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Biotechnology
Indian drugmaker Dr Reddy’s Laboratories has launched its toripalimab in the domestic market, sending the firm’s share up 2%. Toripalimab is a New Biological Entity (NBE), the company noted. 29 November 2024
Pharmaceutical
Germany’s Evotec has said its chief operating officer Craig Johnstone will leave the business at the end of the year. 29 November 2024
Biotechnology
During the Belgian Economic Mission to Brazil, a historic Memorandum of Understanding (MoU) was signed between the Brazilian Oswaldo Cruz Foundation (Fiocruz) through its Institute of Technology on Immunobiologicals (Bio-Manguinhos), and the Belgian companies Quantoom Biosciences and Univercells. 29 November 2024
Pharmaceutical
A new indication for olverembatinib, developed by Suzhou-based Ascentage Pharma will be added to China’s National Reimbursement Drug List (NRDL) from next year. 28 November 2024
Biotechnology
The US Food and Drug Administration has received new reports of hematologic malignancies, including life-threatening cases of myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML), following treatment of early, active cerebral adrenoleukodystrophy (CALD) patients with Skysona (elivaldogene autotemcel). 28 November 2024
Biotechnology
Kronos Bio, a biotech with a presence on the east and west coasts of the USA, has unveiled a major restructuring plan. 28 November 2024
Biotechnology
Johnson & Johnson has made significant strides in multiple myeloma treatment, with breakthroughs in targeted therapies like CAR-T and bispecific antibodies. At the 2024 ASH meeting, J&J aims to showcase progress, with a goal of achieving a functional cure for multiple myeloma. 28 November 2024
Biotechnology
After trading closed yesterday, Exelixis revealed that the US Food and Drug Administration (FDA) has notified the company that the supplemental New Drug Application (sNDA) for cabozantinib (Cabometyx) for the treatment of adults with previously treated advanced pancreatic neuroendocrine tumors (pNET) and advanced extra-pancreatic NET (epNET) will be discussed at an Oncologic Drugs Advisory Committee (ODAC) meeting in March 2025. 27 November 2024
Pharmaceutical
Novartis announced today that the European Commission (EC) has approved Kisqali (ribociclib) in combination with an aromatase inhibitor (AI) for the adjuvant treatment of patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative early breast cancer (EBC) at high risk of recurrence. 27 November 2024
Biotechnology
Chengdu-based Kelun-Biotech has received marketing authorization in China for sacituzumab tirumotecan (sac-TMT), a Trop2-directed antibody-drug conjugate (ADC). 27 November 2024
Biosimilars
Samsung Bioepis has appointed Kyung-Ah Kim as its new president and chief executive, succeeding Christopher Hansung Ko, who will lead the Samsung Future Business Division. 27 November 2024
Biotechnology
Clinical-stage US CAR-T therapies developer Poseida Therapeutics saw its shares skyrocket 227% to $9.36 pre-market today, on the news of a proposed takeover by Swiss pharma giant Roche. 26 November 2024
Biotechnology
Italian oncology focused biotech Nerviano Medical Sciences yesterday announced that it has successfully negotiated with Germany’s Merck KGaA to buy back the full world-wide rights of NMS 293 (also known as NMS-03305293). 26 November 2024
Biotechnology
The Phase III SKYSCRAPER-01 trial has missed its primary endpoint, Swiss cancer giant Roche has reported. 26 November 2024
Biotechnology
The US Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for belantamab mafodotin in combinations with bortezomib plus dexamethasone (BorDex [BVd]) and pomalidomide plus dexamethasone (PomDex [BPd]) for multiple myeloma patients who have received at least one prior line of therapy. 25 November 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has approved Imkeldi (imatinib) oral solution, the first oral liquid form of imatinib to treat certain forms of leukemia and other cancers, from privately-held US-Ireland-based pharmaceutical company Shorla Oncology. 25 November 2024
Biotechnology
Danish biotech Adcendo today announced the successful closing of an oversubscribed $135 million Series B financing round. 25 November 2024
Generics
Sino-American oncology company BeOne Medicines, until now known as BeiGene, has entered into a settlement agreement with MSN Pharmaceuticals and MSN Laboratories Private resolving patent litigation related to MSN’s Abbreviated New Drug Application (ANDA) seeking approval to market a generic version of Brukinsa (zanubrutinib) in the USA. 25 November 2024
Pharmaceutical
UK pharma major AstraZeneca today released positive high-level results from the CAPItello-281 Phase III trial showing that its Truqap (capivasertib) in combination with abiraterone and androgen deprivation therapy (ADT). 25 November 2024
Biotechnology
Research news last week included US biotech releasing early data for its FT819 in the treatment of systemic lupus erythematosus (SLE), which sent the firm’s shares leaping as much as 70%. Also, Netherlands-based NewAmsterdam Pharma announced positive data on its obicetrapib and ezetimibe combination in cardiovascular disease. On the regulatory front, Dutch firm argenX and China’s Zai Lab gained approval from the Chinese medicines regulator for their Vyvgart Hytrulo in chronic inflammatory demyelinating polyneuropathy (CIDP) care. Meantime, USA-based Kura Oncology signed a collaboration with Japan’s Kyowa Kirin on the development of ziftomenib for myeloid leukemia (ALS). 24 November 2024
