FDA widens label for BMS’ cancer drug Augtyro
pharmaphorum
JUNE 14, 2024
FDA widens label for BMS’ cancer drug Augtyro Phil.Taylor Fri, 14/06/2024 - 08:17 Bookmark this
2024 FDA Labelling 
Analytica 2024 in overview
European Pharmaceutical Review
MARCH 5, 2024
International participation and trending topics With over 900 exhibitors, analytica 2024 promises an impressive lineup. Digitalisation also relieves laboratory personnel through optimised inventory management with online inventory maintenance and automatic label printing, enhancing efficiency and occupational safety.
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FDA Releases Draft Guidance on Essential Drug Delivery Outputs
The FDA Law Blog
JULY 23, 2024
Lenz, Principal Medical Device Regulation Expert — For several years, FDA has requested that sponsors of drug or biologic led combination products identify essential performance requirements (EPRs) related to the device constituent in their applications. Comments may be submitted by September 30, 2024. By Adrienne R.
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STAT+: Akili abandons prescription business model, to lay off 40% of workers
STAT
SEPTEMBER 13, 2023
The Boston-based company will continue offering its pediatric treatment, EndeavorRx, by prescription until it can convert it to over-the-counter labeling — it plans to submit data to FDA in 2024. In its second-quarter results reported in August, Akili said it earned just $114,000 on $15.3 million in expenses.
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Novartis’ ‘wild card’ drug Scemblix gets FDA nod for leukaemia
pharmaphorum
NOVEMBER 1, 2021
Novartis has claimed FDA approval for one of its ‘wild card’ drugs – Scemblix – a first-in-class STAMP inhibitor for patients with previously-treated chronic myeloid leukaemia (CML). The post Novartis’ ‘wild card’ drug Scemblix gets FDA nod for leukaemia appeared first on.
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FDA guidance highlights E&L considerations for ophthalmic drug products
European Pharmaceutical Review
JANUARY 25, 2024
Draft guidance published by the US Food and Drug Administration (FDA) in December 2023, discussed quality considerations for topical ophthalmic drug products, including key considerations for extractables and leachables (E&L) testing. Ophthalmic drug products should be evaluated for extractables and leachables, FDA asserted.
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Our 2024 Nursing Calculations Quiz
OctariusRx
MAY 13, 2024
Our 2024 nursing calculations quiz is now available. Food and Drug Administration (FDA) receives more than 100,000 reports associated with a suspected medication error. Read the medication label carefully: This is a critically important step and one that often leads to errors and potential patient harm. Each year, the U.S.
Traditional Meat Industry’s Beef With Alternative Protein Continues with the FAIR on Labels Act
The FDA Law Blog
MARCH 5, 2024
Many individual states have pursued some type of legislation to restrict the use of traditional meat terminology for the labeling of APPs. Many states have proposed but failed to enact legislation regulating the labeling of APPs, in some cases due to concerns of potential legal challenges based on federal preemption claims.
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FDA Issues Long-Awaited QMSR Final Rule
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. Notably, Part 820 will look different. Revised § 820.3
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FDA OKs first biosimilar of Roche’s blockbuster AMD drug Lucentis
pharmaphorum
SEPTEMBER 20, 2021
Samsung Bioepis and Biogen have claimed the first FDA approval for a biosimilar version of Roche and Novartis’ Lucentis (ranibizumab) for leading causes of blindness, raising the prospect of a cheaper treatment option for US patients. The post FDA OKs first biosimilar of Roche’s blockbuster AMD drug Lucentis appeared first on.
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FDA’s Revised Draft Guidance on Biological Product Promotion Provides Additional Recommendations/Clarifications
The FDA Law Blog
APRIL 25, 2024
Promotional labeling is generally any labeling other than FDA-required labeling that is devised for the promotion of a product, as well as other functions, and can include printed, audio, or visual matter that describes the product. l)(1) (e.g.,
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First pill for desmoid tumours approved
European Pharmaceutical Review
NOVEMBER 28, 2023
The US Food and Drug Administration (FDA) has approved the first drug for desmoid tumours (desmoid fibromatosis), an oral gamma secretase inhibitor. The FDA’s approval of Ogsiveo is based on results from the Phase III DeFi clinical trial , which were published this year in the New England Journal of Medicine.
