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
Pharmaceutical
The world’s first fully-automated drug discovery facility is to be built in Oxfordshire, UK. 6 June 2018
Pharmaceutical
British medicines cost-effectiveness watchdog the National Institute for Health and Care Excellence (NICE) has issued draft guidance not recommending Zytiga (abiraterone acetate) plus androgen deprivation therapy (ADT) within its marketing authorization, for men with untreated high-risk hormone-sensitive metastatic prostate cancer (mHSPC). 6 June 2018
Pharmaceutical
British charity Meningitis Now has issued a statement criticising a government report on vaccine cost effectiveness, saying it represents “a significant threat to the future of the UK’s lifesaving meningitis vaccine program.” 6 June 2018
Biotechnology
Even after the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting, the good news on Keytruda (pembrolizumab) keeps coming. 6 June 2018
Biotechnology
The US Food and Drug Administration has accepted the supplemental Biologics License Application (sBLA) and granted Priority Review for Hemlibra (emicizumab-kxwh) for adults and children with hemophilia A without factor VIII inhibitors, an indication that would attract a much wider patient population than currently available. 6 June 2018
Biotechnology
The US Food and Drug Administration has granted approval for a new indication for Eli Lilly’s Alimta (pemetrexed for injection) in combination with carboplatin and Keytruda (pembrolizumab) for the initial treatment of patients with metastatic non-squamous non-small cell lung cancer (NSCLC), irrespective of PD-L1 expression status. 5 June 2018
Biotechnology
The USA’s Institute for Clinical and Economic Review has released an Evidence Report assessing the comparative clinical effectiveness and value of three calcitonin gene-related peptide (CGRP) inhibitors for prevention of migraine attacks. 5 June 2018
Pharmaceutical
The UK’s reimbursement agency is moving to reject Ipsen’s application to provide Cabometyx (cabozantinib) for routine first-line use against renal cell carcinoma (RCC). 5 June 2018
Biosimilars
The US Food and Drug Administration has approved Fulphila (pegfilgrastim-jmbd), a biosimilar to Amgen’s Neulasta (pegfilgrastim). 5 June 2018
Pharmaceutical
The Russian national Parliament (State Duma), together with the government, will suspend introducing a ban on the imports of drugs from the USA and other ‘unfriendly’ Western states by at least the end of the current year, according to recent statements of some senior officials in the Russian government, including the Russian Health Minister Veronika Skvortsova, report The Pharma Letter’s local correspondent. 5 June 2018
Pharmaceutical
The Health Resources and Services Administration (HRSA), a sub-agency of the US Department of Health and Human Services (HHS), is delaying a rule establishing ceiling prices on outpatient drugs under the 340B Drug Pricing Program and fines for violating manufacturers after finding it needs more time to reconsider certain details and that companies need time to adjust, according to a filing in the Federal Register. 4 June 2018
Biotechnology
Early data from two clinical trials show reduced survival with Keytruda (pembrolizumab) and Tecentriq (atezolizumab) when used as first-line treatments for urothelial cancer (cancer of the bladder and urinary tract) in patients with low levels of a protein called PD-L1, the European Medicines Agency stated on Friday. 4 June 2018
Biotechnology
The US Food and Drug Administration has lifted a partial clinical hold placed on CA209-602 (CheckMate-602), a randomized, open-label Phase III study evaluating the addition of Opdivo (nivolumab) to pomalidomide and dexamethasone in patients with relapsed or refractory multiple myeloma (MM). 4 June 2018
Biosimilars
With the high cost associated with branded biologics, the healthcare industry has seen a growing interest in biosimilars. However, significant barriers to accessing alternatives to biologics still exist, writes Dr Nicola Davies in her monthly FDA blog for The Pharma Letter. 4 June 2018
Pharmaceutical
In health care, who should decide value? In many industrialized countries with single-payer health systems, the answer is “the government.” 4 June 2018
Pharmaceutical
Even ahead of the much anticipated ASCO meeting that kicked off on Friday in Chicago, there was positive new data on AstraZeneca’s Imfinzi in lung cancer, which appears to reinforce the company’s hold on a particular segment of the lung cancer market. Also on the drug trials front, a new study demonstrated that Novo Nordisk’s diabetes drug oral semaglutide appeared to be better than Boehringer Ingelheim’s Jardiance in a comparative trial. On the regulatory front, Clovis Oncology finally received approval from the European regulator for its Rubraca in ovarian cancer, while Loxo Oncology gained US Food and Drug Administration priority review for its larotrectinib, which is now partnered with German pharma major Bayer, for the treatment of adult and pediatric patients with locally advanced or metastatic solid tumors harboring an NTRKgene fusion. 3 June 2018
Biotechnology
The news of US approval for Olumiant (baricitinib), while clearly welcomed, was not as good as it could have been for the drug’s developers, Eli Lilly and Incyte, which have already faced long delays, and it came with some caveats. 2 June 2018
Biotechnology
Swiss pharma giant Roche saw its shares close up 2.32% at 215.95 euros on Friday after it announced that its combination treatment for breast cancer had received approval in Europe. 2 June 2018
Biosimilars
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended nine medicines for approval, including two orphan medicines, at its May 28-31, 2018 meeting. 2 June 2018
Pharmaceutical
In an expert view piece, Ronald Wisor and Hein van den Bos — partners at the global law firm Hogan Lovells — discuss the challenges created by Europe's evolving transparency laws. 1 June 2018
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