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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Pharmaceutical
There were again a number of important financial results reports in the past week, with three – Pfizer, Shire and Teva Pharmaceutical Industries – attracting most external comments. Clovis Oncology’s deal with Bristol-Myers Squibb on its cancer drug Rubraca had a negative impact on the former’s, share price and - for a change in recent times – there was good news for AstraZeneca with regard to its cancer drug Imfinzi. 7 August 2017
Generics
The Indian government is looking to review the existing drug price control measures in order to make medicines more affordable in the country, and at increasing the number of clinical trials taking place in the country, reports The Pharma Letter’s India correspondent. 5 August 2017
Pharmaceutical
The Prescription Drug User Fee Act (PDUFA) has passed its final congressional hurdle, with approval in the US Senate coming three weeks after the House of Representatives greenlit the quinquennial reauthorization bill. 4 August 2017
Biotechnology
The US Food and Drug Administration (FDA) has granted Priority Review to a supplemental New Drug Application (sNDA) for Alecensa (alectinib) (first-line) as a treatment for people with anaplastic lymphoma kinase (ALK)-positive, locally advanced or metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test. 4 August 2017
Biotechnology
AbbVie has received approval from the US Food and Drug Administration to market Mavyret (glecaprevir and pibrentasvir) as a treatment for chronic hepatitis C (HCV). 4 August 2017
Pharmaceutical
The National Institute for Health and Care Excellence (NICE), the cost-effectiveness watchdog for England and Wales, has issued draft guidance recommending Skilarence (dimethyl fumarate). 4 August 2017
Biotechnology
Just as things were looking up for Dynavax Technologies and its hepatitis B drug candidate, US regulators have thrown a spanner in the works, causing the firm’s share to plunge 9.74% to $15.34 in after-hours trading on Thursday. 4 August 2017
Pharmaceutical
The US Food and Drug Administration has approved Vyxeos (daunorubicin and cytarabine) liposome for injection for the treatment of adults with two types of acute myeloid leukemia (AML), a rapidly progressing and life-threatening blood cancer. 4 August 2017
Pharmaceutical
A package of new and updated guidance on licensing and certification processes for manufacturers of medicines and biologicals in Australia, has been developed in consultation with the Therapeutic Goods Administration (TGA) Industry Working Group on GMP (TIWGG), to better support manufacturers and sponsors and provide additional clarity for applicants. 4 August 2017
Biotechnology
Today, UK medicines cost-effectiveness watchdog the National Institute for Health and Care Excellence (NICE) has recommended the use of nab-paclitaxel in combination with gemcitabine, in eligible patients, for the first-line treatment of a type of metastatic pancreatic cancer, known as metastatic pancreatic ductal adenocarcinoma (mPDAC). 4 August 2017
Biotechnology
After questioning whether it has the power or duty to commission Pre-Exposure Prophylaxis (PrEP) for HIV, lost a court case along the way and found itself at the center of a long-running controversy, NHS England is to finally start giving people the drug. 3 August 2017
Generics
The Cabinet Committee on Economic Affairs of India (CCEA) has decided to block Shanghai Fosun Pharmaceutical’s 8.5 billion yuan ($1.3 billion) takeover of the Indian drugmaker Gland Pharma, according to reports. 3 August 2017
Biotechnology
The US Food and Drug Administration (FDA) has expanded the approval of Imbruvica (ibrutinib) for the treatment of adult patients with chronic graft versus host disease (cGVHD) after failure of one or more treatments. 3 August 2017
Pharmaceutical
CVS Caremark has released its 2018 formulary, revealing 17 drugs will be removed from the list next year, including Merck & Co’s Zetia, Daiichi Sankyo’s Benicar and Teva Pharmaceutical’s Nuvigil. 3 August 2017
Biotechnology
Puma Biotechnology saw its shares dip 1.4% to $87.95 in after-hours trading on Wednesday, after the US company revealed a delay in approval of its breast cancer drug neratinib. 3 August 2017
Biotechnology
UK medicines cost-effectiveness watchdog the NICE has today published draft guidance which does not recommend French molecular nuclear medicine specialist Advanced Accelerator Applications’ Lu-177 dotatate (trade name Lutathera) for treating neuroendocrine tumors of gastrointestinal and pancreatic origin. 3 August 2017
Pharmaceutical
Express Scripts, the USA’s largest pharmaceutical benefits manager (PBM), has published its National Preferred Formulary (NPF) for 2018. 2 August 2017
Biotechnology
Swift work from US biotech Celgene, cancer metabolism specialist Agios Pharmaceuticals and the US Food and Drug Administration (FDA) has led to the approval of a new targeted treatment for relapsed or refractory (R/R) acute myeloid leukemia (AML) in the USA. 2 August 2017
Biotechnology
The UK’s health technology assessor has issued draft guidance not recommending Roche’s immunotherapy Tecentriq (atezolizumab) as a treatment for advanced urothelial cancer. 2 August 2017
Pharmaceutical
The application procedure to host the two UK-based European Union agencies, the European Medicines Agency (EMA) and the European Banking Authority (EBA), came to a close at midnight on July 31, 2017, the European Commission announced yesterday, thus firing the starting gun for bids from various European cities to become the location for these important regulatory agencies. Some 19 cities have posted formal bids to host the EMA post Brexit. 2 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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