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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
Generics
The Indian Patent Office has issued the first-ever compulsory licence in India to a generic drug manufacturer. This effectively ends the monopoly in India on the drug Nexavar (sorafenib tosylate) used to treat kidney and liver cancer for German drug major Bayer (BAY: DE). Indian generics firm Natco Pharma (524816: BY) was issued the license under section 84 (1) (b) of the Patents Act. 13 March 2012
Pharmaceutical
USA-based Tranzyme Pharma (Nasdaq: TZYM) and independent drugmaker Norgine of the Netherlands yesterday announced top-line results of the primary analysis of ULISES 007, the first of two Phase III pivotal trials evaluating its bowel cancer drug candidate ulimorelin, noting that it failed to meet its primary and secondary efficacy endpoints. 12 March 2012
Biotechnology
Belgian drugmaker UCB (Euronext Brussels: UCB) and Domainex, a UK-based drug discovery company, have jointly published the results of a collaboration in the field of cancer drug discovery. 12 March 2012
Pharmaceutical
As scientists continue making breakthroughs in personalized cancer treatment, delivering those therapies in the most cost effective manner has become increasingly important. Now researchers at the University of Colorado School of Medicine, USA, have identified new ways of doing just that, allowing more patients to benefit from this revolution in cancer care. 12 March 2012
Biotechnology
Privately-held US biopharma firm Apexigen has entered into a collaboration to grant an exclusive license to Gansu Duyiwei Biological Pharmaceutical (GDBP) to develop and commercialize APX004 in China. 12 March 2012
Pharmaceutical
Janssen Research & Development, a subsidiary of US health care giant Johnson & Johnson (NYSE: JNJ), has unblinded the Phase III study of Zytiga (abiraterone acetate) plus prednisone for the treatment of asymptomatic or mildly symptomatic patients with metastatic castration-resistant prostate cancer (CRPC) who have not received chemotherapy, showing that the combination significantly delayed the growth of prostate cancer and helped patients live longer compared to placebo. 9 March 2012
Pharmaceutical
The US Food and Drug Administration has issued a Complete Response Letter to Japanese drug major Eisai (TYO: 4523) for the supplemental New Drug Application (sNDA) for Dacogen (decitabine) for Injection for patients with acute myeloid leukemia (AML) in adults aged 65 years or older who are not considered candidates for induction therapy. The drug is partnered with US developer Astex Pharmaceuticals (Nasdaq: ASTX). 8 March 2012
Biotechnology
Privately-held Mersana Therapeutics has joined the antibody-drug conjugate space, announcing its first ADC deal with fellow USA-based Endo Pharmaceuticals (Nasdaq: ENDP), in return for an undisclosed upfront payment and a potential of over $270 million in royalties. 8 March 2012
Pharmaceutical
The Pharmaceutical Management Agency of New Zealand, PHARMAC, says it is funding two new targeted cancer medicines following an agreement with UK pharma giant GlaxoSmithKline (LSE: GSK). 5 March 2012
Pharmaceutical
USA-based SciClone Pharmaceuticals (Nasdaq: SCLN) said on Friday that results from a pre-planned interim analysis of the Phase IIb trial of SCV-07 in patients with oral mucositis (OM) indicate that the trial would not meet the pre-specified efficacy endpoints. 5 March 2012
Biotechnology
The share offering last week by Canadian firm biotechnology firm YM BioSciences (TSX: YM), which raised $80.5 million for the company and was the biggest funding raising by a Canadian biotech firm in four years, has significantly boosted its cash balance, and should effectively allow it to fund Phase III development of the JAK1/2 inhibitor CYT387, if needed. The compound was acquired in 2010 along with Australian biotech company Cytopia. 5 March 2012
Pharmaceutical
Never has the pharmaceutical industry made as much progress against cancer as in the past few years, said Birgit Fischer, director general of the German pharma association, the VFA. There are 13 new drugs currently awaiting approval or about to be introduced to the market. Pharma devotes a third of its research to cancer, noted Ms Fischer, and it is paying off. 1 March 2012
Pharmaceutical
Clinicians treating patients with nasopharyngeal cancer may have to wait for the scientific breakthrough they seek, as university-funded research on unique treatments may fail to offer a fast alternative, a new report by pharmaceutical market experts GlobalData has found. 1 March 2012
Biotechnology
Japanese drugmaker Dainippon Sumitomo Pharma (4506: JP) says it has reached an agreement for the acquisition of privately-held US biotech firm Boston Biomedical Inc, headquartered in Norwood, Massachusetts. 1 March 2012
Pharmaceutical
Bristol-Myers Squibb has forged a partnership with Duke University in the USA that will see the
academic institution work more closely with the company on a broad range of drug development
projects. 29 February 2012
Pharmaceutical
USA-based specialist in supportive care for cancer patients Access Pharmaceuticals (OTCBB: ACCP) revealed on Friday that its partner in China, Rhei Pharmaceuticals, has received regulatory and marketing approval for MuGard from the Chinese State Food and Drug Administration (SFDA), to treat oral mucositis in cancer patients. 26 February 2012
Pharmaceutical
Tennessee, USA-based GTx (Nasdaq: GTXI) saw its shares plunge 30% to $3.98 earlier this week, after the company revealed that US Food and Drug Administration had notified it via a telephone call on Friday (February 17), that the agency has placed a clinical hold on the firm's clinical trials evaluating Capesaris (GTx-758) for primary (first line) androgen deprivation therapy for advanced prostate cancer and secondary (second line) hormonal treatment. 24 February 2012
Pharmaceutical
Investigators from Vanderbilt-Ingram Cancer Center (VICC) and 12 other centers in the USA and Australia have found that a new drug for patients with metastatic melanoma nearly doubled median overall survival. 23 February 2012
Generics
The US Food and Drug Administration this week spelt out a series of steps to increase the supply of critically needed cancer drugs and build on President Obama's Executive Order to help prevent future drug shortages, a situation which has been exacerbated by the temporary closure of Ben Venue Laboratories due to manufacturing issues. 22 February 2012
Pharmaceutical
Swiss drug major Roche (ROG: SIX) says that the European Commission has approved Zelboraf (vemurafenib) as a monotherapy for the treatment of adult patients with BRAF V600 mutation-positive unresectable or metastatic melanoma, the most aggressive form of skin cancer. Zelboraf is designed to target and inhibit mutated forms of the BRAF protein found in about half of all cases of melanoma. 21 February 2012
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