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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
Pharmaceutical
In a second research disappointment within a matter of days, US drugs behemoth Pfizer (NYSE: PFE) revealed on Friday that the Phase III INTORACT trial (B1771006) evaluating its Torisel (temsirolimus) in combination with Roche's Avastin (bevacizumab) compared with bevacizumab plus interferon-alfa-2a (IFN--2a) in the first-line treatment of patients with advanced renal cell carcinoma (RCC) across risk groups, did not meet its primary endpoint of superiority in extending progression free survival (PFS) in the study population. 13 August 2012
Pharmaceutical
Swiss drug major Roche (ROG: SIX) announced on Friday that the Phase III AVAglio study of its blockbuster cancer drug Avastin (bevacizumab) plus radiation and temozolomide chemotherapy in people with newly diagnosed glioblastoma met its co-primary endpoint of a significant improvement in progression-free survival (PFS). 13 August 2012
Generics
US injectable drugs and infusion specialist Hospira (NYSE: HSP) last week announced the US re-launch of oxaliplatin injection, its generic version of French drug major Sanofi's (Euronext: SAN) anticancer drug Eloxatin, US sales of which were around $1.5 billion last year. 12 August 2012
Biotechnology
There was bad news not just for US biotech giant Amgen (Nasdaq: AMGN), which last week announced that, on the advice of an independent data monitoring board, the company will discontinue development of the investigational pancreatic cancer ganitumab (The Pharma Letter August 9). 12 August 2012
Pharmaceutical
California, USA-based Talon Therapeutics (OTCBB: TLON) yesterday gained accelerated approval from the Food and Drug Administration for its Marqibo (vinCRIStine sulfate LIPOSOME injection) for the treatment of adult patients with Philadelphia chromosome negative (Ph-) acute lymphoblastic leukemia (ALL) in second or greater relapse or whose disease has progressed following two or more anti-leukemia therapies. 10 August 2012
Pharmaceutical
UK health care watchdog the National Institute for Health and Clinical Excellence (NICE) today (August 10) issued draft guidance requesting Swiss drug major Roche (ROG: SIX), the manufacturer of skin cancer drug Zelboraf (vemurafenib) provides further information on the use of its drug for the treatment of unresectable locally advanced or metastatic BRAF V600 mutation-positive melanoma. 10 August 2012
Pharmaceutical
UK pharma giant GlaxoSmithKline (LSE: GSK) says that the European Medicines Agency has approved Votrient (pazopanib) for the treatment of adult patients with selective subtypes of advanced STS who have received prior chemotherapy for metastatic disease or who have progressed within 12 months after (neo) adjuvant therapy. 9 August 2012
Pharmaceutical
Germany and USA-based drug discover Agennix (FSE: AGX) saw its shares plummet 74% to 0.49 euros after reporting disappointing results from a Phase III trials with its investigational non-small cell lung cancer (NSCLC) drug talactoferrin alfa, calling into question the company's future, according to analysts at EP Vantage, a unit of EvaluatePharma. 9 August 2012
Biotechnology
USA-based Amgen (Nasdaq: AMGN), the world's largest independent biotech firm, late yesterday revealed its decision to stop the ganitumab (AMG 479) Phase III GAMMA (Gemcitabine and AMG 479 in Metastatic Adenocarcinoma of the Pancreas) trial following the recommendation of an independent Data Monitoring Committee (DMC) overseeing the trial. 9 August 2012
Biotechnology
US cancer drug developer MEI Pharma (Nasdaq: MEIP) has entered into a definitive asset purchase agreement with Singapore's privately-held biotech firm S*BIO Pte to acquire the latter's exclusive worldwide rights to pracinostat, an investigational, potential best-in-class, oral histone deacetylase (HDAC) inhibitor. 8 August 2012
Pharmaceutical
In yet another Pharma move to link up with academia, Swiss drug major Novartis (NOVN: VX) this week announced it has entered into an exclusive global collaboration with the University of Pennsylvania (Penn) to research, develop and commercialize targeted chimeric antigen receptor (CAR) immunotherapies for the treatment of cancers. 8 August 2012
Biotechnology
French nano-medicines group Nanobiotix has entered into a strategic partnership with PharmaEngine (TWO: 4162) of Taiwan for the rapid development of NBTXR3, the lead product from the NanoXray pipeline of Nanobiotix. 8 August 2012
Pharmaceutical
The US Food and Drug Administration has assigned a Prescription Drug User Fee Act (PDUFA) action date of November 22, 2012, for the review of the investigational agent enzalutamide (formerly MDV3100) New Drug Application for the potential treatment of men with castration-resistant prostate cancer previously treated with docetaxel-based chemotherapy. 7 August 2012
Pharmaceutical
UK pharma giant GlaxoSmithKline (LSE: GSK) last week submitted regulatory filings in the European Union and USA related to single-agent use of its BRAF inhibitor dabrafenib and MEK inhibitor trametinib to treat patients with BRAF V600 mutation positive metastatic melanoma. Specifically, the company has filed: 7 August 2012
Biotechnology
Shares of Israel's Pluristem Therapeutics (TASE: PLTR), a leading developer of placenta-based cell therapies, soared 22% to $4.04 on Monday after the biotech company announced that the life of a patient suffering from bone marrow failure in which there was a dangerous reduction in the number of red blood cells, white blood cells, and platelets (pancytopenia) has been saved using Placental eXpanded (PLX) cells. 6 August 2012
Pharmaceutical
The US Food and Drug Administration on Friday approved French drug major Sanofi (Euronext: SAN) and US partner Regeneron Pharmaceuticals' (Nasdaq: REGN) Zaltrap (ziv-aflibercept) injection for intravenous infusion, in combination with 5-fluorouracil, leucovorin, irinotecan (FOLFIRI), for patients with metastatic colorectal cancer (mCRC) that is resistant to or has progressed following an oxaliplatin-containing regimen. 6 August 2012
Pharmaceutical
California, USA-based Pharmacyclics (Nasdaq: PCYC) says it that enrolment of the fifth patient in the international Phase III randomized, multicenter, open-label clinical trial, RESONATE (PCYC-1112), of ibrutinib versus ofatumumab for patients with relapsed or refractory chronic lymphocytic leukemia has triggered a $50 million milestone payment from partner Janssen Pharmaceuticals, part of US health care giant Johnson & Johnson (NYSE: JNJ). 3 August 2012
Pharmaceutical
Postmenopausal women with the most common type of metastatic breast cancer now have a new treatment option that lengthens their lives, according a study led by UC Irvine oncologist Rita Mehta and conducted by the Southwest Oncology Group. The findings appear in the August 2 issue of the New England Journal of Medicine. 2 August 2012
Biotechnology
US biotech firm Cell Therapeutics (Nasdaq: CTIC) yesterday reported second-quarter 2012 financial results and recent accomplishments, including plans for the launch of its Pixuvri (pixantrone) in Europe during the fourth quarter of this year. 1 August 2012
Pharmaceutical
US health care major Abbott Laboratories (NYSE: ABT) today announced that the European Commission (EC) has approved Humira (adalimumab) for the treatment of adults with severe axial spondyloarthritis (axSpA) who have no X-ray evidence of structural damage. 30 July 2012
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