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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
UK pharma major AstraZeneca today released positive high-level results from the CAPItello-281 Phase III trial showing that its Truqap (capivasertib) in combination with abiraterone and androgen deprivation therapy (ADT). 25 November 2024
Biotechnology
Research news last week included US biotech releasing early data for its FT819 in the treatment of systemic lupus erythematosus (SLE), which sent the firm’s shares leaping as much as 70%. Also, Netherlands-based NewAmsterdam Pharma announced positive data on its obicetrapib and ezetimibe combination in cardiovascular disease. On the regulatory front, Dutch firm argenX and China’s Zai Lab gained approval from the Chinese medicines regulator for their Vyvgart Hytrulo in chronic inflammatory demyelinating polyneuropathy (CIDP) care. Meantime, USA-based Kura Oncology signed a collaboration with Japan’s Kyowa Kirin on the development of ziftomenib for myeloid leukemia (ALS). 24 November 2024
Biotechnology
US biotech major Gilead Sciences (Nasdaq: GILD), best known for its prowess in antivirals (HIV and hepatitis dugs), yesterday (September 11) revealed that it has submitted a New Drug Application to the US Food and Drug Administration for approval of idelalisib, an investigational, targeted, oral inhibitor of PI3K delta, for the treatment of indolent non-Hodgkin's lymphoma (iNHL). 12 September 2013
Pharmaceutical
Swiss drug major Roche (ROG: SIX) has signed an exclusive, worldwide license agreement with US drug developer Inovio Pharmaceuticals (NYSE MKT: INO) to research, develop and commercialize Inovio's highly-optimized, multi-antigen DNA immunotherapies targeting prostate cancer and hepatitis B. 11 September 2013
Pharmaceutical
Anglo-Swedish drug major AstraZeneca (LSE: AZN) and US pharma giant Merck & Co (NYSE: MRK) this morning revealed that they have entered into a worldwide licensing agreement for Merck's oral small molecule inhibitor of WEE1 kinase (MK-1775). 11 September 2013
Pharmaceutical
In a further collaboration with academia, German pharma and chemical major Bayer (BAYN: DE) has entered into a strategic alliance with the Broad Institute in Cambridge, Massachusetts, USA, in the area of oncogenomics and drug discovery. Financial terms of the accord were not disclosed. 10 September 2013
Biotechnology
US biotech firm Celgene (Nasdaq: CELG) said on Friday (September 6) that the US Food and Drug Administration has approved its supplemental New Drug Application of Abraxane (paclitaxel protein-bound particles for injectable suspension; albumin-bound) as first-line treatment for patients with metastatic adenocarcinoma of the pancreas, in combination with gemcitabine. Adenocarcinoma, a sub-type of exocrine tumors, accounts for about 95% of cancers of the pancreas. 9 September 2013
Biotechnology
Swedish Orphan Biovitrum (STO: SOBI) said this morning that it has acquired the full rights to develop and commercialize Kineret (anakinra) from US biotech giant Amgen (Nasdaq: AMGN) for all therapeutic indications. 9 September 2013
Pharmaceutical
The increasing number of sufferers and the uptake of new drugs will see the prostate cancer market grow from $4.4 billion to $6.6 billion by 2021, according to independent analyst Datamonitor Healthcare, which has revealed that the prostate cancer market is expected to grow by 50% over the next nine years. 6 September 2013
Biotechnology
US biotech major Celgene (Nasdaq: CELG) announced that positive updated results from MM-003, a Phase III multicenter, randomized open-label study (n=455) of pomalidomide (marketed as Pomalyst in the USA and Imnovid in the European Union) plus low-dose dexamethasone, were published on-line ahead of print in The Lancet Oncology. 5 September 2013
Biotechnology
Following heavy speculation on Wednesday (see The Pharma Letter story earlier today), this morning Japanese drugmaker Otsuka (TYO: 4768) confirmed that it plans to acquire USA-based Astex Pharmaceuticals (Nasdaq: ASTX) for $8.50 per share in cash, representing a 48% premium to the average closing stock price for the prior 30 day period. 5 September 2013
