Blog Archives | Page 81 of 101

Recent BioBlast® Updates

Rani Therapeutics to Present Further Clinical Data for Oral Ustekinumab Biosimilar

May 9, 2024

On 9 May 2024, Rani Therapeutics announced that it will present pre-clinical and clinical data at Digestive Disease Week in the US (18-21 May 2024) regarding RT-111, an oral delivery platform known as the RaniPill® capsule, containing Celltrion’s ustekinumab...

Telix & Cardinal Health Finalise Clinical Supply Agreement for Actinium-225

May 8, 2024

On 8 May 2024, Telix announced an agreement with Cardinal Health Nuclear & Precision Health Solutions for the global clinical supply of actinium-225 (Ac-225). This therapeutic radioisotope will support the development of Telix's targeted alpha therapy (TAT)...

Galderma’s Nemolizumab Accepted For Review Under Access Consortium Framework

May 7, 2024

On 7 May 2024, Galderma announced that its nemolizumab, for the treatment of prurigo nodularis and for moderate to severe atopic dermatitis has been accepted for review in Australia, Singapore, Switzerland and the UK under the Access Consortium Framework, a...

AZ Withdraws COVID Vaccine (Vaxzevria®) from EU Market

May 7, 2024

On 7 May 2024, the EU Medicines Agency (EMA) withdrew marketing authorisation (MA) approval for AZ's COVID-19 vaccine Vaxzevria, at AZ’s request. AZ requested the withdrawal reportedly due to decline in demand for the vaccine and it no longer being manufactured or...

Amgen and Arrotex Partner to Promote Prolia® (denosumab) in Australia

May 7, 2024

On 7 May 2024, Pharma In Focus reported that Arrotex has partnered with Amgen to promote Amgen’s Prolia® (denosumab) in Australia. It is planned that the partnership “will support the future growth of Prolia in the Australian market, utilising the infrastructure and...

Sandoz Biosimilars Earnings Up 21% in Q1/24 Underpinned By Ranibizumab & Adalimumab Launches

May 7, 2024

On 7 May 2024, Sandoz announced Q1 2024 net sales of USD1.9 billion, with its biosimilars growing 21% to USD 623 million. The biosimilar growth is said to be driven by Sandoz’s 2023 US/EU launch of Hyrimoz®, biosimilar to AbbVie’s Humira® (adalimumab), and the...

Calliditas Therapeutics Announces Positive Phase 2 Results for Setanaxib and Pembrolizumab for Head and Neck Cancer

May 6, 2024

On 6 May 2024, Calliditas announced positive Phase 2 results for Setanaxib and Pembrolizumab for the treatment of head and neck cancer. The trial was randomized, placebo-controlled, and double-blinded and patients completed at least 15 weeks of treatment with 800mg...

Lupin & Sandoz Launch Rymti® (etanercept) Biosimilar in Canada

May 3, 2024

On 3 May 2024, Indian-headquartered Lupin, in partnership with Sandoz, announced its Canadian launch of etanercept biosimilar Rymti®, biosimilar to Amgen's Enbrel®, with a full indication set. Rymti® is supplied in a pre-filled pen and syringe and is Lupin's first...

Amgen Initiates Ph 3 Study for Pembrolizumab Biosimilar

May 2, 2024

On 2 May 2024, Amgen revealed that it initiated a Phase 3 study to compare the efficacy, pharmacokinetics, safety and immunogenicity of its pembrolizumab biosimilar, ABP 234, with Keytruda® in patients with advanced or metastatic non-squamous non-small cell lung...

Celltrion Wins Bid to Supply Remsima®, Infliximab Biosimilar, and Herzuma®, Trastuzumab Biosimilar, in Peru

May 2, 2024

On 2 May 2024, Celltrion announced that it has won a 12 month tender to supply Remsima®, biosimilar to Janssen’s Remicade® (infliximab) and Herzuma®, biosimilar to Roche’s Herceptin® (trastuzumab), in Peru. Celltrion expects to capture 86% of Peru’s infliximab market...

J&J Indication Expansion for Tremfya® (guselkumab)

May 1, 2024

On 01 May 2024, Johnson & Johnson announced that it submitted applications to the European Medicines Agency (EMA) to expand the Marketing Authorisation for Tremfya® (guselkumab) to include the treatment of adult patients with moderately to severely active...

Phase 3 Supports MSD’s Keytruda® Combo for Gastric Cancer

May 1, 2024

On 1 May 2024, MSD announced that the final analysis of the Phase 3 KEYNOTE-811 clinical trial (sponsored by MSD) demonstrated that Keytruda® (pembrolizumab), in combination with trastuzumab and chemotherapy, provided gastric cancer patients with a statistically...