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
With more than 90% of US prescriptions being for a generic medicine, generic drugs might be thought of as a growth area. 22 August 2018
Biotechnology
The US Food and Drug Administration (FDA) has granted priority review to Alexion's ALXN1210, a long-acting C5 complement inhibitor, for the treatment of paroxysmal nocturnal hemoglobinuria (PNH). 21 August 2018
Pharmaceutical
Perhaps not surprisingly, the HHS report starts with a comment congratulating the President and the plan, with the department’s Secretary Alex Azar quoted as saying: “The President’s blueprint for lower drug prices is working, drug prices are coming down, and American patients are going to see the savings in their pocketbook.” 21 August 2018
Biotechnology
The Japanese Ministry of Health, Labor and Welfare (MHLW) has approved Tagrisso (osimertinib) for the first-line treatment of patients with inoperable or recurrent epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC), following priority review. 21 August 2018
Pharmaceutical
The China Food and Drug Administration (CFDA) has asked the country’s second-biggest rabies vaccine maker Changchun Changsheng Biotechnology to terminate the production of its Vero-cell rabies vaccines in July 2018 for violating the country’s drug production quality protocols. 21 August 2018
Biotechnology
Takeda's first-in-class allogneic stem cell therapy for the treatment of perianal fistulas in patients suffering from Crohn's Disease has been snubbed in a recommendation of the National Institute for Health and Care Excellence (NICE), the cost-effectiveness watchdog for England and Wales. 20 August 2018
Generics
The Chinese company Zhejiang Tianyu is no longer authorized to manufacture the valsartan active substance for European Union medicines following the suspension of its CEP – a certificate verifying that the quality of its valsartan meets European requirements, the European Medicines Agency announced today (August 20). 20 August 2018
Biotechnology
Vertex Pharmaceuticals' Orkambi (lumacaftor/ivacaftor) is set to be reimbursed on Australia's Pharmaceutical Benefits Scheme after it was cleared by a cost-effectiveness watchdog. 20 August 2018
Biotechnology
The China National Drug Administration (CNDA) has expedited the approval process for Roche's cancer therapy Alecensa (alectinib), an innovative therapy for anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer. 20 August 2018
Pharmaceutical
Among interesting pharma news, Motif Bio has its skin infections drug candidate iclaprim accepted for priority review by the US Food and Drug Administration. On the research front, Gemphire saw its stock decimated as it terminated a study of its liver disease drug gemcabene; and GlaxoSmithKline’s ViiV Healthcare HIV unit presented positive new data on a combination once-monthly combination drug. Meantime, Germany’s BioNTech signed a potentially lucrative deal with Pfizer for its mRNA-based flu vaccine program. 19 August 2018
Pharmaceutical
Innovative payment schemes should be a top priority for governments and pharma companies, suggests a new study of European payer opinion. 17 August 2018
Biotechnology
Following a setback just a few days ago, when the US Food and Drug Administration issued a complete response letter (CRL) to a supplemental Biologics License Application (sBLA) for Eylea (aflibercept) injection due to ongoing labeling discussions, the FDA has now come up with a positive decision. 17 August 2018
Biotechnology
The US Food and Drug Administration (FDA) has approved a new indication for Opdivo (nivolumab) based on early-stage data. 17 August 2018
Generics
On Thursday, the US Food and Drug Administration (FDA) approved the first generic version of the EpiPen and EpiPen Jr (epinephrine) auto-injectors for the emergency treatment of allergic reactions. 17 August 2018
Pharmaceutical
Despite gaining US approval for what is considered an important added indication for its cancer drug Lenvima (lenvatinib), Japanese pharma major Eisai saw its shares dip 1.7% to 9,569 yen by the time trading in Tokyo came to a halt today. 17 August 2018
Biotechnology
Officials are facing swift action in China over a vaccine scandal that has hit stocks and risked undermining public confidence in healthcare in the country. 17 August 2018
Biotechnology
Scott Gottlieb, Commissioner of the US Food and Drug Administration, released a statement on Thursday discussing the role of probiotics and microbiota in the biologic landscape. 17 August 2018
Pharmaceutical
The USA’s Drug Enforcement Administration (DEA) and Department of Justice (DoJ) on Thursday moved to curtail drugmaker production of the most commonly abused prescription opioids, saying the cut will inhibit illicit sales of narcotic painkillers. 17 August 2018
Pharmaceutical
Anglo-American antibiotics developer Summit Therapeutics opened up more than 10% on Thursday following news that it is to receive further US government funding for its C difficile infection (CDI) drug candidate. 16 August 2018
Pharmaceutical
India's largest drugmaker, Sun Pharmaceutical, closed more than 3% up on Thursday after the US Food and Drug Administration (FDA) approved its ophthalmic drug Cequa (cyclosporine ophthalmic solution). 16 August 2018
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