Bio/Pharma News

Takeda Pharmaceutical partners with US biopharmaceutical company, TESARO, in deal worth up to $340 million to develop and commercialize PARP inhibitor.

Eli Lilly and Incyte face a roughly 18-month application delay for rheumatoid arthritis drug, baricitinib, in the US with a request from FDA for additional clinical data.

Manufacturing capacity will be increased by one third and approximately 300 new high-wage and highly-skilled jobs will be created at the Fremont site.

The new center will help biopharmaceutical and pharmaceutical manufacturers with product development.

GSK plans to invest in several UK manufacturing sites and to close its Slough site in conjunction with the sale of the Horlicks brand manufactured in Slough.

GSK plans to deliver up to 40 million doses of its quadrivalent flu vaccine for the 2017–2018 season.

The company has entered into a settlement agreement with generic-drug companies to resolve patent litigation.

FDA advisory committee has recommended for approval Novartis CAR-T cell therapy CTL019 for the treatment of relapsed and refractory B-cell acute lymphoblastic leukemia in pediatric and young adult patients.

The acquisition will add recombinant-based influenza vaccine to Sanofi Pasteur’s portfolio

After FDA found a “significant shift in the route of abuse,” Endo voluntarily removes OPANA ER from the market.

Fresenius Kabi has added two new antibiotics production lines at its plant in Santiago de Besteiros, Portugal.

SOBI003 is a chemically modified variant of a recombinant human sulfamidase product candidate, using Sobi’s proprietary glycan modification technology.

Partners will use an AI-enabled platform to discover new small molecules across different therapeutic areas.

ADV7103 is being evaluated in a Phase III trial in Europe in children and adults with distal renal tubulopathy acidosis. Results from the study are expected in the coming months.

The collaboration will focus on the discovery, development, and commercialization of novel therapeutics targeting an undisclosed G protein-coupled receptor (GPCR) that plays an important role in inflammatory diseases.

The company has broken ground on a R&D and process development facility in Missouri.

Two recently-signed agreements will transfer Takeda’s measles and acellular pertussis vaccine technologies to India-based multinational company Biological E. Limited to develop low-cost combination vaccines including diphtheria, tetanus and acellular pertussis (DTaP), and measles-rubella (MR) vaccines.

The companies expanded their alliance to develop plasmid DNA drugs.

Takeda inaugurated expanded capacity of solid-dosage drugs at its site in Oranienburg, Germany.

The European Medicines Agency approved Prezista (darunavir) made via a continuous manufacturing process at Janssen's facility in Puerto Rico.

The patent was filed for a chewing gum composition with controlled release of cannabinoids and opioid agonists, and antagonists for addiction or dependence treatment.

A loan from the European Investment Bank will give BiondVax resources for Phase III trials and a manufacturing facility for its universal flu vaccine.

By purchasing the BMS Sword, Ireland facility, SK Biotek will be the first South Korean company to invest in pharmaceutical manufacturing in Ireland.

The European Commission approved Rixathon for use in all indications of its reference medicine, MabThera.

SK Biotek plans to operate the Swords, Ireland API manufacturing facility as a contract development and manufacturing site.

Basilea Pharmaceutica International Ltd. entered into a distribution and license agreement with Pfizer and Avir Pharma Inc. to distribute Basilea’s antifungal treatments.

The companies are partnering to provide new fill/finish facilities and solutions for biopharmaceutical products.

The company said it expects to transaction to close on June 16, 2017.

Proceeds from the sale will be used to repay the company’s term loan debt under its Senior Secured Credit Facility.

Germany-based Grünenthal will gain rights to market and sell Zomig (zolmitriptan) outside of Japan.