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
Politicians and bureaucrats in London and Brussels might be squabbling over the terms of Brexit, but the borderless nature of science and health imperatives are remaining resilient to such squabbles, a funding award shows. 2 August 2017
Biotechnology
Following yesterday’s news that the US Food and Drug Administration had granted breakthrough status to acalabrutinib, London-listed AstraZeneca has announced the drug has also been accepted for priority review by the American regulator. 2 August 2017
Biotechnology
Realm Therapeutics has submitted for approval to launch a Phase II trial for PR013, a candidate treatment for allergic conjunctivitis, in the USA. 2 August 2017
Biotechnology
Safety will be a major topic when the merits or otherwise of sirukumab injection, a drug from US healthcare giant Johnson & Johnson’s Janssen Biotech unit, is discussed by the US Food and Drug Administration’s (FDA) Arthritis Advisory Committee (AAC) on Wednesday. 1 August 2017
Biotechnology
Bristol-Myers Squibb has received approval from the US Food and Drug Administration for Opdivo in a new indication. 1 August 2017
Pharmaceutical
The enforcement of a much more stringent pricing revision policy in Japan, both for new products as well as off-patent brands, is behind the decline of the products currently on the market which are forecast to drop about 2% annually in sales through 2022, a new report shows. 1 August 2017
Biosimilars
Following news last month that a US Food and Drug Administration (FDA) advisory panel had given its backing to a biosimilar version of Swiss pharma giant Roche’s big-selling cancer drug Herceptin (trastuzumab), a separate copycat version has moved closer to market. 1 August 2017
Biotechnology
For the second time in two days, Anglo-Swedish pharma company AstraZeneca announced that the US Food and Drug Administration (FDA) had given Breakthrough Therapy Designation to one of its oncology medicines. 1 August 2017
Biotechnology
US cancer drug developer Kite Pharma has become the first company to submit a Marketing Authorization Application (MAA) for a chimeric antigen receptor (CAR) T-cell therapy to the European Medicines Agency (EMA). 1 August 2017
Pharmaceutical
In late June this year, the US Food and Drug Administration’s Commissioner Scott Gottlieb, issued a statement on the Drug Quality and Security Act (DQSA). The FDA’s commitment to upholding and following through on moves to protect the public from poorly compounded drugs shows that the Administration means business. 1 August 2017
Biosimilars
MSD, the non-North America operating name of US pharma giant Merck & Co, has announced the availability of biosimilar Renflexis (infliximab) on the Australian Pharmaceutical Benefits Scheme (PBS) from August 1. 1 August 2017
Pharmaceutical
The US Food and Drug Administration has accepted with a Priority Review designation the New Drug Application (NDA) for RBP-6000. 1 August 2017
Pharmaceutical
The disconnect between the UK government’s target to make the country a world leader in the life sciences, and its failure to provide patients with the drugs that result from this science, has been underlined by a new report. 31 July 2017
Biotechnology
US biotech firm Spark Therapeutics has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for Luxturna, the proposed trade name for voretigene neparvovec, an investigational, one-time gene therapy for patients with vision loss due to Leber congenital amaurosis or retinitis pigmentosa caused by confirmed biallelic RPE65 mutations. 31 July 2017
Biotechnology
Privately-held Italian biopharma company Dompé today revealed that the European Commission has granted a marketing authorization for Oxervate (cenegermin eye drops) for the treatment of moderate to severe neurotrophic keratitis. 31 July 2017
Biotechnology
Whether the 16% hit that AstraZeneca’s share price took last week on the setback in its Mystic lung cancer trial was a market over-reaction or not, the damage will be hard to repair. 31 July 2017
Pharmaceutical
The Irish Pharmaceutical Healthcare Association (IPHA) has welcomed the statement by the Health Service Executive (HSE) confirming that it will fund nine delayed medicines for prescribing to patients, but lambasts a “dysfunctional process.” 31 July 2017
Generics
In testimony presented to the U.S. House of Representatives’ Judiciary Committee Subcommittee on Regulatory Reform, Commerical and Antitrust Law, the USA’s Federal Trade Commission described its efforts to stop anticompetitive conduct in the pharmaceutical industry. 31 July 2017
Biotechnology
Shares in Japan’s Kyowa Hakko Kirin are up nearly 4% following news that the company will proceed next month with its planned US regulatory submission for burosumab, a monoclonal antibody developed with Californian firm Ultragenyx Pharmaceutical. 31 July 2017
Biotechnology
Australia’s Health Ministry says that Bristol-Myers Squibb’s Opdivo (nivolumab), a revolutionary new medicine for lung and renal cancer, has been listed on the Pharmaceutical Benefits Scheme (PBS). 31 July 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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