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Biotechnology
AstraZeneca and Daiichi Sankyo’s breast cancer med Enhertu (trastuzumab deruxtecan) will be included in China’s state-run health insurance scheme from next year, boosting availability at the cost of reduced pricing. 29 November 2024
Biotechnology
Allink Biotherapeutics, a Chinese start-up focused on bispecific antibody and antibody-drug conjugates (ADC), has raised $42 million in a financing round led by Lanchi Ventures. 29 November 2024
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
Biotechnology
US biotech major Amgen (Nasdaq: AMGN) has submitted a supplemental Biologics License Application (sBLA) to the Food and Drug Administration to expand the indication for Xgeva (denosumab) to treat men with castrate-resistant prostate cancer to reduce the risk of developing bone metastases. 29 June 2011
Biotechnology
Cambridge, Massachusetts, USA-based small-molecule therapeutics developer FORMA Therapeutics has entered into an agreement granting Genentech, Swiss drug major Roche's (ROG: SIX) US biotech subsidiary, exclusive worldwide rights to acquire a preclinical small-molecule program against a single undisclosed cancer target. Financial terms were not revealed. 28 June 2011
Biotechnology
US biotech firm Seattle Genetics (Nasdaq: SGEN) says it will receive a $5 million payment under its Adcetris (brentuximab vedotin) collaboration with Millennium, a subsidiary of Japan's largest drugmaker Takeda Pharmaceutical (TSE: 4502). 28 June 2011
Biotechnology
The US Food and Drug Administration on Friday recommended more conservative dosing guidelines for erythropoiesis-stimulating agents (ESAs) when used to treat anemia in patients with chronic kidney disease (CKD) because of the increased risks of cardiovascular events such as stroke, thrombosis and death. 27 June 2011
Generics
Indian drugmakers Lupin Ltd (500257: BY) and Natco Pharma (524816: BY announced yesterday that they have entered into an alliance to jointly commercialize a generic equivalent of UK drug giant GlaxoSmithKline's (LSE: GSK) cancer drug Tykerb (lapatinib ditosylate) tablets. Natco had filed an abbreviated new drug application (ANDA) seeking US FDA's approval for marketing generic equivalent of Tykerb 250 mg tablets. 24 June 2011
Biotechnology
US drugmaker Poniard Pharmaceuticals (Nasdaq: PARD) says it has signing of a definitive merger agreement with Allozyne, a privately held biotechnology company focused on the development of bioconjugated protein therapeutics in a share exchange deal. 24 June 2011
Pharmaceutical
The UK drugs watchdog the National Institute for Health and Clinical Excellence (NICE) has issued final guidance recommending National Health Service use of US pharma giant Merck & Co's (NYSE: MRK) Simponi (golimumab) as an option for treating rheumatoid arthritis in specific circumstances where previous treatments have not worked. 23 June 2011
Pharmaceutical
US health care giant Johnson & Johnson (NYSE: JNJ), together with its pharmaceutical division Janssen Pharmaceutica, has signed an agreement with the Russian Skolkovo Foundation, for the development of innovative Russian pharmaceutics products and the support of Russian startups in the field of medicine. The initial investment fund is estimated to be around $30 million. 23 June 2011
Pharmaceutical
R-Farm, one of Russia's largest drugs' distributors, has reached an agreement with Roche (ROG: SIX) on the production and sales of its blockbuster cancer drug Herceptin (trastuzumab) - which generated sales of 5.43 billion Swiss francs ($6.4 billion) last year for the Swiss drug major - at P-Pharm's Ortat plant, which is located in the city of Kostroma. 23 June 2011
Pharmaceutical
Swiss drug major Roche (ROG: SIX) yesterday reported positive results from a mid-stage trial on vismodegib at the 7th European Association of Dermato-Oncology (EADO) Congress taking place in Nantes, France. 22 June 2011
Pharmaceutical
The European Medicines Agency (EMA) and the US Food and Drug Administration have agreed to accept the first application under their pilot program for the parallel evaluation of marketing authorization applications involving 'quality by design' (QbD). 20 June 2011
Pharmaceutical
In final draft guidance published on Friday, UK drug watchdog the National Institute for Health and Clinical Excellence (NICE) recommends two treatments for multiple myeloma: USA biotech firm Celgene's (Nasdaq: CELG) Thalidomide (thalidomide) and Johnson & Johnson (NYSE: JNJ) subsidiary Janssen-Cilag's Velcade (bortezomib). The NICE issued a positive draft guidance on both drugs earlier this month (The Pharma Letter June 3). 20 June 2011
Pharmaceutical
USA-headquartered Celgene (Nasdaq: CELG) presented strong data from a Phase II study, conducted by investigators from the MD Anderson Cancer Center in Houston, Texas, evaluating the combination regimen of its blockbuster cancer drug Revlimid (lenalidomide) plus Roche's Rituxan (rituximab; R2) in untreated, advanced stage, indolent B-cell non-Hodgkin's lymphomas, at the 11th International Conference on Malignant Lymphoma in Lugano, Switzerland. 19 June 2011
Pharmaceutical
US drugs giant Merck & Co's (NYSE: MRK) Japanese subsidiary has entered into an agreement with local firm Taiho Pharmaceutical, a subsidiary of Otsuka (4768: JP), for vorinostat, an anticancer drug for the treatment of cutaneous T-cell lymphoma (CTLC), which the US firm markets as Zolinza. Financial terms of the accord were not disclosed. 17 June 2011
Pharmaceutical
Bayer HealthCare Pharmaceuticals, a USA-based unit of Germany's Bayer (BAY: DE), has submitted an Investigational New Drug application to the Food and Drug Administration for the Targeted Antibody Payload (TAP) technology-based compound BAY 94-9343, which triggers a $2 million milestone payment to partner ImmunoGen (Nasdaq: IMGN). 16 June 2011
Pharmaceutical
The US Food and Drug Administration has warned that the labeling for drugs used to treat enlarged prostate - 5-alpha reductase inhibitor (5-ARI) class of drugs - is being revised to include new safety information about the increased risk of being diagnosed with a more serious form of prostate cancer (high-grade prostate cancer). 13 June 2011
Pharmaceutical
USA-based Chelsea Therapeutics International's (Nasdaq: CHTP) shares soared 16% to $4.87 early Friday after analysts at Roth Capital tripled their price target of the stock to $18, following positive Phase III data for its neurology drug Northera (droxidopa). Also, shares of Micromet (NasdaqGS: MITI) leapt 14% to $6.05 on good Phase II results for its leukemia drug candidate blinatumomab. 13 June 2011
Biotechnology
US biotech group Seattle Genetics (Nasdaq: SGEN) says it has exercised an option to co-develop a second antibody-drug conjugate (ADC) under the company's existing ADC collaboration with Agensys, which was acquired for $537 million in 2007 by Japanese drug major Astellas Pharma (Tokyo: 4503). 10 June 2011
Pharmaceutical
The oral JAK1/2 inhibitor CYT387 has emerged as Canada-based YM BioSciences' (TSX: YM) lead development project, having been acquired through last year's takeover of the Australian biotech company Cytopia, say analysts at Edison Investment Research. 9 June 2011
Biotechnology
US biotech company Avila Therapeutics announced that it has achieved a significant goal in its $209 million alliance with Clovis Oncology (The Pharma Letter May 26, 2010). Together, the partners have selected a drug candidate to advance into clinical development from their epidermal growth factor receptor (EGFR) mutant‐selective inhibitor (EMSI) alliance. 9 June 2011
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