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uniQure signs license deal for Apic Bio’s gene therapy for SOD1-ALS

Pharmaceutical Technology

Gene therapy company uniQure has entered into a global licensing agreement with Apic Bio for APB-102 to treat patients with amyotrophic lateral sclerosis (ALS) caused by mutations in superoxide dismutase 1 (SOD1). The gene therapy received Orphan Drug and Fast Track designations from the US Food and Drug Administration (FDA).

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FTC, in unusual move, leads Sanofi to terminate a drug research deal

Bio Pharma Dive

Just before clearing Pfizer’s buyout of Seagen, the regulator threatened to block Sanofi’s licensing deal with Maze Therapeutics, a challenge the biotech called ‘‘unprecedented.”

Licensing 304
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CDSCO centralises powers to issue NOC for unapproved, banned & new drugs solely for exports

AuroBlog - Aurous Healthcare Clinical Trials blog

The national drug regulator has withdrawn the powers delegated to the State and Union Territory (UT) Licensing Authorities to issue No Objection Certificates (NOCs) for manufacture of unapproved, banned or new drugs solely for export purpose, asking the industry to file fresh applications with the central authority online from May 15.

Drugs 241
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CDSCO reminds medical device firms to pay retention fee to continue holding licenses & certificates

AuroBlog - Aurous Healthcare Clinical Trials blog

The Central Drugs Standard Control Organisation (CDSCO) has requested all stakeholders in the medical devices sector to deposit the requisite fee for retention of license or registration certificate under the Medical Devices Rules (MDR), 2017, well before the stipulated timeline in order to avoid cancellation of the approvals.The drug regulator, in (..)

Licensing 189
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CDSCO releases draft standard evaluation protocols for issuing license for IVDs

AuroBlog - Aurous Healthcare Clinical Trials blog

The Central Drugs Standard Control Organisation (CDSCO) and Indian Council of Medical Research (ICMR) have together released the draft standard evaluation protocols for the purpose of issuing license for in-vitro diagnostics (IVDs) under the Medical Devices Rules (MDR), 2017.

Licensing 180
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Ayush ministry informs HC that it has instructed drug regulators against use of Unani label for Ayurveda drug

AuroBlog - Aurous Healthcare Clinical Trials blog

The Union Ministry of Ayush has submitted in the Delhi High Court that it has instructed the licensing authority for the Ayush systems of medicines in all the States and Union Territories that they should ensure that the labelling and naming of the products for the Ayurvedic and Unani drugs should be as per the […]

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PTC rebuffed again by EMA; Novartis licenses China-based biotech’s cancer drug

Bio Pharma Dive

European regulators have for the fourth time issued a negative opinion on PTC's Translarna. Elsewhere, Amylyx read out data and Leqembi hit a roadblock in Australia.

Licensing 167