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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
Biotechnology
China has been engaging in monoclonal antibody R&D for some time, but still lags far behind European and American countries in terms of industrialization, according to a new report added to the offering of Research and Markets. In 2010, the market for monoclonal antibody drugs in China was worth more than $340 million, while global sales in the same period hit the $44 billion level, the report noted. 10 July 2011
Pharmaceutical
In two clinical disappointments announced yesterday, French drug major Sanofi (Euronext: SAN) and Germany's Merck KGaA (MRK: DE) each pulled the plug on studies due to safety concerns. Sanofi saw its shares dip 1.1% to 55.30 euros. 8 July 2011
Pharmaceutical
UK pharma giant GlaxoSmithKline (LSE: GSK) says that it has submitted a variation to the Marketing Authorisation Application to the European Medicines Agency for Votrient (pazopanib) for the treatment of patients with advanced soft tissue sarcoma who have received prior chemotherapy, or for patients who are unsuited for such therapy. 8 July 2011
Pharmaceutical
Swiss drug major Roche (ROG: SIX) today announced a strategic partnership agreement with the USA's Cancer Prevention and Research Institute of Texas (CPRIT) to accelerate the development of promising oncology-related cancer research projects in Texas. Under the terms of the agreement, CPRIT and Roche will collaborate to identify ventures and technologies from academia and early stage projects in Texas that have the potential to strengthen Roche's R&D portfolio. 8 July 2011
Biotechnology
US drug major Bristol-Myers Squibb (NYSE: BMY) has signed a global agreement with French biotech firm Innate Pharma (Euronext Paris: FR0010331421 IPH) for the development and commercialization of IPH2102, a novel antibody in Phase I development for the treatment of cancer. 7 July 2011
Pharmaceutical
UK specialist health care company BTG (LSE: BGC) has acquired US commercial rights to US privately-held Wellstat Therapeutics's product candidate uridine triacetate for use as a treatment for accidental overexposure to the chemotherapeutic 5-fluorouracil (5-FU). 6 July 2011
Pharmaceutical
As a result of strong Phase III clinical data with its already marketed kidney cancer drug Afinitor (everolimus), Swiss drug major Novartis (NOVN: VX) says it plans to file for worldwide regulatory approval in the added indication of metastatic breast cancer by the end of the year. 6 July 2011
Pharmaceutical
In a trial dubbed EURTAC, the first Phase III study to include Western lung cancer patients first-line treatment with erlotinib, Swiss drug major Roche's (ROG: SIX) blockbuster Tarceva, nearly doubled progression-free survival compared with chemotherapy, according to research presented at the 14th World Conference on Lung Cancer in Amsterdam, Netherlands, hosted by the International Association for the Study of Lung Cancer (IASLC). 6 July 2011
Pharmaceutical
Spain's largest pharmaceutical firm, Almirall (ALM: MC) yesterday announced the German launch of cannabis-based drug Sativex for the treatment of spasticity in multiple sclerosis (MS) and the approval of Actikerall (LAS1005) for the treatment of hyperkeratotic actinic keratosis (grade I/II) in adult patients, which will be launched on July 15. 6 July 2011
Pharmaceutical
French drug major Sanofi (Euronext: SAN) yesterday announced the UK launch of Jevtana (cabazitaxel), in combination with prednisone/prednisolone for the treatment of men with mHRPC previously treated with docetaxel. 5 July 2011
Pharmaceutical
US drug giant Merck & Co (NYSE: MRK) revealed on Friday that the Japanese Ministry of Health, Labor and Welfare (MHLW) had approved three of its products - Gardasil (human papillomavirus quadrivalent [types 6, 11, 16 and 18) Vaccine, Recombinant], Zolinza (vorinostat) and Cubicin (daptomycin for injection) ' for use in Japan, the world's second largest pharmaceutical market. 4 July 2011
Biotechnology
There was a batch of good news for Seattle, USA-based Dendreon (Nasdaq: DNDN) that support broad availability for on-label use of its novel, but expensive ($93,000 therapy cost), prostate cancer treatment Provenge (sipuleucel-T). Also, the Food and Drug Administration approved the company's second manufacturing facility for the product. 4 July 2011
Pharmaceutical
In a draft guidance issued last Friday, the UK's drug watchdog, the National Institute for Health and Clinical Excellence (NICE) said that the clinical and cost effectiveness of two breast cancer drugs that may be offered alongside hormone therapy to some postmenopausal women who have a particular type of the disease has not been clearly demonstrated and therefore recommends .against their use in the National Health Service for this condition. 3 July 2011
Pharmaceutical
AstraZeneca this morning revealed that its blockbuster gastrointestinal drug Nexium (esomeprazole magnesium) 10mg and 20mg capsules has received regulatory approval in Japan for the treatment of acid-related conditions including non-erosive reflux disease (NERD), reflux esophagitis and peptic ulcer disease (PUD). Nexium also received regulatory approval for prevention of recurrence of gastric ulcer and duodenal ulcer in patients treated with non-steroidal anti-inflammatory drugs (NSAIDs). 1 July 2011
Pharmaceutical
Following in the footsteps of Switzerland's Roche, global drugs behemoth Pfizer (NYSE: PFE) has signed a Memorandum of Understanding (MoU) with the Russian pharmaceutical investment and R&D group ChemRar High Tech Center to explore a collaboration focused on research, development and commercialization of innovative drugs in Russia and other countries (The Pharma Letter May 30). The announcement was made during the BIO International Convention in Washington DC, USA. 1 July 2011
Pharmaceutical
Genentech, the US subsidiary of Swiss drug major Roche (RGO: SIX), suffered a blow yesterday, when, after a two-day appeal hearing, a US Food and Drug Administration advisory panel unanimously (six to zero) voted that the company's Avastin (bevacizumab) should not stay on the market for the treatment of breast cancer, saying that it was neither effective or safe for the treatment of the condition. 30 June 2011
Pharmaceutical
There was good news this morning for Anglo-Swedish drug major AstraZeneca (LSE: AZN), when the UK's drug watchdog, the National Institute for Health and Clinical Excellence (NICE) issued a draft guidance recommending the National Health Service use of the company's clot-busting drug Brilique (ticagrelor; which also uses the trade name Brilinta) in combination with aspirin as an option to treat adults with acute coronary syndromes. 30 June 2011
Biotechnology
Nuvilex enters $21.5 billion stem cell arena through SG Austria acquisition 29 June 2011
Pharmaceutical
Having previously issued negative opinions on the cancer drug, this morning the UK's National Institute for Health and Clinical Excellence (NICE) declared that it has been unable to recommend the use of Swiss drug major Roche's (ROG: SIX) Tarceva (erlotinib) as a maintenance treatment for people with non-small-cell lung cancer (NSCLC) who have had first line treatment with platinum-based chemotherapy and their disease has remained stable. 29 June 2011
Pharmaceutical
The US Food and Drug Administration has accepted global drugs behemoth Pfizer's (NYSE: PFE) filing for standard review of axitinib for patients with advanced renal cell carcinoma (RCC), the company said yesterday. Pfizer filed for European approval of the drug earlier this month (The Pharma Letter June 2). 29 June 2011
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