The US Food and Drug Administration has approved pharma major Eli Lilly’s Cyramza (ramucirumab) as a single-agent treatment for patients with advanced or metastatic gastric cancer or gastroesophageal junction (GEJ) adenocarcinoma with disease progression on or after prior fluoropyrimidine- or platinum-containing chemotherapy. 22 April 2014
US clinical-stage biopharma firm Epizyme announced the achievement of the lead candidate milestone for the third of the three histone methyltransferase (HMT) targets in the company's collaboration with UK pharma giant GlaxoSmithKline and is receiving $4 million in milestone and license payments. 22 April 2014
UK-based small molecule drug discovered Sentinel Oncology has signed a collaboration agreement with the US biotech firm Oncothyreon for the development of Sentinel’s Checkpoint Kinase 1 (Chk1) program. 22 April 2014
Over $17 billion of sales will be at risk in 2018/19 as many of the top performing oncology drugs lose their patent or exclusivity protection, according to Datamonitor Healthcare, and this will grow to more than $32 billion by 2022. 17 April 2014
The US Food and Drug Administration and the European Commission have granted German family-owned drug major Boehringer Ingelheim orphan drug designation for volasertib for the treatment of patients with acute myeloid leukemia. 17 April 2014
The Thomson Reuters Intellectual Property & Science business has released its annual forecast of the leading drugs to watch in 2014, including three potential blockbuster treatments anticipated to attain more than $1 billion in sales through 2019, after entering the marketplace this year. 17 April 2014
British charity Cancer Research UK has joined forces with Anglo-Swedish drug major AstraZeneca and US pharma giant Pfizer to create a pioneering clinical trial for patients with advanced lung cancer. 17 April 2014
The European Medicines Agency says it has been informed that vials of Swiss drug major Roche’s blockbuster cancer drug Herceptin (trastuzumab), thought to have been stolen in Italy, including from hospitals, have been tampered with and re-introduced under false credentials into the supply chain in some countries. 16 April 2014
French orphan drug developer BioAlliance Pharma and Denmark’s Topotarget today announced their intention to merge to create a leading orphan oncology company with a highly complementary pipelines of late-stage products addressing significant unmet medical needs. 16 April 2014
Orphan disease specialist BioAlliance Pharma says that the European Independent Board of Experts (Data Safety and Monitoring Board, DSMB), in charge of the safety profile of the ReLive Phase III trial, has unanimously recommended continuing the study without modification. 15 April 2014
In final draft guidance published today, the UK’s National Institute for Health and Care Excellence (NICE) has recommended Firmagon (degarelix) from privately-held Swiss company Ferring Pharmaceuticals for treating advanced hormone dependent prostate cancer in people with spinal metastases who present with signs or symptoms of spinal cord compression. 15 April 2014
USA-based NeoStem has entered into a definitive agreement to acquire California Stem Cell, an Irvine, California-based stem cell biotechnology company in a stock and potential cash deal. 14 April 2014
Brazilian biotech company Bionovis and Germany’s Merck KGaA have signed an agreement for the development and production of biological medicines in Brazil, according to Brazil Pharma News. 14 April 2014
US biotech firm Dendreon has released positive preliminary data from a long-term analysis of the Phase II STAND study with its prostate cancer drug Provenge (sipuleucel-T). 12 April 2014
Japanese drugmaker Chugai Pharmaceutical has filed a new drug application to the Ministry of Health, Labor and Welfare for oral, selective BRAF kinase inhibitor vemurafenib for the treatment of melanoma with BRAFV600 mutation. 11 April 2014
The UK’s High Court has ruled that two patents on Swiss drug major Roche’s breast cancer drug Herceptin (trastuzumab) were invalid, allowing global speciality pharma company Hospira to launch a generic version. 11 April 2014
