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Proposed amendments to the PM(NOC) Regulations: Patents claiming different salt forms of medicinal ingredients eligible for inclusion on the Patent Register

Pharma in Brief

These amendments permit patents claiming different forms of a medicinal ingredient (e.g., As previously reported , the Proposed FDR Amendments were intended to clarify the regulatory requirements under the Abbreviated New Drug Submission (“ ANDS ”) pathway for generic drug products that contain different forms (e.g.,

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FDA Approves First Generic of Symbicort to Treat Asthma and COPD

The Pharma Data

Agency Supports Development of Complex Generic Drug-Device Combination Product to Improve Competition and Access to More Affordable Medicines. This complex generic drug-device combination product, which is a metered-dose inhaler, should not be used to treat acute asthma attacks. Today, the U.S.

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Quality by design with a focus on biosimilars

Pharmaceutical Technology

It aims to ensure the quality of medicines by employing statistical, analytical, and risk-management methodology in the design, development, and manufacturing processes of medicines. In the case of generics, the only concerns you might see is where the brand name and generic drug contain different excipients,” explained Dr Amiji. “A

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In the News: October Regulatory and Development Updates

Camargo

In November 2017, Foundation Medicine received approval for FoundationOne CDx , a genomic profiling test for solid state tumors, which paved the way for partnerships with pharma companies’ therapeutics. In 2019, Foundation Medicine and Bayer Healthcare Pharmaceuticals, Inc. for patients with NTRK fusion cancer across all solid tumors.

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Teva Announces Launch of an Authorized Generic of Epiduo® Forte Gel (adapalene and benzoyl peroxide gel 0.3%/2.5%), in the U.S.

The Pharma Data

is a topical prescription medicine used to treat acne vulgaris. The launch of our first-to-market authorized generic version of Epiduo® Forte Gel in the U.S. provides patients with another important treatment option,” said Christine Baeder, SVP, Chief Operating Officer US Generics, Teva USA.

Doctors 52
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Pharma Microbiology East Coast Conference – A Virtual Conference with Remote Access

pharmaphorum

Her previous FDA management positions include serving as the Director of the OPF’s Division of Microbiology Assessment, Director of the OPS’s New and Generic Drug Product Quality Microbiology staff, and Director of OGD’s Division of Microbiology. Container Closure Integrity Evaluation: USP Perspective. • in Biology and Ph.D.

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Buscopan vs Mebeverine | OTC IBS treatment

Druggist

Mebeverine, on the other hand, is a generic name of the drug, which is also known as Colofac (brand name). Both products contain the same active ingredients regardless of whether they are prescribed or purchased over the counter: Each Buscopan tablets contains 10mg of hyoscine butylbromide.