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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
Canada-based Generex Biotechnology (OTC Bulletin Board: GNBT) last week provided an overview of the current pipeline and potential of its wholly-owned US subsidiary Antigen Express, which a couple of years ago the firm said it planned to spin-out as a separate DTC-eligible Securities and Exchange Commission-registered company valuing the asset at around $300 million (The Pharma Letter April 1, 2011). In September 2012, the parent said that it is proceeding with the previously-announced spinout of Antigen Express. 10 February 2013
Pharmaceutical
Through 2018, five new drugs will launch for the treatment of myelodysplastic syndromes (MDS), three of which are expected to offer much-needed second-line therapeutic options in the hypomethylating agent (HMA)-refractory higher-risk MDS population, according to a new report from health care advisory firm Decision Resources. 10 February 2013
Pharmaceutical
US pharma giant Merck & Co (NYSE: MRK) has received a favorable ruling from the US Court of Appeals for the Federal Circuit (Washington) in its patent dispute with Mylan (Nasdaq: MYL) over its cholesterol lowerers Zetia (ezetimibe) and Vytorin (ezetimibe and simvastatin), according to reports by Bloomberg and Reuters. 8 February 2013
Pharmaceutical
US cancer drug developer Celsion Corp (Nasdaq: CLSN) says that Zhejiang Hisun Pharmaceutical (SSE: 600267) does not plan to pursue the exclusive option to license ThermoDox, a proprietary heat-activated liposomal encapsulation of doxorubicin, for the Greater China market, which had been granted just last month (The Pharma Letter January 24). 7 February 2013
Pharmaceutical
In a second European approval within a matter of days, French drug major Sanofi (Euronext: SAN) said yesterday that the European Commission has granted marketing authorization for Zaltrap (aflibercept) - partnered with the USA's Regeneron (Nasdaq: REGN) - in combination with FOLFIRI chemotherapy in adults with metastatic colorectal cancer (mCRC) that is resistant to or has progressed after an oxaliplatin-containing regimen. This decision was based on the efficacy and safety results of the VELOUR Phase III trial. 6 February 2013
Generics
The US Food and Drug Administration has approved the first generic version of the cancer drug Doxil (doxorubicin hydrochloride liposome injection), from US health care giant Johnson & Johnson's (NYSE: JNJ) Janssen subsidiary. 6 February 2013
Pharmaceutical
Through 2021, the treatment landscape for thyroid carcinoma will change dramatically in the USA and Europe due to the expected approval of several new therapies, according to a new report from health care advisory firm Decision Resources. 5 February 2013
Biotechnology
Aduro BioTech, a privately-held, US venture capital backed biotechnology company, says it has acquired all GVAX assets from US drug developer BioSante Pharmaceuticals (Nasdaq: BPAX), including intellectual property and cell lines. This acquisition substantially expands Aduro's immunotherapy portfolio and strengthens its competitive position in the field. 5 February 2013
Biotechnology
UK pharma giant GlaxoSmithKline (LSE: GSK) has initiated COMBI-AD, a Phase III study evaluating the combination of dabrafenib, its BRAF inhibitor and trametinib, its MEK inhibitor as adjuvant therapy for melanoma in-licensed from Japan Tobacco. 4 February 2013
Biotechnology
The US Food and Drug Administration on Friday approved Hyperion Therapeutics' (Nasdaq: HPTX) Ravicti (glycerol phenylbutyrate) for the chronic management of some urea cycle disorders (UCDs) in patients aged two years and older. 4 February 2013
Biotechnology
Swiss drug major Roche (ROG: SIX) says that the first stage of a Phase III study with its investigational cancer drug obinutuzumab met its primary endpoint and an additional futility analysis suggested that it could show superiority compared to the company's currently marketed MabThera/Rituxan (rituximab) in first line chronic lymphatic leukemia (CLL). 4 February 2013
Biotechnology
US biotech firm Spectrum Pharmaceuticals (NasdaqGS: SPPI) says it has reacquired development and commercialization rights for apaziquone in the USA, Europe and other territories under an agreed-upon restructuring of Spectrum's collaboration with Allergan (NYSE: AGN). In exchange, Allergan will receive a royalty on future revenue. Spectrum shares rose 7.4% to $12.81 in afternoon trading the day of the announcement (last Thursday). 3 February 2013
Biotechnology
USA-based drug developer CEL-SCI Corp (NYSE MKT: CVM) says that its longstanding collaboration with Northeast Ohio Medical University has produced a new investigational breast cancer vaccine which prevents and treats a HER-2/neu expressing breast cancer tumor in a mouse model of the disease. 3 February 2013
Pharmaceutical
UK drugs watchdog the National Institute for Health and Clinical Excellence (NICE) has published draft guidance today (February 1) on the use of Swiss drug major Roche's (ROG: SIX) Avastin (bevacizumab) for treating advanced ovarian cancer that has returned six months or more after initial treatment with platinum-based chemotherapy (platinum-sensitive disease). 1 February 2013
Biotechnology
Israel-based Teva Pharmaceutical Industries (NYSE: TEVA) says that it has terminated its collaboration with CureTech for the development of an experimental cancer. Teva entered into agreements with CureTech in 2006. Teva intends to book a noncash net charge of $109 million as a result of the impairment of its investment in CureTech. 1 February 2013
Biotechnology
Through 2021, the continued uptake of Novartis (NOVN: VX)/Incyte's (Nasdaq: INCY) recently launched JAK-2 inhibitor Jakafi (ruxolitinib) will be the greatest driver of growth in the myelofibrosis therapy market in the USA and Europe, according to a new report from health care advisory firm Decision Resources. 31 January 2013
Pharmaceutical
Swiss firm Vifor Pharma, a subsidiary of the Galenica Group (GALN: SIX), notes the publication of an observational study in routine oncological and hematological settings encompassing anaemic and iron-deficient patients with a wide variety of tumours (420 subjects, efficacy population). 31 January 2013
Generics
Taiwanese drugmaker ScinoPharm (TWSE: 1789) and Foresee Pharmaceuticals, a Delaware, USA-based spin-out from the research division of QPS Holdings), have jointly announced an investment agreement to form a joint venture. 31 January 2013
Biotechnology
Although interviewed oncologists in the USA and Europe would like to see a future of personalized medicine targeting different soft tissue sarcoma subtypes, they believe that it is in fact novel chemotherapies that hold the most near-term promise for improving outcomes in this highly fragmented indication. According to a new report from health care advisory firm Decision Resources. 30 January 2013
Pharmaceutical
Japanese drug major Eisai (TYO: 4523) says it is expanding its operations into South Africa, with the filing of its two products - Halaven (eribulin) for metastatic breast cancer and Fycompa (perampanel) for epilepsy - to The Medicines Control Council (MCC). 30 January 2013
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