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
The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) has named David Ricks, the chairman and chief executive of US pharma major Eli Lilly, as its new president. 11 December 2018
Biotechnology
Australia has become the first country anywhere to grant regulatory approval to a cancer drug originally found in a marine microorganism. 11 December 2018
Pharmaceutical
The US regulator has granted approval to reSET-O, a digital therapy intended to increase retention of outpatients being treated for Opioid Use Disorder (OUD). 11 December 2018
Pharmaceutical
From opioids to biosimilars, US Food and Drug Administration (FDA) Commissioner Scott Gottlieb has announced proposals on a huge range of issues across the drug industry since taking over the role 18 months ago. 11 December 2018
Pharmaceutical
Just head of UK Prime Minister Theresa May’s decision was announced to postpone the parliamentary vote on the Brexit withdrawal declaration that was due on Tuesday, the European Federation of Pharmaceutical Industries and Associations (EFPIA) today issued another warning about the implications for the pharma industry. 10 December 2018
Pharmaceutical
The Greek pharmaceutical industry has reached its limits due to a number of “unreasonable” burdens imposed by the government during the crisis, Olympios Papadimitriou, president of the Hellenic Association of Pharmaceutical Companies (SFEE) and general manager of Novo Nordisk in Greece, told EURACTIV.com in an interview that is posted on the trade group’s website. 10 December 2018
Pharmaceutical
The UK government has provided an update on its contingency planning surrounding the possibility of a so-called “no deal” Brexit, including measures affecting pharmaceuticals. 7 December 2018
Pharmaceutical
The US Food and Drug Administration has issued a statement detailing a new strategic framework to promote the use of real-world evidence (RWE) and real-world data (RWD) in the drug development process. 7 December 2018
Biotechnology
Following its acceptance in the UK’s Cancer Drug Fund in October, the medicines cost-effectiveness watchdog has now agreed to the regular NHS England funding of Yescarta (axicabtagene ciloleucel). 7 December 2018
Biotechnology
Johnson & Johnson subsidiary Actelion has agreed to pay $360 million to resolve claims that it illegally used a foundation as a conduit to pay the co-pays of thousands of Medicare patients taking Actelion’s pulmonary arterial hypertension drugs, in violation of the False Claims Act, the US Department of Justice announced yesterday. 7 December 2018
Pharmaceutical
Roche has been granted US Food and Drug Administration approval for a combination of Tecentriq (atezolizumab) and Avastin (bevacizumab), plus chemo, for first-line treatment of metastatic non-squamous non-small cell lung cancer (NSCLC). 7 December 2018
Pharmaceutical
The well-documented case of Medicaid being overcharged over EpiPen (epinephrine), the emergency allergy treatment from Mylan, has led two Senators to propose a bipartisan bill. 5 December 2018
Pharmaceutical
Drug-making is sometimes pictured as one of the last surviving “traditional” industries, successfully resisting waves of change that have overtaken other businesses. 5 December 2018
Pharmaceutical
Today the UK government has published the second Life Sciences Sector Deal, the extension of a previous set of deals announced alongside the UK’s Industrial Strategy in November 2017. 5 December 2018
Biotechnology
The US Food and Drug Administration has accepted the supplemental Biologics License Application (sBLA) and granted Priority Review for Tecentriq (atezolizumab), in combination with carboplatin and etoposide (chemotherapy), for the initial (first-line) treatment of people with extensive-stage small cell lung cancer (ES-SCLC). 5 December 2018
Pharmaceutical
Approval by the US Food and Drug Administration of a highly potent opioid has garnered national attention and criticism from physicians, politicians, and others concerned about the increasing numbers of Americans dying from opioid overdoses, notes Dr Nicola Davies in her latest exclusive blog for The Pharma Letter. 5 December 2018
Biotechnology
Gilead Sciences has received approval from China’s National Medical Products Administration (NMPA) for Harvoni (ledipasvir 90mg/sofosbuvir 400mg) for the treatment of chronic hepatitis C virus (HCV) genotype 1-6 infection in adults and adolescents aged 12 to 18 years. 5 December 2018
Pharmaceutical
The worth of extended-release treatments for opioid use disorder has been questioned in analysis from the Institute for Clinical and Economic Review (ICER). 4 December 2018
Generics
The US Food and Drug Administration (FDA) has published final guidance for the generics industry on post-complete response letter (CRL) meetings. 4 December 2018
Pharmaceutical
Many European Union and US pharma companies are unaware that if a no-deal Brexit is reached between the UK and the EU, they will need to meet a crucial EU export administration deadline by March 29, 2019, a regulatory expert has confirmed. 4 December 2018
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
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
Pharmaceutical
Lexicon Pharmaceuticals has announced a major strategic shift, prioritizing its late-stage pipeline following a rejection by the US Food and Drug Administration (FDA). 25 November 2024
Biotechnology
The US Food and Drug Administration (FDA) on Friday approved Attruby (acoramidis), an orally-administered near-complete (≥90%) stabilizer of Transthyretin (TTR) for the treatment of adults with ATTR-CM to reduce cardiovascular death and cardiovascular-related hospitalization. 25 November 2024
Pharmaceutical
Efforts to combat antimicrobial resistance (AMR) are gaining momentum in Europe, with the introduction of innovative measures to drive the development of new antimicrobials. 25 November 2024
Biotechnology
Research news last week included US biotech releasing early data for its FT819 in the treatment of systemic lupus erythematosus (SLE), which sent the firm’s shares leaping as much as 70%. Also, Netherlands-based NewAmsterdam Pharma announced positive data on its obicetrapib and ezetimibe combination in cardiovascular disease. On the regulatory front, Dutch firm argenX and China’s Zai Lab gained approval from the Chinese medicines regulator for their Vyvgart Hytrulo in chronic inflammatory demyelinating polyneuropathy (CIDP) care. Meantime, USA-based Kura Oncology signed a collaboration with Japan’s Kyowa Kirin on the development of ziftomenib for myeloid leukemia (ALS). 24 November 2024
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