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FDA cites contamination concerns in warning to Sanofi MA plant
22 Jan 2025 14:50 GMT
… (cGMP) for drug substance production.
“FDA documented that approximately … can reproduce an active pharmaceutical ingredient (API) with … from both the FDA and European Medicines Agency (EMA) … both Fabrazyme and Cerezyme (imiglucerase for injection) – the …
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ISU Abxis’ Gaucher disease drug enters Middle East-North African market
12 Dec 2024 07:07 GMT
… of its Gaucher disease treatment Abcertin (imiglucerase) in the Middle East … East 2024,” an international pharmaceutical and biotechnology exhibition, held at … manufactures, distributes its generic pharmaceutical products and performs contract manufacturing …
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Rare Diseases With FDA-Approved Treatments | Sentynl Therapeutics, Inc.
08 Sep 2024 19:22 GMT
… of clinical trials required to support an application for FDA approval. …
Miglustat
Eliglustat
Velaglucerase alfa
Imiglucerase
Taliglucerase
Future Developments
While … and medical researchers continue to seek cures, palliative treatments, and drug protocols …
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FDA Approved Drug Products Approval List July 2024
08 Aug 2024 12:44 GMT
… 3 SOMATROGON-GHLA PFIZER IRELAND PHARMACEUTICALS Approval 07… 210951 SUPPL-17 APALUTAMIDE JANSSEN BIOTECH Manufacturing (CMC) Approval 07 … CEREZYMEBLA #020367 SUPPL-121 IMIGLUCERASE GENZYME Approval 07… #47;31/2024 MEDICAL AIR, USPNDA #219709 …
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Human medicines European public assessment report (EPAR): Cerezyme, imiglucerase, Date of authorisation: 17/11/1997, Revision: 32, Status: Authorised
23 May 2024 09:19 GMT
Cerezyme is used for the long-term treatment of patients with Gaucher disease. Gaucher disease is a rare inherited disorder, in which people do not have enough of an enzyme called acid beta-glucosidase, which normally breaks down a fatty waste product …
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Neuronopathic therapies are a serious unmet need in the treatment of Gaucher disease
19 Oct 2023 12:16 GMT
… include Sanofi’s Cerezyme (imiglucerase), Takeda’s VPRIV ( … the creation of drugs designed to cross … with fast-track FDA designation, PR001 treatment could significantly … Looking ahead, collaboration between pharmaceutical innovators, dedicated researchers, …
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Enzyme Replacement Therapy Emerges as a Game-Changer in the Pharmaceutical Market
24 Apr 2023 11:16 GMT
… Inc.
9. Sanofi
10. Takeda Pharmaceuticals
𝐄𝐧𝐳𝐲𝐦𝐞 𝐑𝐞𝐩𝐥𝐚𝐜𝐞𝐦𝐞𝐧𝐭 𝐓𝐡𝐞𝐫𝐚𝐩𝐲 𝐌𝐚𝐫𝐤𝐞𝐭 𝐑𝐞𝐩𝐨𝐫𝐭 𝐇𝐢𝐠𝐡𝐥𝐢𝐠𝐡𝐭𝐬
𝐏𝐫𝐨𝐝𝐮𝐜𝐭:
• … Imiglucerase: Imiglucerase is an enzyme replacement therapy used for the treatment … market-A10293
Neurodegenerative Drugs Market - https …
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April - June 2023 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)
10 Feb 2023 08:45 GMT
… labels that contribute to wrong drug errors
FDA is evaluating the need … therapy
Brineura (cerliponase alfa)
Cerezyme (imiglucerase)
Elelyso (taliglucerase alfa)
Fabrazyme (agalsidase … labels that contribute to wrong drug errors
FDA is evaluating the need …
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Expert Moots New Economic Model For Malaysia To Evaluate Drug Prices
20 Jan 2023 11:18 GMT
… treatment in society, and be accessible to patients through the doctor … willingness to pay, orphan medicines require different considerations as … per QALY for Imiglucerase, a drug used to treat … explore super population, precision medicine, and the trade-up …
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Benign Prostatic Hyperplasia (BPH) Prostate Treatment Market to Grow at a CAGR of ~6% during 2023-2033; Market to Expand Owing to the Growing Rate of BPH Surgical Treatment and Rising Geriatric Population –Research Nester
18 Oct 2022 14:01 GMT
… investment in the biotechnology sector by … Treatment Type
Drug Treatment – 58%
Surgical Treatment – 42%
Out of these, the drug treatment … quickly than other pharmaceuticals.
Explore Our … Product (Agalsidase Beta, Imiglucerase, Velaglucerase Alfa, Idursulfase, …
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