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EHA 2024: AstraZeneca’s Calquence plus chemoimmunotherapy offers new standard for MCL
Pharmaceutical Technology
JUNE 17, 2024
If Calquence receives FDA label expansion in MCL, it will achieve a unique position in the treatment-naive MCL market share.
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2023 IS the Year for OTC Naloxone!
The FDA Law Blog
MARCH 29, 2023
Richardson — Early on March 29, 2023, FDA announced the landmark approval of Narcan (naloxone hydrochloride) Nasal Spray for use as a nonprescription opioid overdose reversal agent. FDA Commissioner Robert M. According to this announcement, FDA approval of RiVive is anticipated in July 2023 and the U.S. By Kalie E. Califf, M.D.
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Another Attack on the Carve-Out: Novartis Seeks a TRO Enjoining ENTRESTO Generic
The FDA Law Blog
AUGUST 7, 2024
But recently, a new challenge was filed in the District Court for the District of Columbia questioning whether modifications to labeling as a result of patent protections—beyond the mere omission of language—are permissible under the section viii carve-out requirements.
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FDA Hosts Webinar for Stage 1 Requirements under LDT Final Rule
The FDA Law Blog
SEPTEMBER 22, 2024
The webinar largely consisted of summarizing the general requirements under Parts 803, 806 and 820.198, which we do not reproduce here ( but see another of our prior blog posts discussing these requirements and their applicable to LDTs in greater detail; you can also find FDA’s slides from the webinar here ).
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Joint Basis for FDA/HHS Marijuana Rescheduling Recommendation Unveiled
The FDA Law Blog
JANUARY 18, 2024
Houck — In August 2023 the Food and Drug Administration (“FDA”) and Health and Human Services (“HHS”) recommended that the Drug Enforcement Administration (“DEA”) reschedule marijuana from schedule I under the federal Controlled Substances Act (“CSA”) to schedule III. HHS forwards FDA’s analysis and recommendation to DEA. By Larry K.
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It’s the Law Now –Cybersecurity Information in Premarket Submissions
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. Loose Ends IDEs.
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US FDA accepts Satsuma’s 505(b)(2) NDA for STS101
Pharmaceutical Technology
MAY 19, 2023
The US Food and Drug Administration (FDA) has accepted Satsuma Pharmaceuticals’ 505(b)(2) new drug application (NDA) for STS101 for acute treatment of migraine, for review. The prescription drug user fee act (PDUFA) date is expected to be set as January 2024.
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CMS Finalizes Guidance on Medicare Part D Manufacturer Discount Program
The FDA Law Blog
DECEMBER 3, 2023
As part of this change, the Coverage Gap Discount Program (CGDP), a program that has existed since 2011, will sunset on December 31, 2024, and be replaced by the Medicare Part D Manufacturer Discount Program (the “Discount Program”). Manufacturers must sign the agreement by March 1, 2024, to participate in the 2025 plan year.
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FDA Flexes its New FDORA Muscles in Withdrawing an Accelerated Approval
The FDA Law Blog
FEBRUARY 28, 2024
This is the third withdrawal of an accelerated approval FDA has performed, following Avastin in 2011 and Makena in 2023. Without commenting on the merits of the decision, it is an interesting window into how FDA may use these new procedures in practice. Tobolowsky & Michelle L.
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What to do during Mounjaro shortage
The Checkup by Singlecare
APRIL 10, 2024
The Food and Drug Administration (FDA) first reported the shortage in December 2022, but availability issues have continued long after that. In fact, as recently as April 2, 2024, the FDA announced that shortages of certain Mounjaro dosages were expected to continue at least through the end of April.
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OPDP Says TV Ad is Out of Bounds with Fourth Untitled Letter of 2024
The FDA Law Blog
SEPTEMBER 17, 2024
By Sarah Wicks & Dara Katcher Levy — FDA’s Office of Prescription Drug Promotion (OPDP) has issued its fourth Untitled Letter of 2024 – this one to AbbVie, Inc. Advantage, OPDP. UBRELVY is indicated for the acute treatment of migraine with or without aura in adults and is not indicated for the preventive treatment of migraine.
