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The European Medicines Agency (EMA) has granted Orphan Designation to the company’s lead asset for the treatment of pancreatic cancer. “We are very pleased that the European Medicines Agency has granted orphan designation to our lead asset mitazalimab in the treatment of pancreatic cancer,” says Søren Bregenholt, CEO of Alligator Bioscience. “It is our second […]

Calliditas Therapeutics has announced that the U.S. Food and Drug Administration has accepted the submission for the supplemental New Drug Application (sNDA) for TARPEYO delayed release capsules and granted Priority Review. The Prescription Drug User Fee Act (PDUFA) goal date is 20 December 2023. The significant eGFR treatment benefit observed across the entire study population […]

Forxiga has been approved in China to reduce the risk of cardiovascular death, hospitalization for heart failure (HF), or urgent HF visits in adults with symptomatic chronic HF. Forxiga has previously been approved in China for HF patients with reduced ejection fraction (HFrEF) meaning that Forxiga is now approved in China to reduce the risk […]

On Tuesday, 15th of August, NDA Group and SSI Strategy announced the merger of their companies, creating an industry leading life sciences consulting firm. This collaboration combines two trusted consultancies to provide end-to-end support for drug development companies, guiding them from concept to commercialization. SSI Strategy brings exceptional medical, clinical, and development expertise to complement NDA’s regulatory capabilities. Their teams, […]

Sprint Bioscience has licensed the global rights to its cancer program VADA (VRK1) to Day One Biopharmaceuticals Inc. “This agreement is yet another confirmation that the work we do within the company is of the highest international class. The VADA (VRK1) program has generated great interest in the industry globally and we have chosen Day […]

The company’s 360° patient-centric app was named the winner of the Nordic Health App Award 2023 at Arendalsuka in Norway. “Winning the Nordic Health App Award 2023, combined with our recently approved registration by the FDA as Medical Product Class 1, is extremely promising for our commercialization and provides exciting opportunities for our international expansion […]

Calliditas Therapeutics has announced publication in The Lancet of the full data from the Phase 3 NefIgArd Study with Nefecon in adults with Primary IgA nephropathy (IgAN). The Phase 3 trial met the primary endpoint, estimated glomerular filtration rate (eGFR), with Nefecon demonstrating significant kidney protective effect over placebo, states the company in a press […]

Annexin Pharmaceuticals has announced that an independent evaluation of potential signals of effect has been carried out in the company’s Phase 2-study in retinal vein occlusion with the investigational new drug ANXV. Positive findings justify an extended follow-up period, states the company. “With these early signals in the RVO study, a favorable safety profile and […]

Oncopeptides has announced that CEO Monica Shaw will be departing the company and transition over to Sofia Heigis who will move from the CCO role to take on the CEO role. “I am saddened to be leaving Oncopeptides at a time when the promise of Pepaxti for patients with Multiple Myeloma is truly coming to […]

Novo Nordisk has agreed to acquire Inversago Pharma for up to 1.075 billion USD in cash if certain development and commercial milestones are achieved. “The acquisition of Inversago Pharma will further strengthen our clinical development pipeline in obesity and related disorders,” says Martin Holst Lange, executive vice president for Development at Novo Nordisk. “This promising […]