the end of 2027. BA is the leading cause of liver transplant in children and is caused by damaged or absent bile ducts, leading to build-up of bile in the liver and cirrhosis.

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FDA 52

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

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

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

pharmaphorum

JANUARY 10, 2023

New drugs for immunological and inflammatory diseases feature prominently among new product launches this year that could top $1 billion in annual sales by 2027 or be clinical “game changers,” according to Clarivate.

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FDA Labelling 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

pharmaphorum

JULY 26, 2022

It had expected the drug would not face biosimilar competition in Europe until at least 2027. Biogen has been attempting to defend its franchise with a subcutaneous formulation given once a month, which was approved in the EU and UK last year but hasn’t yet made it past the FDA in the US.

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FDA 52

pharmaphorum

JULY 18, 2022

Last month, the drugmaker reported new data with atogepant in prevention of chronic migraine – defined by the FDA as having at least 15 migraine days per month for at least three months – that AbbVie has suggested could help it differentiate atogepant from its rival.

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FDA 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

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 71

pharmaphorum

APRIL 5, 2022

Leqvio meanwhile is only just getting started after a delayed FDA approval at the end of last year, although it has been available in Europe for a few months longer. billion in sales by 2027, ahead of Repatha at $2.2 Nevertheless, analysts at GlobalData recently predicted that Novartis’ drug would make $2.5

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FDA 52

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 54

pharmaphorum

JANUARY 18, 2022

million in 2020 and with the rapid growth of the industry, is expected to grow at a CAGR of 8.95% up to 2027. Guest FDA Speaker: John Barr Weiner, Associate Director for Policy and Product Classification Office, Office of Combination Products FDA. . The global pre-filled syringes market was valued at $1139.6

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Packaging FDA Documentation Vaccines 52

European Pharmaceutical Review

MARCH 7, 2024

billion between 2022 to 2027. Based on these promising results, the US Food and Drug Administration (FDA) granted Breakthrough Therapy Designation to AlphaMedix in February 2024. percent for the gastroenteropancreatic neuroendocrine tumours (GEP-NET) patients who had never received radioligand therapy).

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Pharmaceutical Companies Pharmaceutical Companies Immunization FDA 52

The FDA Law Blog

JUNE 7, 2023

Recall that CMS will require manufacturers of selected drugs to negotiate a maximum fair price (“MFP”) with the agency according to the following timeline (the dates apply from applicable year 2027 onwards).

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Communication 45

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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