Sangamo, Pfizer Deepen Relationship With New $162M ALS R&D Pact
Sangamo and Pfizer will use the company's ZFP-TFs to develop the treatments that are linked to mutations of the C9ORF72 gene, which can cause both ALS and FTLD. Source: BioSpace
Korean Manufacturer Warned for Adulterated Products
The FDA issued a warning letter to Korean drug manufacturer Amaros, citing significant quality and GMP violations. Source: Drug Industry Daily
TGA Issues New Criteria for Comparable Overseas Regulators
Australia’s Therapeutic Goods Administration issued revised guidelines for its comparable overseas regulators (CORs) program, designed to collaboratively regulate prescription medicines using an international report-based process. Source: Drug Industry Daily
FDA Novel Drug Approvals Spiked Last Year
The FDA approved 46 novel drugs in 2017, hitting a two-decade high after approvals plunged in the previous year — a record 53 novel drugs were approved in 1996. Source:…
Judge Tosses ‘Inconsistent’ AbbVie Bellwether Verdict, Orders New Trial
A federal judge overturned a July verdict against AbbVie in a bellwether case involving AndroGel. Source: Drug Industry Daily
FDA Issues Guidance on Trial Design for Hypogonadism Drugs
A new FDA draft guidance outlines clinical trial designs for treatments of male hypogonadotropic hypogonadism, including enrollment criteria and efficacy endpoints. Source: Drug Industry Daily
Celgene Co-Founder Bags $23M for Johns Hopkins Spinout NexImmune
In conjunction with the financing, Tony Yao, MD, PhD, a Partner at ArrowMark Partners, will join NexImmune’s Board of Directors. Source: BioSpace
Former Pfizer CEO's Boston Startup Centrexion Lands $67M for Ph3 Osteoarthritis Pain Drug
Centrexion closed on a Series D financing worth $67M to develop its knee osteoarthritis drug in Phase III. Source: BioSpace
3 Biotechs Seeking $271M IPO in the New Year
Three biotech companies want to start out the new year with a new start. Source: BioSpace
Optinose Gets $100M Debt Financing From Athyrium Capital Management
At closing of the agreement, $75 million in aggregate principal amount of the Senior Secured Notes were issued. Source: BioSpace
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