Pharma & Biotech Pricing, Policy & Regulation
Pharmaceutical
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
Today's issue
Refine Search
Pharmaceutical
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
Pharmaceutical
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
Biotechnology
PTC Therapeutics is to sell its rare pediatric disease priority review voucher (PRV) for $150 million. 28 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 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
Pharmaceutical
The first iteration of the European Shortages Monitoring Platform (ESMP) has gone live. 28 November 2024
Pharmaceutical
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
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
Generics
The US Food and Drug Administration (FDA) yesterday announced its Fiscal Year 2025 Generic Drug User Fee Amendments (GDUFA). 28 November 2024
Pharmaceutical
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
Biotechnology
The European medicines regulator has approved a combo therapy starring PD-1 inhibitor Tevimbra (tislelizumab), from cancer firm BeiGene. 27 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
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
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
Pharmaceutical
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
Pharmaceutical
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
Pharmaceutical
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
Pharmaceutical
Berlin, Germany-based Eckert & Ziegler Radiopharma has received approval of its proprietary non-carrier added Lutetium-177 chloride, Theralugand, by the European Commission (EC). 27 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
Biotechnology
The China Food and Drug Administration (CFDA) has approved Sovaldi (sofosbuvir 400mg), a once-daily oral nucleotide analog polymerase inhibitor for the treatment of chronic hepatitis C virus (HCV) infection. 25 September 2017
Pharmaceutical
The Russian government has prepared a bill simplifying the introduction of new drugs into the domestic pharmaceutical market, a spokesman of state press-service has said recently, reports The Pharma Letter’s local correspondent. 25 September 2017
Biosimilars
As the largest pharma event in South Korea, the confidence amongst the attendees at the CPhI Korea meeting this year is a good indication of the industry’s overall health. 25 September 2017
Biotechnology
The European Commission has granted a marketing authorization for Tecentriq (atezolizumab) as a monotherapy for the treatment of people with locally advanced or metastatic non-small cell lung cancer (NSCLC) after they have been previously treated with chemotherapy regardless of PD-L1 status. 25 September 2017
Pharmaceutical
News last week attracted a great deal of comment included Neos Therapeutics gaining US Food and Drug Administration for its attention deficit hyperactivity disorder (ADHD) drug Adzenys. Also garnering attention were: Ultragenyx’ rival bid to acquire Dimension Therapeutics; supplemental approval for Ipsen’s Somatuline Depot; an FDA safety alert on Intercept Pharmaceuticals’ Ocaliva; and a Phase III success for Nabriva’s lefamulin 23 September 2017
Biotechnology
The US Food and Drug Administration has issued a complete response letter (CRL) for the Biologics License Application (BLA) seeking approval of sirukumab for the treatment of moderately to severely active rheumatoid arthritis (RA). 23 September 2017
Biotechnology
Steve Miller, chief medical officer at Express Scripts, the USA’s leading pharmacy benefit manager (PBM), has made a public push for reform of the way that drugs are paid for. 22 September 2017
Pharmaceutical
American advocacy group Public Citizen is launching a legal bid to force a ruling on a petition it launched three years ago regarding the use of benzocaine in over-the-counter medicines. 22 September 2017
Biotechnology
With the leading pair of immuno-oncology (I-O) agents Keytruda (pembrolizumab) and Opdivo (nivolumab) seemingly scoring new approvals by the month in major markets, it would be easy to ignore the importance of the latest nod for the latter drug in Japan. 22 September 2017
Pharmaceutical
USA-based Intercept Pharmaceuticals closed 25% down at $73.70 at the end of trading on Thursday. 22 September 2017
Pharmaceutical
The UK’s medicines cost-effectiveness watchdog the National Institute for Health and Care Excellence (NICE) has provided final positive recommendation for Eylea (aflibercept solution for injection) for adults for the treatment of visual impairment due to myopic chorodial neovascularization (mCNV). 22 September 2017
Pharmaceutical
First approved in the USA in 2006, Sutent has brought in over a billion dollars for Pfizer every year since 2010, including last year, thanks to its broad use as a first-line kidney cancer therapy. 21 September 2017
Pharmaceutical
The US Food and Drug Administration has granted Rare Pediatric Disease designation to Altemia Soft Gelatin Capsules for the treatment of sickle cell disease (SCD) in children. 21 September 2017
Pharmaceutical
The European Commission has approved Xermelo (telotristat ethyl) 250mg three times a day (tid) for the treatment of carcinoid syndrome diarrhea in combination with somatostatin analogue (SSA) therapy in adults inadequately controlled by SSA therapy. 20 September 2017
Biotechnology
Malaysia has issued a “government-use” licence enabling access to more affordable versions of an expensive and patented medicine to treat hepatitis C. 20 September 2017
Pharmaceutical
‘Repeal and replace’ refuses to lie down and go to sleep, despite successive stakes to the heart. 19 September 2017
Biotechnology
Opdivo (nivolumab), one of the frontrunners in the first wave of immuno-oncology treatments, should be made available to some English people with lung cancer through the Cancer Drugs Fund (CDF), according to the National Institute for Health and Care Excellence (NICE). 19 September 2017
Pharmaceutical
Just days after receiving a positive committee recommendation setting it up for approval in Europe, the first once-daily product that combines three active molecules in a single inhaler as a maintenance treatment for appropriate patients with chronic obstructive pulmonary disease (COPD), has been given the nod by the US regulator. 19 September 2017
Pharmaceutical
Neos Therapeutics has received approval from the US Food and Drug Administration for Adzenys ER (amphetamine) extended-release oral suspension, with the news sending the firm’s share more than 5% lower in after-hours trading. 19 September 2017
Biotechnology
Ono Pharmaceuticals says it South Korean subsidiary has received supplemental approval of Opdivo (nivolumab) intravenous infusion from the Korean Ministry of Food and Drug Safety (MFDS), for expanded use for the treatment of patients with unresectable or metastatic melanoma. 19 September 2017
Sign up to receive email updates
Join industry leaders for a daily roundup of biotech & pharma news
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze