The Pharma Data

JULY 8, 2021

is a leading global pharmaceutical company headquartered in Japan. One of the world’s first global biotechnology companies, Biogen was founded in 1978 by Charles Weissmann, Heinz Schaller, Kenneth Murray and Nobel Prize winners Walter Gilbert and Phillip Sharp. Follow us on social media – Twitter , LinkedIn , Facebook , YouTube.

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FDA Law Blog: Biosimilars

APRIL 21, 2024

Taiho Pharmaceutical Co., Usually at this point in a post we would identify the date of approval of the relevant NDA. 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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The Pharma Data

DECEMBER 28, 2020

29, 2020 (GLOBE NEWSWIRE) — Amphastar Pharmaceuticals, Inc. , (NASDAQ: AMPH) announced that the U.S. Food and Drug Administration (“FDA”) has approved its Abbreviated New Drug Application (“ANDA”) for Glucagon for Injection Emergency Kit, 1 mg. Contact Information: Amphastar Pharmaceuticals, Inc.

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The Pharma Data

MAY 2, 2022

Teva Branded Pharmaceutical Products R&D, Inc. and Auspex Pharmaceuticals, Inc., affiliates of Teva Pharmaceutical Industries Ltd. AUSTEDO is the first and only FDA-approved product to treat both tardive dyskinesia in adults and chorea associated with Huntingdon’s disease. Teva Pharmaceutical Industries Ltd.

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FDA Law Blog: Biosimilars

JANUARY 4, 2024

HPM is ably represented by seasoned drug product development and authorization attorney—and former FDA counsel— Deborah Livornese. Deb assists pharmaceutical drug companies of all sizes on regulatory requirements and strategies related to obtaining FDA approval and other paths to market, as well as on post-marketing regulatory requirements.

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Agency IQ

JANUARY 19, 2024

Seventeen products were orphan drugs, fourteen were generics and eight were biosimilars. Reviews of orphan medicines and biosimilars have remained stable over the past three years. There were eight biosimilars reviewed in 2023, which is comparable to 2021 (seven) and 2022 (eight), but lower than 2020, which saw 12 biosimilars reviewed.

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FDA Law Blog: Biosimilars

MARCH 26, 2024

Late last week, the FTC submitted an Amicus Brief in recent Hatch-Waxman patent litigation in the District Court of New Jersey between Reference Listed Drug holder Teva Branded Pharmaceutical Products R&D Inc.

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FDA Law Blog: Biosimilars

MARCH 13, 2024

4,631,286, where the PTO considered “whether Hoechst-Roussel is eligible to file an application for [PTE] based on a regulatory review conducted by its competitor, the marketing applicant Warner-Lambert, wherein Hoechst-Roussel was not associated with the regulatory review that led to FDA approval for commercial marketing of the approved product.”

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FDA Law Blog: Biosimilars

SEPTEMBER 6, 2023

Food and Drug Administration – labeled an “Official Action Indicated” classification – is generally devastating for the facility, not least because it can stall FDA approval of applications to market drugs manufactured at the facility. Farquhar — A drug manufacturer’s bad post-inspection grade from the U.S.

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FDA Law Blog: Biosimilars

JULY 24, 2023

Koblitz — Neither Jazz Pharmaceuticals nor Avadel CNS Pharmaceuticals has taken the battle of sodium oxybate—a drug approved to treat narcolepsy—lying down. 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.

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FDA Law Blog: Biosimilars

AUGUST 17, 2023

Tobolowsky — In January 2023, Vanda Pharmaceuticals, Inc. FDA-2023-P-0313 and FDA-2023-P-0344 ) regarding its product Hetlioz (tasimelteon). Vanda’s Hetlioz was, in fact, the first FDA-approved drug product to include braille labeling. 355(j)(2)(A)(v). patients in harm’s way.”

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The Pharma Data

AUGUST 3, 2021

Product sales increased 3% globally, driven by double digit volume growth across a number of our products including Prolia ® (denosumab), Repatha ® (evolocumab) and our biosimilar products MVASI ® (bevacizumab-awwb) and KANJINTI ® (trastuzumab-anns). AMGEVITA continued to be the most prescribed adalimumab biosimilar in Europe.