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Promising schizophrenia drug faces tough competition
European Pharmaceutical Review
NOVEMBER 25, 2022
GlobalData’s report showed LY03010 is expected to launch in the US in 2024. According to the pre-IND meeting with the US Food and Drug Administration (FDA), Luye Pharma plans to submit the New Drug Application (NDA) for LY03010 to the FDA through the 505(b)(2) pathway. If successful, the drug is forecasted to reach sales of $63.5
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“Heigh-ho” Taiho! The PTO Says LYTGOBI Patent is Ineligible for PTE Because of Untimely Application. And a Corrected NDA Approval Letter is No Saving Grace
The FDA Law Blog
APRIL 21, 2024
Post-AIA, and a later change to the law to account for controlled substance FDA application approvals, the PTE statute at 35 U.S.C. § 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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Wegovy backorder: Why it happens and what to do about it
The Checkup by Singlecare
MARCH 25, 2024
Unlike Ozempic, which is FDA approved to treat Type 2 diabetes, Wegovy is approved for weight loss in patients with a body mass index (BMI) of 30 or higher and in patients with a BMI of 27 or higher who also have a weight-related medical condition like Type 2 diabetes, high blood pressure, or high cholesterol.
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Join Us for ACI’s Advanced Legal Regulatory and Compliance Forum on OTC Drugs
The FDA Law Blog
NOVEMBER 13, 2023
On January 23-24, 2024, the American Conference Institute (“ACI”) will host its “ Advanced Legal, Regulatory and Compliance Forum on OTC Drugs ” conference at the Sofitel New York, NY. FDA Law Blog readers can save 10% with the following promo code: D10-999-FDA24. Click here to view this year’s agenda and to register for the event.
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Novartis bags elusive US approval for cholesterol drug inclisiran
pharmaphorum
DECEMBER 23, 2021
At its second attempt, Novartis has won FDA approval for its cholesterol lowering drug inclisiran, which can reduce levels with just two injections a year. Novartis will have to wait for the results of the ORION-4 study – due in 2024 – before it has a chance of matching the labels of Amgen and Sanofi/Regeneron’s drugs.
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RWE There Yet? FDA’s New Pilot Program Seeks to Help Usher in a New Era for Real World Evidence
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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Novartis’ big bet on inclisiran nears fruition, as CHMP backs drug
pharmaphorum
OCTOBER 19, 2020
Both Repatha and Praluent have that in hand, but Novartis will have to wait for the results of the ORION-4 study – due in 2024 – before it has a chance of matching the labels of Amgen and Sanofi/Regeneron’s drugs. That said, Novartis is no stranger to building a slow-starting cardiovascular drug into a blockbuster franchise.
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It’s a Cruel Summer – Two New OPDP Untitled Letters
The FDA Law Blog
AUGUST 11, 2024
on July 17, 2024 for a social media post published by Instagram influencer Brittany Mahomes (who has 2 million Instagram followers) about AUVI-Q (epinephrine injection, USP) that “entirely omit[ed] all risk information” about the drug. August 2024 Untitled Letter to Mirati Therapeutics Inc.
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Regulator and Funder? FDA’s Orphan Products Grants Program awards significant funding to help move promising treatments through clinical development
The FDA Law Blog
NOVEMBER 10, 2024
Food and Drug Administration (FDA) plays a pivotal role in fostering the development of treatments for rare diseases through its Orphan Products Grants Program. Each year, FDA selects a limited number of clinical trials to fund to help sponsors pursue development of medical products for rare diseases and advance their field.
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FDA pushes back on approving mirikizumab due to manufacturing issues
Pharmaceutical Technology
APRIL 21, 2023
On 14 April, the FDA rejected Lilly’s biologic licence application (BLA) for their anti-interleukin (IL)-23, mirikizumab, which is in development for the treatment of ulcerative colitis (UC). The recent setback dents mirikizumab’s chances to be the first among the IL-23 inhibitors to launch in the US for UC.