The effect of a therapy on overall survival and progression-free survival are attributes that most influence surveyed US and European hematological oncologists' prescribing decisions for relapsed/refractory (R/R) chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). 11 April 2014
The full year report from Anglo-Swedish drug major AstraZeneca (LSE: AZN) in February was full of optimism. The Pharma Letter spoke to Susan Galbraith, senior vice president head of oncology innovative medicines unit, about AstraZeneca’s exciting oncology pipeline. 11 April 2014
French cancer focused drug developer Erytech Pharma has added a new product development candidate, ERY-MET, to its tumor starvation product pipeline. 10 April 2014
US biopharma firm Halozyme Therapeutics says that the US Food and Drug Administration informed the company yesterday that a clinical hold has been placed on patient enrollment and dosing of PEGPH20 in an ongoing Phase II trial (Study 202) evaluating PEGPH20 in patients with pancreatic cancer. 9 April 2014
In what Astella Pharma calls “a landmark decision for advanced bladder cancer patients,” the Japanese drugmaker gained approval in the UK for its treatment regimen. 10 October 2024
Pfizer released positive top line results from the final prespecified overall survival (OS) analysis of the TALAPRO-2 study of Talzenna (talazoparib), an oral poly ADP-ribose polymerase (PARP) inhibitor, in combination with Xtandi (enzalutamide). 10 October 2024
US healthcare giant Johnson & Johnson’s Tecvayli (teclistamab) has been recommended by the National Institute for Health and Care Excellence (NICE) as a first-line option to treat myeloma in England and Wales. 10 October 2024
Cancer start-up Black Diamond Therapeutics has announced a significant restructuring as part of its plan to focus resources on its lead drug, BDTX-1535. 10 October 2024
The European Medicines Agency (EMA) has accepted for review the Marketing Authorization Applications for AVT03, a proposed biosimilar candidate to the Prolia and Xgeva (denosumab), submitted by Germany’s STADA Arzneimittel. 10 October 2024
China’s Quantum Pharmaceuticals has announced a significant licensing agreement between its biologics-focused subsidiary, Ailux Biologics, and Johnson & Johnson. 10 October 2024
Advances in gene editing, such as the FDA approval of Vertex Pharmaceuticals’ Casgevy (exagamglogene autotemcel) in December 2023 for the treatment of beta thalassemia and sickle cell disease, have fueled significant interest in innovative epigenetic drugs. 10 October 2024
German family-owned pharma major Boehringer Ingelheim and USA-based Circle Pharma (have entered into a research collaboration and license agreement with the shared goal to develop a first-in-class cyclin inhibitor that can halt the growth of cancer cells potentially offering hope to those living with hard-to-treat cancers. 9 October 2024
Bayer has entered into a collaboration with MOMA Therapeutics to develop a small molecule oncology program using the latter’s proprietary KNOMATIC platform. 9 October 2024
Genor Biopharma has announced plans for a significant merger with Edding Group, marking one of the first reverse takeovers involving a Hong Kong-listed biopharma company. 8 October 2024
China-headquartered clinical-stage biotech MediLink Therapeutics has announced a global clinical trial collaboration and supply agreement with US major Amgen. 8 October 2024
Germany’s Eckert & Ziegler, a specialist in radioisotopes for medical, scientific and industrial applications, has announced a global clinical supply agreement with GlyTherix, an Australian targeted radiotherapy firm specializing in developing antibody radiopharmaceuticals for solid tumors. 8 October 2024
US clinical-stage biotech OnKure Therapeutics has announced the completion of its previously announced merger with Reneo Pharmaceuticals. 8 October 2024
Daejeon-based Orum Therapeutics, a specialist in degrader-antibody conjugates (DAC), has filed for an initial public offering (IPO) on South Korea's Kosdaq market. 7 October 2024
Mosaic Therapeutics, a UK-based oncology therapeutics company dedicated to resolving cancer’s complexity to power new combination therapies for patients, has announced the appointment of Barry Davies as chief scientific officer. 7 October 2024