In what could be construed to be India's quest for pharmaceutical supremacy, a clarion call has been made for the country to set its indigenous standards. 25 November 2024
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
China’s Innovent Biologics has announced that the updated 2024 National Reimbursement Drug List (NRDL) now includes Sintbilo (tafolecimab) injection, an anti-PCSK9 monoclonal antibody for the first time. The updated NRDL will be officially effective from January 1, 2025. 29 November 2024
The Danish Ministry of Interior and Health has announced that the political parties have decided to permanently legalize treatment with medical cannabis in Denmark. 29 November 2024
Industry is showing a very high level of readiness for upcoming new packaging and labelling measures impacting the UK market, according to the Medicines and Healthcare products Regulatory Agency (MHRA). 29 November 2024
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
The UK subsidiary of Dutch drugmaker argenx confirmed today that its investigational therapy, subcutaneous efgartigimod alfa has been granted Promising Innovative Medicine (PIM) designation by the UK Medicines and Healthcare products Regulatory Agency (MHRA) for the treatment of adults with chronic inflammatory demyelinating polyneuropathy (CIDP). 28 November 2024
The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the New Drug Application (NDA) for govorestat, a novel, central nervous system (CNS)-penetrant aldose reductase inhibitor (ARI), for the treatment of classic galactosemia, under development by Applied Therapeutics. 28 November 2024
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
UK-based drugmaker Advanz Pharma has announced that following the grant of a temporary suspension, as announced on last month, the General Court of the European Union (General Court) has decided not to further extend the suspension of the European Commission (EC) decision to revoke the conditional marketing authorization (CMA) for Ocaliva (obeticholic acid) in Europe. 28 November 2024
The European medicines regulator has approved a combo therapy starring PD-1 inhibitor Tevimbra (tislelizumab), from cancer firm BeiGene. 27 November 2024
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
The European Commission (EC) has approved a single-vial, fully liquid presentation of Menveo (meningococcal Group A, C, W-135 and Y conjugate vaccine, MenACWY vaccine) to help protect against invasive meningococcal disease (IMD) caused by bacterial serogroups A, C, W and Y, UK pharma major GSK announced today. 27 November 2024
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
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
The Biden administration has proposed a new rule that could significantly expand Medicare and Medicaid coverage for obesity medications, potentially benefiting millions of Americans. 27 November 2024
The US Food and Drug Administration (FDA) has extended the review period for Soleno Therapeutics’ the New Drug Application (NDA) for DCCR (diazoxide choline) extended-release tablets 27 November 2024
Japanese drugmaker Otsuka has announced the submission of a New Drug Application (NDA) to the Japanese Ministry of Health, Labor and Welfare (MHLW) for the manufacture and sale in Japan of bempedoic acid - trade name Nexletol in Japan - for the treatment of hypercholesterolemia and familial hypercholesterolemia. 27 November 2024
In December, the UK pharmaceutical industry gave evidence to the Exiting the EU Committee where, though its trade body the Association of the British Pharmaceutical Industry (ABPI), it stated that in the opinion of the UK's £60 billion (~$74 billion) Life Sciences sector, a primary objective for government in Brexit negotiations should be to secure alignment and cooperation with EU medicines regulation. 14 January 2017
VivaGel (astodrimer sodium) has been designated a Qualified Infectious Disease Product and given Fast Track status by the US Food and Drug Administration. 13 January 2017
In an early benefit assessment the German Institute for Quality and Efficiency in Health Care (IQWiG) investigated whether crizotinib offers advantages for patients over the appropriate comparator therapies. 13 January 2017
There were two new developments in the backlash against Mylan’s US pricing policy for its EpiPen Auto-Injector (epinephrine injection, USP) this week. 13 January 2017
Heron Therapeutics has submitted a New Drug Application (NDA) for Cinvanti (HTX-019), for the prevention of chemotherapy-induced nausea and vomiting (CINV), to the US Food and Drug Administration. 13 January 2017
Even before the new US President has been inaugurated, the health care provision introduced to ensure affordable health care for millions of poorer Americans – and heavily criticized by Donald Trump during his election campaign – appears to be on its way out. 12 January 2017
Shares of US cancer drug developer Tesaro dipped 2.48% to $142.028 by mid-morning trading today, after the company revealed that the US regulator had rejected approval of its intravenous presentation of rolapitant. 12 January 2017
Japanese drugmaker Shionogi has announced positive top-line trial results for cefiderocol (S-649266), a novel siderophore cephalosporin in late-stage development, 12 January 2017
Afinitor (everolimus) has been recommended for use on the National Health Service (NHS) in England and Wales after Novartis agreed to reductions to its £32,076 ($39,165) annual treatment cost per patient. 12 January 2017
Ever since his surprise election win in November, what Donald Trump’s Presidency might mean for pharma has been the subject of plenty of guesswork. 11 January 2017
The European Commission has granted marketing authorization for Vemlidy (tenofovir alafenamide, TAF) 25mg, a once-daily tablet for the treatment of chronic hepatitis B virus (HBV) infection in adults and adolescents. 11 January 2017
Netherlands-incorporated generics major Mylan and Indian biotech Biocon are a step closer to gaining approval for a biosimilar version of Herceptin (trastuzumab) in the USA. 11 January 2017
Merck & Co today announced that the US Food and Drug Administration has accepted for review a supplemental Biologics License Application (sBLA) for its dual immuno-oncological/chemotherapeutic treatment candidate. 11 January 2017
The European Commission has granted marketing authorization for Fiasp (fast-acting insulin aspart for the treatment of diabetes in adults. 10 January 2017
Excitement at opportunities, dread and doubts over what exactly the presidency of Donald Trump will mean for pharma all feature in predictions for the industry in 2017 expressed by an expert panel brought together by a pharma events organiser. 10 January 2017
Shares in Egalet rose sharply as the company received US Food and Drug Administration approval for Arymo ER (morphine sulfate), a new long-acting opioid, before falling back as details of the label were released hours later. 10 January 2017
Dr Nicola Davies explores the market access steps taken by companies such as Takeda to make medicines available and affordable for high priority patient populations. 10 January 2017
Swiss pharma giant Roche has edged closer to gaining approval from the US Food and Drug Administration (FDA) for a second bladder cancer indication with Tecentriq (atezolizumab). 9 January 2017
Acadia Pharmaceuticals (Nasdaq: ACAD) is a leading pharmaceutical company with a focus on bringing life-changing therapies to patients suffering from CNS diseases.
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