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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
Janssen Research & Development, a subsidiary of US drugs giant Johnson & Johnson (NYSE: JNJ), has submitted a supplemental New Drug Application to the US Food and Drug Administration for its prostate cancer drug Zytiga (abiraterone acetate) for an additional indication. Simultaneously, J&J unit Janssen-Cilag International NV has filed a type II variation to the European Medicines Agency for the drug. 18 June 2012
Pharmaceutical
UK drugs watchdog the National Institute for Health and Clinical Excellence (NICE) has issued draft guidance which does not recommend the use of Swiss drug major Roche's (ROG: SIX) Zelboraf (vemurafenib) for the treatment of unresectable locally advanced or metastatic BRAF V600 mutation-positive melanoma on the National Health Service. 15 June 2012
Pharmaceutical
USA based Millennium, a wholly owned oncology subsidiary of Takeda Pharmaceutical (TYO: 4502), yesterday announced updated survival data from a pivotal Phase II clinical trial of single-agent Adcetris (brentuximab vedotin) in patients with relapsed or refractory Hodgkin lymphoma (HL) after autologous stem cell transplant (ASCT) showing that the median overall survival has not been reached after a 26.5 month median follow-up. 15 June 2012
Pharmaceutical
US biopharmaceutical company Immunomedics (Nasdaq: IMMU) has reported initial clinical experience with a combination of epratuzumab, the Company's humanized anti-CD22 antibody, labeled with the radioisotope, yttrium-90 (90Y), and veltuzumab, the company's humanized anti-CD20 antibody, in patients with relapsed aggressive non-Hodgkin lymphoma (NHL). 13 June 2012
Biotechnology
Following Food and Drug Administration approval of a new cancer medicine, it often takes years of additional research to fully understand the value of the medicine to patients, according to "Recognizing Value in Oncology Innovation," a new paper released by the Boston Healthcare Associates that was commissioned by Pharmaceutical Research and Manufacturers of America (PhRMA). 13 June 2012
Pharmaceutical
A new study by University of Kentucky, USA, researchers shows how light and strained ruthenium-based drugs may be more effective at fighting cancer cells and less toxic to healthy cells than a similar and widely used drug. 12 June 2012
Biotechnology
UK drugs watchdog the National Institute for Health and Clinical Excellence (NICE) today launched a second consultation on US biotech giant Amgen's (Nasdaq: AMGN) Xgeva (denosumab), citing changes to draft recommendations concerning the drug as a treatment to prevent skeletal-related events in cancer patients whose disease has spread from a solid tumor site (eg, breast, prostate or lung) to their bones. 12 June 2012
Biotechnology
The US Food and Drug Administration on Friday approved Swiss drug major Roche (ROG: SIX) subsidiary Genentech's Perjeta (pertuzumab). Perjeta is cleared for marketing in combination with Herceptin (trastuzumab) and docetaxel chemotherapy for the treatment of people with HER2-positive metastatic breast cancer (mBC) who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease. 11 June 2012
Generics
Branded drugs for the treatment of non-small cell lung cancer (NSCLC) in Indonesia cost almost three times as much as generic drugs. Their high prices are expected to compensate manufacturers for the decline in sales volumes, as generics are the first line therapy and often the only form of drug treatment for NSCLC in Indonesia. 8 June 2012
Pharmaceutical
The annual American Society of Clinical Oncology (ASCO) meeting, held this year in Chicago from June 1-5, consistently features heavily hyped presentations on the next great cancer drug, comment analysts at business intelligence provider GlobalData. 7 June 2012
Biotechnology
With the aim of capitalizing on the batch of patent expires for blockbuster biotechnology-based drugs (worth some 40% of global biologics sales of $63 billion), German pharma major Merck KGaA (MRK: DE) and India's second largest drug company Dr Reddy's Laboratories (NYSE: RDY) have entered into a partnership to co-develop a portfolio of biosimilar compounds in oncology, primarily focused on monoclonal antibodies (MAbs). The partnership covers co-development, manufacturing and commercialization of the compounds around the globe, with some specific country exceptions. 7 June 2012
Pharmaceutical
UK pharma giant GlaxoSmithKline (LSE: GSK) has signed a cooperation agreement with the government of Kazakhstan, which involves the local production of the company's vaccines and drugs in this former Soviet state. 6 June 2012
Pharmaceutical
US drug giant Merck & Co (NYSE: MRK) has received a complete response letter from the US Food and Drug Administration regarding the New Drug Application for ridaforolimus (proposed trade name Taltorvic), for which Merck obtained an exclusive license from Ariad Pharmaceuticals (Nasdaq: ARIA) for oncology indications, calling for additional clinical data. 6 June 2012
Biotechnology
Belgium-based biopharma company ThromboGenics NV (Euronext Brussels: THR) and co-development partner Sweden's BioInvent International (OMXS: BINV) announced this morning that they will regain global rights to TB-403 from Swiss drug major Roche (ROG: SIX). 5 June 2012
Pharmaceutical
More positive late-stage clinical data continued to roll out at the Annual Meeting of the American Society of Clinical Oncology (ASCO) taking place in Chicago, including some good news for Germany's Bayer (BAYN: DE), USA-based Eli Lilly (NYSE: LLY) and the UK's GlaxoSmithKline (LSE: GSK), adding to cancer drug developments already reported (The Pharma Letter June 4). 5 June 2012
Biotechnology
US biotech firm Onyx Pharmaceuticals (Nasdaq: ONXX) and The University of Texas MD Anderson Cancer Center have announced a non-exclusive research alliance for pre-clinical and clinical research to continue to understand the role that novel experimental therapies, including Onyx' carfilzomib and oprozomib, can play in the potential treatment of multiple myeloma and lymphoma. The term of the agreement extends for two years. Financial terms of the collaboration were not disclosed. 5 June 2012
Biotechnology
US oncologists surveyed by advisory firm Decision Resources indicate that they would prescribe the emerging vaccine rindopepimut - Celldex Therapeutics' CDX-110 - to 36% of their newly diagnosed glioblastoma multiforme (GBM) patients. The vaccine is still undergoing Ph III and Ph II clinical testing. 5 June 2012
Biotechnology
The annual prestigious American Society of Clinical Oncology (ASCO) meeting taking place in Chicago, as usual, saw a plethora of new data on cancer drugs under development by the pharmaceutical and biotechnology industry, some of which are highlighted below. 4 June 2012
Pharmaceutical
Sweden's Orexo AB (STO: ORX) and Scotland-based ProStrakan, a subsidiary of Japanese drugmaker Kyowa Hakko Kirin (TYO: 4151) have reconfigured the commercial rights to the product, Abstral, in various territories worldwide. 4 June 2012
Pharmaceutical
The Pharmaceutical Management Agency of New Zealand, PHARMAC, is seeking feedback on a proposal to: 31 May 2012
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