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
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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
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
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
About a month ago, the Chinese Food and Drug Administration (CFDA) issued a draft proposal about easing the process for imported drugs to get into China, ie, ‘amended management for imported drugs registration.’ 12 April 2017
Pharmaceutical
After Allergan chief executive Brent Saunders pledged to limit price increases to single digits, three pharmaceutical companies agreed to make the same commitment, according to Public Citizen. 12 April 2017
Biotechnology
The US Food and Drug Administration has approved Ingrezza (valbenazine) capsules for the treatment of adults with tardive dyskinesia (TD). 12 April 2017
Pharmaceutical
New measures introduced by Romania’s Ministry of Health Order 269/2017 are to blame for medicines shortages, as these target all the medicines available in Romania with no time limit. 11 April 2017
Pharmaceutical
The US Food and Drug Administration has set a Prescription Drug User Fee Act (PDUFA) date of September 8, 2017 for its decision on the New Drug Application for Zerviate (cetirizine ophthalmic solution) 0.24%. 11 April 2017
Biotechnology
In yet another negative decision of a new cancer drug, the medicines cost-effectiveness watchdog for England and Wales has issued new draft guidance that has also come in for criticism from the Institute for Cancer Research, though the latter sees a role for Pharma to reduce the cost of drug development. 11 April 2017
Pharmaceutical
The European Medicines Agency’s management board has adopted a new policy on how the EMA handles allegations of improprieties received from external parties, it was announced today. 10 April 2017
Biotechnology
The USA’s Institute for Clinical and Economic Review, (ICER), an independent not-for-profit organization, has released a Final Evidence Report and Meeting assessing the comparative clinical effectiveness and value of targeted immune modulators (TIMs) for treatment of moderately-to-severely active rheumatoid arthritis (RA). 10 April 2017
Generics
US Representatives David McKinley (Republican: West Virginia-1) and Peter Welch (Democrat: Vermont) last week introduced the Fair Access for Safe and Timely (FAST) Generics Act. 8 April 2017
Pharmaceutical
Shares in US pharma giant Merck & Co slipped in the morning’s trading on news that the US Food and Drug Administration (FDA) has issued a Complete Response Letter regarding the company’s Supplemental New Drug Applications for Januvia (sitagliptin) and its two Janumet (sitagliptin and metformin HCl) formulations. 7 April 2017
Biotechnology
The US Food and Drug Administration today approved supplemental applications for Sovaldi (sofosbuvir) and Harvoni (ledipasvir and sofosbuvir) to treat hepatitis C virus (HCV) in children ages 12 to 17. 7 April 2017
Biotechnology
The European Medicines Agency (EMA) has given Switzerland-based Actelion the OK to continue selling Uptravi (selexipag), after five patient deaths in France triggered a safety review. 7 April 2017
Biotechnology
Ireland’s Health Service Executive (HSE) National Drugs Management Program (NDMP) and Neurology Program have introduced a national reimbursement scheme which will facilitate access for patients with multiple sclerosis (MS) to approved high cost treatments. 7 April 2017
Biosimilars
For the last two years, the European Medicines Agency has carried out ‘single assessments’ of post-marketing safety reports which relate to products with the same active substance. 6 April 2017
Pharmaceutical
Briviact (brivaracetam) has been accepted for use in Ireland as an add-on treatment for partial onset seizures (POS) with or without secondary generalized seizures in adults with epilepsy. 6 April 2017
Biotechnology
The US Food and Drug Administration has granted Breakthrough Therapy designation status to evinacumab for the treatment of hypercholesterolemia in patients with homozygous familial hypercholesterolemia (HoFH). 6 April 2017
Pharmaceutical
The Pacific Research Institute has criticized reimbursement practices in the UK, describing the country’s public health watchdog, the National Institute for Health and Care Excellence, as ‘a cautionary tale’ for the US healthcare system. 6 April 2017
Generics
Jordanian drugmaker Hikma Pharmaceuticals has reached a settlement with Jazz Pharmaceuticals that resolves patent litigation related to the Ireland-based company’s Xyrem (sodium oxybate) oral solution, 500mg/mL product. 6 April 2017
Pharmaceutical
Lawmakers have confirmed that they will demand the relocation of the European Medicines Agency from its current base in London when the UK exits the EU. 6 April 2017
Pharmaceutical
Republicans in the US Congress went into last month’s vote to repeal and replace the Affordable Care Act with guidance from President Trump, effectively: ‘Vote yes or you’re stuck with Obamacare.’ 5 April 2017
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