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

BioPharma Drive: Drug Pricing

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.”

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

BioPharma Drive: Drug Pricing

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
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Schedule III Marijuana Would Still Be Regulated Marijuana

FDA Law Blog: Biosimilars

Dispensing marijuana to patients, as required for other schedule III substances, would require a prescription issued for legitimate medical purpose by a DEA-registered and state licensed practitioner. Marijuana down-rescheduled to schedule III would still be regulated for legitimate medical, scientific and industrial use.

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What you should know about the FDA’s Biological License Application Process

Reprocell

The biological license application (BLA) is one of the many requests for marketing approval received by the FDA. Unlike the New Drug Application (NDA) which is usually the go-to submission for chemically synthesized, low molecular weight drugs BLAs grant sponsors the ability to introduce Biologics into interstate commerce.

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In-Home Daycare vs. Licensed Facility – A Working Mom’s Perspective

Perficient: Drug Development

While it proved to be tricky to find an opening for an infant, we endeavored to compare in-home daycares and licensed facilities. In contrast, the licensed facilities we used maintained extended afternoon hours, providing a tad more flexibility for evening pickups. Luckily, Perficient is very family friendly.

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Hyman, Phelps & McNamara, P.C. (HP&M) is Pleased to Announce the Addition of Sara M. Keup as the new State Licensing Regulatory Expert for the Firm’s Licensing Practice

FDA Law Blog: Biosimilars

HP&M has been helping clients navigate the challenges of state licensing regulations for drugs, biologics, medical devices, OTCs, 503B outsourcing facilities, 503A pharmacies, foods, dietary supplements, cannabis, and wholesalers/distributors for many years. Keup has joined the firm to assist attorneys Karla L.

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Teva and MODAG Announce Licensing Collaboration for Neurodegenerative Disease Drug Candidate

The Pharma Data

NYSE and TASE: TEVA) and MODAG GmbH today announced a strategic collaboration on the exclusive worldwide licensing and development of MODAG’s lead compound anle138b and a related compound, sery433. Small molecule candidate Anle138b targets disease modification for multiple system atrophy and other neurological disorders.