STAT

MAY 13, 2024

When it comes to a crucial controversy over pharmaceutical patents, the FDA has been MIA. Known as the Orange Book , it holds a key, behind-the-scenes role in shaping the competitive landscape of the pharmaceutical industry.

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FDA 141

The FDA Law Blog

SEPTEMBER 19, 2023

Karst — Listing patent information in the Orange Book is a matter of judgment, but that judgment call is about to get a bit more scrutiny. Last week, the FTC held a Listening Session about the listing of patents in the Orange Book, which concluded with a unanimous vote to issue a Policy Statement.

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The FDA Law Blog

SEPTEMBER 25, 2024

Throughout his illustrious career, Al has been engaged with Hatch-Waxman, even authoring one of the earliest papers providing an account of the law: “ Special Patent Provisions for Pharmaceuticals: Have They Outlived Their Usefulness? ” In his new book, “Breaking the Medicine Monopolies: Reflections of a Generic Drug Pioneer,” which will be released (..)

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Fierce Pharma

DECEMBER 21, 2023

Federal Trade Commission's recent crackdown on "improper" patents in the FDA's Orange Book, GSK, Amneal and Kaleo have made the requested changes. Following the U.S. Following the U.S.

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FDA 76

The FDA Law Blog

NOVEMBER 7, 2023

” At least that’s this blogger’s reaction to the recent news that FTC sent out Notice letters to 10 different drug companies about the patent information they list in the Orange Book. As FTC explains in a Press Release , the Agency “challenged more than 100 patents” that it believes are improperly or inaccurately listed in the Orange Book.

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FDA Dosage 59

STAT

SEPTEMBER 30, 2022

When does the FDA call in security? Then, oncologist Mikkael Sekeres joins us to talk about his new book, which is a history of the FDA and an insider’s look at one of the agency’s most contentious drug approval hearings. Does the latest Alzheimer’s disease drug actually work? Read the rest…

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FDA 97

STAT

MAY 13, 2024

Today we learn whether AI might help hasten the development of n-of-1 therapies (hint: not yet), explore why the FDA hasn’t offered Orange Book guidance on drug-device combinations, and talk about CRISPR.   Sign up  to get our biotech newsletter in your inbox. Read the rest…

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FDA 106

STAT

MAY 13, 2024

… When it comes to a crucial controversy over pharmaceutical patents, the FDA has been MIA, STAT explains. For Known as the Orange Book, it holds a key, behind-the-scenes role in shaping the competitive landscape of the pharmaceutical industry.

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FDA 109

Fierce Pharma

NOVEMBER 7, 2023

Only two months after the Federal Trade Commission said it was eying a crackdown on improper patents listed by the FDA, the agency has filed challenges against more than 100 patents in the agency's Orange Book. Pharma, you were warned. The companies have 30 days to respond.

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FDA 132

STAT

SEPTEMBER 14, 2023

In explaining its new policy statement , the FTC noted that some drug companies have failed to follow requirements for listing patents in the so-called Orange Book in hopes of thwarting competition from lower-cost generic medicines. Continue to STAT+ to read the full story…

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Pharmacy Times

NOVEMBER 6, 2022

Beth Macy, author of New York Times-bestselling book Dopesick and executive producer and writer on the Hulu series “Dopesick,” explains how FDA-approved drugs that treat opioid use disorder still aren’t getting into the hands of patients who need it most.

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FDA 123

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.

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Communication FDA 69

The FDA Law Blog

SEPTEMBER 23, 2024

Hatch Foundation’s For cheap generic drug prices, you can thank 40 years of Hatch-Waxman We Work For Health’s Hatch-Waxman Act: Celebrating 40 Years of a Balanced and Innovative Drug Ecosystem Tradeoffs’ Race to the Bottom Series FDA CDER Conversations – 40th Anniversary of the Generic Drug Approval Pathway The U.S. Waxman (sadly, Sen.

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FDA Dosage 59

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

MARCH 13, 2022

The FDA has cleared AstraZeneca and Merck & Co’s Lynparza as an adjuvant or neoadjuvant treatment for breast cancer, extending its lead over pretenders to its PARP inhibitor crown. billion in sales for AZ last year, a rise of around 25%, while Merck booked just under $1 billion from the drug.

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FDA Chemotherapy Labelling 140

The FDA Law Blog

MARCH 12, 2024

Koblitz — After years of silence from FDA on whether certain patents could be listed in the Orange Book, some manufacturers of drug and device combination products have had a rude awakening lately. Rather, the FTC questioned whether these patents meet the statutory and regulatory criteria for listing in the Orange Book.

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Dosage FDA 59

pharmaphorum

MARCH 25, 2022

The FDA has given ViiV healthcare and Johnson & Johnson a boost in the market for long-acting injectable HIV drugs, approving a new regimen for their Cabenuva product that does away with the need for an oral lead-in period. The post ViiV, J&J get FDA nod for simpler HIV injectable dosing appeared first on.

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STAT

JUNE 25, 2024

Today, STAT published our  annual list of the top books and podcasts  to check out this summer. Want to stay on top of the science and politics driving biotech today?    Sign up  to get our biotech newsletter in your inbox. Good morning.

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FDA 114

The People's Pharmacy

MAY 8, 2023

Why, then, are FDA inspections abroad so infrequent and disappointing? FDA Inspections Suspended: During the COVID pandemic, the Food and Drug Administration suspended its inspections at most foreign pharmaceutical facilities. Even under the best of conditions, the FDA never inspects all foreign pharmaceutical plants annually.