Biotechnology
UK pharma giant GlaxoSmithKline (LSE: GSK) and partner US biotech firm Agenus (Nasdaq: AGEN) this morning (September 5) announced that the Phase III DERMA study of investigational MAGE-A3 antigen-specific cancer immunotherapeutic in melanoma did not meet the first co-primary endpoint of significantly extend disease-free survival when compared to placebo in the overall MAGE-A3 positive trial population. GSK's shares drifted 1.7% lower to 1637.68 pence in mid-morning trading. 5 September 2013
Pharmaceutical
German pharma major Bayer (BAYN: DE) said this morning (September 5) that it has submitted an application for marketing authorization to the European Medicines Agency for the oral multi-kinase inhibitor, regorafenib, for the treatment of patients with gastrointestinal stromal tumors (GlST) who have been previously treated with two tyrosine kinase inhibitors. 5 September 2013
Biotechnology
Japanese mid-size drugmaker Otsuka (TYO: 4768) is planning to acquire USA-based Astex Pharmaceuticals (Nasdaq: ASTX) for about 90 billion yen ($912 million) to access the cancer drugs that Astex is developing, according to Japan's Nikkei, but unconfirmed by either party. 5 September 2013
Pharmaceutical
Anglo-Swedish drug major AstraZeneca (LSE: AZN) says it has enrolled the first patient in the Phase III clinical program for olaparib, an innovative oral poly ADP ribose polymerase (PARP) inhibitor being investigated for the treatment of BRCA mutated ovarian cancer, on which the company stopped development a couple of years ago (The Pharma Letter December 21, 2011). 4 September 2013
Pharmaceutical
Privately-held US epigenetics firm Syndax Pharmaceuticals and Eddingpharm, a leading specialty pharmaceutical company in China, have entered into a licensing, development and commercialization agreement that gives Eddingpharm exclusive rights to develop, market and sell entinostat in China and certain other Asian countries/regions. 4 September 2013
Biotechnology
French biotech firm Transgene (Euronext Paris: TNG) has revealed that TRAVERSE, a randomized Phase IIb study of Pexa-Vec (JX-594, pexastimogene devacirepvec) in second-line, advanced liver cancer patients had reached the pre-specified number of events for analysis. 4 September 2013
Pharmaceutical
Janssen Research & Development, a subsidiary of US health care giant Johnson & Johnson (NYSE: JNJ), yesterday (September 3) made simultaneous submissions of a Biologic License Application to the US Food and Drug Administration and a Marketing Authorization Application to the European Medicines Agency for siltuximab for the treatment of patients with multicentric Castleman disease (MCD) who are HIV-negative and human herpes virus-8 (HHV-8)-negative. 4 September 2013
Biotechnology
US biotech firm CytRx Corp (Nasdaq: CYTR) is entering a critical six-month period as aldoxorubicin delivers important clinical milestones, comment analysts at Edison Investment Research. 3 September 2013
Pharmaceutical
UK pharma giant GlaxoSmithKline's (LSE: GSK) Tafinlar (dabrafenib) has been cleared for marketing by the European Medicines Agency as monotherapy for the treatment of adult patients with melanoma that cannot be removed by surgery (unresectable) or that has spread to other parts of the body (metastatic) with a mutated BRAF protein - specifically the BRAF V600 genetic mutation. 2 September 2013
Biotechnology
Swiss pharma major Roche (ROG: SIX) revealed this morning (September 2) that a new injectable (subcutaneous) formulation of Herceptin (trastuzumab) has been approved by the European Commission for the treatment of HER2-positive breast cancer, an aggressive sub-type of the disease. 2 September 2013
Pharmaceutical
In a second piece of good news within a couple of days for German drug major Bayer (BAYN: DE), the European Commission has approved Stivarga (regorafenib) tablets for the treatment of adult patients with metastatic colorectal cancer (mCRC) who have previously been treated with, or are not considered candidates for, available therapies. These include fluoropyrimidine based chemotherapy, an anti VEGF therapy and an anti EGFR therapy. 30 August 2013
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