Alta Sciences

OCTOBER 30, 2023

35: Critical Considerations for the Safe and Compliant Manufacture of Highly Potent Drugs Mainly driven by oncological research, the demand for highly potent active pharmaceutical ingredients (HPAPIs) has increased over the past 10 years—with over 25% on the market formulated with HPAPIs. Read or listen now.

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The Pharma Data

NOVEMBER 9, 2020

Löbenberg is a director of XPhyto and is the founder and director of the Drug Development and Innovation Centre, Faculty of Pharmacy and Pharmaceutical Sciences, University of Alberta, Edmonton, Canada. About XPhyto Therapeutics Corp. XPhyto Therapeutics Corp. XPhyto Therapeutics Corp. ON BEHALF OF THE BOARD.

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The Pharma Data

DECEMBER 17, 2020

Ampholipad recently achieved an important milestone in its global commercialization efforts, having signed the first term sheet in Latin America, with options in other markets. The Phase I clinical trial is ongoing in Taiwan in Australia, with results expected in 2021. Patient enrollment of EXCELLENCE pivotal trial reaches 98%.

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Agency IQ

JULY 8, 2024

and the E.C.

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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). Amanda Conti, AgencyIQ What kind of biologic products entered the market?

FDA 52

FDA Biosimilars Science Drugs 52

Agency IQ

FEBRUARY 12, 2024

A new real-world evidence guidance on the list is meant to address the integration of randomized controlled trials for drug and biological products into routine clinical practice. Other guidances of note include one on the “study of sex differences in the clinical evaluation of medical products.”

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Biosimilars Science Clinical Pharmacology FDA 40

Drug Target Review

SEPTEMBER 5, 2024

I am a pharmacist by training and continued with a PhD in Clinical Pharmacology. However, my goal was all the time to work with drug development in the pharma industry, so I moved on and started that journey in 1992 when I took on a role as Clinical Research Manager at AstraHässle, a mid-size Swedish pharma company.

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Pharma Companies Licensing Licensing Disease 111

Agency IQ

JUNE 16, 2023

0910-AH55 December 2023 September 2023 Proposed Rule Clinical Holds in Medical Device Investigations The proposed rule would create procedures for suspending, i.e., imposing a hold (a “clinical hold”) on, a clinical investigation of a medical device. the drug and device) of the combination product.

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Agency IQ

JUNE 2, 2023

6/27/2023 Notification FDORA, Section 3201 Within 180 days of the passage of FDORA, all biologics and biosimilars sponsors must submit a written notice to the FDA of all actively marketed products (i.e., These inspections will be routine surveillance rather than inspections as part of an approval application.

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Agency IQ

OCTOBER 27, 2023

WUSF / AgencyIQ November 1 Initial deadline for NDSRIs Under a 2023 guidance document, the FDA has recommended that pharmaceutical companies assess Nitrosamine Drug-Related Substance Impurities for their products by November 1, 2023, with confirmatory testing due by August 1, 2025.

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The Pharma Data

OCTOBER 15, 2020

formed a Partnership Advisory Committee comprised of former multi-national pharmaceutical veterans and industry leaders. marketing and diagnostics. Prior to that role, Hanna served as CEO at ORIC Pharmaceuticals and before that, Hanna was head of Commercial and Medical Affairs Finance at Genentech and CFO of the Genentech Foundation.

Pharmaceuticals 52

Pharmaceuticals Clinical Pharmacology Medical Schools Therapies 52

Agency IQ

MAY 3, 2024

and the E.C.

FDA 40

FDA Science Regulations Clinical Trials 40

Agency IQ

FEBRUARY 15, 2024

Priority A List.

FDA 40

FDA Science Biosimilars Clinical Trials 40

Agency IQ

SEPTEMBER 29, 2023

Due to the presence of nitrosamines in certain drug products, FDA had required that drug manufacturers conduct an initial risk assessment of approved or marketed products, with an initial completion date of October 1, 2021, and then confirmatory testing due by October 1, 2023. AgencyIQ October 1 Nitrosamine testing due to FDA.

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Agency IQ

MARCH 1, 2024

EPA March 1 FDA Budget FDA’s budget authority will expire as of midnight on March 1 POLITICO March 5 Lawsuit (Vanda vs. FDA) FDA required to have resolved dispute with Vanda Pharmaceuticals or hold a hearing. The following PDUFA dates were obtained from publicly available sources.

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Agency IQ

FEBRUARY 2, 2024

Legal Deadline March 7 Considerations for the Development of CAR T Cell Products FDA CBER March 15 Patient Listening Session: Patients with ADHD FDA March 22 Patient Listening Session: Patients with ADHD FDA March 25 Deadline to participate in the Quality Management Maturity Program Pilot.

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The Pharma Data

FEBRUARY 8, 2021

Hypokalemia, Fluid Retention, and Cardiovascular Adverse Reactions due to Mineralocorticoid Excess – ZYTIGA ® may cause hypertension, hypokalemia, and fluid retention as a consequence of increased mineralocorticoid levels resulting from CYP17 inhibition [see Clinical Pharmacology (12.1)]. Learn more at www.janssen.com.

Pharmaceutical Companies 52

Pharmaceutical Companies Treatment Clinical Trials Therapies 52

Agency IQ

DECEMBER 1, 2023

12/29/2023 FDORA, Section 3602 Clinical Trials Modernization : FDA is directed to require the submission of a “diversity action plan” for all Phase 3 clinical trials of new drugs. ” The report will also cover Federal agency roles in addressing vulnerabilities and statutory limitations.

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Alta Sciences

MARCH 27, 2025

"This recognition reflects our CDMO teams unwavering dedication and expertise of our CDMO team, as well as our unrelenting commitment to advancing drug development in collaboration with leading pharmaceutical and biotech innovators, says Marie-Hlne Raigneau, Co-Chief Operating Officer at Altasciences.

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FDA Law Blog: Drug Discovery

OCTOBER 28, 2024

will often not elapse for all subjects who received an investigational [gene therapy] product in the pre-marketing program before the product is licensed. Considering that, the safety data generated during clinical trials may not capture all possible delayed adverse events.”

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Drug Target Review

NOVEMBER 27, 2024

The global biomarker discovery outsourcing service market was estimated at $2.7 11 Pharmaceutical companies are increasingly outsourcing due to resource and capacity constraints, the need for specialised expertise, and the flexibility outsourcing offers in project management. Clinical Pharmacology & Therapeutics.

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Drug Development Regulations Laboratories FDA 52

New Drug Approvals

APRIL 21, 2025

under reduced pressure to afford a solid residue of Formula IX.Example 7Preparation of a Pharmaceutically Acceptable Salt of Formula I The solid residue of Formula IX was dissolved in water (57 mL) and stirred for 10 min and cooled to 05 C. The aqueous solution was acidified with conc. 26 November 2024. . 25 November 2024. January 2020).

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Agency IQ

JULY 12, 2024

Proposed Rule Rulemaking to Provide by Regulation that an Ingredient Is Not Excluded From the Dietary Supplement Definition December 2024 This proposed rule, if finalized, would allow a specific ingredient to be marketed in or as a dietary supplement. and the E.C.

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