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Can I take Ozempic if I’m not diabetic?
The Checkup by Singlecare
AUGUST 14, 2024
Ozempic (semaglutide) is an injectable drug approved by the Food and Drug Administration (FDA) to treat Type 2 diabetes and reduce the risk of major cardiovascular events in people with Type 2 diabetes and known heart disease. Ozempic is not approved by the FDA for weight loss. Is Ozempic approved for weight loss?
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Is Latuda covered by Medicare?
The Checkup by Singlecare
AUGUST 3, 2024
Latuda (lurasidone) is a brand-name prescription drug that’s approved by the Food and Drug Administration (FDA) to treat schizophrenia as well as bipolar depression associated with bipolar I disorder. It’s also sometimes prescribed off-label to treat major depressive disorder and other mental health conditions.
Does Medicare cover Ozempic?
The Checkup by Singlecare
MARCH 7, 2024
Yet the Food and Drug Administration (FDA) hasn’t approved this GLP-1 agonist injection for weight loss. Instead, it’s FDA approved to improve glycemic control in adults with Type 2 diabetes and to reduce the risk of adverse cardiovascular events in adults with Type 2 diabetes and known heart disease.
Innovative biologic prefilled syringe approved in EU
European Pharmaceutical Review
DECEMBER 13, 2024
This authorises a novel CE-labelled needle for intravitreal injection. Subsequently, Vabysmo PFS was granted first approval for the conditions by the US Food and Drug Administration (FDA) in July 2024, Roche shared.
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PharmaTher and Vitruvias partner to commercialise Ketarx in US
Pharmaceutical Technology
JUNE 21, 2023
Ketarx will be marketed under the FDA-approved label of ketamine and in dosages that include 10mg/ml, 50mg/ml and 100mg/ml, with the option to boost the concentration and ready-to-administer applications. Ketamine is currently on the FDA’s drug shortage list. Ketarx will then be commercially launched in the second quarter.
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Botanical drugs – what is the best way forward for regulatory and market approval?
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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Developing a new treatment paradigm for chronic kidney disease
European Pharmaceutical Review
MARCH 14, 2024
For IgA nephropathy (IgAN), key highlights include the US Food And Drug Administration (FDA) approval of Calliditas Therapeutics’ TARPEYO and the Committee for Medicinal Products for Human Use (CHMP)’s recommendation of a conditional marketing authorisation for Filspari (sparsentan). Internet] Vera Therapeutics. cited 2024Mar].
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Developing a new treatment paradigm for IgAN
European Pharmaceutical Review
MARCH 14, 2024
For IgA nephropathy (IgAN), key highlights include the US Food And Drug Administration (FDA) approval of Calliditas Therapeutics’ TARPEYO and the Committee for Medicinal Products for Human Use (CHMP)’s recommendation of a conditional marketing authorisation for Filspari (sparsentan). Internet] Vera Therapeutics. cited 2024Mar].
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DSCSA Postponement And What It Means For Independent Pharmacies
DiversifyRx
JULY 11, 2024
Small Dispensers and the 6/12/2024 FDA Announcement Concerning DSCSA This week’s article on the recent DSCSA postponement comes from PRS Pharmacy Services. If the FDA or another regulator requests DSCSA transaction data, the DSCSA regulations give you up to 48 hours to respond. The original article can be found HERE.
Is compounded semaglutide safe?
The Checkup by Singlecare
DECEMBER 12, 2024
In fact, the Food and Drug Administration (FDA) says consumers should exercise a lot of caution when considering using a compounded drug. Ozempic is arguably the most popular semaglutide drug, not because of its FDA-approved use for treating Type 2 diabetes but because of the amount of weight people have lost while taking it.
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Does Medicare cover Mounjaro?
The Checkup by Singlecare
JULY 2, 2024
Mounjaro is a popular brand-name medication approved by the Food and Drug Administration (FDA) to improve blood sugar control in people with Type 2 diabetes, along with diet and exercise. One common side effect of Mounjaro is weight loss, which is why it may sometimes be prescribed off-label (for a non-FDA-approved use) for that purpose.
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