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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 deal announced today (April 22), Anglo-Swedish drug major AstraZeneca (LSE: AZN) revealed it has joined forces with UK-based provider of research tools to support the development of personalized medicines Horizon Discovery for an exclusive collaboration and license agreement to explore Horizon's first-in-class kinase target program, HD-001, as a means of developing novel therapies for multiple cancer types, adding to the accord with BIND Therapeutics for cancer nanomedicines (The Pharma Letter April 22). 22 April 2013
Pharmaceutical
Anglo-Swedish drug major AstraZeneca and BIND Therapeutics, a US clinical-stage biopharmaceutical, have entered into a strategic collaboration to develop and commercialize an Accurin, a targeted and programmable cancer nanomedicine from BIND's Medicinal Nanoengineering platform, based on a molecularly targeted kinase inhibitor developed and owned by AstraZeneca. 22 April 2013
Biotechnology
French biopharma company Erytech Pharma, a company that designs innovative treatments for acute leukemia and other oncology indications with unmet medical needs, says that the French market regulator, AMF, granted its visa no13-166 on April 17, 2013, for the prospectus relative to the listing of Erytech shares on the NYSE Euronext regulated market in Paris. 21 April 2013
Biotechnology
Chronic Myeloid Leukemia (CML) patients are now able to access more successful treatment, which has led to decreasing mortality rates, and may yet lead to desperately-needed research on the causes of this little-understood disease, states new analysis from research and consulting firm GlobalData. 18 April 2013
Pharmaceutical
The Japanese Supreme Court has upheld high court rulings that the Japanese unit of Anglo-Swedish drug major AstraZeneca (LSE: AZN) carries no liability over fatal side effects caused by the lung cancer drug Iressa (gefitinib), reports the Japan Times and other local media. 17 April 2013
Pharmaceutical
USA-based Merrimack Pharmaceuticals' (Nasdaq: MACK) recent R&D day (The Pharma Letter April 11) highlighted an impressive pipeline of six clinical stage drug candidates assembled largely through its integrated, systems biology-driven drug discovery and development approach, comment analysts at Edison Equity Research. 17 April 2013
Generics
US generics major Actavis (NYSE: ACT, previously trading as Watson) said yesterday (April 16) that it has re-launched Vestura (3mg drospirenone and 0.02mg ethinyl estradiol), a generic version of Germany's Bayer's (BAYN: DE) Yaz oral contraceptive product, following a ruling from the US Court of Appeals for the Federal Circuit that US Patent No RE 37,564 is invalid. The patent expires on June 30, 2014, the ruling said. 17 April 2013
Pharmaceutical
US private equity company Royalty Pharma today (April 15) issued a firm improved takeover offer for Ireland-based drugmaker Elan (NYSE: ELN), following its rejected, unsolicited bid for the company earlier this year, which Elan called opportunistic and overly conditional (The Pharma Letter February 26). 16 April 2013
Biotechnology
New Zealand's Pharmaceutical Management Agency, PHARMAC, is seeking feedback on a proposal to list pegfilgrastim (Neulastim, sold by originator Amgen as Neulasta) for the prevention of neutropenia in patients undergoing cancer chemotherapy, and tocilizumab (Actemra) for systemic juvenile idiopathic arthritis, from July 1, 2013, through a provisional agreement with the local subsidiary of Swiss drug major Roche (ROG: SIX). Comments will be accepted until April 29, 2013. 12 April 2013
Biotechnology
Privately-held Austrian company Activartis has developed a novel patented cancer immunotherapy concept, AV0113, based on dendritic cells (DC). While DCs have already demonstrated their potential in cancer immunotherapy, the novel feature of AV0113 is that exposure to bacterial endotoxins enables the DC to prime type 1 T helper cells, which support cytolytic anti-tumor immune responses. This is comparable to conjugated vaccines, which are a more artificial way to modulate the features of an immune response. 12 April 2013
Pharmaceutical
USA-based Merrimack Pharmaceuticals (Nasdaq: MACK) has announced preclinical study results showing that the novel therapy MM-121 restores tumor sensitivity and delays the onset of resistance to the aromatase inhibitor, letrozole, in an ER+ breast cancer model. The study was presented as part of the American Association for Cancer Research's 2013 Annual Meeting in Washington DC, April 6-10. 11 April 2013
Pharmaceutical
Global pharma behemoth Pfizer (NYSE: PFE) is the latest to gain a "Breakthrough Therapy" designation by the US Food and Drug Administration, this being for the firm's investigational compound palbociclib (PD-0332991) for the potential treatment of patients with breast cancer. 11 April 2013
Biotechnology
There was good news for Swiss drug major Novartis (NOVN: VX) this morning, when UK drugs watchdog the National Institute for Health and Clinical Excellence (NICE) recommended that Lucentis (ranibizumab) be approved for use within the National Health Service in England and Wales to treat people with visual impairment due to macular edema secondary to retinal vein occlusion (RVO). 11 April 2013
Pharmaceutical
Chinese drugmaker Eddingpharm has entered into a collaboration agreement with UK pharma giant GlaxoSmithKline's (LSE: GSK China subsidiary to import, market, promote, distribute and sell Tykerb (lapatinib), a treatment for advanced or metastatic breast cancer that was recently approved by the China State Food and Drug Administration (SFDA). 10 April 2013
Biotechnology
Guidelines for off-label drug use hold immense commercial implications, and stricter controls are needed on medical compendia, given their influence in this field, according to recent analysis by research and consulting firm GlobalData. 10 April 2013
Biotechnology
Canadian drugmaker Resverlogix (TSX:RVX), which is exploring a sale, says that its board of directors has approved a proposal to spin-out its subsidiary, RVX Therapeutics which will focus on innovative drug R&D by leveraging its epigenetics platform. RVX Therapeutics will exclude Apolipoprotein A-1 (Apo A-1) and RVX-208 technologies, rather focusing on multiple therapeutic indications including autoimmune diseases and cancer. 10 April 2013
Pharmaceutical
German drug major Bayer (BAYN: DE) said revealed this morning that it will extend if already successful strategic alliance in the oncology filed with the German Cancer Research Center (DKFZ) into the field of immunotherapy. Immunotherapies are a promising approach to treat cancer with the aim to selectively reactivate the body's own immune system so that it attacks tumor cells, the company said. 10 April 2013
Pharmaceutical
Pharmacyclics (Nasdaq: PCYC) saw its shares gain 4.5% to $78.96 in early trading Monday, after it revealed that the US Food and Drug Administration had granted an additional Breakthrough-Therapy designation for the investigational oral agent ibrutinib, which is under development with Johnson & Johnson (NYSE: JNJ) subsidiary Janssen in a deal that involved $150 million upfront and further potential payments of $825 million. 9 April 2013
Biotechnology
A novel combination of two drugs has shown anti-cancer activity in patients who had incurable solid tumors and carried a germline mutation in their BRCA genes, Dana-Farber Cancer Institute researchers are reporting at the American Association for Cancer Research annual meeting in Washington, April 6-10. 8 April 2013
Pharmaceutical
Millennium, the USA-based oncology unit of Japan's largest drugmaker Takeda Pharmaceutical (TSE:4502), has announced positive data from a meta-analysis of Velcade (bortezomib)-based regimens compared to non- Velcade-based regimens as induction therapy prior to autologous stem cell transplant (ASCT) in patients with previously untreated multiple myeloma (MM). 8 April 2013
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