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 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
Pharmaceutical
On Thursday, the US Department of Health and Human Services (HHS) announced that approximately $2.34 billion in Ryan White HIV/AIDS Program grants were awarded to cities, counties, states, and local community-based organizations in fiscal year 2018. 12 October 2018
Pharmaceutical
For a very long time executives visiting or living in Japan agonized over what they perceived as resistance to change and a drawn out, time consuming decision-making process, writes long-time Japan pharma watcher and president of International Alliances Limited P Reed Maurer in his exclusive column for The Pharma Letter. 11 October 2018
Biotechnology
The firm that calls itself the leading oncology company in Japan strengthened its position on Wednesday with the approval of its breast cancer drug in a new indication in the Asian country. 11 October 2018
Pharmaceutical
The Scottish government has launched a new “ultra-orphan” designation for medicines in development for certain severe rare diseases for which there is a high level of unmet need. 11 October 2018
Biotechnology
The US Food and Drug Administration has lifted the clinical hold placed in May this year and accepted the Investigational New Drug application (IND) for CTX001 for the treatment of sickle cell disease (SCD). 11 October 2018
Pharmaceutical
US President Donald Trump has signed legislation preventing so-called ‘gag clauses,’ used for years by pharmacy benefit managers to restrict access to cheaper off-plan options. 11 October 2018
Pharmaceutical
Mike Thompson, chief executive of the Association of the British Pharmaceutical Industry (ABPI), which represents the branded pharmaceutical industry in the UK, yesterday appeared in front of the DExEU Commons Select Committee, where he pointed out: 11 October 2018
Biotechnology
France’s Valneva has won US FDA approval for an accelerated dosing regimen of its Japanese encephalitis (JE) vaccine, Ixiaro. 11 October 2018
Generics
US Food and Drug Administration (FDA) Commissioner Scott Gottlieb has championed the cause of generics since starting in the role nearly 18 months ago. 10 October 2018
Pharmaceutical
Swedish startup Lobsor has won its first approval for Lecigon (levodopa/carbidopa/entacapone), a new therapeutic system for symptomatic treatment of advanced Parkinson’s disease, a decision which could shake up a market dominated by AbbVie. 10 October 2018
Pharmaceutical
The market value of US biopharma Trevena is worth just a third of its worth at Monday’s close after a US Food and Drug Administration (FDA) report raised concerns with its opioid injection to treat acute pain. 10 October 2018
Pharmaceutical
The European Medicines Agency’s (EMA) Brexit preparedness business continuity plan (BCP) entered into its third phase on October 1, 2018, as announced at the beginning of August 2018. 10 October 2018
Biotechnology
The National Institute for Health and Care Excellence (NICE) has issued final guidance recommending Crysvita (burosumab) within its marketing authorization, for treating X-linked hypophosphatemia (XLH) in children and young people with growing bones in England and Wales. 10 October 2018
Pharmaceutical
The Russian government plans to provide access to imported drugs that have not undergone clinical trials within Russia, according to recent statements by some senior officials of the Russian Ministry of Health. 10 October 2018
Pharmaceutical
A leading British clinical research organization (CRO), Richmond Pharmacology, has published a detailed report criticizing current UK immigration policy and supporting proposals to install a skills-based migration system after Brexit. 9 October 2018
Pharmaceutical
During the third quarter, pharmaceutical pricing dynamics remained under scrutiny. Specifically, regulators have highlighted the elimination of rebates as a way to protect consumers since patients' out-of-pocket expenses are influenced by the list, rather than net, price of each therapy. 9 October 2018
Pharmaceutical
A final report from the Institute for Clinical and Economic Review (ICER) finds that the pricing of new therapies for the treatment of hereditary transthyretin amyloidosis (hATTR) “far exceeds commonly cited thresholds for cost effectiveness.” 8 October 2018
Pharmaceutical
Over the past 24 months, the Latin American cannabis industry has emerged from the shadows to command the attention of the international cannabis community as over ten major markets have legalized medical cannabis. 8 October 2018
Biotechnology
Shares of US biotech firm Akcea Therapeutics gained 4.39% to $31.85 by close of trading and a further 2.04% to $32.50 in after-hours on Friday, after the company revealed that the US Food and Drug Administration had approved Tegsedi (inotersen) for the treatment of the polyneuropathy of hereditary transthyretin (hATTR) amyloidosis in adults. 8 October 2018
Pharmaceutical
The US Food and Drug Administration (FDA) has accepted for filing with priority review the New Drug Application (NDA) seeking accelerated approval for Karyopharm Therapeutics’ selinexor. 8 October 2018
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