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
The US Food and Drug Administration yesterday approved Vitrakvi (larotrectinib), the first ever oral TRK inhibitor, for solid tumors 27 November 2018
Pharmaceutical
A research note from industry analyst GlobalData concludes that India’s new national insurance scheme Ayushman Bharat has potential to be a “game changer,” while warning that there are “policy issues which need to be addressed by the government to make it sustainable for all the stakeholders.” 27 November 2018
Biosimilars
The NHS is set to save a record £300 million ($384 million) after negotiating deals with five manufacturers on low cost versions of the health service’s most costly drug, NHS England chief executive Simon Stevens announced today. 27 November 2018
Pharmaceutical
New rules proposed by the administration of US President Donald Trump would see insurers participating in the government-backed Medicare scheme permitted to exclude pharmaceuticals if price rises outpaced inflation. 27 November 2018
Biotechnology
US biotech suffered another setback in drug development yesterday, as the US regulator put a clinical hold on its investigational drug ZGN-1061. 27 November 2018
Pharmaceutical
A new Expert Consensus Decision Pathway issued by the American College of Cardiology (ACC) recommends Jardiance (empagliflozin) as the preferred SGLT2 inhibitor for its proven benefit in reducing the risk of cardiovascular death in adults with type 2 diabetes and established cardiovascular disease. 27 November 2018
Pharmaceutical
Forty-five years ago, Japan eliminated strict limits on the percentage ownership permitted for foreign pharma companies in Japan. The path was cleared for 100% ownership of a Japan entity, writes long-time Japan pharma watcher and president of International Alliances Limited P Reed Maurer in his exclusive column for The Pharma Letter. 26 November 2018
Biotechnology
The European Commission has granted a marketing authorization to Poteligeo (mogamulizumab), a humanized monoclonal antibody (MAb) directed against CC chemokine receptor 4 (CCR4), for the treatment of adult patients with mycosis fungoides (MF) or Sézary syndrome (SS) who have received at least one prior systemic therapy. 26 November 2018
Pharmaceutical
Australia’s medicines regulator, the Therapeutic Goods Administration (TGA), says that mandatory reporting of medicines shortages in Australia will commence on January 1, 2019. These changes will facilitate more proactive, timely and transparent management and communication about medicine shortages for the benefit of Australian consumers and health professionals. 26 November 2018
Biotechnology
The European Court of Justice will not stand in the way of Roche’s cancer drug Avastin (bevacizumab) being prescribed for an unlicensed indication. 23 November 2018
Biosimilars
The Mundipharma network of independent associated companies today announced that the European Commission (EC) has granted approval for the use of Pelmeg (pegfilgrastim). 23 November 2018
Pharmaceutical
Europe’s leading pharma trade body, the European Federation of Pharmaceutical Industries and Associations (EFPIA), has endorsed the Brexit transitional deal proposed by the UK and European Union. 23 November 2018
Pharmaceutical
At a time when the sector is engulfed in Brexit uncertainty, some rare good news has been announced for drugmakers and patients in the UK. 23 November 2018
Pharmaceutical
Indonesia's National Agency for Drug and Food Control (BPOM) held the First Meeting of the Heads of National Medicines Regulatory Authorities (NMRAs) from the Organization of Islamic Cooperation (OIC) member states in Jakarta, on November 21-22. 23 November 2018
Biotechnology
Switzerland-based Novartis has won European approval for the one-time gene therapy Luxturna (voretigene neparvovec). The treatment was approved in the USA in late December 2017. 23 November 2018
Biotechnology
The UK government-backed Cell and Gene Therapy Catapult (CGT Catapult) has launched a new apprenticeship program aimed at supporting the development of Advanced Therapy Medicinal Products (ATMP). 23 November 2018
Pharmaceutical
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended fexinidazole, the first all-oral treatment for sleeping sickness. 22 November 2018
Biotechnology
Venclexta (venetoclax) has been approved in the USA in a further form of blood cancer. 22 November 2018
Pharmaceutical
A sub-committee in the UK House of Lords has written to the Health Secretary requesting information on what plans are in place to ensure continued access to medicines in the event of a so-called “no deal” Brexit. 22 November 2018
Generics
Mylan closed 1.5% down on Wednesday as the drugmaker sought to explain an issue that has disrupted supply of some of its products. 22 November 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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