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
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 BeOne Medicines, formerly 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
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
StemCyte, a subsidiary of StemCyte International, has secured approval from the US Food and Drug Administration for Regenecyte, a cord blood-derived stem cell therapy. 25 November 2024
Generics
In a May 31 statement, US Food and Drug Administration Commissioner Scott Gottlieb said the agency was reforming its regulations around the Risk Evaluation and Mitigation Strategy (REMS), a method for pharmaceutical companies to control the distribution of drugs that have serious risks and balance drug benefits with hazards. 1 June 2018
Biotechnology
Zug, Switzerland-based oncology specialist Tesaro has received a positive reimbursement decision from the UK’s health technology assessor for Zejula (niraparib). 31 May 2018
Biotechnology
CNS specialist Sage Therapeutics could have its first commercial product by Christmas. 31 May 2018
Pharmaceutical
There is more good news for Pfizer, after the UK’s National Institute for Health and Care Excellence (NICE) agreed to reimburse Xalkori (crizotinib). 31 May 2018
Pharmaceutical
For patients with serious or immediately life-threatening diseases, the US Food and Drug Administration remains committed to enhancing access to promising investigational medicines for those unable to access products through clinical trials. 31 May 2018
Biotechnology
The US Food and Drug Administration (FDA) announced on Wednesday the expansion of Pfizer's Xeljanz (tofacitinib) label to encompass adults with ulcerative colitis. 30 May 2018
Pharmaceutical
British pharma major GlaxoSmithKline has announced that its chronic obstructive pulmonary disorder (COPD) treatment Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol) will be reimbursed under Australia's Pharmaceutical Benefits Scheme (PBS). 30 May 2018
Biotechnology
Following a favorable opinion from the European Medicines Agency advisory committee in March this year, the European Commission (EC) has now approved the first poly ADP-ribose polymerase (PARP) inhibitor licensed for ovarian cancer in the European Union. 30 May 2018
Biotechnology
The China State Drug Administration (CSDA) has approved Epclusa (sofosbuvir 400mg/velpatasvir 100mg) for the treatment of adults with genotype 1-6 chronic hepatitis C virus (HCV) infection. 30 May 2018
Pharmaceutical
The US Food and Drug Administration has granted Novartis Priority Review designation for a new use of Promacta (eltrombopag), an oral thrombopoietin receptor agonist marketed outside the USA as Revolade. 30 May 2018
Pharmaceutical
As the high price of orphan drugs continues to be a major issue, the Indian government is looking to exempt orphan drugs from price control. The government has decided to take legal and other measures to control the price of drugs for rare diseases in order to ensure their affordability and health system sustainability, reports The Pharma Letter’s India correspondent. 30 May 2018
Generics
The overseas generic pharmaceutical industry from the ICH region (USA, Japan, European Union) and 'pharmerging' countries have good opportunities to gain profits in Russia, despite the strong governmental support of local drug manufacturers. 30 May 2018
Pharmaceutical
The US regulator has granted New York’s Pfizer two Breakthrough Therapy designations for Xalkori (crizotinib), a tyrosine kinase inhibitor (TKI) with widespread approval against lung cancer. 30 May 2018
Pharmaceutical
A strongly-worded editorial in the British Medical Journal (BMJ) has called on healthcare professionals to stand up and highlight what it calls the ‘risks of Brexit to our health and our health services’. 29 May 2018
Pharmaceutical
The US Food and Drug Administration has accepted and granted Priority Review for the New Drug Application (NDA) for gilteritinib. 29 May 2018
Biotechnology
News of positive regulatory development for its larotrectinib – which has been called the biotech firm’s ‘golden goose’ – sent shares of Loxo Oncology up 2.12% to $169.24 in morning trading. 29 May 2018
Biotechnology
France’s AB Science will not fight the latest negative recommendation that it has received from the European Medicines Agency’s (EMA) Committee for Human Medicinal Products (CHMP) for masitinib. 29 May 2018
Generics
A new report by CPhI forecasts sizable changes ahead for the pharma markets in the Middle East and Africa over the next few years. It highlights recent regulatory changes, coupled with increased geopolitical stability and rising generics consumption as key drivers in transforming the prospects of pharma manufacturers in the region. 29 May 2018
Pharmaceutical
The European Medicines Agency has accepted a filing from Japan’s Mitsubishi Tanabe Pharma to market edaravone for amyotrophic lateral sclerosis (ALS), often referred to as Lou Gehrig’s disease. 29 May 2018
Biotechnology
Belgian drugmaker UCB has entered the field of immuno-dermatology with the US Food and Drug Administration’s (FDA) approval of a label expansion for the blockbuster inflammatory diseases drug Cimzia (certolizumab pegol). 29 May 2018
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