Biotechnology
US drug developer Inovio Pharmaceuticals has demonstrated the success of its new DNA plasmid technology in generating therapeutic monoclonal antibodies. 25 September 2013
Pharmaceutical
From today HER2-positive breast cancer patients in the UK could benefit from a faster, more efficient delivery method of Herceptin. 24 September 2013
Pharmaceutical
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended German drug major Bayer’s (BAYN: DE) radium Ra 223 dichloride (radium-223) for approval with a proposed indication for the treatment of adults with castration-resistant prostate cancer. 20 September 2013
Pharmaceutical
The cancer drug Kadcyla (trastuzumab emtansine) has today received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for the treatment of people with HER2-positive metastatic breast cancer. 20 September 2013
Pharmaceutical
A new survey in the UK has found that four in five adults want the National Health Service to offer levels of access to treatment at least comparable with other countries. 20 September 2013
Pharmaceutical
Swiss drug major Novartis (NOVN: VX) has released an update on its clinical trial program on evaluating the potential for patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) to maintain undetectable levels of disease after stopping drug therapy. 19 September 2013
Biotechnology
Japanese drug major Eisai (TYO: 4523) says that its US research subsidiary H3 Biomedicine has entered into a collaborative agreement with Poland-based biotech firm Selvita (PL: SLV), one of the largest drug discovery companies in Eastern Europe, to create novel anticancer agents. 18 September 2013
Pharmaceutical
The US Food and Drug Administration has approved Treanda (bendamustine HCI) Injection from
Israeli generics giant Teva Pharmaceutical Industries (NYSE: TEVA). 18 September 2013
Pharmaceutical
US biotech firm Dendreon (Nasdaq: DNDN) says that the European Commission has granted marketing authorization for Provenge (autologous peripheral blood mononuclear cells activated with PAP-GM-CSF or sipuleucel-T) for the treatment of prostate cancer. 18 September 2013
Generics
The US Food and Drug Administration approved the first generic version of Swiss drug major Roche's (ROG: SIX) blockbuster Xeloda... 17 September 2013
Pharmaceutical
German pharma major Boehringer Ingelheim has gained Breakthrough Therapy Designation from the US Food and Drug Administration for its investigational leukemia agent volasertib. 17 September 2013
Biotechnology
UK pharma giant GlaxoSmithKline (LSE: GSK) has announced positive news relating to three of its drugs, Tafinlar (dabrafenib), Mekinist (trametinib) and Arzerra (ofatumumab) over the past few days in terms of the products US regulatory process. 16 September 2013
Pharmaceutical
Eisai EMEA (Europe, Middle East, Africa, Russia and Oceania), a division of Japanese drug major Eisai (TYO: 4523) has opened a new business operation in Belgium. 16 September 2013
Biotechnology
A pair of studies by researchers at the Stanford University School of Medicine has identified a molecular pathway - a series of interaction among proteins - involved in the development of diabetes. Furthermore, they have found that a drug already approved for use in humans can regulate the pathway. The findings were published on-line September 15 in two articles in Nature Medicine and reported by EurekAlert. 16 September 2013
Pharmaceutical
Japanese drugmaker Chugai Pharmaceutical (TYO: 4519) has launched the anti-cancer agent Perjeta (pertuzumab) for the indication of HER2-positive inoperable or recurrent breast cancer. 13 September 2013
Biotechnology
Biotech firm Valneva (Euronext: VLA), the company recently created through the merger of France's Vivalis and Austria's Intercell (The Pharma Letter May 14), has signed an agreement with German biopharmaceutical company Delta-Vir GmbH, for the production of Newcastle disease virus, which is a component of its novel cancer therapy vaccine, in Valneva's EB66 production cell line. 13 September 2013
Biotechnology
The US Food and Drug Administration's Oncologic Drugs Advisory Committee (ODAC) yesterday (September 13) voted 13 to 0, with one abstention, in favor of recommending accelerated approval of Swiss drug major Roche (ROG: SIX) subsidiary Genentech's Perjeta (pertuzumab) for neoadjuvant treatment (use before surgery) in people with high-risk, HER2-positive early stage breast cancer. 13 September 2013
Pharmaceutical
Japanese drug major Eisai (TYO: 4523) said this morning (September 12) that Halaven (eribulin) is now available in Russia as a novel treatment for patients with metastatic breast cancer who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease. 12 September 2013
Pharmaceutical
US drug major Bristol-Myers Squibb (NYSE: BMY) has released disappointing results from its Phase III trial of Yervoy (ipilimumab) in previously-treated castration-resistant prostate cancer. 12 September 2013
Biotechnology
Belgium-based preclinical stage biotech firm arGEN-X has generated potent antibody antagonists of Nav1.7 using its proprietary SIMPLE Antibody technology. 12 September 2013
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