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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
Anglo-Swedish drug major AstraZeneca (LSE: AZN) announced this morning that the European Commission has granted marketing authorization for Caprelsa (vandetanib) for the treatment of aggressive and symptomatic medullary thyroid cancer (MTC) in patients with unresectable locally advanced or metastatic disease. Caprelsa is the first approved treatment for advanced MTC in Europe, the company noted. 21 February 2012
Biotechnology
Finalizing its review on orlistat-containing medicines and the possible risk of severe liver injuries, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefit of these medicines continue to outweigh their risks in the treatment of obese or overweight patients with a body mass index of 28kg/m2 or above. 20 February 2012
Biotechnology
Based on clinical data and the opinions of interviewed thought leaders, Pharmacyclics (Nasdaq: PCYC) and Janssen Biotech's (a Johnson & Johnson [NYSE: JNJ] company) PCI-32765 has earned advisory firm Decision Resources' proprietary clinical gold standard status for the treatment of relapsed/refractory diffuse large B-cell lymphoma. 19 February 2012
Pharmaceutical
After a decade and a half of near stagnation, four new drugs could help make advanced prostate cancer a chronic illness instead of a terminal disease, a leading Colorado prostate cancer expert writes on the Colorado Cancer blog. 19 February 2012
Pharmaceutical
In an early benefit assessment under the German Act on the Reform of the Market for Medicinal Products (AMNOG), the country's Institute for Quality and Efficiency in Health Care (IQWiG) examined whether Japanese drug major Eisai's (TYO: 4523) breast cancer drug Halaven (eribulin) ' which was approved by the European Commission last spring (The Pharma Letter March 25, 2011) - offers an added benefit compared with the present standard therapy, concluding that it does not. 17 February 2012
Pharmaceutical
UK drug watchdog the National Institute for Health and Clinical Excellence (NICE) today issued new draft guidance requesting that Swiss drug major Roche (ROG: SIX), the manufacturer of Tarceva (erlotinib), provides further information on the use of this drug for the first-line treatment of locally advanced or metastatic EFGR mutation-positive non-small-cell lung cancer (NSCLC). The draft guidance has been issued for consultation. 17 February 2012
Pharmaceutical
UK pharma giant GlaxoSmithKline (LSE: GSK) said yesterday that it has submitted regulatory applications in Europe and the USA related to Tykerb/Tyverb (lapatinib) and its use in combination with trastuzumab to treat patients with HER2 (ErbB2)-positive metastatic breast cancer. 17 February 2012
Pharmaceutical
The European Medicines Agency has been formally notified by UK pharma giant GlaxoSmithKline (LSE: GSK) of its decision to withdraw its application for an extension of the therapeutic indication for the centrally authorized breast cancer drug Tyverb (lapatinib), 250mg film-coated tablets. 16 February 2012
Pharmaceutical
Anglo-Swedish drug major AstraZeneca (LSE: AZN) has launched what it says is its first-ever direct-to-patient program offering those with a valid prescription for its breast cancer drug Arimidex (anastrozole), which has lost patent exclusivity, the opportunity to have the brand Arimidex delivered directly to their home by Express Scripts, a specialty pharmacy services provider in the USA, for $40 per month, including shipping. 16 February 2012
Pharmaceutical
The US Food and Drug Administration said yesterday that it is warning health care professionals and patients about a counterfeit version of Swiss drug major Roche's (ROG; SIX) Avastin (bevacizumab), 400mg/16mL, which may have been purchased and used by some medical practices in the USA. 16 February 2012
Pharmaceutical
German drugmaker Riemser Arzneimittel AG is extending its range of supportive cancer therapy products by purchasing the world-wide rights to Swiss drug major Roche's (ROG: SIX) Ostac (clodronic acid), a drug used in chemotherapy regimens for the treatment of metastatic bone lesions. Financial terms of the deal were not disclosed. 15 February 2012
Pharmaceutical
The UK drug watchdog the National Institute for Health and Clinical Excellence (NICE) has published draft guidance today which proposes to advise the National Health Service that lapatinib or trastuzumab with aromatase inhibitors should not be prescribed for a particular type and stage of breast cancer. This is because the extent to which they can improve overall survival compared to existing treatments is uncertain and so they do not appear to represent value for money for the NHS. 14 February 2012
Pharmaceutical
Swiss drug major Novartis (NOVN: VX) said this morning that it has received a Complete Response letter from the US Food and Drug Administration on its application for the expanded use of Menveo (meningococcal [groups A, C, Y and W-135] oligosaccharide diphtheria CRM197 conjugate vaccine) in infants and toddlers from two months of age. Menveo is already approved in the USA for use in individuals two to 55 years of age. 13 February 2012
Pharmaceutical
German drug major Bayer (BAY: DE) and Norwegian partner Algeta (OSE: ALGETA) announced that the survival analysis has been completed on updated clinical data generated from the ALSYMPCA Phase III trial evaluating Alpharadin(radium-223 chloride) in patients with castration-resistant prostate cancer (CRPC) and bone metastases. 13 February 2012
Biotechnology
The world's largest independent biotech firm, Amgen (Nasdaq: AMGN), has failed to convince a Food and Drug Administration advisory panel that its Xgeva (denosumab), already approved for marketing in the USA to prevent bone pain and fractures caused by bone metastases in prostate cancer patients (The Pharma Letter November 19, 2010), should be approved to delay tumors spreading to bones in this patient population. Amgen stock declined 1.6% to $68.06 by close of trading yesterday. 9 February 2012
Pharmaceutical
The rising number of children under four years is creating more cases of retinoblastoma, a rare cancerous tumor of the retina in children, producing a gap in the market for further drug developments despite the effectiveness of current treatments, a new study by health care analysis specialist GlobalData has found. 8 February 2012
Generics
Japan's ASKA Pharmaceuticals has announced the launch of irinotecan, the active ingredient of Campto (originated by Rhone-Poulenc, now a Sanofi legacy company), the first oncology product from Icelandic generics group Actavis in Japan. 8 February 2012
Pharmaceutical
2
Treatment with three relatively new "targeted" cancer drugs has been linked to a slightly elevated chance of fatal side effects, according to a new analysis led by scientists at Dana-Farber Cancer Institute. USA. They added that the risk remains low, but should be taken into account by physicians and patients. 8 February 2012
Biotechnology
Merck Serono, a division of German pharma and chemical major Merck KGaA (MRK: DE) has signed a global agreement with US biotech firm Threshold Pharmaceuticals (Nasdaq: THLD) to co-develop and commercialize TH-302, Threshold's small molecule hypoxia-targeted drug, aiming for a stake in the pancreatic cancer therapy market. 6 February 2012
Pharmaceutical
France-based AB Science (AB: EN Paris) saw its share price rocket as much as 72% to 10.60 euros after the company announced encouraging results from a Phase II study with its investigational drug, masitinib, in Gleevec (imatinib)-resistant gastrointestinal stromal tumors (GIST). 6 February 2012
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