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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
Swiss drug major Roche (ROG: SIX) and subsidiary Genentech's Perjeta (pertuzumab), which has been available in the USA for one month has a positive initial perception by medical oncologists, according to the findings of BioTrends Research, a Decision Resources company. Perjeta is a first-in-class HER-dimerization inhibitor that was approved by the US Food and Drug Administration in the summer (The Pharma Letter June 11, 2012. 7 September 2012
Pharmaceutical
Closely-held USA-based ImmuNext has entered into an agreement with Janssen Biotech, a unit of US health care giant Johnson & Johnson (NYSE: JNJ), focused on the development of novel therapeutics that modulate the immune system for the treatment of cancer. 6 September 2012
Biotechnology
At a London investor event this week, Swiss drug major Roche (ROG: SIX) presented an update on its strategy, which continues to be focused on medical innovation and sustainable growth. Through its leadership in personalized health care, Roche says it is uniquely positioned to develop therapies that advance current standards of care and improve people's lives. 6 September 2012
Biotechnology
Privately-held Danish drug developer Symphogen A/S announced this morning that it has signed an exclusive worldwide license agreement with Merck Serono, the pharma unit of Germany's Merck KGaA (MRK: DE), for Sym004, an investigational antibody mixture targeting the epidermal growth factor receptor (EGFR). 6 September 2012
Pharmaceutical
In a third cancer drug approval in just over a year for drugs behemoth Pfizer (NYSE: PFE), the US Food and Drug Administration has approved the company's Bosulif (bosutinib), an Abl and Src kinase inhibitor, for the treatment of adult patients with chronic, accelerated, or blast phase Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML) with resistance, or intolerance to prior therapy. 6 September 2012
Biotechnology
US drug developer EpiCept (Nasdaq: EPCT) says it has received notice of termination, effective as of August 28, 2012, of its license and collaboration agreement with biotech firm Myrexis (Nasdaq: MYRX, previously known as Myriad Pharmaceuticals). Among the compounds that had been licensed to Myrexis under the terminated agreement was EpiCept's anti-cancer drug candidate Azixa (MPC-6827). 6 September 2012
Pharmaceutical
Japanese drug major Dainippon Sumitomo Pharma (TYO: 4506) has submitted an imported drug registration application in China for anticancer antibiotic amrubicin HCI (brand name Calsed in Japan) to China's State Food and Drug Administration, for the treatment of small cell lung cancer. 6 September 2012
Biotechnology
Approval times for new oncology drugs in the USA during the last decade were shorter than those for non-oncology products, while the reverse was the case in the European Union, according to a study recently completed by the Tufts Center for the Study of Drug Development. 5 September 2012
Pharmaceutical
The European Commission yesterday granted marketing authorization for Pfizer's (NYSE: PFE) Inlyta (axitinib) for the treatment of adult patients with advanced renal cell carcinoma (RCC), a type of kidney cancer, after failure of prior treatment with sunitinib (the company's Sutent) or a cytokine. 5 September 2012
Pharmaceutical
The South Korean sales subsidiary of Japanese drug major Eisai (TYO: 4523) has received approval from the regulatory authorities in South Korea to market the anticancer agent Halaven (eribulin mesylate) for the treatment of locally advanced or metastatic breast cancer patients who previously have been treated with at least two prior chemotherapies, including an anthracycline and a taxane. 4 September 2012
Generics
German drug major Bayer (BAYN: DE) yesterday headed to India's Intellectual Property Appellate Board in Chennai in a bid to overturn a compulsory licence which has allowed more affordable generic versions of its cancer drug Nexavar (sorafenib tosylate), to be produced in the interests of public health, said the international humanitarian health organization Medecins Sans Frontieres (MSF) which criticized Bayer for the move. 4 September 2012
Biotechnology
USA-based Medivation (Nasdaq: MDVN and Japanese drug major Astellas Pharma (TYO: 4503) say that the US Food and Drug Administration has granted approval for Xtandi (enzalutamide) capsules for the treatment of patients with metastatic castration-resistant prostate cancer who have previously received docetaxel. 3 September 2012
Biotechnology
Denmark's Genmab A/S (OMX: GEN) saw its shares leap 20% to 81 Danish kroner in morning trading yesterday, after the company announced today a global license and development agreement for daratumumab (HuMax-CD38), a human CD38 monoclonal antibody with Janssen Biotech, part of US health care giant Johnson & Johnson (NYSE: JNJ), worth potentially more than $1.1 billion to the Danish firm. Genmab shares have more than doubled this year, giving the Copenhagen-based company a market value of 3.62 billion kroner, noted Bloomberg. 31 August 2012
Biotechnology
The US subsidiary of Germany's Bayer (BAYB: DE) has submitted a New Drug Application to the US Food and Drug Administration for the oral multi-kinase inhibitor regorafenib for the treatment of metastatic and/or unresectable gastrointestinal stromal tumors (GIST) in patients whose disease has progressed despite prior treatment. 31 August 2012
Pharmaceutical
USA-based Ariad Pharmaceuticals (Nasdaq: ARIA) has filed a Marketing Authorization Application for its investigational BCR-ABL inhibitor, ponatinib, to the European Medicines Agency, seeking approval for use of its drug in adult patients with resistant or intolerant chronic myeloid leukemia (CML) and Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL). 31 August 2012
Biotechnology
The US Food and Drug Administration yesterday approved Swiss drug major Novartis' (NOVN: VX) Afinitor Disperz (everolimus tablets for oral suspension), a new pediatric dosage form of this anti-cancer drug used to treat a rare brain tumor called subependymal giant cell astrocytoma (SEGA). Afinitor Disperz is the first approved pediatric-specific dosage form developed for the treatment of a pediatric tumor. 30 August 2012
Biotechnology
There were two pieces of good news for US health care giant Johnson & Johnson (NYSE: JNJ) subsidiaries yesterday. First, the US Food and Drug Administration has approved Janssen Pharmaceuticals' supplemental New Drug Application (sNDA) for Nucynta ER (tapentadol) extended-release tablets, an oral analgesic taken twice daily, for the management of neuropathic pain associated with diabetic peripheral neuropathy (DPN) in adults when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. 30 August 2012
Pharmaceutical
Danish CNS drug specialist Lundbeck A/S (LUND: DC) says that medicines regulator Health Canada has approved Treanda (bendamustine hydrochloride for injection) to treat patients with relapsed indolent B-cell non-Hodgkin's lymphoma and chronic lymphocytic leukemia, following the success of the brand in both Europe and the USA. 29 August 2012
Biotechnology
Despite the considerable heterogeneity across different European countries, surveyed hematologist-oncologists generally perceive Johnson & Johnson (NYSE: JNJ) subsidiary Janssen's Velcade (bortezomib), Celgene's Thalomid (thalidomide) and dexamethasone (VTD) to be the most preferred regimen in terms of efficacy for the treatment of first-line, autologous stem-cell transplant (ASCT) eligible multiple myeloma patients, according to a new report from BioTrends Research, a Decision Resources unit. 29 August 2012
Pharmaceutical
Swiss drug major Novartis (NOVN: VX) received approval yesterday from the European Commission for Jakavi (INC424, ruxolitinib), a JAK 1 and JAK 2 inhibitor for the treatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis (also known as chronic idiopathic myelofibrosis), post-polycythemia vera myelofibrosis or post-essential thrombocythemia myelofibrosis. This is the first treatment to gain approval in Eurooe for this indication, an uncommon, life-threatening blood cancer. 29 August 2012
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