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
Biosimilars
The US Food and Drug Administration (FDA) has approved Pfizer’s (NYSE: PFE) biosimilar drug Ixifi (infliximab-qbtx), which references the big-selling inflammatory diseases drug Remicade. 14 December 2017
Biotechnology
In a reversal of a previous guidance, the UK’s National Institute for Health and Care Excellence (NICE) has issued draft guidance recommending ibrutinib (or routine National Health Service (NHS) use to treat mantle cell lymphoma in people who have had only one prior line of therapy. 14 December 2017
Biotechnology
The US Food and Drug Administration yesterday expanded the approved use of Nucala (mepolizumab) to treat adult patients with eosinophilic granulomatosis with polyangiitis (EGPA), a rare autoimmune disease that causes vasculitis, an inflammation in the wall of blood vessels of the body. 13 December 2017
Pharmaceutical
The US Food and Drug Administration has extended the action date by three months for the supplemental New Drug Application (sNDA) for Xeljanz (tofacitinib), an oral treatment under investigation for adult patients with moderately to severely active ulcerative colitis (UC). 13 December 2017
Pharmaceutical
The UK and European Union (EU) have made enough progress to move on to a second phase of Brexit talks focusing on trade, they announced last week. 13 December 2017
Pharmaceutical
German pharma major Bayer is among the four latest companies named and shamed for breaching the Code of Practice of the Association of the British Pharmaceutical Industry (ABPI). 12 December 2017
Pharmaceutical
Privately-held drugmaker Consilient Health has revealed the UK’s health technology assessor NICE has rejected its appeal against July’s negative reimbursement decision for its obesity med Mysimba. 12 December 2017
Pharmaceutical
Drugs that prove to be an effective treatment for migraines could find their way into the hands of as many as 13% of Americans, so it is no surprise that several of pharma’s biggest players are in the race to gain a share of the market. 12 December 2017
Biosimilars
The US Food and Drug Administration has approved Admelog (insulin lispro injection), the first follow-on (ie, a similar) insulin lispro to help people living with diabetes manage blood sugar levels at mealtime. 12 December 2017
Pharmaceutical
The US lobby group Pharmaceutical Research and Manufacturers of America (PhRMA) has initiated litigation in the US District Court for the Eastern District of California challenging SB 17, describing it as ‘an unprecedented and unconstitutional California law.’ 11 December 2017
Pharmaceutical
A survey compiled by US consulting firm the Reputation Institute put Bayer in the top 10 of a list of the world’s most reputable pharma companies. 11 December 2017
Pharmaceutical
The news early Friday morning that Britain and the European Union had finally agreed that enough progress has been made in the Brexit talks for the UK to leave the EU, to move on to more detailed trade agreement discussions, was broadly welcomed by the pharma and biotech industry. 8 December 2017
Pharmaceutical
In a reversal of its earlier draft decision, the UK’s health technology assessor has provided final draft guidance recommending Eisai’s Kisplyx (lenvatinib), in combination with everolimus, as an option for treating kidney cancer. 8 December 2017
Biotechnology
Seven months post-launch, the clear majority of US neurologists (n=103) have initiated at least one patient on Roche (ROG: SIX) subsidiary Genentech's Ocrevus (ocrelizumab), with the brand share being boosted by uptake in both relapsing remitting multiple sclerosis (RRMS) and primary progressive multiple sclerosis (PPMS) patients, new report shows. 8 December 2017
Pharmaceutical
A report from advocacy group AARP - the American Association of Retired Persons - has found that retail prices for 768 prescription drugs commonly used by older adults increased by an average of 6.4% in 2015, despite a low inflation rate of 0.1% for the period. 7 December 2017
Pharmaceutical
The Australian Competition and Consumer Commission (ACCC) has instituted proceedings in the Federal Court of Australia against the local consumer health subsidiaries of GlaxoSmithKline and Novartis, alleging they made false or misleading representations in the marketing of Voltaren Osteo Gel and Voltaren Emulgel pain relief products. 7 December 2017
Pharmaceutical
The UK’s National Institute for Health and Care Excellence (NICE) has today published draft guidance on the following technology appraisals: 7 December 2017
Pharmaceutical
The upward momentum seen in the pharma and biotech sectors during 2017 looks set to continue into 2018, with more novel medicines set to hit the market and investor support for the industry remaining strong. 7 December 2017
Pharmaceutical
Following a positive advisory committee vote in October, the US Food and Drug Administration has now given its formal approval to allow the marketing of Ozempic (semaglutide injection) in the USA. 6 December 2017
Biotechnology
Three months after the US FDA put a partial hold on three clinical trials investigating Opdivo combinations in multiple myeloma, the agency has given Bristol-Myers Squibb and its collaborators the all clear to continue two of the studies. 6 December 2017
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