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
Hours after US pharma giant Pfizer announced the news of regulatory approval for its drug Besponsa (inotuzumab ozogamicin) in the USA, the company suffered a setback with its attempts to sell the drug in the UK. 18 August 2017
Biotechnology
In timely fashion, US pharma giant Pfizer has received US Food and Drug Administration (FDA) approval for Besponsa (inotuzumab ozogamicin) for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). 18 August 2017
Biotechnology
US biotech Amicus Therapeutics says the Australian Therapeutic Goods Administration (TGA) has approved its Galafold (migalastat) for long-term treatment of adults and adolescents aged 16 years and older with a confirmed diagnosis of Fabry disease (alpha-galactosidase A deficiency) and who have an amenable mutation. 18 August 2017
Pharmaceutical
On the morning of August 16,2017, Wu Zhen, vice minister of the China Food and Drug Administration (CFDA), met with visiting Dr Ian Hudson, the chief executive of the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA), and his delegation. 18 August 2017
Pharmaceutical
New Zealand’s Pharmaceutical Management Agency PHARMAC today announced the approval of a proposal to fund pemetrexed for the treatment of mesothelioma and non-small cell lung cancer (NSCLC) in conjunction with the awarding of pemetrexed tender bids as part of PHARMAC’s 2015/16 annual Invitation to Tender. 18 August 2017
Biosimilars
Harriet Lewis, medicines optimization lead for UK trade group the Association of the British Pharmaceutical Industry (ABPI), looks at the impact of biosimilar competition and what comes next, in an Expert View piece. 17 August 2017
Pharmaceutical
The genomics-based drug discovery company Exelixis has submitted for regulatory approval to market Cabometyx in a new indication in the USA. 17 August 2017
Generics
Canada’s Valeant Pharmaceuticals International says the US Food and Drug Administration confirmed it intends to issue a Voluntary Action Indicated (VAI) inspection classification for its Bausch + Lomb manufacturing facility in Tampa, Florida, as part of a forthcoming Establishment Inspection Record for the facility. 17 August 2017
Pharmaceutical
A new coagulation reversal agen, Praxbind (idarucizumab) from German family-owned pharmaceutical company Boehringer Ingelheim, is now being used in Brazil, following marketing clearance earlier this year. 17 August 2017
Biosimilars
Biocon, an Indian drugmaker that together with Netherlands-headquartered Mylan is a frontrunner in the race to take big-selling biosimilars to major markets, has suffered a damaging blow affecting two of its oncology submissions in Europe. 16 August 2017
Generics
Privately-held USA-headquartered generics manufacturer Amneal Pharmaceuticals is voluntarily recalling 13 lots of lorazepam oral concentrate, USP 2mg/mL, to the consumer level due to a defect in the dropper markings, the US Food and Drug Administration announced today. 16 August 2017
Pharmaceutical
US trade group Pharmaceutical Research and Manufacturers of America (PhRMA) has responded to yesterday’s release of a study published in JAMA, questioning the US Food and Drug Administration’s Accelerated Approval pathway. 16 August 2017
Pharmaceutical
Questions about the US Food and Drug Administration’s Accelerated Approval pathway are revealed today (August 15) in a study published in the Journal of the American Medical Association (JAMA). 15 August 2017
Pharmaceutical
It seems the pharmaceutical industry cannot escape the spotlight under the presidency of Donald Trump, with the actions of a senior executive making Tuesday’s front pages. 15 August 2017
Biotechnology
Ireland-headquartered rare diseases specialist Shire has submitted lifitegrast for regulatory approval in Europe, the company says. 15 August 2017
Pharmaceutical
As part of the Australian Therapeutic Goods Administration’s (TGA) ongoing efforts to improve its processes and guidance to industry, the regulator said today it will be publishing an updated revision of the Good Manufacturing Practices (GMP) clearance guidance document shortly. 15 August 2017
Biotechnology
With the news that the US Food and Drug Administration has lifted the clinical hold it imposed on CEL-SCI (NYSE: CVM), the company’s 35-year quest for a marketable product has moved one step closer to its goal. 14 August 2017
Biotechnology
German drug developer Paion has provided a clinical and commercial update of its activities, indicating that lead candidate remimazolam will now likely be filed for regulatory approval in the USA in the second half of next year, later than had previously been expected. 14 August 2017
Biotechnology
The Institute for Clinical and Economic Review (ICER) will develop a report assessing the comparative clinical effectiveness and value of emicizumab, from Swiss pharma giant Roche. 14 August 2017
Pharmaceutical
How the USA views the UK’s state reimbursement came up for comment last week, following the recent approval by the National Institute for Health and Care Excellence (NICE) of Eli Lilly’s cancer drug Lartruvo. Also attracting attention were MyoKardia’s heart drug mavacamten, Valeant Pharmaceutical International not getting US approval for its eye drug candidate latanoprostene bunod, and Demira’s acquisition of Roche cast-off lebrikizumab, a dermatology candidate. 13 August 2017
Biotechnology
AstraZeneca and Daiichi Sankyo’s breast cancer med Enhertu (trastuzumab deruxtecan) will be included in China’s state-run health insurance scheme from next year, boosting availability at the cost of reduced pricing. 29 November 2024
Biotechnology
China’s Innovent Biologics has announced that the updated 2024 National Reimbursement Drug List (NRDL) now includes Sintbilo (tafolecimab) injection, an anti-PCSK9 monoclonal antibody for the first time. The updated NRDL will be officially effective from January 1, 2025. 29 November 2024
Pharmaceutical
The Danish Ministry of Interior and Health has announced that the political parties have decided to permanently legalize treatment with medical cannabis in Denmark. 29 November 2024
Pharmaceutical
Industry is showing a very high level of readiness for upcoming new packaging and labelling measures impacting the UK market, according to the Medicines and Healthcare products Regulatory Agency (MHRA). 29 November 2024
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 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
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