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
Over the past 20 years, more than 700 New Active Substances (NASs) - new small and large molecular entities - have been successfully discovered, developed and authorized by regulatory bodies for use with patients. 7 February 2017
Pharmaceutical
Our most detailed article yet on what we know, and do not yet know, about how the new US President could affect pharma. 6 February 2017
Pharmaceutical
Express Scripts, the USA’s largest pharmacy benefits management firm, has put the blame for rising prices of medicines in the USA at the door of drugmakers. 6 February 2017
Pharmaceutical
Australian Minister for Health Greg Hunt has said that his government’s backing of the country’s researchers and scientists will help them to make the next major medical breakthrough. 6 February 2017
Biotechnology
Belgian drug developer Ablynx was up by 1.5% at 12.20 euros as Monday’s trading neared its end after announcing news on caplacizumab, its anti-von Willebrand factor (vWF) nanobody for acquired thrombotic thrombocytopenic purpura (aTTP). 6 February 2017
Pharmaceutical
Taiwan-based Foresee Pharmaceuticals has announced progress in filing for European approval for its investigational prostate cancer drug. 6 February 2017
Pharmaceutical
The Food and Drug Administration has issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for CL-108 (hydrocodone, acetaminophen, promethazine). 6 February 2017
Biotechnology
Intarcia Therapeutics says the US Food and Drug Administration has accepted for active review its New Drug Application (NDA) for ITCA 650 (exenatide), an investigational therapy for the treatment of type 2 diabetes (T2D). 6 February 2017
Pharmaceutical
As the US President Donald Trump rally fades away, such anxiety weighs heavy on investors’ minds. But underperforming drug company Pfizer may yet profit from the President’s contradictions, wrote Financial Times Lex writer Christopher Thompson. 5 February 2017
Biotechnology
The US Food and Drug Administration has approved multi-billion dollar selling immuno-oncology treatment Opdivo (nivolumab) for use against urothelial carcinoma, the most common kind of bladder cancer. 3 February 2017
Pharmaceutical
Drug prices in Russia may increase by 20%-25% this year, due to the implementation of the latest state initiative for the introduction of mandatory QR-labelling on drugs in the local market. 3 February 2017
Pharmaceutical
The National Institute for Health and Care Excellence (NICE) has today published draft guidance which does not recommend breast cancer drug Ibrance (palbociclib) for routine funding on the NHS. 3 February 2017
Generics
Teva Pharmaceutical Industries says that it is seeking approval to market the generic version of Victoza (liraglutide) injection, in the USA. 2 February 2017
Pharmaceutical
US drugmaker MannKind Corp today announced the launch of a new titration pack containing 60 – 4 unit cartridges, 60 – 8 unit cartridges and 60 – 12 unit cartridges of Afrezza (insulin human) inhalation powder. 1 February 2017
Biotechnology
How new US President Donald Trump’s meeting with pharma bosses went on Tuesday was always going to be a matter of interpretation, with the industry, the new administration and its critics all likely to put their own spin on the discussions. 1 February 2017
Biotechnology
French pharma major Sanofi and US biotech firm Regeneron Pharmaceuticals have received marketing authorization in Canada for Kevzara (sarilumab). 1 February 2017
Pharmaceutical
From Wednesday, Australians have subsidized access to new drugs for ovarian and lung cancer which will reduce the price they pay by nearly 100%. 1 February 2017
Pharmaceutical
The European Commission has approved Keytruda (pembrolizumab) for the first-line treatment of metastatic non-small cell lung cancer (NSCLC) in adults whose tumors have high PD-L1 expression (tumor proportion score [TPS] of 50% or more) with no EGFR or ALK positive tumor mutations. 1 February 2017
Generics
Mylan might have had some share-boosting news with a court victory over a rival on Tuesday, but the shadow of a Federal Trade Commission (FTC) investigation continues to hang over the Netherlands-incorporated company. 31 January 2017
Pharmaceutical
Stephen Ubl, president and chief executive of Pharmaceutical Research and Manufacturers of America (PhRMA), is meeting with President Donald Trump on Tuesday morning. 31 January 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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