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pharmaphorum

NOVEMBER 30, 2021

The FDA will deliver a verdict on AstraZeneca’s PARP inhibitor Lynparza as an adjuvant treatment for breast cancer in the first quarter of next year, after granting the application a priority review. billion in sales for AZ last year, while Merck booked $725 million from the drug.

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FDA Chemotherapy Labelling 111

pharmaphorum

MARCH 14, 2022

AstraZeneca has failed in its bid to get US approval for its IL-5 inhibitor Fasenra as a treatment for chronic rhinosinusitis in people with nasal polyps, after the FDA rejected its marketing application. Sanofi – which books Dupixent sales – reported it made $5.7 billion from the drug last year. billion for GSK last year.

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FDA 116

pharmaphorum

JANUARY 25, 2022

The FDA has limited the use of COVID-19 antibody therapies developed by Eli Lilly and Regeneron, on the back of data suggesting they have are “highly unlikely” to be effective against the now-dominant Omicron variant. billion sales for its COVID-19 antibodies in the first nine months of 2021, while Regeneron booked a whopping $4.7

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FDA 98

pharmaphorum

JUNE 24, 2021

The FDA has started a review of a new implant version of Roche’s ranibizumab therapy for wet age-related macular degeneration, that could offer patients with the sight-robbing disorder an alternative to monthly eye injections. . Last year, Roche booked around $1.5 Ranibizumab PDS is also under review by the EMA in Europe.

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FDA 95

The FDA Law Blog

JULY 24, 2024

Join us to address emerging and growing areas of concern, including the implementation of the Inflation Reduction Act, FTC’s—and now a District Court’s—attack on Orange Book patent listings, and the proposed use of the Bayh Doyle Act. FDA Law Blog readers receive a 10% discount off the tuition fee (promo code D10-999-FDA25 ).

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FDA 52

pharmaphorum

OCTOBER 24, 2021

Roche’s Genentech unit has won FDA approval for Susvimo, an implant for eyesight-robbing disease wet age-related macular degeneration (AMD) that gives patients an alternative to regular injections into the eye. Last year, Roche booked around $1.5 The FDA started a priority review of the drug in July.

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FDA 98

The FDA Law Blog

JUNE 12, 2024

The ideal candidate will have a book of business. Our firm culture is collaborative, and the subject matter is intellectually stimulating. Strong verbal and writing skills are required. Strong verbal and writing skills are required. Compensation is competitive and commensurate with experience. HP&M is an equal opportunity employer.

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Department of Veterans Affairs FDA 59

STAT

SEPTEMBER 13, 2024

Or if you prefer to enjoy the great indoors, you could curl up with a good book or binge watch moving pictures on the telly. As with company drug advertisements, social-media posts sponsored by drug makers are required by the FDA to cite the risks. Beaches, lakes and walking trails are beckoning. But be safe.

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Medical Records Insurance Labelling FDA 109

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 Labelling Communication 52

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. Sales reached a peak in 2019, when Roche booked $1.8 billion, but fell back to $1.4

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FDA Labelling 72

STAT

JULY 21, 2023

You could plan an overdue getaway if you can swallow the cost of last-minute bookings. Conversely, you could take in a moving picture — Barbieheimer may be at a cinema near you — and luxuriate in the chilled air. Or you could simply sit about quietly and be Zen. Well, whatever you do, have a grand time. But be safe. … U.

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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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Med Ed 101

OCTOBER 24, 2021

FDA-approved biosimilars have been compared to a biologic and shown to be highly similar in structure and function. At the time this article was written, there are currently 31 FDA-approved biosimilars. The “Purple Book” can be found on the FDA website […].

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FDA 40

pharmaphorum

JANUARY 10, 2022

Swiss biotech Idorsia has claimed FDA approval for its first product – insomnia treatment Quviviq – setting up a market challenge to class rivals from Merck & Co and Eisai. Idorsia has said it expects to be profitable when it starts booking sales of Quviviq and clazosentan alongside its Ponvory royalty stream.

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FDA Labelling 52

STAT

JANUARY 27, 2023

STAT visited 24 vape shops earlier this month in Oxnard, Ventura, Pasadena, El Monte, Carson and West Hollywood — all of which have had bans on flavored vapes on the books for at least a year; most for two or more years. Seventeen of the shops, or 70%, were selling the products anyway.

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FDA 106

pharmaphorum

NOVEMBER 17, 2021

Hear key regulatory updates from regulatory bodies including FDA and WHO on guidance for regulatory compliance. EARLY-BIRD RATES: BOOK BY 30 TH SEPTEMBER AND SAVE £400. BOOK BY 29 TH OCTOBER AND SAVE £200. BOOK BY 30 TH NOVEMBER AND SAVE £100. We look forward to welcoming you to the conference in January. pharmaphorum .

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Vaccines FDA 52

STAT

JUNE 2, 2023

This is also a fine time to putter around the grounds or sit back with a good book.  Right now, Leqembi and Biogen’s Aduhelm only have accelerated approval from the FDA, and are subject to even more restrictive coverage limits that require patients to be enrolled in a clinical trial to receive the medications. But be safe.

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FDA 98

European Pharmaceutical Review

OCTOBER 19, 2022

The US Food and Drug Administration (FDA) has recently expressed concern to the US PTO about some types of innovator patent strategies that potentially delay generic entry into the market. FDA highlighted that over three quarters of new patents in the Orange Book between 2005 and 2015 were assigned to existing drugs.

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