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Agency IQ

OCTOBER 6, 2023

CDER is the FDA office in charge of reviewing pharmaceuticals and therapeutic biologics. All products are received in one of two forms: A New Drug Application (or NDA, for pharmaceuticals) or a Biologics License Application (BLA, for biologics). FDA approved 13 NMEs through the AA pathway in FY 2023, making up 25.5%

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The Pharma Data

APRIL 7, 2023

Food and Drug Administration (FDA) has accepted for review the Supplemental New Drug Applications (sNDAs) for BRAFTOVI® (encorafenib) + MEKTOVI® (binimetinib) for patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by an FDA-approved test. Ono Pharmaceutical Co. In the U.S.,

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FDA Law Blog: Biosimilars

JUNE 27, 2023

Amongst his accomplishments, Law360 considered the role James has played in leveraging little-used pathways to FDA approval for often first-ever drugs to treat rare diseases (e.g., James was only one of five life sciences attorneys selected and the only food and drug lawyer to make the list.

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Agency IQ

SEPTEMBER 29, 2023

October 2023 Amendments to the Final Rule Regarding the List of Bulk Substances That Can Be Used to Compound Drug Products in Accordance With Section 503A of the Federal Food, Drug, and Cosmetic Act (Proposed Rule) FDA has issued a regulation creating a list of bulk drug substances (active pharmaceutical ingredients) that can be used to compound (..)

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FDA Law Blog: Biosimilars

OCTOBER 29, 2023

With this guidance, the Departments decided to reference the 2019 HRSA Guideline rather than the FDA Birth Control Guide for the range of identified categories of contraception (FAQ Part 54, Q2), stating that plans and issuers must cover without cost sharing at least one form of contraception in each category.

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The Pharma Data

APRIL 27, 2021

Pharmaceuticals. First-quarter 2021 Pharmaceutical sales increased 3.8% At the end of March, the FDA approved Sarclisa ® in combination with carfilzomib and dexamethasone for patients with relapsed multiple myeloma. Pharmaceuticals business operating income. to €2,638 million. At CER, BOI increased 13.3%.

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The Pharma Data

OCTOBER 29, 2020

29, 2020– Alexion Pharmaceuticals, Inc. ULTOMIRIS – Atypical Hemolytic Uremic Syndrome (aHUS): In September 2020 , Japan’s MHLW approved ULTOMIRIS for adults and children with aHUS. FDA approved the ULTOMIRIS 100 mg/mL formulation for PNH and aHUS. ALEXION PHARMACEUTICALS, INC. Tables Follow). .

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Agency IQ

OCTOBER 27, 2023

Date What’s Happening Explanation Source October 31 FDA deadline on Florida drug importation plan The FDA has said in court filings that it plans to make a ruling on Florida’s prescription drug importation plan by October 31. The following PDUFA dates were obtained from publicly available sources.

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Agency IQ

DECEMBER 1, 2023

12/29/2023 FDORA, Section 3210 Accelerated Approval : FDA’s Accelerated Approval Council must publish a report within one year of the passage of the FDORA legislation regarding its annual activities. ” The report will also cover Federal agency roles in addressing vulnerabilities and statutory limitations.

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The Pharma Data

MAY 4, 2021

Multiple innovative and biosimilar products across our portfolio delivered growth, demonstrating the strength of our business and the depth and breadth of our growth drivers. Lorbrena is now indicated for adults with metastatic NSCLC whose tumors are ALK-positive as detected by an FDA-approved test.

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FDA Law Blog: Biosimilars

JANUARY 9, 2024

The final rule permitted FDA to solicit Section 804 Importation Programs (SIPs) from States and Tribes to import prescription drugs from Canada. The final rule met quick opposition from the pharmaceutical industry. So far, the Agency has received SIPs from at least five states. See 21 C.F.R. 251.5; § 251.6(c).

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