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
giant Novartis today became the only company with an approved chimeric antigen receptor T cell (CAR-T) cell therapy for pediatric relapsed or refractory (r/r)/B cell acute lymphoblastic leukemia (ALL). 28 August 2018
Pharmaceutical
The China National Drug Administration has approved AstraZeneca's Lynparza (olaparib) for the maintenance treatment of recurrent platinum-sensitive ovarian cancer, the first targeted therapy approved there for the indication. 28 August 2018
Biotechnology
BeiGene today announced the acceptance by the China Drug Administration (CDA) of a new drug application (NDA) for its zanubrutinib, an investigational Bruton's tyrosine kinase (BTK) inhibitor, for the treatment of patients with relapsed/refractory mantle cell lymphoma (MCL). 28 August 2018
Pharmaceutical
Among last week’s news of interest was Danish diabetes care giant Novo Nordisk’s acquisition of a small UK-based biotech firm Ziylo. Regulatory news included a blow for Allergan when the US Food and Drug Administration issued a complete response letter on its uterine fibroids therapy Esmya while Shire was rewarded with approval of its novel hereditary angioedema drug Takhzyro. On the research front, Novo Nordisk pleased when it presented positive results from a Phase IIIa study of its oral diabetes candidate semaglutide. 26 August 2018
Pharmaceutical
Following the publication by the UK government of 24 technical papers covering the likely impact of a no-deal Brexit, including five papers covering the healthcare sector, the pharmaceuticals industry now has some guidance on how to prepare for this eventuality and to some extent greater certainty over what to expect after Britain leaves the European Union. 25 August 2018
Pharmaceutical
Japanese drugmaker Kyowa Hakko Kirin has been sent a warning letter by the US Food and Drug Administration (FDA) over issues at its manufacturing plant in Hofu-shi, Yamaguchi, Japan. 24 August 2018
Biotechnology
Vertex Pharmaceuticals is still restless over the lack of a reimbursement agreement for Orkambi (lumacaftor/ivacaftor) in the UK, 1,000 days after the drug was initially green-lit by the European Medicines Agency. 24 August 2018
Biotechnology
The cost-effectiveness provided by the spinal muscular atrophy (SMA) treatments, Novartis’ AVXS-101 and Biogen’s Spinraza (nusinersen), is to be assessed by the Institute for Clinical and Economic Review (ICER). 24 August 2018
Biotechnology
Irish pharma major Shire announced on Friday that the US Food and Drug Administration (FDA) had granted approval for Takhzyro (lanadelumab), its novel preventative therapy for hereditary angioedema. 24 August 2018
Pharmaceutical
In light of a report on the 10 most important medicines over the life of the UK's National Health Service (NHS), the Association of the British Pharmaceutical Industry's (ABPI) deputy chief scientific officer, Sheuli Porkess, outlines how pharma's process of taking a substance from molecule to medicine requires persistence. 24 August 2018
Biotechnology
The USA’s Institute for Clinical and Economic Review (ICER) yesterday released a Draft Evidence Report assessing the comparative clinical effectiveness and value of therapies for long-term prophylaxis against hereditary angioedema attacks. 24 August 2018
Pharmaceutical
German life sciences group Bayer had a welcome opportunity on Friday to talk about some news that did not involve potential problems with its takeover of the US agro-chemicals company Monsanto. 24 August 2018
Biotechnology
Ipsen announced on Friday that it has received a recommendation from the National Institute of Care Excellence (NICE) for National Health Service funding of Cabometyx (cabozantinib) for use in adult patients with advanced renal cell carcinoma. 24 August 2018
Biotechnology
The US Food and Drug Administration’s (FDA) approval of Seqirus’ cell-based influenza vaccine manufacturing process at a US facility will allow the company to more than double production levels of Flucelvax Quadrivalent. 24 August 2018
Pharmaceutical
In a move to encourage drug development in areas of unmet need, the US Food and Drug Administration yesterday announced the addition of Lassa fever, chikungunya virus disease, rabies and cryptococcal meningitis to the list of tropical diseases. 24 August 2018
Pharmaceutical
Adding to a similar US approval last week, the European Commission (EC) has also granted a marketing authorization for the oral receptor tyrosine kinase (RTK) inhibitor Lenvima (lenvatinib mesylate) as a single agent for the first-line treatment of adult patients with advanced or unresectable hepatocellular carcinoma (HCC), or liver cancer, who have received no prior systemic therapy. 23 August 2018
Pharmaceutical
The US Food and Drug Administration yesterday issued a Complete Response Letter related to the New Drug Application (NDA) for stannsoporfin. 23 August 2018
Pharmaceutical
The US Food and Drug Administration yesterday approved the first drug, Oxervate (cenegermin), for the treatment of neurotrophic keratitis, a rare disease affecting the cornea (the clear layer that covers the colored portion of the front of the eye). 23 August 2018
Pharmaceutical
A question that is arising with increasing frequency when the widely-discussed topic of US drug prices comes up in public forums is whether technology is the only force that can bring radical disrupt. 22 August 2018
Pharmaceutical
The US Food and Drug Administration has issued a Complete Response Letter (CRL) in response to the New Drug Application (NDA) for Esmya (ulipristal acetate; UPA) for the treatment of abnormal uterine bleeding in women with uterine fibroids. 22 August 2018
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
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