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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
In ongoing news from the American Society of Hematology (ASH) meeting taking place in San Diego, Swiss drug major Novartis (NOVN: VX) reported results from the pivotal THALASSA study showing that Exjade (deferasirox) can significantly reduce liver iron concentrations in patients with non-transfusion-dependent thalassemia compared to placebo (p<0.001). Regulatory submissions based on these findings are planned by end of 2011. 14 December 2011
Pharmaceutical
There was mixed news this morning from the UK's National Institute for Health and Clinical Excellence (NICE), when the agency published final guidance on AstraZeneca's (LSE: AZN) breast cancer drug Faslodex (fulvestrant) and Roche's (ROG; SIX) RoActemra (tocilizumab) in young children. 14 December 2011
Pharmaceutical
In continuing news from the 53rd annual meeting of the American Society of Hematology (ASH) in San Diego, data from two Phase III clinical trial were presented by Swiss drug major Novartis (NOVN: VX) which contribute to the growing evidence that adult patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase who are treated with the company's Tasigna (nilotinib) have deeper levels of response compared to those treated with Gleevec (imatinib mesylate) tablets. 13 December 2011
Pharmaceutical
US drugmaker Onyx Pharmaceuticals (Nasdaq: ONXX) saw its shares fall 7.1% to $37.76 in early trading yesterday, though closed the day just 4% lower at $39, after the company revealed that the US Food and Drug Administration has refused its application for accelerated review of its cancer drug candidate carfilzomib, which it made in the fall (The Pharma Letter September 29). 13 December 2011
Biotechnology
Among presentations at this year's Annual Meeting of the American Society of Hematology (ASH), held December 10-13, in San Diego, Canada-based AEterna Zentaris (TSX: AEZ) reported encouraging preclinical data for its oral anticancer Akt inhibitor, perifosine, in Hodgkin Lymphoma. In vitro data from Hodgkin lymphoma (HL) cell lines showed that perifosine combined with sorafenib induced increased apoptosis, while in vivo data for the same combination treatment for HL significantly increased survival in mice. 13 December 2011
Pharmaceutical
For years, science has generally considered the phosphorylation of proteins - the insertion of a phosphorous group into a protein that turns it on or off - as perhaps the factor regulating a range of cellular processes from cell metabolism to programmed cell death, comments EurekAlert. 12 December 2011
Pharmaceutical
In further news from the the San Antonio Breast Cancer Symposium (SABCS) that took place in Texas, USA (see also The Pharma Letter December 9), UK pharma giant GlaxoSmithKline (LSE: GSK) presented Phase III trial data showing that Tykerb (lapatinib), currently approved for the treatment of advanced or metastatic breast cancer, in the delayed adjuvant setting in women with HER2 positive breast cancer failed to significantly improve disease-free survival (DFS) compared to placebo. 12 December 2011
Pharmaceutical
The renal cell carcinoma drug market will experience robust 3.7% annual growth from 2010 to 2020 in the leading markets of the USA, France, Germany, Italy, Spain, the UK and Japan, according to health care advisory firm Decision Resources. Market growth will be driven mainly by the uptake of GlaxoSmithKline's Votrient (pazopanib, the launches of premium-priced emerging therapies, rising treatment rates and an increase in the number of diagnosed patients. 11 December 2011
Pharmaceutical
US health care giant Johnson & Johnson (NYSE: JNJ), through its subsidiary Janssen Biotech, has executed an agreement with fellow USA-based Pharmacyclics (Nasdaq: PCYC) to jointly develop and market the anti-cancer compound, PCI-32765. 9 December 2011
Pharmaceutical
Global drugs behemoth Pfizer (NYSE: PFE) says that the U.S. Food and Drug Administration's Oncologic Drugs Advisory Committee (ODAC) voted unanimously 13 to 0 that data for the investigational oral agent axitinib (proposed trade name Inlyta) support a favorable benefit/risk profile for the treatment of patients with advanced renal cell carcinoma (RCC) after failure of a first-line systemic therapy. 9 December 2011
Pharmaceutical
The US Food and Drug Administration's Oncologic Drugs Advisory Committee (ODAC) voted 15 to one, with one abstention, that peginesatide (formerly known as Hematide), demonstrated a favorable benefit/risk profile for use in the treatment of dialysis patients with anemia due to chronic kidney disease (CKD). The drug's sponsor is US drugmaker Affymax (Nasdaq: AFFY) which has as its partner Takeda Pharmaceutical (TSE:4502), Japan's largest pharma firm. The news pushed Affymax shares 30.5% higher to $7.65. 9 December 2011
Pharmaceutical
This year's CTRC-AACR San Antonio Breast Cancer Symposium (SABCS) in Texas, USA, heard of developments from several companies, including Generex, Novartis and Roche, presenting new data on existing and investigational treatments for breast cancer. 9 December 2011
Biotechnology
US pharma company Dendreon (Nasdaq: DNDN) says that it has agreed to sell for $125 million in cash its royalty interest related to intellectual property licensed to Schering-Plough, now merged into drug giant Merck & Co (NYSE: MRK) and associated with Victrelis (boceprevir), a treatment for chronic hepatitis C. 8 December 2011
Pharmaceutical
UK health care firm BTG (LSE: BGC) says that it has licensed the Japanese rights to glucarpidase (which carries the trade name Voraxaze) to Japan's Ohara Pharmaceutical. Under the terms of the license agreement BTG will also supply glucarpidase to Ohara. 7 December 2011
Pharmaceutical
More than 160,000 patients will benefit directly from changes to Australia's Pharmaceutical Benefits Scheme (PBS) from this month, including people being treated for cancer, HIV and chronic obstructive pulmonary disease, the government has announced. 7 December 2011
Generics
Despite the arrival of generic competition ' and ensuing sales erosion for several key agents used in the management of the disease, the non-small-cell lung cancer (NSCLC) drug market will increase 2.5% annually between 2010 and 2020, although growth will be generated exclusively in Europe and Japan, says advisory firm Decision Resources. 6 December 2011
Pharmaceutical
In new draft guidance, the UK drug watchdog the National Institute for Health and Clinical Excellence (NICE) has recommended Tasigna (nilotinib) and Glivec (imatinib) both made by Swiss drug major Novartis' (NOVN: VX) for the first line treatment of CML (chronic myeloid leukemia) in the National Health Service. However, the NICE has not recommended Sprycel (dasatinib) from US drugmaker Bristol-Myers Squibb (NYSE: BMY). 6 December 2011
Pharmaceutical
USA-based XenoPort (Nasdaq: XNPT) saw its shares rise 3% to $4.73 on Friday, when the company said it has received confirmation from its partner, Astellas Pharma (TYO: 4503) that, following a meeting that day in Japan, the drug evaluation committee of the Japanese Ministry of Health, Labor and Welfare (MHLW) recommended approval of gabapentin enacarbil, which will be known by the trade name Regnite in Japan, for the treatment of Restless Legs Syndrome. 5 December 2011
Biotechnology
A drug discovery team at Genentech, a subsidiary of Swiss drug major Roche (ROG: SIX) has uncovered a chink in the molecular armor of Ras, the most commonly occurring oncogene, which is a gene that when mutated has the potential of causing cancer in humans, reports the science news service EurekAlert. 4 December 2011
Pharmaceutical
USA-based Idera Pharmaceuticals (Nasdaq: IDRA) revealed yesterday that it has regained global rights to IMO-2055, an agonist of Toll-like Receptor (TLR) 9, as part of an agreed-upon termination of its oncology collaboration with Germany's Merck KGaA (MRK: DE), which started back in 2007. 1 December 2011
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