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MorphoSys and Incyte Announce Acceptance by Health Canada of the New Drug Submission for Tafasitamab
January 12, 2021 GMT
PLANEGG/MUNICH, GERMANY and MONTREAL, QC / ACCESSWIRE / January 12, 2021 / MorphoSys AG (FSE:MOR; Prime Standard Segment; MDAX & TecDAX; NASDAQ:MOR) and Incyte (NASDAQ:INCY) today announced that Health Canada has accepted the New Drug Submission (NDS) for tafasitamab, an anti-CD19 antibody. The application seeks approval of tafasitamab in combination with lenalidomide, followed by tafasitamab monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), including DLBCL arising from low grade lymphoma, who are not eligible for, or refuse, autologous stem cell transplant (ASCT).
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PLANEGG/MUNICH, GERMANY and MONTREAL, QC / ACCESSWIRE / January 12, 2021 / MorphoSys AG (FSE:MOR; Prime Standard Segment; MDAX & TecDAX; NASDAQ:MOR) and Incyte (NASDAQ:INCY) today announced that Health Canada has accepted the New Drug Submission (NDS) for tafasitamab, an anti-CD19 antibody. The application seeks approval of tafasitamab in combination with lenalidomide, followed by tafasitamab monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), including DLBCL arising from low grade lymphoma, who are not eligible for, or refuse, autologous stem cell transplant (ASCT). With the acceptance of the NDS by Health Canada, review of the data can begin, an important step on the path to making tafasitamab available in Canada for use in combination with lenalidomide in eligible patients with relapsed or refractory DLBCL, said Josée Brisebois, Ph.D., Head of Medical Affairs, Incyte Biosciences Canada. We intend to work clo
Radius Health Announces Commercial Agreement with Paladin Labs for Abaloparatide in Canada
Agreement incorporates TYMLOS
® and abaloparatide-TD
Consideration includes upfront payment, milestones based on clinical, regulatory and commercial progression, as well as royalties
Key first step in expanding the global footprint for the abaloparatide asset beyond the U.S. and Japan; a key focus area for the company for 2021
BOSTON, Jan. 05, 2021 Radius Health, Inc. (“Radius” or the “Company”) (Nasdaq: RDUS) today announced that the Company has entered into definitive agreements with Endo Ventures Limited, a subsidiary of Endo International plc (“Endo”) (NASDAQ: ENDP), to register, commercialize, and distribute abaloparatide on an exclusive basis in Canada. Paladin Labs Inc. (“Paladin”), an operating company of Endo, will be responsible for all commercial activities related to abaloparatide. Under the terms of the agreements, Paladin will pay Radius upfront and mile
Over the past 12 months, the
Telix Pharmaceuticals Ltd(ASX: TLX) share price has posted massive gains exceeding 150%. The Telix share price kicked off 2020 at $1.53, closed the year at $3.78 and is currently sitting at $3.86 per share.
So what has Telix done to achieve this remarkable pump for its share price?
Significant US Food and Drug Administration (FDA) wins
In January 2020, Telix announced that the US Food and Drug Administration (FDA) approved the recruitment of American participants in the company’s Zirconium Imaging in Renal Cancer Oncology (ZIRCON) study. This was an important milestone because it extended the Phase III study into new territory beyond Australia and Europe.
Tetra Bio-Pharma Files New Drug Submission for REDUVO in Canada
Tetra meets another key milestone before the end of the year
OTTAWA, ON / ACCESSWIRE / December 30, 2020 /
Tetra Bio-Pharma Inc. ( Tetra or the Company ) (TSX:TBP)(OTCQB:TBPMF), a leader in cannabinoid-derived drug discovery and development announced today that the New Drug Submission (NDS) for the Dronabinol Soft Gel capsules, has been filed with Health Canada. If successful, it will provide Tetra with its first Drug Identification Number (DIN) for a THC-based prescription drug. The new drug name, REDUVO, is pending approval by Health Canada.
REDUVO will allow Tetra to establish a revenue stream based on a synthetic cannabinoid drug for major markets in Chemotherapy-induced Nausea and Vomiting (CINV). The addressable market is estimated to be $80M CDN by 2022