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September 20, 2019

SanBio gets FDA RMAT designation for SB623 cell therapy

SanBio has secured regenerative medicine advanced therapy (RMAT) designation from the US Food and Drug Administration (FDA) for its SB623 cell therapy to treat chronic neurological motor deficits secondary to traumatic brain injury (TBI).

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Image: The US FDA’s Center for Drug Evaluation and Research. Photo: courtesy of The U.S. Food and Drug Administration.
September 19, 2019

Roche gets FDA breakthrough therapy designation for Gazyva to treat lupus nephritis

Image: Site Roche Basel. Photo: courtesy of F. Hoffmann-La Roche Ltd.
September 19, 2019

Novartis’ Cosentyx meets primary endpoint at Week 16 in PREVENT trial

Image: Novartis reports positive 16-week PREVENT results for Cosentyx. Photo: courtesy of Novartis AG.

Contracts

May 22, 2019

WuXi Biologics signed letter of intent for long-term vaccine manufacturing contract

Image: WuXi Vaccines will build an integrated vaccine manufacturing facility. Photo: courtesy of Arek Socha / Pixabay.

TaiwanJ Pharmaceuticals out-licenses liver drug candidate in Asia

GeoVax, Leidos expand collaboration to malaria vaccines

World’s largest pharmaceutical firm selects ValGenesis to standardize corporate validation process enterprise-level

Deals

Deals September 17, 2019

Lundbeck to buy Alder BioPharmaceuticals for £1.56bn

Pharmaceutical Business Review

Aytu BioScience to acquire Innovus Pharmaceuticals

Avalon Ventures and COI Pharmaceuticals announce acquisition of Sitari Pharmaceuticals by GSK

Mallinckrodt to divest BioVectra for £202m

Popular

  1. Gilead, Renown Institute for Health Innovation announce collaboration to advance understanding of NASH
  2. Celsius Therapeutics signs collaboration agreement with Janssen to identify response biomarkers for ulcerative colitis
  3. Ipsen, Servier announce initial phase 1/2 data of liposomal irinotecan in metastatic pancreatic cancer
  4. VALBIOTIS announces positive results from phase IIA trial of VALEDIA in prediabetics
  5. GSK begins phase 3 trial for otilimab in patients with rheumatoid arthritis

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Multi-Deck Hygienic Sifter for Pharmaceutical Powders
Multi-Deck Hygienic Sifter for Pharmaceutical Powders
Tosoh Announces Two New Application Notebooks
Tosoh Announces Two New Application Notebooks
Join NSF’s Robyn Meurant and Rachel Carmichael at the MMPathIC Event, September 23, 2019
Join NSF’s Robyn Meurant and Rachel Carmichael at the MMPathIC Event, September 23, 2019
Enamine Expands Collaboration with UCSF to Explore Synthetically Feasible Chemical Space
Enamine Expands Collaboration with UCSF to Explore Synthetically Feasible Chemical Space
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