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
The stand-off between Vertex Pharmaceuticals and the UK’s cost watchdog for medicines over the cystic fibrosis (CF) drug Orkambi (lumacaftor/ivacaftor) has now gone on for two-and-a-half years. 12 November 2018
Pharmaceutical
Prices for drugs in Russia may rise significantly as soon as the beginning of 2019, according to recent statements by an official spokesman of the Russian Pharmacy Guild, a public association, which unites Russian leading pharmacies and some local drugmakers, reports The Pharma Letter’s local correspondent. 12 November 2018
Biotechnology
Merck & Co’s Keytruda (pembrolizumab) has now been approved in a remarkable 14 indications. 12 November 2018
Pharmaceutical
Big things are happening in oncology at the moment. Considering all stages of clinical development, there are thought to be up to 8,000 anticancer candidates being tested by drugmakers globally. 12 November 2018
Generics
Pricing concerns have re-emerged for Gilead Sciences and other participants in the HIV class after suggestions that United Healthcare would be offering incentives to HIV-infected individuals to use lower priced generic, or partially generic, HIV regimens, instead of Gilead and GlaxoSmithKline’s recently introduced best-in-class combinations, comments Leerink Research analyst Geoffrey Porges. 12 November 2018
Pharmaceutical
Food and Drug Administration decisions of note last week included approval of AcelRx’ opioid analgesic Dsuvia but rejection of Trevena’s Olinovo (oliceridine) and also approval of Pfizer’s Lorbrena, which puts the company all along the continuum for ALK-positive lung cancer. On the political front, US mid-term elections resulted in a split Congress, which has implications for the pharma industry. Among deal-making news, it seems that Nektar has convinced another big pharma – Pfizer –on the promise of its cancer immunotherapy NKTR-214. 11 November 2018
Generics
In September 2018, the US Food and Drug Administration issued 54 product-specific guidance documents containing methodologies and evidence to support the development of generic drugs.1 Each document provides the latest in a series of steps undertaken by the FDA and the US Congress to combat high drug prices by encouraging the production of quality generic drugs, writes Dr Nicola Davies in her monthly FDA blog for The Pharma Letter. 10 November 2018
Pharmaceutical
Anglo-Swedish pharma major AstraZeneca is calling for a change of heart at England’s medicines cost regulator after it failed to consider its cancer drug Lynparza (olaparib) as cost-effective. 9 November 2018
Pharmaceutical
Jazz Pharmaceuticals has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency for solriamfetol. 9 November 2018
Pharmaceutical
The US Food and Drug Administration has announced a revision to the labels of three of Gilead Sciences’ (Nasdaq: GILD) HIV medications, all of which contain the pharmacokinetic enhancer cobicistat. 9 November 2018
Pharmaceutical
The European Medicines Agency has released new guidelines on good pharmacovigilance practices (GVP) related to pediatric populations. 8 November 2018
Biotechnology
China’s BeiGene (Nasdaq: BGNE) has disclosed a delay in plans to file a New Drug Application (NDA) for zanubrutinib in relapsed/refractory (R/R) Waldenstrom's macroglobulinemia (WM) from first-half 2019 to 2019-Early 2020 in light of updated US Food and Drug Administration feedback. 8 November 2018
Pharmaceutical
Much like US politics as a whole, opinions are divided about what the midterm results mean for prescription drug prices. 8 November 2018
Biotechnology
Vaccines Europe, a trade group representing vaccines manufacturers in Europe, warns that vaccines have become “a victim of their own success,” as the absence of severe diseases has created a perception that vaccination is no longer necessary. 8 November 2018
Pharmaceutical
The National Institute for Health and Care Excellence (NICE) on Thursday recommended routine National Health Service (NHS) funding for first-line treatment with Lenvima (lenvatinib) in adults with untreated, advanced, unresectable hepatocellular carcinoma (HCC). 8 November 2018
Pharmaceutical
Ireland-based drugmaker Jazz Pharmaceuticals has had its Vyxeos (daunorubicin and cytarabine) product for adults with specific types of secondary acute myeloid leukemia (AML) recommended for public funding in England and Wales. 8 November 2018
Pharmaceutical
Drug companies, which have learned to live with advertisements calling out a litany of possible side effects for their drugs, may want to take a couple of aspirin. That’s because the Department of Health and Human Services recently announced a new proposed rule by the Centers for Medicare and Medicaid Services that would require them to disclose the list price — more precisely, the wholesale acquisition cost — of medications they sell in direct-to-consumer television ads. 7 November 2018
Pharmaceutical
In case it was lost in the excitement of the US midterms on Tuesday, the Food and Drug Administration (FDA) published some important draft guidance for drugmakers. 7 November 2018
Biotechnology
The US Food and Drug Administration has approved Empliciti (elotuzumab) injection for intravenous use in combination with pomalidomide and dexamethasone (EPd) for the treatment of adult patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor.1 7 November 2018
Biotechnology
Japanese pharma major Daiichi Sankyo says that the European Medicines Agency has validated for review and granted accelerated assessment to the Marketing Authorization Application (MAA) for quizartinib for the treatment of adults with relapsed or refractory acute myeloid leukemia (AML) which is FLT3-ITD positive. 6 November 2018
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
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
Pharmaceutical
Lexicon Pharmaceuticals has announced a major strategic shift, prioritizing its late-stage pipeline following a rejection by the US Food and Drug Administration (FDA). 25 November 2024
Biotechnology
The US Food and Drug Administration (FDA) on Friday approved Attruby (acoramidis), an orally-administered near-complete (≥90%) stabilizer of Transthyretin (TTR) for the treatment of adults with ATTR-CM to reduce cardiovascular death and cardiovascular-related hospitalization. 25 November 2024
Pharmaceutical
Efforts to combat antimicrobial resistance (AMR) are gaining momentum in Europe, with the introduction of innovative measures to drive the development of new antimicrobials. 25 November 2024
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