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
Biotechnology
US biotech company Advaxis saw its shares surge 68% in premarket trading on Friday after the Food and Drug Administration lifted a clinical hold on the company's Phase I/II trial for an immuno-oncology drug combination. 16 July 2018
Pharmaceutical
Leading Russian and foreign drug manufacturers operating in the local market have warned the national government about the forthcoming rise in prices that will come about as a result of certain innovations introduced by the Russian government in the national pharmaceutical industry. 16 July 2018
Pharmaceutical
Deal-making news last week included Benitec Biopharma’s collaboration with Axovant Sciences on rare disease drug BB-301, which sent the Australian firm’s shares more than doubling. On the M&A front, BioCryst’s merger with Idera was resisted by shareholders. Company news included disappointment for Regulus Therapeutics when it paused clinical studies and slashed its work force. Also attracting attention was Pfizer’s announcement to defer planned drug price hikes and Pfizer’s decision to reorganize its business. 15 July 2018
Biotechnology
As was largely expected, Tegsedi (inotersen) has received marketing authorization approval from the European Commission for the treatment of stage 1 or stage 2 polyneuropathy in adult patients with hereditary transthyretin amyloidosis (hATTR). 13 July 2018
Pharmaceutical
Following a review of data showing a possible risk of earlier death and an increase in fractures with Xofigo (radium-223 dichloride), the European Medicines Agency's (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has recommended restricting the use of this cancer medicine to patients who have had two previous treatments for metastatic prostate cancer or who cannot receive other treatments. 13 July 2018
Pharmaceutical
Be they about boosting generics, advancing gene therapies or other aspects of the drug development and manufacturing industry that it is trying to improve, announcements have been coming thick and fast from the US Food and Drug Administration (FDA). 13 July 2018
Pharmaceutical
The US Food and Drug Administration’s Antimicrobial Drugs Advisory Committee (AMDAC) at its meeting on Thursday voted that there is substantial evidence of the effectiveness (13 for; 0 against) and adequate evidence of the safety (12 for; 1 against) of single-dose tafenoquine for the radical cure (prevention of relapse) of Plasmodium vivax (P. vivax) malaria in patients aged 16 years and older. 13 July 2018
Biotechnology
Following the UK’s publication of its proposed Brexit deal, the country’s biotech industry has issued a statement interpreting the likely impact for the sector, noting a range of effects from the UK’s relationship with the EMA, to IP protection and other legal issues. 13 July 2018
Biotechnology
US biotech major Amgen and Belgian pharma company UCB have resubmitted their Biologics License Application (BLA) to the US Food and Drug Administration for Evenity (romosozumab), 13 July 2018
Pharmaceutical
When it comes to reducing the cost of prescription medicines, where President Trump has increasingly failed, a new price transparency law in California appears to be succeeding. 12 July 2018
Pharmaceutical
A new draft guidance document, published by the UK’s National Institute for Health and Care Excellence (NICE), warns physicians to take antimicrobial resistance (AMR) into account when prescribing antibiotics for COPD. 12 July 2018
Pharmaceutical
Switzerland’s Roche and Chicago, USA-based AbbVie have submitted to extend the US label for Venclexta (venetoclax) as a first-line acute myeloid leukaemia (AML) therapy. 12 July 2018
Biotechnology
Having last year announced its comprehensive policy framework for regenerative medicine, the US Food and Drug Administration (FDA) has this week unveiling complementary measures for the development, review and approval of gene therapies. 12 July 2018
Biotechnology
Hemel Hempstead, UK-based EUSA Pharma has received a positive reimbursement decision from the UK’s health technology assessor for its targeted cancer immunotherapy, Qarziba (dinutuximab beta). 12 July 2018
Pharmaceutical
At the annual meeting of 340B Health, a trade body representing hospitals participating in the 340B scheme, Health Secretary Alex Azar promised greater oversight in an effort to reign in costs. 11 July 2018
Pharmaceutical
Having come under direct castigation from the US president, pharma giant Pfizer said yesterday that it will pull back on planned drug prices increases. 11 July 2018
Biotechnology
After its European Medicines Agency (EMA) approval in this indication in April, Sobi's Kineret (anakinra) has launched in the UK for the treatment of adult onset stills disease (AOSD) and systemic-onset juvenile idiopathic arthritis (SOJIA). 11 July 2018
Generics
Like other victims of a toxic US political environment, Obama-era FDA pick Robert Califf did not long survive the political turbulence of presidential election season. 11 July 2018
Biotechnology
US pharma major Bristol-Myers Squibb has scored an approval in a third tumor type with the combination of its two immuno-oncology drugs, Opdivo (nivolumab) and Yervoy (ipilimumab). 11 July 2018
Pharmaceutical
With safety reviews underway in Europe and warnings for the Canadian regulator, the Food and Drug Administration is strengthening the current warnings in the prescribing information that fluoroquinolone antibiotics may cause significant decreases in blood sugar and certain mental health side effects. 11 July 2018
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